Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016


Version Date: 06 Jan 2025

Listing of Current Sections Search for ** Double Asterix to see Updated Documents

SectionDocuments relatedProcesses Direct Links

4 Quality management system

4.1
Quality management system		Top Level Document: QMS Route Map Viamed Ltd ISO13485_2016
Revision Document ID169314
**Date Revision 02 Dec 2024 Reviewed 02 Dec 2024
Top Level Document: Viamed ISO 13485:2016 Scope
Revision Document ID168096
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
Top Level Document: VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Revision Document ID164833
Date Revision 14 Oct 2024 Reviewed 04 Nov 2024
Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
BS EN ISO 13485-2016
Revision Document ID19400
Date Revision 27 Mar 2017 Reviewed 27 Mar 2017
BS5750 Viamed
Revision Document ID21353
Date Revision 10 Aug 2017 Reviewed 10 Aug 2017
Chart 40 Management review plan Issues followup
Revision Document ID22458
Date Revision 05 Oct 2017 Reviewed 05 Oct 2017
Chart 42 Processes, Tasks and Audits Review
Revision Document ID23559
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Chart 43 Processes and Intrastats
Revision Document ID23561
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Intrastats overview
Revision Document ID23567
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Issues Overview
Revision Document ID23112
Date Revision 22 Oct 2017 Reviewed 22 Oct 2017
Document Index Overview
Revision Document ID8047
Date Revision 17 Mar 2011 Reviewed 17 Mar 2011
VM3COP00.01 Company objectives
Revision Document ID22842
Date Revision 17 Oct 2017 Reviewed 17 Oct 2017
Need Risks and Expectations of External Parties Viamed
Revision Document ID165559
Date Revision 21 Oct 2024 Reviewed 21 Oct 2024
Viamed Certification ISO 13485:2016 MD78787
Revision Document ID117540
Date Revision 27 Apr 2023 Reviewed 24 Jan 2024
Process: 8057
Emergency Services Show 29 Dec 2023
4.1.1
The organization shall document a quality management system and maintain its effectiveness in
accordance with the requirements of this International Standard and applicable regulatory requirements.
The organization shall establish, implement and maintain any requirement, procedure, activity or
arrangement required to be documented by this International Standard or applicable regulatory
requirements.
The organization shall document the role(s) undertaken by the organization under the applicable
regulatory requirements.
NOTE Roles undertaken by the organization can include manufacturer, authorized representative, importer
or distributor.		Top Level Document: Viamed ISO 13485:2016 Scope
Revision Document ID168096
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 41
Responsibility Allocation : Documentation Control 16 Feb 2016
Process: 9
Distribution Of Faxes 16 Feb 2016
Process: 10
Distribution Of Emails 16 Feb 2016
Process: 8025
Check We Do Not Require A EU European Representatives 09 Mar 2023
4.1.2
The organization shall:
a) determine the processes needed for the quality management system and the application of
these processes throughout the organization taking into account the roles undertaken by the
organization;
b) apply a risk based approach to the control of the appropriate processes needed for the quality
management system;
c) determine the sequence and interaction of these processes.		Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Top Level Document: VOP 21 Risk, Risk Management and Risk Analysis
Revision Document ID75935
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Chart 00 System Model
Revision Document ID8674
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 01 System and Documentation
Revision Document ID8675
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 02 Resource Management
Revision Document ID8676
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 03 Customer Requirements
Revision Document ID8677
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 04 Design and Development
Revision Document ID8678
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 05 Product Realisation
Revision Document ID8679
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 06 General Process Control
Revision Document ID8680
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 07 Measurement and Analysis
Revision Document ID8681
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 08 Correction and Prevention
Revision Document ID8682
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 09 Management System
Revision Document ID8683
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 10 Documentation
Revision Document ID8684
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 11 Provision of Resources
Revision Document ID8685
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 12 Infrastructure and Environment
Revision Document ID8686
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 13 Sales Orders
Revision Document ID8687
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 15 Purchasing
Revision Document ID8688
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 16 Internal Audits
Revision Document ID8689
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 17 Design Repairs
Revision Document ID8690
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 18 Calibration
Revision Document ID8691
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 19 HSE Risk Assesments
Revision Document ID8692
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 20 Production
Revision Document ID8693
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 21 Repairs
Revision Document ID8694
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 22 Stock Control
Revision Document ID8695
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 23 Picking and Packing
Revision Document ID8696
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 24 Goods Inwards
Revision Document ID8697
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 25 Inspection and Test
Revision Document ID8698
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 26 Data Analysis
Revision Document ID8699
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 27 Customer Complaints Chart 27
Revision Document ID8700
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 28 Quarantine and Hold
Revision Document ID8701
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 29 Sales Acquisition
Revision Document ID8702
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 30 System Design Plan
Revision Document ID8703
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 31 Chart Interfaces
Revision Document ID8704
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 32 Generic Sales Process
Revision Document ID8705
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 33 Launch of a new product
Revision Document ID8706
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 34 Process Teams Org Chart
Revision Document ID8707
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
4.1.3
For each quality management system process, the organization shall:
a) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective;
b) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes;
c) implement actions necessary to achieve planned results and maintain the effectiveness of these
processes;
d) monitor, measure as appropriate, and analyse these processes;
e) establish and maintain records needed to demonstrate conformance to this International Standard
and compliance with applicable regulatory requirements (see 4.2.5).		Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
VM3COP27.01 Searching Intrastats Issues
Revision Document ID6657
Date Revision 02 Nov 2009 Reviewed 02 Nov 2009
VM3COP27.17 Complete Auto_calender Issues
Revision Document ID16995
Date Revision 26 May 2016 Reviewed 26 May 2016
Issues Overview
Revision Document ID23112
Date Revision 22 Oct 2017 Reviewed 22 Oct 2017
Intrastats overview
Revision Document ID23567
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Employee Roles
Revision Document ID20125
Date Revision 16 May 2017 Reviewed 16 May 2017
Employee roles Example Process
Revision Document ID20129
Date Revision 16 May 2017 Reviewed 16 May 2017
VM3COP27.02 Collecting Emails and Distributing
Revision Document ID85362
Date Revision 22 Mar 2022 Reviewed 22 Mar 2022
Employee Roles Individual Processes
Revision Document ID20127
Date Revision 16 May 2017 Reviewed 16 May 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 5889
Responsibility Allocation : Audit And Task - Audit 24 Feb 2016
Process: 7714
Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7718
Audit 06 Calibration Viamed 24 Aug 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7724
Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 7726
Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7727
Audit 15 Production Viamed 24 Aug 2016
Process: 7728
Audit 17 Internal Audits Viamed 24 Aug 2016
Process: 7729
Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 7731
Audit 21 Audit Of Audit Viamed 24 Aug 2016
Process: 7732
Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7733
Audit 23 Analysis Of Data Viamed 24 Aug 2016
Process: 26
Company Resources 16 Feb 2016
Process: 8025
Check We Do Not Require A EU European Representatives 09 Mar 2023
Process: 8028
Viamed Shopify Sales Report Export 11 Apr 2023
4.1.4
For each quality management system process, the organization shall:
The organization shall manage these quality management system processes in accordance with
the requirements of this International Standard and applicable regulatory requirements. Changes to be
made to these processes shall be:
a) evaluated for their impact on the quality management system;
b) evaluated for their impact on the medical devices produced under this quality management system
c) controlled in accordance with the requirements of this International Standard and applicable
regulatory requirements.		Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Issues Overview
Revision Document ID23112
Date Revision 22 Oct 2017 Reviewed 22 Oct 2017
Employee Roles
Revision Document ID20125
Date Revision 16 May 2017 Reviewed 16 May 2017
Employee roles Example Process
Revision Document ID20129
Date Revision 16 May 2017 Reviewed 16 May 2017
Employee Roles Individual Processes
Revision Document ID20127
Date Revision 16 May 2017 Reviewed 16 May 2017
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Explanation Employee Roles Titles Responsibilitys Processes and Repeating Tasks Monitoring
Revision Document ID22287
Date Revision 27 Sep 2017 Reviewed 27 Sep 2017
Chart 43 Processes and Intrastats
Revision Document ID23561
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Chart 42 Processes, Tasks and Audits Review
Revision Document ID23559
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Chart 40 Management review plan Issues followup
Revision Document ID22458
Date Revision 05 Oct 2017 Reviewed 05 Oct 2017
VM3COP24.02 Document Change Performing a Risk Assessment
Revision Document ID75310
Date Revision 17 Nov 2021 Reviewed 17 Nov 2021
VM3COP24.01 Definitions of Risk
Revision Document ID75525
Date Revision 19 Nov 2021 Reviewed 19 Nov 2021
VM3COP24.00 Viamed Overall Risk Analysis Program Risk Register
Revision Document ID47771
Date Revision 12 Nov 2020 Reviewed 17 Dec 2024
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7878
Review Possible Upcoming Regulation Changes 22 Oct 2017
Process: 8025
Check We Do Not Require A EU European Representatives 09 Mar 2023
Process: 8077
Download HMRC Reports 18 Jun 2024
4.1.5
For each quality management system process, the organization shall:
When the organization chooses to outsource any process that affects product conformity to
requirements, it shall monitor and ensure control over such processes. The organization shall retain
responsibility of conformity to this International Standard and to customer and applicable regulatory
requirements for outsourced processes. The controls shall be proportionate to the risk involved and the
ability of the external party to meet the requirements in accordance with 7.4. The controls shall include
written quality agreements.		Top Level Document: VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Revision Document ID75847
Date Revision 23 Nov 2021 Reviewed 23 Nov 2021
Audit 05 Purchasing suppliers Viamed
Revision Document ID159433
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7199
Non Conformities Review Viamed 09 Mar 2016
Process: 8025
Check We Do Not Require A EU European Representatives 09 Mar 2023
4.1.6
For each quality management system process, the organization shall:
The organization shall document procedures for the validation of the application of computer
software used in the quality management system. Such software applications shall be validated prior to
initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be
proportionate to the risk associated with the use of the software.
Records of such activities shall be maintained (see 4.2.5).		Top Level Document: VOP 27 Software Validation
Revision Document ID91486
Date Revision 10 Jun 2022 Reviewed 10 Jun 2022
Top Level Document: Audit 27 Software Validation Viamed
Revision Document ID156701
Date Revision 12 Jul 2024 Reviewed 12 Jul 2024
Intrastats Amendment Log
Revision Document ID20136
Date Revision 16 May 2017 Reviewed 16 May 2017
Validation of Intrastats
Revision Document ID20140
Date Revision 16 May 2017 Reviewed 16 May 2017
Process: 7850
Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7851
Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852
Software Validation Expired Stock 01 Oct 2017
Process: 7853
Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854
Software Validation In Production List 01 Oct 2017
Process: 7855
Software Validation - Production Lists 01 Oct 2017
Process: 7856
Software Validation Unchecked Orders 01 Oct 2017
Process: 7857
Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858
Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861
Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7865
Software Validation Conflicting Audits 07 Oct 2017
Process: 7870
Software Validation Non Conformance Product Risk Feedback Loop 15 Oct 2017
Process: 8083
**Software Validation SRS To Nonconformance 31 Dec 2024
Process: 8085
**Stock Figure - Correct Xero To Intrastats 16 Dec 2024
4.2
Documentation requirements		Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
4.2.1
The quality management system documentation (see 4.2.4) shall include:
a) documented statements of a quality policy and quality objectives;
b) a quality manual;
c) documented procedures and records required by this International Standard;
d) documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation, and control of its processes;
e) other documentation specified by applicable regulatory requirements.		Top Level Document: VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Revision Document ID164833
Date Revision 14 Oct 2024 Reviewed 04 Nov 2024
Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
Explaination Quality Objectives
Revision Document ID18483
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
VM3COP00.01 Company objectives
Revision Document ID22842
Date Revision 17 Oct 2017 Reviewed 17 Oct 2017
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 23
Company Objectives 16 Feb 2016
Process: 22
Company Policys 16 Feb 2016
Process: 23
Company Objectives 16 Feb 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7834
Financial Review 20 Sep 2017
Process: 7862
Review The Audit Calender Screen 04 Oct 2017
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
Process: 5877
Review Company Data 17 Feb 2016
Process: 6861
Management Meeting Review Weekly Meeting 09 Mar 2016
Process: 7037
Responsibility Allocation : Responsibility, authority and communication 09 Mar 2016
Process: 7057
Responsibility Allocation : Complaints and Vigilance Notifications 09 Mar 2016
Process: 7070
Management Review 09 Mar 2016
Process: 7713
Review Roles And Responsibilitys 17 Aug 2016
Process: 7830
Review Q.A. Failures Report 18 Sep 2017
Process: 7837
Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 7838
Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7839
Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7842
Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7845
7.1.4 Environment Of Operations 25 Sep 2017
Process: 7848
Review ISO Scopes 27 Sep 2017
Process: 7849
Review Product Failures New Codes 28 Sep 2017
Process: 7120
General Maintenance Requirements 09 Mar 2016
Process: 28
Supplier Review 16 Feb 2016
Process: 5887
Review ISO/EN Documents 24 Feb 2016
Process: 5889
Responsibility Allocation : Audit And Task - Audit 24 Feb 2016
Process: 6866
Internal Process Verification Complete Systems Review 09 Mar 2016
Process: 7199
Non Conformities Review Viamed 09 Mar 2016
Process: 7828
Review The Quality Policy Viamed 16 Sep 2017
Process: 6821
Responsibility Allocation : VIAMED Management Meeting Supplier Review 09 Mar 2016
Process: 7697
Yearly Pricing Review 09 May 2016
Process: 57
Temporary Stock Notices 17 Feb 2016
Process: 8029
Send Intercompany Invoices To Jean 12 Apr 2023
4.2.2
The organization shall document a quality manual that includes:
a) the scope of the quality management system, including details of and justification for any exclusion
or non-application;
b) the documented procedures for the quality management system, or reference to them;
c) a description of the interaction between the processes of the quality management system.
The quality manual shall outline the structure of the documentation used in the quality management
system.		Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Top Level Document: Viamed ISO 13485:2016 Scope
Revision Document ID168096
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Structure of the documentation used in the quality management system
Revision Document ID151811
Date Revision 21 May 2024 Reviewed 21 May 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
4.2.3
For each medical device type or medical device family, the organization shall establish and maintain one
or more files either containing or referencing documents generated to demonstrate conformity with the
requirement of this International Standard and compliance with applicable regulatory requirements.
The content of the file(s) shall include, but is not limited to:
a) general description of the medical device, intended use/purpose, and labelling, including any
instructions for use;
b) specifications for product;
c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f) as appropriate, procedures for servicing. Medical device file Documentation requirements		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Route to Medical device files
Revision Document ID18495
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
4.2.4
Documents required by the quality management system shall be controlled. Records are a special type
of document and shall be controlled according to the requirements given in 4.2.5.
A documented procedure shall define the controls needed to:
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
c) ensure that the current revision status of and changes to documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin, determined by the organization to be necessary
for the planning and operation of the quality management system, are identified and their
distribution controlled;
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable identification to them.
The organization shall ensure that changes to documents are reviewed and approved either by the
original approving function or another designated function that has access to pertinent background
information upon which to base its decisions.
The organization shall define the period for which at least one copy of obsolete documents shall be
retained. This period shall ensure that documents to which medical devices have been manufactured
and tested are available for at least the lifetime of the medical device as defined by the organization,
but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable Control of documents Documentation requirements		Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
Explanation Control of documents
Revision Document ID21322
Date Revision 06 Aug 2017 Reviewed 06 Aug 2017
DO NOT USE VM3COP01 Document Updates / Amendment control
Revision Document ID22201
Date Revision 23 Sep 2017 Reviewed 23 Sep 2017
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
DO NOT USE VM3COP14 Documentation
Revision Document ID9276
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
VM3COP10.02 Product Recall locate products out in the Field
Revision Document ID74788
Date Revision 12 Nov 2021 Reviewed 12 Nov 2021
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 8032
Review Contact Documentation 22 Aug 2023
4.2.5
Records shall be maintained to provide evidence of conformity to requirements and of the effective
operation of the quality management system.
The organization shall document procedures to define the controls needed for the identification,
storage, security and integrity, retrieval, retention time and disposition of records.
The organization shall define and implement methods for protecting confidential health information
contained in records in accordance with the applicable regulatory requirements.
Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain
identifiable.
The organization shall retain the records for at least the lifetime of the medical device as defined by the
organization, or as specified by applicable regulatory requirements, but not less than two years from
the medical device release by the organization. Control of records Documentation requirements		Top Level Document: VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Revision Document ID120321
Date Revision 01 Jun 2023 Reviewed 01 Jun 2023
DO NOT USE VM3COP01 Document Updates / Amendment control
Revision Document ID22201
Date Revision 23 Sep 2017 Reviewed 23 Sep 2017
VM3COP14.01 Disposition of Documents / Records.
Revision Document ID15464
Date Revision 14 Aug 2015 Reviewed 14 Aug 2015
Guide to Intrastats
Revision Document ID24779
Date Revision 22 Dec 2017 Reviewed 22 Dec 2017
Intrastats overview
Revision Document ID23567
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
DO NOT USE VM3COP14 Documentation
Revision Document ID9276
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 8027
Update Pricing For Viamed Shopify 11 Apr 2023

5 Management commitment

5.1
Top management shall provide evidence of its commitment to the development and implementation of
the quality management system and maintenance of its effectiveness by:
a) communicating to the organization the importance of meeting customer as well as applicable
regulatory requirements;
b) establishing the quality policy;
c) ensuring that quality objectives are established;
d) conducting management reviews;
e) ensuring the availability of resources. Management commitment		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Top Level Document: VOP 18 Maintenance Building, Fabric and Infrastructure
Revision Document ID119029
Date Revision 15 May 2023 Reviewed 15 May 2023
Top Level Document: VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Revision Document ID164833
Date Revision 14 Oct 2024 Reviewed 04 Nov 2024
VM3COP02 Organisation Responsibilities Viamed
Revision Document ID17423
Date Revision 07 Sep 2016 Reviewed 07 Sep 2016
Chart 01 System and Documentation
Revision Document ID8675
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 02 Resource Management
Revision Document ID8676
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
VM3COP19 Health and Safety
Revision Document ID21800
Date Revision 05 Sep 2017 Reviewed 05 Sep 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Explaination Quality Objectives
Revision Document ID18483
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Explanation Control of documents
Revision Document ID21322
Date Revision 06 Aug 2017 Reviewed 06 Aug 2017
How to Hold Intrastat Meetings
Revision Document ID8928
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Viamed Top Level Quality Objectives
Revision Document ID130426
Date Revision 27 Sep 2023 Reviewed 27 Sep 2023
Chart 40 Management review plan Issues followup
Revision Document ID22458
Date Revision 05 Oct 2017 Reviewed 05 Oct 2017
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7833
Importance Of Effective Quality Management 20 Sep 2017
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
Process: 7070
Management Review 09 Mar 2016
Process: 7848
Review ISO Scopes 27 Sep 2017
Process: 23
Company Objectives 16 Feb 2016
Process: 7686
Thorough Checking Of Awaiting Action Tray - Priority 8s 21 Apr 2016
Process: 7919
Send Debtors Overview To Derek 06 Dec 2018
Process: 8080
Review Back To Stock Report On Shopify 10 Sep 2024
5.2
Top management shall ensure that customer requirements and applicable regulatory requirements are
determined and met.

Customer focus		Top Level Document: VOP 03 Contract Review, Enquires, Office Processes
Revision Document ID77875
Date Revision 15 Dec 2021 Reviewed 21 May 2024
Top Level Document: Audit 02 Contract Review and Sales Order Processing Viamed
Revision Document ID163469
Date Revision 27 Sep 2024 Reviewed 27 Sep 2024
Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Audit 16 Sales and Marketing Viamed
Revision Document ID159461
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7
Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 11
Distribution Of Post 16 Feb 2016
Process: 5882
Responsibility Allocation : Send Post To Humanmed 24 Feb 2016
Process: 2
Answering Telephones 16 Feb 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7696
Send VIAMED Delivery Notifications 28 Apr 2016
Process: 6898
GHX Web Pricing 09 Mar 2016
Process: 19
Maintaining Leaflet Stocks 16 Feb 2016
Process: 14
Fax Paper 16 Feb 2016
Process: 15
Filing and Archiving 16 Feb 2016
Process: 10
Distribution Of Emails 16 Feb 2016
Process: 9
Distribution Of Faxes 16 Feb 2016
Process: 7996
Verification Repairs Older Repairs 07 Feb 2022
Process: 7934
Test Website Questions 02 May 2019
Process: 8075
Tenders Review UK 14 Feb 2024
Process: 8076
Medica Review 21 Feb 2024
Process: 7968
Shred CC Slips 06 Aug 2021
5.3
Top management shall ensure that the quality policy:
a) is applicable to the purpose of the organization;
b) includes a commitment to comply with requirements and to maintain the effectiveness of the
quality management system;
c) provides a framework for establishing and reviewing quality objectives;
d) is communicated and understood within the organization;
e) is reviewed for continuing suitability. Quality policy		Top Level Document: VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Revision Document ID164833
Date Revision 14 Oct 2024 Reviewed 04 Nov 2024
VM3COP00.01 Company objectives
Revision Document ID22842
Date Revision 17 Oct 2017 Reviewed 17 Oct 2017
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 23
Company Objectives 16 Feb 2016
Process: 22
Company Policys 16 Feb 2016
Process: 23
Company Objectives 16 Feb 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7833
Importance Of Effective Quality Management 20 Sep 2017
Process: 7828
Review The Quality Policy Viamed 16 Sep 2017
Process: 7827
Review The Quality Policy VST 16 Sep 2017
5.4
Planning
5.4.1
Top management shall ensure that quality objectives, including those needed to meet applicable
regulatory requirements and requirements for product, are established at relevant functions and levels
within the organization. The quality objectives shall be measurable and consistent with the quality policy. Quality objectives		Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
VM3COP18 Post Market Surveilance
Revision Document ID75985
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Explaination Quality Objectives
Revision Document ID18483
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Viamed Top Level Quality Objectives
Revision Document ID130426
Date Revision 27 Sep 2023 Reviewed 27 Sep 2023
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7830
Review Q.A. Failures Report 18 Sep 2017
Process: 26
Company Resources 16 Feb 2016
Process: 5877
Review Company Data 17 Feb 2016
5.4.2
Top management shall ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements
given in 4.1, as well as the quality objectives;
b) the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented. Quality management system planning		Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Top Level Document: VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Revision Document ID164833
Date Revision 14 Oct 2024 Reviewed 04 Nov 2024
Top Level Document: VOP 21 Risk, Risk Management and Risk Analysis
Revision Document ID75935
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Explaination Quality Objectives
Revision Document ID18483
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
Explanation Control of documents
Revision Document ID21322
Date Revision 06 Aug 2017 Reviewed 06 Aug 2017
Route to Medical device files
Revision Document ID18495
Date Revision 18 Jan 2017 Reviewed 18 Jan 2017
VM3COP20.01 Post In Distributing the Post
Revision Document ID103501
Date Revision 14 Nov 2022 Reviewed 14 Nov 2022
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Viamed Top Level Quality Objectives
Revision Document ID130426
Date Revision 27 Sep 2023 Reviewed 27 Sep 2023
VM3COP00.01 Company objectives
Revision Document ID22842
Date Revision 17 Oct 2017 Reviewed 17 Oct 2017
Process: 11
Distribution Of Post 16 Feb 2016
Process: 5882
Responsibility Allocation : Send Post To Humanmed 24 Feb 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
5.5
Responsibility, authority and communication		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Top Level Document: QC 44 MHRA / CMDCAS Risk Assessment Initial Assessment form
Revision Document ID75549
Date Revision 19 Nov 2021 Reviewed 19 Nov 2021
Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
5.5.1
Top management shall ensure that responsibilities and authorities are defined, documented and
communicated within the organization.
Top management shall document the interrelation of all personnel who manage, perform and verify work
affecting quality and shall ensure the independence and authority necessary to perform these tasks. Responsibility and authority		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
VM3COP02 Organisation Responsibilities Viamed
Revision Document ID17423
Date Revision 07 Sep 2016 Reviewed 07 Sep 2016
Chart 01 System and Documentation
Revision Document ID8675
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 02 Resource Management
Revision Document ID8676
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Viamed Company Format Company format 1
Revision Document ID9039
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Viamed Company Format Company format 2
Revision Document ID9040
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Viamed Company Format Company format 3
Revision Document ID9041
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Viamed Company Format Company format 4
Revision Document ID9042
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Audit 08 Training, Competence and Human Resources Viamed
Revision Document ID162725
Date Revision 19 Sep 2024 Reviewed 19 Sep 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Revision Document ID159483
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7713
Review Roles And Responsibilitys 17 Aug 2016
Process: 6837
Personnel Requirements and Training 09 Mar 2016
5.5.2
Top management shall appoint a member of management who, irrespective of other responsibilities,
has responsibility and authority that includes:
a) ensuring that processes needed for the quality management system are documented;
b) reporting to top management on the effectiveness of the quality management system and any need
for improvement;
c) ensuring the promotion of awareness of applicable regulatory requirements and quality
management system requirements throughout the organization. Management representative		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Top Level Document: VM3COP02.02 VST Company Responsibilitys organisation chart structure
Revision Document ID29373
Date Revision 23 Apr 2019 Reviewed 25 Jan 2024
Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
VM3COP02 Organisation Responsibilities Viamed
Revision Document ID17423
Date Revision 07 Sep 2016 Reviewed 07 Sep 2016
VM3COP02 Organisation VST
Revision Document ID13954
Date Revision 19 May 2014 Reviewed 19 May 2014
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7833
Importance Of Effective Quality Management 20 Sep 2017
5.5.3
Top management shall ensure that appropriate communication processes are established within
the organization and that communication takes place regarding the effectiveness of the quality
management system. Internal communication		VM3COP27.01 Searching Intrastats Issues
Revision Document ID6657
Date Revision 02 Nov 2009 Reviewed 02 Nov 2009
Intrastats overview
Revision Document ID23567
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Issues Overview
Revision Document ID23112
Date Revision 22 Oct 2017 Reviewed 22 Oct 2017
Overview Issues Meeting Headers List
Revision Document ID22169
Date Revision 22 Sep 2017 Reviewed 22 Sep 2017
Chart 42 Processes, Tasks and Audits Review
Revision Document ID23559
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Chart 43 Processes and Intrastats
Revision Document ID23561
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
Chart 37 New Processes
Revision Document ID23563
Date Revision 28 Oct 2017 Reviewed 28 Oct 2017
5.6
Management review
5.6.1
The organization shall document procedures for management review. Top management shall review
the organization’s quality management system at documented planned intervals to ensure its
continuing suitability, adequacy, and effectiveness. The review shall include assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy
and quality objectives.
Records from management reviews shall be maintained General		Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
How to Hold Intrastat Meetings
Revision Document ID8928
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Management Review
Revision Document ID30851
Date Revision 18 Sep 2019 Reviewed 18 Sep 2019
Management reviews
Revision Document ID19801
Date Revision 05 May 2017 Reviewed 05 May 2017
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7846
ISO System Management Review Viamed 26 Sep 2017
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
Process: 7070
Management Review 09 Mar 2016
5.6.2
The input to management review shall include, but is not limited to, information arising from:
a) feedback;
b) complaint handling;
c) reporting to regulatory authorities;
d) audits;
e) monitoring and measurement of processes;
f) monitoring and measurement of product;
g) corrective action;
h) preventive action;
i) follow-up actions from previous management reviews;
j) changes that could affect the quality management system;
k) recommendations for improvement;
l) applicable new or revised regulatory requirements. General Review input		Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Top Level Document: VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Revision Document ID167103
Date Revision 06 Nov 2024 Reviewed 06 Nov 2024
Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Chart 27 Customer Complaints Chart 27
Revision Document ID8700
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
VM3COP18 Post Market Surveilance
Revision Document ID75985
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
How to Hold Intrastat Meetings
Revision Document ID8928
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Audit 21 Audit of Audit Viamed
Revision Document ID159485
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Viamed Management Review Blank Minutes 20xx
Revision Document ID126137
Date Revision 04 Aug 2023 Reviewed 04 Aug 2023
QC 21 Non Conformance Form
Revision Document ID74728
Date Revision 11 Nov 2021 Reviewed 25 Nov 2022
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7838
Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7839
Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7842
Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7846
ISO System Management Review Viamed 26 Sep 2017
Process: 7848
Review ISO Scopes 27 Sep 2017
Process: 7849
Review Product Failures New Codes 28 Sep 2017
Process: 7871
Review Exclusion From Viamed 13485:2016 And VST 9001:2015 15 Oct 2017
Process: 7837
Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 7830
Review Q.A. Failures Report 18 Sep 2017
Process: 7741
Review Ethical Policy 14 Sep 2016
Process: 7713
Review Roles And Responsibilitys 17 Aug 2016
Process: 7070
Management Review 09 Mar 2016
Process: 6931
Customer Complaints 09 Mar 2016
Process: 7091
Calibration Index 09 Mar 2016
Process: 8014
Review VIAMED Product Feedback Positive 25 Jul 2022
Process: 8016
Review VIAMED Customer Feedback Positive 25 Jul 2022
5.6.3
The output from management review shall be recorded (see 4.2.5) and include the input reviewed and
any decisions and actions related to:
a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality
management system and its processes;
b) improvement of product related to customer requirements;
c) changes needed to respond to applicable new or revised regulatory requirements;
d) resource needs. Review output		Top Level Document: QC 44 MHRA / CMDCAS Risk Assessment Initial Assessment form
Revision Document ID75549
Date Revision 19 Nov 2021 Reviewed 19 Nov 2021
Issues Overview
Revision Document ID23112
Date Revision 22 Oct 2017 Reviewed 22 Oct 2017
VM3COP27.01 Searching Intrastats Issues
Revision Document ID6657
Date Revision 02 Nov 2009 Reviewed 02 Nov 2009
Management Review
Revision Document ID30851
Date Revision 18 Sep 2019 Reviewed 18 Sep 2019
Management reviews
Revision Document ID19801
Date Revision 05 May 2017 Reviewed 05 May 2017
Management reviews minutes
Revision Document ID19803
Date Revision 05 May 2017 Reviewed 05 May 2017
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016

6 Resource management

6
Resource management
6.1
The organization shall determine and provide the resources needed to:
a) implement the quality management system and to maintain its effectiveness;
b) meet applicable regulatory and customer requirements. Provision of resources		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
6.2
Personnel performing work affecting product quality shall be competent on the basis of appropriate
education, training, skills and experience.
The organization shall document the process(es) for establishing competence, providing needed
training, and ensuring awareness of personnel.
The organization shall:
a) determine the necessary competence for personnel performing work affecting product quality;
b) provide training or take other actions to achieve or maintain the necessary competence;
c) evaluate the effectiveness of the actions taken;
d) ensure that its personnel are aware of the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives;
e) maintain appropriate records of education, training, skills and experience (see 4.2.5).
NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for
which the training or other action is being provided. Human resources		Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
Top Level Document: VOP 12 Training
Revision Document ID166222
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Audit 08 Training, Competence and Human Resources Viamed
Revision Document ID162725
Date Revision 19 Sep 2024 Reviewed 19 Sep 2024
Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Revision Document ID159483
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
6.3
The organization shall document the requirements for the infrastructure needed to achieve
conformity to product requirements, prevent product mix-up and ensure orderly handling of product.
Infrastructure includes, as appropriate:
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
c) supporting services (such as transport, communication, or information systems).
The organization shall document requirements for the maintenance activities, including the interval
of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect
product quality. As appropriate, the requirements shall apply to equipment used in production, the
control of the work environment and monitoring and measurement.
Records of such maintenance shall be maintained Infrastructure		Top Level Document: VOP 06 Measurement Control Viamed VST, Calibration, QA Stock
Revision Document ID168580
Date Revision 22 Nov 2024 Reviewed 22 Nov 2024
Top Level Document: VOP 18 Maintenance Building, Fabric and Infrastructure
Revision Document ID119029
Date Revision 15 May 2023 Reviewed 15 May 2023
Top Level Document: VOP 16 Health and Safety, Company Personnel Manual
Revision Document ID31032
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
Top Level Document: VOP 11 Equipment Control, Office, Warehouse, Pcs and Equipment
Revision Document ID31008
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
DO NOT USE VM3COP11 Calibration
Revision Document ID8713
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
HSE Fire / Exit Escape route Ground Floor plans
Revision Document ID127734
Date Revision 25 Aug 2023 Reviewed 04 Nov 2024
HSE Fire Exit / Escape Route Ground Floor plans Document
Revision Document ID2558
Date Revision 01 Aug 2007 Reviewed 01 Aug 2007
HSE Fire Risk Assessment
Revision Document ID21790
Date Revision 04 Sep 2017 Reviewed 04 Sep 2017
HSE Fire Safety Risk Assessment
Revision Document ID892
Date Revision 25 Oct 2006 Reviewed 25 Oct 2006
HSE Fire / Exit Escape route Basement floor plans
Revision Document ID127738
Date Revision 25 Aug 2023 Reviewed 04 Nov 2024
HSE Fire / Exit Escape route Ghyll House floor plans
Revision Document ID95898
Date Revision 04 Aug 2022 Reviewed 04 Nov 2024
Ghyll House Fire Certificate
Revision Document ID12303
Date Revision 15 Mar 2013 Reviewed 15 Mar 2013
CPM 21 Fire Exit / Escape Route Procedures
Revision Document ID21892
Date Revision 07 Sep 2017 Reviewed 07 Sep 2017
FIRE Report Premisis
Revision Document ID82517
Date Revision 15 Feb 2022 Reviewed 15 Feb 2024
VM3COP20.35 Ups Calculator
Revision Document ID88671
Date Revision 05 May 2022 Reviewed 05 May 2022
VM3COP20.07 UPS Procedures
Revision Document ID8722
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
VM3COP03.05 Procedures for customer returning goods on our UPS account number
Revision Document ID17155
Date Revision 05 Jul 2016 Reviewed 05 Jul 2016
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 15 Production Viamed
Revision Document ID159459
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Revision Document ID159483
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 6855
Risk Assessment HSE 09 Mar 2016
Process: 6856
Fire Alarms 09 Mar 2016
Process: 54
Responsibility Allocation : Gents Toilets 17 Feb 2016
Process: 5907
Hoover Warehouse 03 Mar 2016
Process: 5908
Sweep Warehouse 03 Mar 2016
Process: 5909
Empty Warehouse Bins 03 Mar 2016
Process: 5911
Clear Cardboard 03 Mar 2016
Process: 5856
Cleaning The Kitchen 17 Feb 2016
Process: 7802
Clean Kitchen Sides 22 May 2017
Process: 7803
Dishwashing 22 May 2017
Process: 7804
Sweep Kitchen Floor 22 May 2017
Process: 7805
Empty Kitchen Bins 22 May 2017
Process: 7806
Watering Plants 22 May 2017
Process: 56
Warehouse Outside Heating Guard 17 Feb 2016
Process: 5919
Check Out Side Drain 05 Mar 2016
Process: 5921
Clearing Water Downstairs 05 Mar 2016
Process: 7120
General Maintenance Requirements 09 Mar 2016
Process: 7742
Boiler Check 26 Sep 2016
Process: 7756
Carbon Monoxide Alarm 05 Jan 2017
Process: 7820
North Yorkshire Council Waste Tranfer 15 Jun 2017
Process: 7821
Controlled Waste Description And Transfer 15 Jun 2017
Process: 7835
Electrics Need Checking 20 Sep 2017
Process: 7836
Central Heating For Winter 20 Sep 2017
Process: 7713
Review Roles And Responsibilitys 17 Aug 2016
Process: 7845
7.1.4 Environment Of Operations 25 Sep 2017
Process: 45
Responsibility Allocation : Main Server Status 16 Feb 2016
Process: 48
Responsibility Allocation : Internet 16 Feb 2016
Process: 52
Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 5903
Responsibility Allocation : Weather Station 02 Mar 2016
Process: 5939
Responsibility Allocation : Email ISP Routing 05 Mar 2016
Process: 7121
Responsibility Allocation : General Computer Maintenance 09 Mar 2016
Process: 7129
Intrastats Cross Reference Database Tables Updates 09 Mar 2016
Process: 7672
Off Site Backup 09 Mar 2016
Process: 7704
Responsibility Allocation : Computer Failure Diagnostics 24 May 2016
Process: 7850
Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7851
Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852
Software Validation Expired Stock 01 Oct 2017
Process: 7853
Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854
Software Validation In Production List 01 Oct 2017
Process: 7855
Software Validation - Production Lists 01 Oct 2017
Process: 7856
Software Validation Unchecked Orders 01 Oct 2017
Process: 7857
Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858
Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861
Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7832
Cleardown Emailed Invoices 20 Sep 2017
Process: 7755
Fast Hosts Invoice 08 Dec 2016
Process: 7739
Intrastats Amendment Log 12 Sep 2016
Process: 5853
Vacuuming Of The Office, Hall And Meeting Room 17 Feb 2016
Process: 5878
Empty Office Bins 18 Feb 2016
Process: 5906
Empty Paper Bins 03 Mar 2016
Process: 5910
Clean Duckets 03 Mar 2016
Process: 7961
R D Room - Tidy, Empty Bins, Remove Cups. Caution Around Oxygen Supply 05 Oct 2020
Process: 7896
Tree In Car Park 22 Dec 2017
Process: 7864
ESD Work Stations 07 Oct 2017
Process: 46
Responsibility Allocation : Backup Server Status 16 Feb 2016
Process: 44
Secure Socket Level Certificate 16 Feb 2016
Process: 49
Responsibility Allocation : Wifi 16 Feb 2016
Process: 50
Responsibility Allocation : Guest Access Wifi 16 Feb 2016
Process: 51
Responsibility Allocation : Printers 16 Feb 2016
Process: 53
Emails 16 Feb 2016
6.4
Work environment and contamination control		Top Level Document: VM3COP27.51 Incoming / Goods in Contamination Control
Revision Document ID74855
Date Revision 12 Nov 2021 Reviewed 12 Nov 2021
6.4.1
The organization shall document the requirements for the work environment needed to achieve
conformity to product requirements.
If the conditions for the work environment can have an adverse effect on product quality, the
organization shall document the requirements for the work environment and the procedures to monitor
and control the work environment.
The organization shall:
a) document requirements for health, cleanliness and clothing of personnel if contact between such
personnel and the product or work environment could affect medical device safety or performance;
b) ensure that all personnel who are required to work temporarily under special environmental
conditions within the work environment are competent or supervised by a competent person.
NOTE Further information can be found in ISO 14644 and ISO 14698 Work environment		Top Level Document: VOP 18 Maintenance Building, Fabric and Infrastructure
Revision Document ID119029
Date Revision 15 May 2023 Reviewed 15 May 2023
Top Level Document: VOP 16 Health and Safety, Company Personnel Manual
Revision Document ID31032
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
CPM 15 Disciplinary Procedures
Revision Document ID142873
Date Revision 21 Feb 2024 Reviewed 21 Feb 2024
CPM 16 Dress Code
Revision Document ID7055
Date Revision 26 Apr 2010 Reviewed 22 Jul 2014
CPM 25 Health and Safety Policy Viamed
Revision Document ID14332
Date Revision 25 Sep 2014 Reviewed 04 Sep 2017
CPM 39 Smoking Policy
Revision Document ID6782
Date Revision 15 Feb 2010 Reviewed 15 Feb 2010
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 08 Training, Competence and Human Resources Viamed
Revision Document ID162725
Date Revision 19 Sep 2024 Reviewed 19 Sep 2024
Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Revision Document ID159483
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7729
Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 56
Warehouse Outside Heating Guard 17 Feb 2016
Process: 5919
Check Out Side Drain 05 Mar 2016
Process: 5921
Clearing Water Downstairs 05 Mar 2016
Process: 7120
General Maintenance Requirements 09 Mar 2016
Process: 7742
Boiler Check 26 Sep 2016
Process: 7756
Carbon Monoxide Alarm 05 Jan 2017
Process: 7820
North Yorkshire Council Waste Tranfer 15 Jun 2017
Process: 7821
Controlled Waste Description And Transfer 15 Jun 2017
Process: 7835
Electrics Need Checking 20 Sep 2017
Process: 7836
Central Heating For Winter 20 Sep 2017
Process: 7864
ESD Work Stations 07 Oct 2017
Process: 7873
On Site Environment Review 18 Oct 2017
Process: 54
Responsibility Allocation : Gents Toilets 17 Feb 2016
Process: 5906
Empty Paper Bins 03 Mar 2016
Process: 5907
Hoover Warehouse 03 Mar 2016
Process: 5908
Sweep Warehouse 03 Mar 2016
Process: 5909
Empty Warehouse Bins 03 Mar 2016
Process: 5910
Clean Duckets 03 Mar 2016
Process: 5911
Clear Cardboard 03 Mar 2016
Process: 7698
Clean Toilets 17 May 2016
6.4.2
As appropriate, the organization shall plan and document arrangements for the control of contaminated
or potentially contaminated product in order to prevent contamination of the work environment,
personnel, or product.
For sterile medical devices, the organization shall document requirements for control of contamination
with microorganisms or particulate matter and maintain the required cleanliness during assembly or
packaging processes. Contamination control		Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Revision Document ID75847
Date Revision 23 Nov 2021 Reviewed 23 Nov 2021
Top Level Document: VM3COP27.51 Incoming / Goods in Contamination Control
Revision Document ID74855
Date Revision 12 Nov 2021 Reviewed 12 Nov 2021
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Process: 39
Enviromental Policy Document Review 16 Feb 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7714
Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016

7 Product realization

7
Product realization
7.1
The organization shall plan and develop the processes needed for product realization. Planning of
product realization shall be consistent with the requirements of the other processes of the quality
management system.
The organization shall document one or more processes for risk management in product realization.
Records of risk management activities shall be maintained (see 4.2.5).

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the
product, including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test, handling,
storage, distribution and traceability activities specific to the product together with the criteria
for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.5).
The output of this planning shall be documented in a form suitable for the organization’s method of
operations.
NOTE Further information can be found in ISO 14971. Planning of product realization 		Top Level Document: VM3COP27.11 Performing a Technical File PMS and risk assessment
Revision Document ID75465
Date Revision 18 Nov 2021 Reviewed 18 Nov 2021
Top Level Document: VOP 08 Production, Reworks, New Production
Revision Document ID31072
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
VM3COP24.00 Viamed Overall Risk Analysis Program Risk Register
Revision Document ID47771
Date Revision 12 Nov 2020 Reviewed 17 Dec 2024
VM3COP27.12 Clinical Evaluation Risk assessment Technical Files
Revision Document ID15453
Date Revision 11 Aug 2015 Reviewed 11 Aug 2015
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7732
Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
7.2
Customer-related processes
7.2.1
The organization shall determine:
a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;
b) requirements not stated by the customer but necessary for specified or intended use, as known;
c) applicable regulatory requirements related to the product;
d) any user training needed to ensure specified performance and safe use of the medical device;
e) any additional requirements determined by the organization Determination of requirements related to product		Top Level Document: Audit 02 Contract Review and Sales Order Processing Viamed
Revision Document ID163469
Date Revision 27 Sep 2024 Reviewed 27 Sep 2024
Top Level Document: VM3COP03.07 Humanmed Order Checking
Revision Document ID22266
Date Revision 27 Sep 2017 Reviewed 27 Sep 2017
Top Level Document: VM3COP03.08 Humanmed Order Processing
Revision Document ID24775
Date Revision 22 Dec 2017 Reviewed 22 Dec 2017
Top Level Document: VM3COP12.01 Viamed Policy on End User Training UK
Revision Document ID85827
Date Revision 29 Mar 2022 Reviewed 29 Mar 2022
Top Level Document: VOP 03 Contract Review, Enquires, Office Processes
Revision Document ID77875
Date Revision 15 Dec 2021 Reviewed 21 May 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
VM3COP20.31 Export Order Processing
Revision Document ID165205
Date Revision 16 Oct 2024 Reviewed 16 Oct 2024
VM3COP03.01 Order Processing Priorities
Revision Document ID20049
Date Revision 15 May 2017 Reviewed 15 May 2017
VM3COP20.30 UK Order Processing
Revision Document ID165199
Date Revision 16 Oct 2024 Reviewed 16 Oct 2024
Oxygen Sensor Training Powerpoint
Revision Document ID15736
Date Revision 24 Sep 2015 Reviewed 25 Oct 2016
Oxygen Sensor Training Video
Revision Document ID15737
Date Revision 24 Sep 2015 Reviewed 24 Sep 2015
Resuscitation Unit and TC400 Training Information Resuscitation Cabinet Training
Revision Document ID4111
Date Revision 09 Jul 2008 Reviewed 09 Jul 2008
Resuscitation Unit Maintenance Therapy Equipment Suction Controller Unit and TC400 Training Information Therapy Workshop Inst.
Revision Document ID4122
Date Revision 09 Jul 2008 Reviewed 09 Jul 2008
Single Use Surgical Training Information certificates
Revision Document ID20220
Date Revision 19 May 2017 Reviewed 19 May 2017
SpO2 800 series Training Information
Revision Document ID12687
Date Revision 02 Jul 2013 Reviewed 02 Jul 2013
TECcare Training Material
Revision Document ID11826
Date Revision 11 Jun 2012 Reviewed 11 Jun 2012
Temperature Probe Training Material
Revision Document ID18169
Date Revision 05 Dec 2016 Reviewed 05 Dec 2016
Tom Thumb Training Information
Revision Document ID7880
Date Revision 07 Mar 2011 Reviewed 07 Mar 2011
Tom Thumb Training Information 2009
Revision Document ID15644
Date Revision 16 Sep 2015 Reviewed 16 Sep 2015
Tom Thumb Training Information Training Manual Training Information
Revision Document ID2973
Date Revision 31 Jan 2008 Reviewed 31 Jan 2008
Tom Thumb Training Information Training V1.1
Revision Document ID15641
Date Revision 16 Sep 2015 Reviewed 16 Sep 2015
Training information Infant Resusitation Unit
Revision Document ID8665
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
VM-2500 Product Training Materials - Frequently Asked Questions
Revision Document ID6967
Date Revision 17 Mar 2010 Reviewed 17 Mar 2010
VM-2500 Product Training Materials Capnography Product Application Notes
Revision Document ID6749
Date Revision 08 Feb 2010 Reviewed 08 Feb 2010
VM-2500 Product Training Materials Capnography Product Presentation MASTER
Revision Document ID6750
Date Revision 08 Feb 2010 Reviewed 08 Feb 2010
VM-2500 Product Training Materials Mainstream or Sidestream Capnography
Revision Document ID6753
Date Revision 08 Feb 2010 Reviewed 08 Feb 2010
Audit 01 Picking packing Viamed
Revision Document ID159399
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Infant Resuscitation Cabinet - Training Assessment Form
Revision Document ID14334
Date Revision 25 Sep 2014 Reviewed 25 Sep 2014
VM3COP20.32 Order Checking
Revision Document ID34889
Date Revision 01 Apr 2020 Reviewed 01 Apr 2020
Audit 16 Sales and Marketing Viamed
Revision Document ID159461
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7732
Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7825
Responsibility Allocation : Order Picking 06 Sep 2017
Process: 5
Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 7825
Responsibility Allocation : Order Picking 06 Sep 2017
Process: 7825
Responsibility Allocation : Order Picking 06 Sep 2017
Process: 7
Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 7734
Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 5
Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 7734
Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 7825
Responsibility Allocation : Order Picking 06 Sep 2017
7.2.2
The organization shall review the requirements related to product. This review shall be conducted
prior to the organization’s commitment to supply product to the customer (e.g. submission of tenders,
acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:
a) product requirements are defined and documented;
b) contract or order requirements differing from those previously expressed are resolved;
c) applicable regulatory requirements are met;
d) any user training identified in accordance with 7.2.1 is available or planned to be available;
e) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.5).
When the customer provides no documented statement of requirement, the customer requirements
shall be confirmed by the organization before acceptance.
When product requirements are changed, the organization shall ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements. Review of requirements related to product		Top Level Document: Audit 02 Contract Review and Sales Order Processing Viamed
Revision Document ID163469
Date Revision 27 Sep 2024 Reviewed 27 Sep 2024
Top Level Document: VOP 03 Contract Review, Enquires, Office Processes
Revision Document ID77875
Date Revision 15 Dec 2021 Reviewed 21 May 2024
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7724
Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 5871
Check Sale Or Returns 17 Feb 2016
Process: 5872
Check Sale Or Returns Export 17 Feb 2016
Process: 7990
Verification Invoice Details Accounts 07 Feb 2022
7.2.3
The organization shall plan and document arrangements for communicating with customers in relation
to:
a) product information;
b) enquiries, contracts or order handling, including amendments;
c) customer feedback, including complaints;
d) advisory notices.
The organization shall communicate with regulatory authorities in accordance with applicable
regulatory requirements. Communication		Top Level Document: VOP 03 Contract Review, Enquires, Office Processes
Revision Document ID77875
Date Revision 15 Dec 2021 Reviewed 21 May 2024
Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Top Level Document: Audit 02 Contract Review and Sales Order Processing Viamed
Revision Document ID163469
Date Revision 27 Sep 2024 Reviewed 27 Sep 2024
VM3COP27.31 Processing Proforma Invoices and Quotations
Revision Document ID69812
Date Revision 15 Sep 2021 Reviewed 15 Sep 2021
VM3COP20.05 New Orders - How to enter into Opera Viamed
Revision Document ID13695
Date Revision 12 May 2014 Reviewed 12 May 2014
VM3COP20.32 Order Checking
Revision Document ID34889
Date Revision 01 Apr 2020 Reviewed 01 Apr 2020
VM3COP20.49 Informing Customers of Price Amends
Revision Document ID18357
Date Revision 05 Jan 2017 Reviewed 05 Jan 2017
VM3COP20.031 Viamed Repair Procedures Invoicing / customer paperwork
Revision Document ID24753
Date Revision 21 Dec 2017 Reviewed 21 Dec 2017
VM3COP20.22 Quoting Customer Special prices.
Revision Document ID15613
Date Revision 09 Sep 2015 Reviewed 09 Sep 2015
VM3COP10.02 Product Recall locate products out in the Field
Revision Document ID74788
Date Revision 12 Nov 2021 Reviewed 12 Nov 2021
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 01 Picking packing Viamed
Revision Document ID159399
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 04 Accounts and Finance Viamed
Revision Document ID159427
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 16 Sales and Marketing Viamed
Revision Document ID159461
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 2
Answering Telephones 16 Feb 2016
Process: 7710
Responsibility Allocation : Proforma And Quote Processing 29 Jun 2016
Process: 7825
Responsibility Allocation : Order Picking 06 Sep 2017
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7726
Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 5943
Check Cardea And Multiquote 08 Mar 2016
Process: 7678
Check Catalog 360 Circle For Quotes And Orders 08 Apr 2016
Process: 7758
Check For GHX Orders 17 Jan 2017
Process: 7760
Send Service Offers 31 Jan 2017
Process: 7670
Humanmed general Issues 09 Mar 2016
Process: 7782
Remove Started But Not Used Order Numbers 08 Feb 2017
Process: 7797
Check Order Are Being Picked In Priority Order 10 May 2017
Process: 7798
Orders And Items Shipped Per Month 10 May 2017
Process: 7957
Warehouse Requests 29 May 2020
Process: 6959
Responsibility Allocation : Sales Forward Orders Review 09 Mar 2016
Process: 6921
Responsibility Allocation : Customer pricing agreements 09 Mar 2016
Process: 5876
E.Commerce Cardea And Multiquote 17 Feb 2016
Process: 7748
Check Repair Orders 10 Oct 2016
Process: 7860
Goods Out Picking 03 Oct 2017
Process: 5
Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 6
Responsibility Allocation : Updating Contact Management System 16 Feb 2016
Process: 7
Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 8
Responsibility Allocation : Order And Status Liaison With Customers 16 Feb 2016
Process: 9
Distribution Of Faxes 16 Feb 2016
Process: 10
Distribution Of Emails 16 Feb 2016
Process: 11
Distribution Of Post 16 Feb 2016
Process: 12
Responsibility Allocation : Sales And Technical Information Processing 16 Feb 2016
Process: 36
Emailing Of Invoices 16 Feb 2016
Process: 5850
Purchase Order Log 17 Feb 2016
Process: 5875
Check Paypal For Orders 17 Feb 2016
Process: 5857
Customer Service Logs 17 Feb 2016
Process: 5891
Processing Of Repair Quotes And Orders 25 Feb 2016
Process: 5892
Checking EBay And Amazon For Orders And Messages 25 Feb 2016
Process: 5893
Answering Website Questions 25 Feb 2016
Process: 5899
Proforma And Quote Chasing 25 Feb 2016
Process: 5901
Link Call Log Contacts To The CRM 02 Mar 2016
Process: 5913
Check For Humanmed Orders In Logistics Mailbox 03 Mar 2016
Process: 6958
Responsibility Allocation : Shipped Order Queries 09 Mar 2016
Process: 7686
Thorough Checking Of Awaiting Action Tray - Priority 8s 21 Apr 2016
Process: 7734
Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 7735
Ensure SOR`s Are Followed Up 01 Sep 2016
Process: 7792
Shipped Order Success Report 13 Mar 2017
Process: 7990
Verification Invoice Details Accounts 07 Feb 2022
Process: 7993
Verification Warranty Repairs Customer Approval 07 Feb 2022
Process: 7914
Proofs of Delivery 02 Oct 2018
7.3
Design and development		Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.1
The organization shall document procedures for design and development General		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
BSI Technical File Design File Requirements Dosier
Revision Document ID4959
Date Revision 29 Dec 2008 Reviewed 29 Dec 2008
CE & Design files re-organisation
Revision Document ID9085
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
Chart 04 Design and Development
Revision Document ID8678
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 17 Design Repairs
Revision Document ID8690
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Chart 30 System Design Plan
Revision Document ID8703
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
New Project Design File Content
Revision Document ID9093
Date Revision 18 Oct 2011 Reviewed 18 Oct 2011
VM3COP16 Design and Design Changes Design requirements
Revision Document ID7396
Date Revision 10 Jan 2011 Reviewed 10 Jan 2011
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.2
The organization shall plan and control the design and development of product. As appropriate,
design and development planning documents shall be maintained and updated as the design and
development progresses.
During design and development planning, the organization shall document:
a) the design and development stages;
b) the review(s) needed at each design and development stage;
c) the verification, validation, and design transfer activities that are appropriate at each design and
development stage;
d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design and
development inputs;
f) the resources needed including necessary competence of personnel Design and development planning		Top Level Document: VM3COP27.11 Performing a Technical File PMS and risk assessment
Revision Document ID75465
Date Revision 18 Nov 2021 Reviewed 18 Nov 2021
Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Top Level Document: VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Revision Document ID151817
Date Revision 21 May 2024 Reviewed 21 May 2024
VM3COP16 Design and Design Changes Design requirements
Revision Document ID7396
Date Revision 10 Jan 2011 Reviewed 10 Jan 2011
VM3COP27.07 Project Manager
Revision Document ID12734
Date Revision 11 Jul 2013 Reviewed 11 Jul 2013
VM3COP27.12 Clinical Evaluation Risk assessment Technical Files
Revision Document ID15453
Date Revision 11 Aug 2015 Reviewed 11 Aug 2015
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 08 Training, Competence and Human Resources Viamed
Revision Document ID162725
Date Revision 19 Sep 2024 Reviewed 19 Sep 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
QC 28B Design Changes
Revision Document ID25508
Date Revision 05 Mar 2018 Reviewed 05 Mar 2018
Generic CE File Attached to All Assignment of responsibility Risk Management
Revision Document ID7742
Date Revision 02 Mar 2011 Reviewed 02 Mar 2011
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.3
Inputs relating to product requirements shall be determined and records maintained (see 4.2.5). These
inputs shall include:
a) functional, performance, usability and safety requirements, according to the intended use;
b) applicable regulatory requirements and standards;
c) applicable output(s) of risk management;
d) as appropriate, information derived from previous similar designs;
e) other requirements essential for design and development of the product and processes.
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict
with each other.
NOTE Further information can be found in IEC 62366–1.

Design and development inputs		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.4
Design and development outputs shall:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production and service provision;
c) contain or reference product acceptance criteria;
d) specify the characteristics of the product that are essential for its safe and proper use.
The outputs of design and development shall be in a form suitable for verification against the design
and development inputs and shall be approved prior to release.
Records of the design and development outputs shall be maintained (see 4.2.5). Design and development outputs		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.5
Design and development review		Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.5
At suitable stages, systematic reviews of design and development shall be performed in accordance
with planned and documented arrangements to:
a) evaluate the ability of the results of design and development to meet requirements;
b) identify and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and
development stage being reviewed, as well as other specialist personnel.
Records of the results of the reviews and any necessary actions shall be maintained and include the
identification of the design under review, the participants involved and the date of the review (see 4.2.5).		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.6
Design and development verification shall be performed in accordance with planned and documented
arrangements to ensure that the design and development outputs have met the design and development
input requirements.
The organization shall document verification plans that include methods, acceptance criteria and, as
appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have an interface with, other
medical device(s), verification shall include confirmation that the design outputs meet design inputs
when so connected or interfaced.
Records of the results and conclusions of the verification and necessary actions shall be maintained
(see 4.2.4 and 4.2.5). Design and development verification		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Top Level Document: VOP 15 Data and Information Analysis
Revision Document ID137913
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.7
Design and development validation		Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
QC 30b Project Verification & Validation Summary Master
Revision Document ID25482
Date Revision 01 Mar 2018 Reviewed 01 Mar 2018
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.7
Design and development validation shall be performed in accordance with planned and documented
arrangements to ensure that the resulting product is capable of meeting the requirements for the
specified application or intended use.
The organization shall document validation plans that include methods, acceptance criteria, and, as
appropriate, statistical techniques with rationale for sample size.
Design validation shall be conducted on representative product. Representative product includes
initial production units, batches or their equivalents. The rationale for the choice of product used for
validation shall be recorded (see 4.2.5).
As part of design and development validation, the organization shall perform clinical evaluations or
performance evaluations of the medical device in accordance with applicable regulatory requirements.
A medical device used for clinical evaluation or performance evaluation is not considered to be released
for use to the customer.
If the intended use requires that the medical device be connected to, or have an interface with, other
medical device(s), validation shall include confirmation that the requirements for the specified
application or intended use have been met when so connected or interfaced.
Validation shall be completed prior to release for use of the product to the customer.
Records of the results and conclusion of validation and necessary actions shall be maintained (see
4.2.4 and 4.2.5).
Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Top Level Document: VOP 15 Data and Information Analysis
Revision Document ID137913
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.8
The organization shall document procedures for transfer of design and development outputs to
manufacturing. These procedures shall ensure that design and development outputs are verified
as suitable for manufacturing before becoming final production specifications and that production
capability can meet product requirements.
Results and conclusions of the transfer shall be recorded (see 4.2.5). Design and development transfer		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.9
The organization shall document procedures to control design and development changes. The
organization shall determine the significance of the change to function, performance, usability, safety
and applicable regulatory requirements for the medical device and its intended use.
Design and development changes shall be identified. Before implementation, the changes shall be:
a) reviewed;
b) verified;
c) validated, as appropriate;
d) approved.
The review of design and development changes shall include evaluation of the effect of the changes on
constituent parts and product in process or already delivered, inputs or outputs of risk management
and product realization processes.
Records of changes, their review and any necessary actions shall be maintained (see 4.2.5). Control of design and development changes		Top Level Document: VOP 17 Design Research and Development
Revision Document ID25632
Date Revision 19 Mar 2018 Reviewed 19 Mar 2018
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
QC 28B Design Changes
Revision Document ID25508
Date Revision 05 Mar 2018 Reviewed 05 Mar 2018
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7726
Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.3.10
The organization shall maintain a design and development file for each medical device type or medical
device family. This file shall include or reference records generated to demonstrate conformity to the
requirements for design and development and records for design and development changes. Design and development files		Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 12 CE Files Viamed
Revision Document ID159449
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7172
Responsibility Allocation : CE Technical Files 09 Mar 2016
7.4
Purchasing		DO NOT USE VM3COP04 Purchasing / suppliers
Revision Document ID15473
Date Revision 14 Aug 2015 Reviewed 14 Aug 2015
VM3COP20.29 Checking the Purchase Order Log
Revision Document ID73132
Date Revision 25 Oct 2021 Reviewed 25 Oct 2021
VM3COP27.34 Sending Purchase Orders to Suppliers
Revision Document ID17070
Date Revision 22 Jun 2016 Reviewed 22 Jun 2016
VM3COP04.01 QC06 Supplier Questionnaire ISO Questionnaire Viamed Blank
Revision Document ID21304
Date Revision 06 Aug 2017 Reviewed 06 Aug 2017
Process: 5850
Purchase Order Log 17 Feb 2016
Process: 7707
Send Purchase Orders To Suppliers 13 Jun 2016
7.4.1
The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to
specified purchasing information.
The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be:
a) based on the supplier’s ability to provide product that meets the organizations’ requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the quality of the medical device;
d) proportionate to the risk associated with the medical device.
The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in
meeting requirements for the purchased product shall be monitored. The results of the monitoring
shall provide an input into the supplier re-evaluation process.
Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the
risk associated with the purchased product and compliance with applicable regulatory requirements.
Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or
performance and any necessary actions arising from these activities shall be maintained (see 4.2.5). Purchasing process		Top Level Document: VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Revision Document ID75847
Date Revision 23 Nov 2021 Reviewed 23 Nov 2021
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Top Level Document: VOP 21 Risk, Risk Management and Risk Analysis
Revision Document ID75935
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Audit 05 Purchasing suppliers Viamed
Revision Document ID159433
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 5855
Purchase Order Requirements Teledyne 17 Feb 2016
Process: 8030
Purchase Order Invoice Review 23 Jun 2023
7.4.2
Purchasing information shall describe or reference the product to be purchased, including as appropriate:
a) product specifications;
b) requirements for product acceptance, procedures, processes and equipment;
c) requirements for qualification of supplier personnel;
d) quality management system requirements.
The organization shall ensure the adequacy of specified purchasing requirements prior to their
communication to the supplier.
Purchasing information shall include, as applicable, a written agreement that the supplier notify the
organization of changes in the purchased product prior to implementation of any changes that affect
the ability of the purchased product to meet specified purchase requirements.
To the extent required for traceability given in 7.5.9, the organization shall maintain relevant purchasing
information in the form of documents (see 4.2.4) and records (see 4.2.5). Purchasing information		Top Level Document: VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Revision Document ID75847
Date Revision 23 Nov 2021 Reviewed 23 Nov 2021
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Audit 05 Purchasing suppliers Viamed
Revision Document ID159433
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 6821
Responsibility Allocation : VIAMED Management Meeting Supplier Review 09 Mar 2016
Process: 6831
Responsibility Allocation : VIAMED Management Meeting Supplier Review - Min / Max - Re-Orders 09 Mar 2016
Process: 28
Supplier Review 16 Feb 2016
Process: 5868
Return Goods To Suppliers 17 Feb 2016
Process: 6829
Supplier Review - Outstanding orders 09 Mar 2016
Process: 6832
Supplier Review Future orders 09 Mar 2016
Process: 7679
Check Stock Requirements Supplier Teledyne 18 Apr 2016
Process: 7680
Check Stock Requirements Supplier Envitec 18 Apr 2016
Process: 7681
Check Stock Requirements Supplier Posey 18 Apr 2016
Process: 7682
Check Stock Requirements Supplier Bluepoint 18 Apr 2016
Process: 7683
Check Stock For Proforma 18 Apr 2016
Process: 7784
Check Returns Supplier Envitec 15 Feb 2017
Process: 7785
Check Returns Supplier Teledyne 15 Feb 2017
Process: 7786
Check Returns Supplier Maxtec 15 Feb 2017
Process: 7787
Check Returns All Supplier 15 Feb 2017
Process: 7826
Goods In Processes 06 Sep 2017
Process: 7923
Review Of Credits Received From Suppliers 08 Jan 2019
Process: 6819
Supplier Payments and Invoice processing 09 Mar 2016
Process: 7882
Purchase Payments 23 Oct 2017
Process: 7933
Purchasing Invoice Processing 22 Mar 2019
Process: 8030
Purchase Order Invoice Review 23 Jun 2023
7.4.3
The organization shall establish and implement the inspection or other activities necessary for ensuring
that purchased product meets specified purchasing requirements. The extent of verification activities
shall be based on the supplier evaluation results and proportionate to the risks associated with the
purchased product.
When the organization becomes aware of any changes to the purchased product, the organization shall
determine whether these changes affect the product realization process or the medical device.
When the organization or its customer intends to perform verification at the supplier’s premises,
the organization shall state the intended verification activities and method of product release in the
purchasing information.
Records of the verification shall be maintained (see 4.2.5). Verification of purchased product		Top Level Document: VOP 06 Measurement Control Viamed VST, Calibration, QA Stock
Revision Document ID168580
Date Revision 22 Nov 2024 Reviewed 22 Nov 2024
Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 8030
Purchase Order Invoice Review 23 Jun 2023
7.5
Production and service provision
7.5.1
Production and service provision shall be planned, carried out, monitored and controlled to ensure that
product conforms to specification. As appropriate, production controls shall include but are not limited to:
a) documentation of procedures and methods for the control of production (see 4.2.4);
b) qualification of infrastructure;
c) implementation of monitoring and measurement of process parameters and product characteristics;
d) availability and use of monitoring and measuring equipment;
e) implementation of defined operations for labelling and packaging;
f) implementation of product release, delivery and post-delivery activities.
The organization shall establish and maintain a record (see 4.2.5) for each medical device or batch of
medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount
manufactured and amount approved for distribution. The record shall be verified and approved. Control of production and service provision		Top Level Document: VOP 06 Measurement Control Viamed VST, Calibration, QA Stock
Revision Document ID168580
Date Revision 22 Nov 2024 Reviewed 22 Nov 2024
Top Level Document: VOP 08 Production, Reworks, New Production
Revision Document ID31072
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 22 Picking and Packing Dispatch and Goods Out
Revision Document ID164829
Date Revision 14 Oct 2024 Reviewed 14 Oct 2024
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
VM3COP20.37 Generating a New Service Visit
Revision Document ID17116
Date Revision 28 Jun 2016 Reviewed 28 Jun 2016
Audit 01 Picking packing Viamed
Revision Document ID159399
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 15 Production Viamed
Revision Document ID159459
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 06 Calibration VIAMED
Revision Document ID168080
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 24 Service Logs Viamed
Revision Document ID159493
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7714
Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 7727
Audit 15 Production Viamed 24 Aug 2016
Process: 7673
Check Expiry Dated Stock 09 Mar 2016
Process: 6850
Current Stock Levels 09 Mar 2016
Process: 6838
Opera Negative Stock 09 Mar 2016
Process: 5858
Opera Stock Adjustments 17 Feb 2016
Process: 5935
Stock Allocations 05 Mar 2016
Process: 6945
Missing Stock or Adjustments 09 Mar 2016
Process: 6955
Production Requirements 09 Mar 2016
Process: 7689
Move Stock From QA Shelf To Stock Shelf Monday 21 Apr 2016
Process: 7694
Move Stock From QA Shelf To Stock Shelf Tuesday 28 Apr 2016
Process: 7695
Top Up Quick Shipping Shelves 28 Apr 2016
7.5.2
The organization shall document requirements for cleanliness of product or contamination control
of product if:
a) product is cleaned by the organization prior to sterilization or its use;
b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or
its use;
c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;
d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;
e) process agents are to be removed from product during manufacture.
If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply
prior to the cleaning process. Cleanliness of product		Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
7.5.3
The organization shall document requirements for medical device installation and acceptance criteria
for verification of installation, as appropriate.
If the agreed customer requirements allow installation of the medical device to be performed by an
external party other than the organization or its supplier, the organization shall provide documented
requirements for medical device installation and verification of installation.
Records of medical device installation and verification of installation performed by the organization or
its supplier shall be maintained (see 4.2.5). Installation activities		Resuscitation Unit and TC400 Maintenance TC400 Installation Instructions
Revision Document ID8155
Date Revision 24 Mar 2011 Reviewed 24 Mar 2011
Resuscitation Unit Instructions for Use / Installation Ceratherm v3.01 Resuscitation Unit and TC400 Maintenance
Revision Document ID8178
Date Revision 24 Mar 2011 Reviewed 24 Mar 2011
Resuscitation Unit Instructions for Use / User Manual Nufer Wall Mount Installation
Revision Document ID1312
Date Revision 19 Mar 2007 Reviewed 19 Mar 2007
VM3COP51.20 Resuscitation Cabinet Installation Instructions
Revision Document ID18221
Date Revision 12 Dec 2016 Reviewed 12 Dec 2016
Audit 24 Service Logs Viamed
Revision Document ID159493
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
7.5.4
If servicing of the medical device is a specified requirement, the organization shall document servicing
procedures, reference materials, and reference measurements, as necessary, for performing servicing
activities and verifying that product requirements are met.
The organization shall analyse records of servicing activities carried out by the organization or its
supplier:
a) to determine if the information is to be handled as a complaint;
b) as appropriate, for input to the improvement process.
Records of servicing activities carried out by the organization or its supplier shall be maintained (see
4.2.5). Servicing activities		Top Level Document: VM3COP50.13 Quality Control Tom Thumb
Revision Document ID31154
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
VM3COP20.27 Annual Services for Resuscitation Cabinets
Revision Document ID24509
Date Revision 06 Dec 2017 Reviewed 06 Dec 2017
VM3COP20.37 Generating a New Service Visit
Revision Document ID17116
Date Revision 28 Jun 2016 Reviewed 28 Jun 2016
VM3COP50.12 Quality Control / Service Checks Tom Thumb
Revision Document ID15367
Date Revision 05 Aug 2015 Reviewed 05 Aug 2015
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 24 Service Logs Viamed
Revision Document ID159493
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 5857
Customer Service Logs 17 Feb 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
7.5.5
The organization shall maintain records of the sterilization process parameters used for each
sterilization batch (see 4.2.5). Sterilization records shall be traceable to each production batch of
medical devices. Particular requirements for sterile medical devices		Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
7.5.6
The organization shall validate any processes for production and service provision where the resulting
output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence,
deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results consistently.
The organization shall document procedures for validation of processes including:
a) defined criteria for review and approval of the processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes
e) requirements for records (see 4.2.5);
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes.
The organization shall document procedures for the validation of the application of computer software
used in production and service provision. Such software applications shall be validated prior to initial
use and, as appropriate, after changes to such software or its application. The specific approach and
activities associated with software validation and revalidation shall be proportionate to the risk
associated with the use of the software including the effect on the ability of the product to conform to
specifications.
Records of the results and conclusion of validation and necessary actions from the validation shall be
maintained (see 4.2.4 and 4.2.5). Validation of processes for production and service provision		Top Level Document: VOP 27 Software Validation
Revision Document ID91486
Date Revision 10 Jun 2022 Reviewed 10 Jun 2022
Top Level Document: VOP 15 Data and Information Analysis
Revision Document ID137913
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
VM3COP18 Post Market Surveilance
Revision Document ID75985
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Audit 03 Design Control Viamed
Revision Document ID159133
Date Revision 09 Aug 2024 Reviewed 09 Aug 2024
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 24 Service Logs Viamed
Revision Document ID159493
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7849
Review Product Failures New Codes 28 Sep 2017
Process: 7870
Software Validation Non Conformance Product Risk Feedback Loop 15 Oct 2017
Process: 7879
Software Validation Scheduled Tasks And Audits 22 Oct 2017
Process: 7850
Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7851
Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852
Software Validation Expired Stock 01 Oct 2017
Process: 7853
Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854
Software Validation In Production List 01 Oct 2017
Process: 7855
Software Validation - Production Lists 01 Oct 2017
Process: 7856
Software Validation Unchecked Orders 01 Oct 2017
Process: 7857
Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858
Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861
Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7865
Software Validation Conflicting Audits 07 Oct 2017
Process: 7875
Software Validation Document Control 20 Oct 2017
Process: 7880
Software Validation Out Of Date Documents 22 Oct 2017
Process: 7881
Software Validation - Live Orders 22 Oct 2017
7.5.7
The organization shall document procedures (see 4.2.4) for the validation of processes for sterilization
and sterile barrier systems.
Processes for sterilization and sterile barrier systems shall be validated prior to implementation and
following product or process changes, as appropriate.
Records of the results and, conclusion of validation and necessary actions from the validation shall be
maintained (see 4.2.4 and 4.2.5).
NOTE Further information can be found in ISO 11607-1 and ISO 11607-2. Particular requirements for validation of processes for sterilization and sterile barrier systems		Top Level Document: VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Revision Document ID74571
Date Revision 10 Nov 2021 Reviewed 01 Aug 2024
7.5.8
The organization shall document procedures for product identification and identify product by suitable
means throughout product realization.
The organization shall identify product status with respect to monitoring and measurement
requirements throughout product realization. Identification of product status shall be maintained
throughout production, storage, installation and servicing of product to ensure that only product that
has passed the required inspections and tests or released under an authorized concession is dispatched,
used or installed.
If required by applicable regulatory requirements, the organization shall document a system to assign
unique device identification to the medical device.
The organization shall document procedures to ensure that medical devices returned to the
organization are identified and distinguished from conforming product. Identification		Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Process: 8024
Discontinue/Supersede Stock 01 Mar 2023
7.5.9
Traceability		VM3COP14.01 Disposition of Documents / Records.
Revision Document ID15464
Date Revision 14 Aug 2015 Reviewed 14 Aug 2015
7.5.9.1
The organization shall document procedures for traceability. These procedures shall define the
extent of traceability in accordance with applicable regulatory requirements and the records to be
maintained (see 4.2.5). General		VM3COP14.01 Disposition of Documents / Records.
Revision Document ID15464
Date Revision 14 Aug 2015 Reviewed 14 Aug 2015
VM3COP23.00 EAN13 Barcodes to Stock and the Online Databases
Revision Document ID75624
Date Revision 22 Nov 2021 Reviewed 22 Nov 2021
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
7.5.9.2
The records required for traceability shall include records of components, materials, and conditions for
the work environment used, if these could cause the medical device not to satisfy its specified safety
and performance requirements.
The organization shall require that suppliers of distribution services or distributors maintain records of
the distribution of medical devices to allow traceability and that these records are available for inspection.
Records of the name and address of the shipping package consignee shall be maintained (see 4.2.5). Particular requirements for implantable medical devices		Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
7.5.10
The organization shall identify, verify, protect, and safeguard customer property provided for use
or incorporation into the product while it is under the organization’s control or being used by the
organization. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the
organization shall report this to the customer and maintain records (see 4.2.5). Customer property 		Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
DO NOT USE VM3COP09 Repairs
Revision Document ID8712
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
VM3COP20.03 Repair Procedures Goods in
Revision Document ID13703
Date Revision 13 May 2014 Reviewed 13 May 2014
VM3COP20.031 Viamed Repair Procedures Invoicing / customer paperwork
Revision Document ID24753
Date Revision 21 Dec 2017 Reviewed 21 Dec 2017
VM3COP20.47 Collecting Repair Paperwork
Revision Document ID17485
Date Revision 15 Sep 2016 Reviewed 15 Sep 2016
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Process: 7684
Repairs Ready For Quote 18 Apr 2016
Process: 7685
Repairs Ready For Invoice 18 Apr 2016
Process: 5891
Processing Of Repair Quotes And Orders 25 Feb 2016
Process: 7693
Collect Repair Filing From Warehouse 22 Apr 2016
Process: 7863
Maintain Repair Codes List 05 Oct 2017
Process: 6847
Responsibility Allocation : Quarantine Repairs 09 Mar 2016
Process: 6862
Current Repairs 09 Mar 2016
Process: 7674
Check Repairs Ready For Invoice List 10 Mar 2016
Process: 7897
Daily O2 Sensors Returns 04 Jan 2018
Process: 7944
Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST 09 Oct 2019
Process: 7690
Ship Repairs 21 Apr 2016
Process: 7748
Check Repair Orders 10 Oct 2016
Process: 7749
Check Repair Quotes 10 Oct 2016
Process: 7752
SRS Folder 22 Nov 2016
Process: 8060
Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST Phils Issue 03 Jan 2024
7.5.11
The organization shall document procedures for preserving the conformity of product to requirements
during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts
of a medical device.
The organization shall protect product from alteration, contamination or damage when exposed to
expected conditions and hazards during processing, storage, handling, and distribution by:
a) designing and constructing suitable packaging and shipping containers;
b) documenting requirements for special conditions needed if packaging alone cannot provide
preservation.
If special conditions are required, they shall be controlled and recorded (see 4.2.5). Preservation of product		Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Revision Document ID137933
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Revision Document ID75943
Date Revision 24 Nov 2021 Reviewed 24 Nov 2021
VM3COP20.03 Repair Procedures Goods in
Revision Document ID13703
Date Revision 13 May 2014 Reviewed 13 May 2014
VM3COP20.031 Viamed Repair Procedures Invoicing / customer paperwork
Revision Document ID24753
Date Revision 21 Dec 2017 Reviewed 21 Dec 2017
Audit 01 Picking packing Viamed
Revision Document ID159399
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7684
Repairs Ready For Quote 18 Apr 2016
Process: 7685
Repairs Ready For Invoice 18 Apr 2016
Process: 5891
Processing Of Repair Quotes And Orders 25 Feb 2016
Process: 7673
Check Expiry Dated Stock 09 Mar 2016
7.6
The organization shall determine the monitoring and measurement to be undertaken and the
monitoring and measuring equipment needed to provide evidence of conformity of product to
determined requirements.
The organization shall document procedures to ensure that monitoring and measurement can be
carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements.
As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards: when no such standards
exist, the basis used for calibration or verification shall be recorded (see 4.2.5);
b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded (see
4.2.5);
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
The organization shall perform calibration or verification in accordance with documented procedures.
In addition, the organization shall assess and record the validity of the previous measuring results
when the equipment is found not to conform to requirements. The organization shall take appropriate
action in regard to the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.5).
The organization shall document procedures for the validation of the application of computer software
used for the monitoring and measurement of requirements. Such software applications shall be
validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be
proportionate to the risk associated with the use of the software including the effect on the ability of
the product to conform to specifications.
Records of the results and conclusion of validation and necessary actions from the validation shall be
maintained (see 4.2.4 and 4.2.5).
NOTE Further information can be found in ISO 10012. Control of monitoring and measuring equipment		Top Level Document: VOP 06 Measurement Control Viamed VST, Calibration, QA Stock
Revision Document ID168580
Date Revision 22 Nov 2024 Reviewed 22 Nov 2024
DO NOT USE VM3COP11 Calibration
Revision Document ID8713
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Explanation Control of documents
Revision Document ID21322
Date Revision 06 Aug 2017 Reviewed 06 Aug 2017
Audit 06 Calibration VIAMED
Revision Document ID168080
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Process: 7048
Control of monitoring and measuring devices 09 Mar 2016

8 Measurement, analysis and improvement

8
Measurement, analysis and improvement
8.1
The organization shall plan and implement the monitoring, measurement, analysis and improvement
processes needed to:
a) demonstrate conformity of product;
b) ensure conformity of the quality management system;
c) maintain the effectiveness of the quality management system.
This shall include determination of appropriate methods, including statistical techniques, and the
extent of their use. General		Top Level Document: VM3COP27.11 Performing a Technical File PMS and risk assessment
Revision Document ID75465
Date Revision 18 Nov 2021 Reviewed 18 Nov 2021
Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Top Level Document: VOP 15 Data and Information Analysis
Revision Document ID137913
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
DO NOT USE VM3COP13 Audits
Revision Document ID8715
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Process: 7714
Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7718
Audit 06 Calibration Viamed 24 Aug 2016
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7724
Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 7726
Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7727
Audit 15 Production Viamed 24 Aug 2016
Process: 7728
Audit 17 Internal Audits Viamed 24 Aug 2016
Process: 7729
Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7731
Audit 21 Audit Of Audit Viamed 24 Aug 2016
Process: 7732
Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7733
Audit 23 Analysis Of Data Viamed 24 Aug 2016
Process: 7834
Financial Review 20 Sep 2017
Process: 7862
Review The Audit Calender Screen 04 Oct 2017
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
Process: 5877
Review Company Data 17 Feb 2016
Process: 7070
Management Review 09 Mar 2016
Process: 7830
Review Q.A. Failures Report 18 Sep 2017
Process: 7837
Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 7838
Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7839
Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7840
Review VST Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7841
Review VST Feedback - Customer Complaints 23 Sep 2017
Process: 7842
Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7843
Review VST Product Feedback Negative 23 Sep 2017
Process: 7848
Review ISO Scopes 27 Sep 2017
Process: 7849
Review Product Failures New Codes 28 Sep 2017
Process: 7871
Review Exclusion From Viamed 13485:2016 And VST 9001:2015 15 Oct 2017
Process: 7874
Review For Latest Version Med Dev 2.12. 18 Oct 2017
Process: 7876
Maintain Update Of ISO Route Maps 21 Oct 2017
Process: 7878
Review Possible Upcoming Regulation Changes 22 Oct 2017
8.2
Monitoring and measurement
8.2.1
As one of the measurements of the effectiveness of the quality management system, the organization
shall gather and monitor information relating to whether the organization has met customer
requirements. The methods for obtaining and using this information shall be documented.
The organization shall document procedures for the feedback process. This feedback process shall
include provisions to gather data from production as well as post-production activities.
The information gathered in the feedback process shall serve as potential input into risk management
for monitoring and maintaining the product requirements as well as the product realization or
improvement processes.
If applicable regulatory requirements require the organization to gain specific experience from postproduction activities, the review of this experience shall form part of the feedback process. Feedback		Top Level Document: VM3COP27.11 Performing a Technical File PMS and risk assessment
Revision Document ID75465
Date Revision 18 Nov 2021 Reviewed 18 Nov 2021
Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Management Review
Revision Document ID30851
Date Revision 18 Sep 2019 Reviewed 18 Sep 2019
Management reviews
Revision Document ID19801
Date Revision 05 May 2017 Reviewed 05 May 2017
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7877
Disaster Planning 21 Oct 2017
Process: 5877
Review Company Data 17 Feb 2016
8.2.2
The organization shall document procedures for timely complaint handling in accordance with
applicable regulatory requirements.
These procedures shall include at a minimum requirements and responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions.
If any complaint is not investigated, justification shall be documented. Any correction or corrective
action resulting from the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the complaint, relevant
information shall be exchanged between the organization and the external party involved.
Complaint handling records shall be maintained (see 4.2.5). Complaint handling		Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
8.2.3
If applicable regulatory requirements require notification of complaints that meet specified reporting
criteria of adverse events or issuance of advisory notices, the organization shall document procedures
for providing notification to the appropriate regulatory authorities.
Records of reporting to regulatory authorities shall be maintained (see 4.2.5). Reporting to regulatory authorities		Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
MHRA Correspondence / RG2 Devices list
Revision Document ID14763
Date Revision 12 Feb 2015 Reviewed 12 Feb 2015
MHRA Appendix A / Appendix B Class 1 Device Codes
Revision Document ID4798
Date Revision 24 Oct 2008 Reviewed 24 Oct 2008
CE Guidance 19 Own Brand MHRA position obl
Revision Document ID3656
Date Revision 29 Apr 2008 Reviewed 29 Apr 2008
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
8.2.4
The organization shall conduct internal audits at planned intervals to determine whether the quality
management system:
a) conforms to planned and documented arrangements, requirements of this International Standard,
quality management system requirements established by the organization, and applicable
regulatory requirements;
b) is effectively implemented and maintained.
The organization shall document a procedure to describe the responsibilities and requirements for
planning and conducting audits and recording and reporting audit results.
An audit program shall be planned, taking into consideration the status and importance of the processes
and area to be audited, as well as the results of previous audits. The audit criteria, scope, interval and
methods shall be defined and recorded (see 4.2.5). The selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Records of the audits and their results, including identification of the processes and areas audited and
the conclusions, shall be maintained (see 4.2.5).
The management responsible for the area being audited shall ensure that any necessary corrections
and corrective actions are taken without undue delay to eliminate detected nonconformities and their
causes. Follow-up activities shall include the verification of the actions taken and the reporting of
verification results.
NOTE Further information can be found in ISO 19011. Internal audit		Top Level Document: Audit 02 Contract Review and Sales Order Processing Viamed
Revision Document ID163469
Date Revision 27 Sep 2024 Reviewed 27 Sep 2024
Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Audit 01 Picking packing Viamed
Revision Document ID159399
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 06 Calibration VIAMED
Revision Document ID168080
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Audit 08 Training, Competence and Human Resources Viamed
Revision Document ID162725
Date Revision 19 Sep 2024 Reviewed 19 Sep 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 15 Production Viamed
Revision Document ID159459
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 17 Internal Audits Viamed
Revision Document ID159465
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Revision Document ID159483
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 21 Audit of Audit Viamed
Revision Document ID159485
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Explanation Employee Roles and Titles
Revision Document ID22144
Date Revision 20 Sep 2017 Reviewed 20 Sep 2017
DO NOT USE VM3COP13 Audits
Revision Document ID8715
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Audit Schedule
Revision Document ID23221
Date Revision 24 Oct 2017 Reviewed 24 Oct 2017
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 24 Service Logs Viamed
Revision Document ID159493
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7714
Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7715
Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7716
Audit 03 Design Control Viamed 24 Aug 2016
Process: 7717
Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7718
Audit 06 Calibration Viamed 24 Aug 2016
Process: 7719
Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7720
Audit 08 Training Viamed 24 Aug 2016
Process: 7721
Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 7722
Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7723
Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7725
Audit 12 CE Files Viamed 24 Aug 2016
Process: 7724
Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7726
Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7727
Audit 15 Production Viamed 24 Aug 2016
Process: 7728
Audit 17 Internal Audits Viamed 24 Aug 2016
Process: 7729
Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 7730
Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7731
Audit 21 Audit Of Audit Viamed 24 Aug 2016
Process: 7732
Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7733
Audit 23 Analysis Of Data Viamed 24 Aug 2016
8.2.5
The organization shall apply suitable methods for monitoring and, as appropriate, measurement of the
quality management system processes. These methods shall demonstrate the ability of the processes to
achieve planned results. When planned results are not achieved, correction and corrective action shall
be taken, as appropriate. Monitoring and measurement of processes		Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 27
Management Reviews And Quality Audits 16 Feb 2016
8.2.6
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at applicable stages of the product realization
process in accordance with the planned and documented arrangements and documented procedures.
Evidence of conformity with the acceptance criteria shall be maintained. The identity of the person
authorizing release of product shall be recorded (see 4.2.5). As appropriate, records shall identify the
test equipment used to perform measurement activities.
Product release and service delivery shall not proceed until the planned and documented arrangements
have been satisfactorily completed.
For implantable medical devices, the organization shall record the identity of personnel performing any
inspection or testing. Monitoring and measurement of product		DO NOT USE VM3COP11 Calibration
Revision Document ID8713
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
OLD DO NOT USE VM3COP29 Production
Revision Document ID8727
Date Revision 12 Oct 2011 Reviewed 12 Oct 2011
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 15 Production Viamed
Revision Document ID159459
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
8.3
Control of nonconforming product		Process: 8024
Discontinue/Supersede Stock 01 Mar 2023
8.3.1
The organization shall ensure that product which does not conform to product requirements is
identified and controlled to prevent its unintended use or delivery. The organization shall document
a procedure to define the controls and related responsibilities and authorities for the identification,
documentation, segregation, evaluation, and disposition of nonconforming product.
The evaluation of nonconformity shall include a determination of the need for an investigation and
notification of any external party responsible for the nonconformity.
Records of the nature of the nonconformities and any subsequent action taken, including the evaluation,
any investigation and the rationale for decisions shall be maintained (see 4.2.5) General		Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Top Level Document: VOP 10 Non Conformance, Corrective and Preventive Actions
Revision Document ID124938
Date Revision 24 Jul 2023 Reviewed 24 Jul 2023
VM3COP10.02 Product Recall locate products out in the Field
Revision Document ID74788
Date Revision 12 Nov 2021 Reviewed 12 Nov 2021
Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 09 Goods Inward and Product Identity Viamed
Revision Document ID166168
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
8.3.2
The organization shall deal with nonconforming product by one or more of the following ways:
a) taking action to eliminate the detected nonconformity;
b) taking action to preclude its original intended use or application;
c) authorizing its use, release or acceptance under concession.
The organization shall ensure that nonconforming product is accepted by concession only if the
justification is provided, approval is obtained, and applicable regulatory requirements are met.
Records of the acceptance by concession and the identity of the person authorizing the concession shall
be maintained (see 4.2.5). Actions in response to nonconforming product detected before delivery		Audit 07 Handling and Storage Viamed
Revision Document ID159437
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
8.3.3
When nonconforming product is detected after delivery or use has started, the organization shall take
action appropriate to the effects, or potential effects, of the nonconformity. Records of actions taken
shall be maintained (see 4.2.5).
The organization shall document procedures for issuing advisory notices in accordance with applicable
regulatory requirements. These procedures shall be capable of being put into effect at any time. Records
of actions relating to the issuance of advisory notices shall be maintained (see 4.2.5). Actions in response to nonconforming product detected after delivery		Top Level Document: VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Revision Document ID132118
Date Revision 18 Oct 2023 Reviewed 18 Oct 2023
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
8.3.4
The organization shall perform rework in accordance with documented procedures that takes into
account the potential adverse effect of the rework on the product. These procedures shall undergo the
same review and approval as the original procedure.
After the completion of rework, product shall be verified to ensure that it meets applicable acceptance
criteria and regulatory requirements.
Records of rework shall be maintained (see 4.2.5). Rework		Top Level Document: VOP 09 Repairs and Servicing
Revision Document ID137919
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Top Level Document: VOP 08 Production, Reworks, New Production
Revision Document ID31072
Date Revision 30 Sep 2019 Reviewed 30 Sep 2019
Audit 11 Repairs, Servicing and Returns Viamed
Revision Document ID166158
Date Revision 25 Oct 2024 Reviewed 25 Oct 2024
8.4
The organization shall document procedures to determine, collect and analyse appropriate data
to demonstrate the suitability, adequacy and effectiveness of the quality management system. The
procedures shall include determination of appropriate methods, including statistical techniques and
the extent of their use.
The analysis of data shall include data generated as a result of monitoring and measurement and from
other relevant sources and include, at a minimum, input from:
a) feedback;
b) conformity to product requirements;
c) characteristics and trends of processes and product including opportunities for improvement;
d) suppliers;
e) audits;
f) service reports, as appropriate.
If the analysis of data shows that the quality management system is not suitable, adequate or effective,
the organization shall use this analysis as input for improvement as required in 8.5.
Records of the results of analyses shall be maintained (see 4.2.5). Analysis of data		Top Level Document: VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Revision Document ID135771
Date Revision 28 Nov 2023 Reviewed 28 Nov 2023
Top Level Document: VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Revision Document ID75847
Date Revision 23 Nov 2021 Reviewed 23 Nov 2021
Top Level Document: VOP 15 Data and Information Analysis
Revision Document ID137913
Date Revision 27 Dec 2023 Reviewed 27 Dec 2023
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Process: 8026
Automotive Competitor Price Review 10 Mar 2023
8.5
Improvement
8.5.1
The organization shall identify and implement any changes necessary to ensure and maintain the
continued suitability, adequacy and effectiveness of the quality management system as well as medical
device safety and performance through the use of the quality policy, quality objectives, audit results, postmarket surveillance, analysis of data, corrective actions, preventive actions and management review. General		Top Level Document: VOP 10 Non Conformance, Corrective and Preventive Actions
Revision Document ID124938
Date Revision 24 Jul 2023 Reviewed 24 Jul 2023
Audit 06 Calibration VIAMED
Revision Document ID168080
Date Revision 18 Nov 2024 Reviewed 18 Nov 2024
Audit 18 Management Review Viamed
Revision Document ID159471
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 22 Post Market Survellance Viamed
Revision Document ID159383
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 23 Analysis of Data Viamed
Revision Document ID158752
Date Revision 06 Aug 2024 Reviewed 06 Aug 2024
Audit 21 Audit of Audit Viamed
Revision Document ID159485
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
8.5.2
The organization shall take action to eliminate the cause of nonconformities in order to prevent
recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions
shall be proportionate to the effects of the nonconformities encountered.
The organization shall document a procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action, including, as appropriate,
updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet applicable
regulatory requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken
Records of the results of any investigation and action taken shall be maintained (see 4.2.5). Corrective action		Top Level Document: VOP 10 Non Conformance, Corrective and Preventive Actions
Revision Document ID124938
Date Revision 24 Jul 2023 Reviewed 24 Jul 2023
Audit 20 Process verification to Managment Viamed
Revision Document ID159389
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control Viamed
Revision Document ID159363
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Audit 10 Documentation Control VST
Revision Document ID159361
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
8.5.3
The organization shall determine action to eliminate the causes of potential nonconformities in
order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the
potential problems.
The organization shall document a procedure to describe requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action, including, as appropriate,
updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate.
Records of the results of any investigations and of action taken shall be maintained (see 4.2.5). Preventive action		Top Level Document: VOP 10 Non Conformance, Corrective and Preventive Actions
Revision Document ID124938
Date Revision 24 Jul 2023 Reviewed 24 Jul 2023
Audit 14 Complaints and Corrective Actions Viamed
Revision Document ID159455
Date Revision 13 Aug 2024 Reviewed 13 Aug 2024
Process: 7839
Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7838
Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7842
Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7849
Review Product Failures New Codes 28 Sep 2017
Process: 6866
Internal Process Verification Complete Systems Review 09 Mar 2016
Process: 7743
Customer Complaints Paper File 26 Sep 2016
Process: 7199
Non Conformities Review Viamed 09 Mar 2016
Process: 7671
Humanmed Non Conformances 09 Mar 2016
Process: 7091
Calibration Index 09 Mar 2016
Process: 7138
Non Conformance Issues Any New QC21 Forms 09 Mar 2016

Document IDSub Processes
ID168096 Viamed ISO 13485:2016 Scope
Process: 5887 Review ISO/EN Documents 24 Feb 2016
Process: 7848 Review ISO Scopes 27 Sep 2017
ID74571 VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO
Process: 5887 Review ISO/EN Documents 24 Feb 2016
Process: 7871 Review Exclusion From Viamed 13485:2016 And VST 9001:2015 15 Oct 2017
ID164833 VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives
Process: 23 Company Objectives 16 Feb 2016
Process: 22 Company Policys 16 Feb 2016
Process: 7828 Review The Quality Policy Viamed 16 Sep 2017
Process: 7833 Importance Of Effective Quality Management 20 Sep 2017
ID167103 VM3COP02.02 Viamed Company Responsibilitys organisation chart structure
Process: 5877 Review Company Data 17 Feb 2016
ID117540 Viamed Certification ISO 13485:2016 MD78787
Process: 5887 Review ISO/EN Documents 24 Feb 2016
ID120321 VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records
Process: 5940 Thumb Nail Processor 07 Mar 2016
Process: 7827 Review The Quality Policy VST 16 Sep 2017
Process: 7828 Review The Quality Policy Viamed 16 Sep 2017
Process: 5934 Responsibility Allocation : Staff Training 05 Mar 2016
Process: 7032 Responsibility Allocation : Document Requirements 09 Mar 2016
Process: 41 Responsibility Allocation : Documentation Control 16 Feb 2016
Process: 59 Out Of Date Documents 17 Feb 2016
Process: 5851 Duplicate Documents 17 Feb 2016
Process: 5852 Responsibility Allocation : Retention Of Records 17 Feb 2016
Process: 7130 Intrastats Information for Intrastats and L Drive 09 Mar 2016
Process: 5890 Check Website ISO Documents 24 Feb 2016
Process: 7200 Responsibility Allocation : ISO Issues 09 Mar 2016
Process: 7744 FDA Device Establishment Registration And Listing 28 Sep 2016
Process: 7941 Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found. 23 Sep 2019
Process: 7987 Sync External Telephone Logs 07 Feb 2022
Process: 7992 COSHH Datasheet Reminders 07 Feb 2022
Process: 8001 Verification Stock Linked To Documents 08 Feb 2022
Process: 8029 Send Intercompany Invoices To Jean 12 Apr 2023
Process: 8032 Review Contact Documentation 22 Aug 2023
Process: 8050 Master Indemnity Register 29 Dec 2023
Process: 8053 Check The Whos Who 29 Dec 2023
ID159363 Audit 10 Documentation Control Viamed
Process: 10 Distribution Of Emails 16 Feb 2016
Process: 5939 Responsibility Allocation : Email ISP Routing 05 Mar 2016
Process: 5940 Thumb Nail Processor 07 Mar 2016
Process: 11 Distribution Of Post 16 Feb 2016
Process: 6 Responsibility Allocation : Updating Contact Management System 16 Feb 2016
Process: 52 Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 53 Emails 16 Feb 2016
Process: 7672 Off Site Backup 09 Mar 2016
Process: 7700 Domain Name Management 19 May 2016
Process: 9 Distribution Of Faxes 16 Feb 2016
Process: 15 Filing and Archiving 16 Feb 2016
Process: 7711 Import Bank CSV 01 Jul 2016
Process: 7722 Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7693 Collect Repair Filing From Warehouse 22 Apr 2016
Process: 12 Responsibility Allocation : Sales And Technical Information Processing 16 Feb 2016
Process: 16 Responsibility Allocation : Photocopying 16 Feb 2016
Process: 5901 Link Call Log Contacts To The CRM 02 Mar 2016
Process: 7699 Shred Sensitive Paperwork In JL Office 19 May 2016
Process: 7705 Checking For Uploaded Files 08 Jun 2016
Process: 7754
Process: 6938 Responsibility Allocation : Customer Database Updates 09 Mar 2016
Process: 6940 Responsibility Allocation : Customer Ongoing task List 09 Mar 2016
Process: 7090 Responsibility Allocation : Office Procedures 09 Mar 2016
Process: 7032 Responsibility Allocation : Document Requirements 09 Mar 2016
Process: 41 Responsibility Allocation : Documentation Control 16 Feb 2016
Process: 59 Out Of Date Documents 17 Feb 2016
Process: 5851 Duplicate Documents 17 Feb 2016
Process: 5852 Responsibility Allocation : Retention Of Records 17 Feb 2016
Process: 7124 Responsibility Allocation : Intrastats 09 Mar 2016
Process: 7125 Responsibility Allocation : Intrastats Urgent Problems 09 Mar 2016
Process: 7126 Intrastats Requested Page updates 09 Mar 2016
Process: 7127 Responsibility Allocation : Intrastats Unfinished in progress Processes 09 Mar 2016
Process: 7128 Responsibility Allocation : Intrastats Future Features needed 09 Mar 2016
Process: 7129 Intrastats Cross Reference Database Tables Updates 09 Mar 2016
Process: 7130 Intrastats Information for Intrastats and L Drive 09 Mar 2016
Process: 7131 Responsibility Allocation : Intrastats Opera 09 Mar 2016
Process: 7133 Responsibility Allocation : Intrastats Contact Manager 09 Mar 2016
Process: 7739 Intrastats Amendment Log 12 Sep 2016
Process: 5877 Review Company Data 17 Feb 2016
Process: 44 Secure Socket Level Certificate 16 Feb 2016
Process: 5890 Check Website ISO Documents 24 Feb 2016
Process: 7770 Audit 10 Documentation Control VST 08 Feb 2017
Process: 7863 Maintain Repair Codes List 05 Oct 2017
Process: 7922 Back Up Emily`s Accounts Docs 04 Jan 2019
Process: 7987 Sync External Telephone Logs 07 Feb 2022
Process: 7992 COSHH Datasheet Reminders 07 Feb 2022
Process: 8001 Verification Stock Linked To Documents 08 Feb 2022
Process: 8029 Send Intercompany Invoices To Jean 12 Apr 2023
Process: 8032 Review Contact Documentation 22 Aug 2023
Process: 8039 Weee Report Due Vandagraph Annual 29 Dec 2023
Process: 8050 Master Indemnity Register 29 Dec 2023
Process: 8053 Check The Whos Who 29 Dec 2023
ID159361 Audit 10 Documentation Control VST
Process: 10 Distribution Of Emails 16 Feb 2016
Process: 5939 Responsibility Allocation : Email ISP Routing 05 Mar 2016
Process: 5940 Thumb Nail Processor 07 Mar 2016
Process: 11 Distribution Of Post 16 Feb 2016
Process: 6 Responsibility Allocation : Updating Contact Management System 16 Feb 2016
Process: 52 Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 53 Emails 16 Feb 2016
Process: 7672 Off Site Backup 09 Mar 2016
Process: 7700 Domain Name Management 19 May 2016
Process: 9 Distribution Of Faxes 16 Feb 2016
Process: 15 Filing and Archiving 16 Feb 2016
Process: 7711 Import Bank CSV 01 Jul 2016
Process: 7722 Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7693 Collect Repair Filing From Warehouse 22 Apr 2016
Process: 12 Responsibility Allocation : Sales And Technical Information Processing 16 Feb 2016
Process: 16 Responsibility Allocation : Photocopying 16 Feb 2016
Process: 5901 Link Call Log Contacts To The CRM 02 Mar 2016
Process: 7699 Shred Sensitive Paperwork In JL Office 19 May 2016
Process: 7705 Checking For Uploaded Files 08 Jun 2016
Process: 7754
Process: 6938 Responsibility Allocation : Customer Database Updates 09 Mar 2016
Process: 6940 Responsibility Allocation : Customer Ongoing task List 09 Mar 2016
Process: 7090 Responsibility Allocation : Office Procedures 09 Mar 2016
Process: 7032 Responsibility Allocation : Document Requirements 09 Mar 2016
Process: 41 Responsibility Allocation : Documentation Control 16 Feb 2016
Process: 59 Out Of Date Documents 17 Feb 2016
Process: 5851 Duplicate Documents 17 Feb 2016
Process: 5852 Responsibility Allocation : Retention Of Records 17 Feb 2016
Process: 7124 Responsibility Allocation : Intrastats 09 Mar 2016
Process: 7125 Responsibility Allocation : Intrastats Urgent Problems 09 Mar 2016
Process: 7126 Intrastats Requested Page updates 09 Mar 2016
Process: 7127 Responsibility Allocation : Intrastats Unfinished in progress Processes 09 Mar 2016
Process: 7128 Responsibility Allocation : Intrastats Future Features needed 09 Mar 2016
Process: 7129 Intrastats Cross Reference Database Tables Updates 09 Mar 2016
Process: 7130 Intrastats Information for Intrastats and L Drive 09 Mar 2016
Process: 7131 Responsibility Allocation : Intrastats Opera 09 Mar 2016
Process: 7133 Responsibility Allocation : Intrastats Contact Manager 09 Mar 2016
Process: 7739 Intrastats Amendment Log 12 Sep 2016
Process: 5877 Review Company Data 17 Feb 2016
Process: 44 Secure Socket Level Certificate 16 Feb 2016
Process: 5890 Check Website ISO Documents 24 Feb 2016
Process: 7770 Audit 10 Documentation Control VST 08 Feb 2017
Process: 7863 Maintain Repair Codes List 05 Oct 2017
Process: 7922 Back Up Emily`s Accounts Docs 04 Jan 2019
Process: 7987 Sync External Telephone Logs 07 Feb 2022
Process: 7992 COSHH Datasheet Reminders 07 Feb 2022
Process: 8001 Verification Stock Linked To Documents 08 Feb 2022
Process: 8029 Send Intercompany Invoices To Jean 12 Apr 2023
Process: 8032 Review Contact Documentation 22 Aug 2023
Process: 8039 Weee Report Due Vandagraph Annual 29 Dec 2023
Process: 8050 Master Indemnity Register 29 Dec 2023
Process: 8053 Check The Whos Who 29 Dec 2023
ID8700 Chart 27 Customer Complaints Chart 27
Process: 7743 Customer Complaints Paper File 26 Sep 2016
ID159389 Audit 20 Process verification to Managment Viamed
Process: 7701 AWS Amazon Web Services 23 May 2016
Process: 7723 Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7730 Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7827 Review The Quality Policy VST 16 Sep 2017
Process: 7828 Review The Quality Policy Viamed 16 Sep 2017
Process: 7771 Audit 10b Process Verification VST 08 Feb 2017
Process: 7778 Audit 20 Process Verification To Managment VST 08 Feb 2017
Process: 6866 Internal Process Verification Complete Systems Review 09 Mar 2016
Process: 7755 Fast Hosts Invoice 08 Dec 2016
Process: 7845 7.1.4 Environment Of Operations 25 Sep 2017
Process: 7846 ISO System Management Review Viamed 26 Sep 2017
Process: 7837 Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 7832 Cleardown Emailed Invoices 20 Sep 2017
Process: 7848 Review ISO Scopes 27 Sep 2017
Process: 7851 Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852 Software Validation Expired Stock 01 Oct 2017
Process: 7853 Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854 Software Validation In Production List 01 Oct 2017
Process: 7855 Software Validation - Production Lists 01 Oct 2017
Process: 7856 Software Validation Unchecked Orders 01 Oct 2017
Process: 7857 Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858 Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861 Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7850 Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7871 Review Exclusion From Viamed 13485:2016 And VST 9001:2015 15 Oct 2017
Process: 7865 Software Validation Conflicting Audits 07 Oct 2017
Process: 7870 Software Validation Non Conformance Product Risk Feedback Loop 15 Oct 2017
Process: 7879 Software Validation Scheduled Tasks And Audits 22 Oct 2017
Process: 7875 Software Validation Document Control 20 Oct 2017
Process: 7880 Software Validation Out Of Date Documents 22 Oct 2017
Process: 7881 Software Validation - Live Orders 22 Oct 2017
ID16995 VM3COP27.17 Complete Auto_calender Issues
Process: 27 Management Reviews And Quality Audits 16 Feb 2016
ID85362 VM3COP27.02 Collecting Emails and Distributing
Process: 10 Distribution Of Emails 16 Feb 2016
ID159471 Audit 18 Management Review Viamed
Process: 55 Business Continuity Plan 17 Feb 2016
Process: 23 Company Objectives 16 Feb 2016
Process: 6813 Management Meeting Turnover Report 09 Mar 2016
Process: 27 Management Reviews And Quality Audits 16 Feb 2016
Process: 22 Company Policys 16 Feb 2016
Process: 7750 Meeting With Management 14 Oct 2016
Process: 7793 Team Review Meeting 16 Mar 2017
Process: 7753 Management Meeting Warehouse 22 Nov 2016
Process: 6861 Management Meeting Review Weekly Meeting 09 Mar 2016
Process: 7833 Importance Of Effective Quality Management 20 Sep 2017
Process: 7834 Financial Review 20 Sep 2017
Process: 26 Company Resources 16 Feb 2016
Process: 30 Responsibility Allocation : MHRA Licences And Notifications 16 Feb 2016
Process: 31 Responsibility Allocation : Notified Body Notifications 16 Feb 2016
Process: 32 MDALL Listings 16 Feb 2016
Process: 7057 Responsibility Allocation : Complaints and Vigilance Notifications 09 Mar 2016
Process: 7070 Management Review 09 Mar 2016
Process: 29 Responsibility Allocation : CMDCAS Updates And Licences 16 Feb 2016
Process: 5889 Responsibility Allocation : Audit And Task - Audit 24 Feb 2016
Process: 7744 FDA Device Establishment Registration And Listing 28 Sep 2016
Process: 7829
Process: 6871 ISO14001 Environmental management systems 09 Mar 2016
Process: 7874 Review For Latest Version Med Dev 2.12. 18 Oct 2017
Process: 7877 Disaster Planning 21 Oct 2017
Process: 7876 Maintain Update Of ISO Route Maps 21 Oct 2017
Process: 7878 Review Possible Upcoming Regulation Changes 22 Oct 2017
Process: 7886 Audit 18 Management Review Viamed 24 Oct 2017
Process: 7887 Audit 18 Management Review VST 24 Oct 2017
Process: 7890 New UPS Rates Needs Checking 24 Oct 2017
Process: 7888 Review Processes Linked To VOPs And Audits 24 Oct 2017
Process: 7895 FDA Device Establishment Registration 29 Oct 2017
Process: 7912 Review The Personel Information We Collect Or Store 20 Sep 2018
Process: 7913 Review Personnel Files 20 Sep 2018
Process: 7918 Backup Jeans Local Folder 08 Nov 2018
Process: 7964 Check Roles And Tasks For Incomplete Data 29 Oct 2020
Process: 7980 Review Gov Website For Applicable Required Standards ISO9001 15 Nov 2021
Process: 7972 ISO System Management Review Vst 26 Oct 2021
Process: 7977 Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting 11 Nov 2021
Process: 7978 Regulatory Requirements and Review of QC21 form template 11 Nov 2021
Process: 7979 Review The Template Of The QC 21 Form To Ensure It Is Current And Valid 12 Nov 2021
Process: 7981 Review Process Updates For Risk To Systems 18 Nov 2021
Process: 8018 Wednesday Meeting 09 Aug 2022
Process: 8026 Automotive Competitor Price Review 10 Mar 2023
Process: 8025 Check We Do Not Require A EU European Representatives 09 Mar 2023
Process: 8036 Future Issues Review 19 Dec 2023
Process: 8041 Quarterly Sales And Marketing Meeting 29 Dec 2023
Process: 8072 Quartly Sales And Marketing Meeting Due 03 Jan 2024
Process: 8073 Quarterly Stock Meeting Due 03 Jan 2024
Process: 8074 Carbon Reduction Planning 26 Jan 2024
ID135771 VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market
Process: 55 Business Continuity Plan 17 Feb 2016
Process: 23 Company Objectives 16 Feb 2016
Process: 27 Management Reviews And Quality Audits 16 Feb 2016
Process: 7714 Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7715 Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7716 Audit 03 Design Control Viamed 24 Aug 2016
Process: 7717 Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 7718 Audit 06 Calibration Viamed 24 Aug 2016
Process: 7719 Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7720 Audit 08 Training Viamed 24 Aug 2016
Process: 7721 Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 7722 Audit 10 Documentation Control Viamed 24 Aug 2016
Process: 7723 Audit 10b Process Verification Viamed 24 Aug 2016
Process: 7724 Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7725 Audit 12 CE Files Viamed 24 Aug 2016
Process: 7726 Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 7727 Audit 15 Production Viamed 24 Aug 2016
Process: 7728 Audit 17 Internal Audits Viamed 24 Aug 2016
Process: 7729 Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 7730 Audit 20 Process Verification To Managment Viamed 24 Aug 2016
Process: 7731 Audit 21 Audit Of Audit Viamed 24 Aug 2016
Process: 7732 Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 7733 Audit 23 Analysis Of Data Viamed 24 Aug 2016
Process: 6828
Process: 22 Company Policys 16 Feb 2016
Process: 7754
Process: 7763 Audit 02 Contract Review VST 08 Feb 2017
Process: 7765 Audit 05 Purchasing Suppliers VST 08 Feb 2017
Process: 7767 Audit 07 Handling And Storage VST 08 Feb 2017
Process: 7768 Audit 08 Training VST 08 Feb 2017
Process: 7769 Audit 09 Goods Inward And Product Identity VST 08 Feb 2017
Process: 7771 Audit 10b Process Verification VST 08 Feb 2017
Process: 7772 Audit 11 Repairs And Service VST 08 Feb 2017
Process: 7773 Audit 12 CE Files VST 08 Feb 2017
Process: 7774 Audit 14 Complaints And Corrective Actions VST 08 Feb 2017
Process: 7775 Audit 15 Production VST 08 Feb 2017
Process: 7776 Audit 17 Internal Audits VST 08 Feb 2017
Process: 7777 Audit 19 Health And Saftey VST 08 Feb 2017
Process: 7778 Audit 20 Process Verification To Managment VST 08 Feb 2017
Process: 7779 Audit 21 Audit Of Audit VST 08 Feb 2017
Process: 7780 Audit 22 Post Market Survellance VST 08 Feb 2017
Process: 7781 Audit 23 Analysis Of Data VST 08 Feb 2017
Process: 7808 Ensure All Invoice Correctly Tagged 02 Jun 2017
Process: 6886 Responsibility Allocation : VIAMED Sales And Marketing Sales Viamed Medical Export 09 Mar 2016
Process: 6887 Responsibility Allocation : VIAMED Sales And Marketing Sales Viamed Automotive Export 09 Mar 2016
Process: 7204 Responsibility Allocation : VIAMED Board Directors Meeting Distributor Issues 09 Mar 2016
Process: 24 Responsibility Allocation : Compliance ISO Standards 16 Feb 2016
Process: 28 Supplier Review 16 Feb 2016
Process: 6865 Responsibility Allocation : Non Conformance Effectiveness 09 Mar 2016
Process: 6866 Internal Process Verification Complete Systems Review 09 Mar 2016
Process: 7172 Responsibility Allocation : CE Technical Files 09 Mar 2016
Process: 7782 Remove Started But Not Used Order Numbers 08 Feb 2017
Process: 7090 Responsibility Allocation : Office Procedures 09 Mar 2016
Process: 7138 Non Conformance Issues Any New QC21 Forms 09 Mar 2016
Process: 57 Temporary Stock Notices 17 Feb 2016
Process: 5854 Stock FAQ Admin List 17 Feb 2016
Process: 7043 Responsibility Allocation : Planning of product realization 09 Mar 2016
Process: 7045 Responsibility Allocation : Design and Development 09 Mar 2016
Process: 38 Audits Up to Date and Confirm next years Audit schedule 16 Feb 2016
Process: 5877 Review Company Data 17 Feb 2016
Process: 6904 Responsibility Allocation : Sales And Marketing Internal sales 09 Mar 2016
Process: 6944 Responsibility Allocation : Stock Meeting 09 Mar 2016
Process: 7846 ISO System Management Review Viamed 26 Sep 2017
Process: 7834 Financial Review 20 Sep 2017
Process: 26 Company Resources 16 Feb 2016
Process: 7070 Management Review 09 Mar 2016
Process: 7837 Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 5887 Review ISO/EN Documents 24 Feb 2016
Process: 5889 Responsibility Allocation : Audit And Task - Audit 24 Feb 2016
Process: 7071 Post Market Surveillance 09 Mar 2016
Process: 7093 BSI Audits Calander 09 Mar 2016
Process: 7829
Process: 7762 Audit 01 Picking Packing VST 08 Feb 2017
Process: 7764 Audit 03 Design Control VST 08 Feb 2017
Process: 7766 Audit 06 Calibration VST 08 Feb 2017
Process: 7770 Audit 10 Documentation Control VST 08 Feb 2017
Process: 7670 Humanmed general Issues 09 Mar 2016
Process: 6821 Responsibility Allocation : VIAMED Management Meeting Supplier Review 09 Mar 2016
Process: 6831 Responsibility Allocation : VIAMED Management Meeting Supplier Review - Min / Max - Re-Orders 09 Mar 2016
Process: 6833 Responsibility Allocation : VIAMED Management Meeting MDA Recalls 09 Mar 2016
Process: 6834 Responsibility Allocation : VIAMED Management Meeting Additional Purchase Orders 09 Mar 2016
Process: 6836 Responsibility Allocation : VIAMED Management Meeting Research and Development rnd 09 Mar 2016
Process: 6920 Responsibility Allocation : VIAMED Sales And Marketing Price Lists UK 09 Mar 2016
Process: 6924 Responsibility Allocation : VIAMED Sales And Marketing Price Lists Export 09 Mar 2016
Process: 6935 Responsibility Allocation : VIAMED Sales And Marketing Products to be Marketed 09 Mar 2016
Process: 6936 Responsibility Allocation : VIAMED Sales And Marketing NHS Supplies Future Technology 09 Mar 2016
Process: 6941 Responsibility Allocation : VIAMED Sales And Marketing New Potential Products 09 Mar 2016
Process: 7039 Responsibility Allocation : Provision of Resources 09 Mar 2016
Process: 7187 Responsibility Allocation : VIAMED Board Directors Meeting Profiability 09 Mar 2016
Process: 7196 Responsibility Allocation : VIAMED Board Directors Meeting Stock Levels 09 Mar 2016
Process: 6871 ISO14001 Environmental management systems 09 Mar 2016
Process: 7830 Review Q.A. Failures Report 18 Sep 2017
Process: 7848 Review ISO Scopes 27 Sep 2017
Process: 7849 Review Product Failures New Codes 28 Sep 2017
Process: 7862 Review The Audit Calender Screen 04 Oct 2017
Process: 7877 Disaster Planning 21 Oct 2017
Process: 7879 Software Validation Scheduled Tasks And Audits 22 Oct 2017
Process: 7876 Maintain Update Of ISO Route Maps 21 Oct 2017
Process: 7878 Review Possible Upcoming Regulation Changes 22 Oct 2017
Process: 7885 Audit 04 Accounts and Finance Viamed 23 Oct 2017
Process: 7886 Audit 18 Management Review Viamed 24 Oct 2017
Process: 7887 Audit 18 Management Review VST 24 Oct 2017
Process: 7889 Audit 24 Servicing Viamed 24 Oct 2017
Process: 7888 Review Processes Linked To VOPs And Audits 24 Oct 2017
Process: 7965 VST Feedback 29 Oct 2020
Process: 7964 Check Roles And Tasks For Incomplete Data 29 Oct 2020
Process: 7980 Review Gov Website For Applicable Required Standards ISO9001 15 Nov 2021
Process: 7972 ISO System Management Review Vst 26 Oct 2021
Process: 7973 VST Product Performance - Customers 27 Oct 2021
Process: 7974 VST Product Performance - Suppliers 27 Oct 2021
Process: 7977 Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting 11 Nov 2021
Process: 7978 Regulatory Requirements and Review of QC21 form template 11 Nov 2021
Process: 7981 Review Process Updates For Risk To Systems 18 Nov 2021
Process: 8012 VAT Return Viamed Properties 06 Apr 2022
Process: 8014 Review VIAMED Product Feedback Positive 25 Jul 2022
Process: 8015 Review VST Product Feedback Positive 25 Jul 2022
Process: 8016 Review VIAMED Customer Feedback Positive 25 Jul 2022
Process: 8017 Review VST Customer Feedback Positive 25 Jul 2022
Process: 8018 Wednesday Meeting 09 Aug 2022
Process: 8019 Audit 04 Accounts And Finance VST 14 Sep 2022
Process: 8036 Future Issues Review 19 Dec 2023
Process: 8041 Quarterly Sales And Marketing Meeting 29 Dec 2023
Process: 8072 Quartly Sales And Marketing Meeting Due 03 Jan 2024
Process: 8073 Quarterly Stock Meeting Due 03 Jan 2024
ID159433 Audit 05 Purchasing suppliers Viamed
Process: 7707 Send Purchase Orders To Suppliers 13 Jun 2016
Process: 6972 UPS Shipping Fuel Surcharge 09 Mar 2016
Process: 7717 Audit 05 Purchasing Suppliers Viamed 24 Aug 2016
Process: 5850 Purchase Order Log 17 Feb 2016
Process: 7751 VST Purchase Order Log 02 Nov 2016
Process: 7765 Audit 05 Purchasing Suppliers VST 08 Feb 2017
Process: 7794 V1000 Commissions Review 30 Mar 2017
Process: 7745 UPS Invoices Viamed 06 Oct 2016
Process: 7746 UPS Invoices VST 06 Oct 2016
Process: 7747 UPS Invoices Vandagraph 06 Oct 2016
Process: 7790 Humanmed Invoice them For Previous Month 10 Mar 2017
Process: 28 Supplier Review 16 Feb 2016
Process: 6960
Process: 5855 Purchase Order Requirements Teledyne 17 Feb 2016
Process: 5866 UPS Shipping Fuel Surcharge 17 Feb 2016
Process: 5868 Return Goods To Suppliers 17 Feb 2016
Process: 6829 Supplier Review - Outstanding orders 09 Mar 2016
Process: 6832 Supplier Review Future orders 09 Mar 2016
Process: 6848
Process: 6952 Responsibility Allocation : Lost in Shipping Claims 09 Mar 2016
Process: 6971 Responsibility Allocation : Freight Courier Cost Request 09 Mar 2016
Process: 7679 Check Stock Requirements Supplier Teledyne 18 Apr 2016
Process: 7680 Check Stock Requirements Supplier Envitec 18 Apr 2016
Process: 7681 Check Stock Requirements Supplier Posey 18 Apr 2016
Process: 7682 Check Stock Requirements Supplier Bluepoint 18 Apr 2016
Process: 7784 Check Returns Supplier Envitec 15 Feb 2017
Process: 7785 Check Returns Supplier Teledyne 15 Feb 2017
Process: 7786 Check Returns Supplier Maxtec 15 Feb 2017
Process: 7787 Check Returns All Supplier 15 Feb 2017
Process: 34 Responsibility Allocation : Insurance Is Upto Date 16 Feb 2016
Process: 7683 Check Stock For Proforma 18 Apr 2016
Process: 7882 Purchase Payments 23 Oct 2017
Process: 7956 Teledyne Stock For Vandagraph 27 May 2020
Process: 7975 Arrange Teledyne Returns 03 Nov 2021
Process: 7984 Check For Viking Invoices 19 Jan 2022
Process: 7991 Verification Purchasing Documentation 07 Feb 2022
Process: 8003 Verification Supplier Delivery Notes 17 Feb 2022
Process: 8030 Purchase Order Invoice Review 23 Jun 2023
Process: 8034 Purchase Order Invoice Review Stage 2 30 Nov 2023
Process: 8039 Weee Report Due Vandagraph Annual 29 Dec 2023
Process: 8040 Weee Report Due Vandagraph Qtr 29 Dec 2023
Process: 8051 Purchase Order Log Viamed 29 Dec 2023
ID75847 VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection
Process: 6972 UPS Shipping Fuel Surcharge 09 Mar 2016
Process: 28 Supplier Review 16 Feb 2016
Process: 6960
Process: 7784 Check Returns Supplier Envitec 15 Feb 2017
Process: 7785 Check Returns Supplier Teledyne 15 Feb 2017
Process: 7786 Check Returns Supplier Maxtec 15 Feb 2017
Process: 7787 Check Returns All Supplier 15 Feb 2017
Process: 7975 Arrange Teledyne Returns 03 Nov 2021
Process: 7984 Check For Viking Invoices 19 Jan 2022
Process: 8009 Verification Stock Items And Locations 21 Feb 2022
Process: 7991 Verification Purchasing Documentation 07 Feb 2022
Process: 8002 Verification Todays Goods In 17 Feb 2022
Process: 8003 Verification Supplier Delivery Notes 17 Feb 2022
Process: 8030 Purchase Order Invoice Review 23 Jun 2023
Process: 8034 Purchase Order Invoice Review Stage 2 30 Nov 2023
Process: 8039 Weee Report Due Vandagraph Annual 29 Dec 2023
Process: 8040 Weee Report Due Vandagraph Qtr 29 Dec 2023
Process: 8052 Check Supplier Returns 29 Dec 2023
Process: 8051 Purchase Order Log Viamed 29 Dec 2023
ID91486 VOP 27 Software Validation
Process: 46 Responsibility Allocation : Backup Server Status 16 Feb 2016
Process: 52 Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 7851 Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852 Software Validation Expired Stock 01 Oct 2017
Process: 7853 Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854 Software Validation In Production List 01 Oct 2017
Process: 7855 Software Validation - Production Lists 01 Oct 2017
Process: 7856 Software Validation Unchecked Orders 01 Oct 2017
Process: 7857 Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858 Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861 Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7850 Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7865 Software Validation Conflicting Audits 07 Oct 2017
Process: 7870 Software Validation Non Conformance Product Risk Feedback Loop 15 Oct 2017
Process: 7879 Software Validation Scheduled Tasks And Audits 22 Oct 2017
Process: 7875 Software Validation Document Control 20 Oct 2017
Process: 7880 Software Validation Out Of Date Documents 22 Oct 2017
Process: 7881 Software Validation - Live Orders 22 Oct 2017
Process: 7892 Audit 27 Software Validation Viamed 26 Oct 2017
Process: 8013 Software Validation Test Email System 29 Apr 2022
Process: 8079 Audit 27 Software Validation VST 10 Jul 2024
Process: 8083 **Software Validation SRS To Nonconformance 31 Dec 2024
ID156701 Audit 27 Software Validation Viamed
Process: 52 Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 7668 Responsibility Allocation : Upgrading Intrastats ISO Quality system 09 Mar 2016
Process: 7132 Responsibility Allocation : Intrastats Goldmine 09 Mar 2016
Process: 7851 Software Validation Scan Un-QA Product To Order 01 Oct 2017
Process: 7852 Software Validation Expired Stock 01 Oct 2017
Process: 7853 Software Validation Non Sell Able Shelf 01 Oct 2017
Process: 7854 Software Validation In Production List 01 Oct 2017
Process: 7855 Software Validation - Production Lists 01 Oct 2017
Process: 7856 Software Validation Unchecked Orders 01 Oct 2017
Process: 7857 Software Validation Stock Tracking Check 01 Oct 2017
Process: 7858 Software Validation Attempt To QA Some Stock 01 Oct 2017
Process: 7861 Software Validation Of Training Documents Forced Reading 03 Oct 2017
Process: 7850 Software Validation Scan Incorrect Product 01 Oct 2017
Process: 7865 Software Validation Conflicting Audits 07 Oct 2017
Process: 7870 Software Validation Non Conformance Product Risk Feedback Loop 15 Oct 2017
Process: 7879 Software Validation Scheduled Tasks And Audits 22 Oct 2017
Process: 7875 Software Validation Document Control 20 Oct 2017
Process: 7880 Software Validation Out Of Date Documents 22 Oct 2017
Process: 7881 Software Validation - Live Orders 22 Oct 2017
Process: 7892 Audit 27 Software Validation Viamed 26 Oct 2017
Process: 7951 Server Review 05 Mar 2020
Process: 8013 Software Validation Test Email System 29 Apr 2022
Process: 8083 **Software Validation SRS To Nonconformance 31 Dec 2024
ID159133 Audit 03 Design Control Viamed
Process: 7716 Audit 03 Design Control Viamed 24 Aug 2016
Process: 42 Responsibility Allocation : Design Documentation 16 Feb 2016
Process: 7043 Responsibility Allocation : Planning of product realization 09 Mar 2016
Process: 7045 Responsibility Allocation : Design and Development 09 Mar 2016
Process: 7047 Responsibility Allocation : Production and service provision 09 Mar 2016
Process: 6942 Responsibility Allocation : Co ordination of Implementation 09 Mar 2016
Process: 7173 Responsibility Allocation : Material Generation 09 Mar 2016
Process: 5887 Review ISO/EN Documents 24 Feb 2016
Process: 7764 Audit 03 Design Control VST 08 Feb 2017
Process: 7919 Send Debtors Overview To Derek 06 Dec 2018
ID25632 VOP 17 Design Research and Development
Process: 42 Responsibility Allocation : Design Documentation 16 Feb 2016
Process: 43 Responsibility Allocation : Product Post Market Survelance 16 Feb 2016
Process: 6975 Responsibility Allocation : Projects 09 Mar 2016
Process: 7045 Responsibility Allocation : Design and Development 09 Mar 2016
ID158752 Audit 23 Analysis of Data Viamed
Process: 27 Management Reviews And Quality Audits 16 Feb 2016
Process: 7733 Audit 23 Analysis Of Data Viamed 24 Aug 2016
Process: 7781 Audit 23 Analysis Of Data VST 08 Feb 2017
Process: 5877 Review Company Data 17 Feb 2016
Process: 6931 Customer Complaints 09 Mar 2016
Process: 7839 Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7838 Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 26 Company Resources 16 Feb 2016
Process: 7070 Management Review 09 Mar 2016
Process: 7713 Review Roles And Responsibilitys 17 Aug 2016
Process: 7837 Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 7840 Review VST Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7841 Review VST Feedback - Customer Complaints 23 Sep 2017
Process: 7842 Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7843 Review VST Product Feedback Negative 23 Sep 2017
Process: 7071 Post Market Surveillance 09 Mar 2016
Process: 7830 Review Q.A. Failures Report 18 Sep 2017
Process: 7849 Review Product Failures New Codes 28 Sep 2017
Process: 7862 Review The Audit Calender Screen 04 Oct 2017
Process: 7930 Review Flow Of Data 12 Mar 2019
Process: 7969 Weee Waste Reporting 23 Aug 2021
ID151817 VOP 02 Personnel and Responsibility , Staff and Staffing Issues, Training, Roles and Tasks
Process: 39 Enviromental Policy Document Review 16 Feb 2016
Process: 7741 Review Ethical Policy 14 Sep 2016
Process: 6839 Responsibility Allocation : Personnel Holidays and Time Adjustments 09 Mar 2016
Process: 5881 Training Records Review 18 Feb 2016
Process: 5904 Taking On New Staff 02 Mar 2016
Process: 6837 Personnel Requirements and Training 09 Mar 2016
Process: 6877 Responsibility Allocation : Alarm Key Holders 09 Mar 2016
Process: 6906 Responsibility Allocation : Time Working Away 09 Mar 2016
Process: 6928 Responsibility Allocation : Eye Tests 09 Mar 2016
Process: 7074
Process: 7042 Responsibility Allocation : Work Environment 09 Mar 2016
Process: 5934 Responsibility Allocation : Staff Training 05 Mar 2016
Process: 5874 Childcare Vouchers Edenred 17 Feb 2016
Process: 7753 Management Meeting Warehouse 22 Nov 2016
Process: 34 Responsibility Allocation : Insurance Is Upto Date 16 Feb 2016
Process: 5869 Responsibility Allocation : Legal Company Car Registration 17 Feb 2016
Process: 6841 Responsibility Allocation : Grants 09 Mar 2016
Process: 6843
Process: 6861 Management Meeting Review Weekly Meeting 09 Mar 2016
Process: 30 Responsibility Allocation : MHRA Licences And Notifications 16 Feb 2016
Process: 31 Responsibility Allocation : Notified Body Notifications 16 Feb 2016
Process: 32 MDALL Listings 16 Feb 2016
Process: 7033 Responsibility Allocation : Management commitment to ISO 09 Mar 2016
Process: 7037 Responsibility Allocation : Responsibility, authority and communication 09 Mar 2016
Process: 7057 Responsibility Allocation : Complaints and Vigilance Notifications 09 Mar 2016
Process: 7713 Review Roles And Responsibilitys 17 Aug 2016
Process: 7837 Review External Parties Influencing The QMS VST / Viamed 23 Sep 2017
Process: 29 Responsibility Allocation : CMDCAS Updates And Licences 16 Feb 2016
Process: 7848 Review ISO Scopes 27 Sep 2017
Process: 7891 Fire Alarm Evacuation Drill 25 Oct 2017
Process: 7908 Private Information Data 27 Jul 2018
Process: 7907 Annual Review Doc Management 27 Jul 2018
Process: 7937 Diversity Impact Assessment 27 Jun 2019
Process: 7961 R D Room - Tidy, Empty Bins, Remove Cups. Caution Around Oxygen Supply 05 Oct 2020
Process: 7982 Check There Are No Changes To Employment Law 21 Nov 2021
Process: 7983 To Check On Line And See If There Have Been Any Changes To Gdpr We Need To Be Aware Of. 21 Nov 2021
Process: 8054 Team Building Event - June 29 Dec 2023
Process: 8055 Christmas/Team Building Event - December 29 Dec 2023
Process: 8067 Training Refresh Issues To Send / Questions To Write 03 Jan 2024
ID17423 VM3COP02 Organisation Responsibilities Viamed
Process: 6967 Responsibility Allocation : VIAMED Stock Meeting Repairs Review - Pulse Oximetry Sensors 09 Mar 2016
Process: 7900 Royal Mail - Mail Retention Form 29 Mar 2018
ID119029 VOP 18 Maintenance Building, Fabric and Infrastructure
Process: 5856 Cleaning The Kitchen 17 Feb 2016
Process: 5853 Vacuuming Of The Office, Hall And Meeting Room 17 Feb 2016
Process: 5900 Cleaning Of Office Windows 25 Feb 2016
Process: 5878 Empty Office Bins 18 Feb 2016
Process: 5912 Responsibility Allocation : Main Recycle Bins 03 Mar 2016
Process: 5906 Empty Paper Bins 03 Mar 2016
Process: 7805 Empty Kitchen Bins 22 May 2017
Process: 5909 Empty Warehouse Bins 03 Mar 2016
Process: 7706 Update Virus Software And Scan For Viruses 10 Jun 2016
Process: 7802 Clean Kitchen Sides 22 May 2017
Process: 7803 Dishwashing 22 May 2017
Process: 7804 Sweep Kitchen Floor 22 May 2017
Process: 7806 Watering Plants 22 May 2017
Process: 7807
Process: 54 Responsibility Allocation : Gents Toilets 17 Feb 2016
Process: 5907 Hoover Warehouse 03 Mar 2016
Process: 5908 Sweep Warehouse 03 Mar 2016
Process: 5910 Clean Duckets 03 Mar 2016
Process: 5911 Clear Cardboard 03 Mar 2016
Process: 7698 Clean Toilets 17 May 2016
Process: 7131 Responsibility Allocation : Intrastats Opera 09 Mar 2016
Process: 7133 Responsibility Allocation : Intrastats Contact Manager 09 Mar 2016
Process: 7132 Responsibility Allocation : Intrastats Goldmine 09 Mar 2016
Process: 7896 Tree In Car Park 22 Dec 2017
ID21800 VM3COP19 Health and Safety
Process: 6855 Risk Assessment HSE 09 Mar 2016
ID130426 Viamed Top Level Quality Objectives
Process: 23 Company Objectives 16 Feb 2016
ID77875 VOP 03 Contract Review, Enquires, Office Processes
Process: 5 Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 10 Distribution Of Emails 16 Feb 2016
Process: 36 Emailing Of Invoices 16 Feb 2016
Process: 5892 Checking EBay And Amazon For Orders And Messages 25 Feb 2016
Process: 5894 Checking Of Active List 25 Feb 2016
Process: 7 Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 5943 Check Cardea And Multiquote 08 Mar 2016
Process: 5891 Processing Of Repair Quotes And Orders 25 Feb 2016
Process: 11 Distribution Of Post 16 Feb 2016
Process: 2 Answering Telephones 16 Feb 2016
Process: 37 West Yorkshire Ambulance Stock 16 Feb 2016
Process: 5948 Adding New Accounts To Opera 08 Mar 2016
Process: 5949 Filling Credit Card Slips 08 Mar 2016
Process: 6 Responsibility Allocation : Updating Contact Management System 16 Feb 2016
Process: 5895 Responsibility Allocation : Completing Office Job List 25 Feb 2016
Process: 5875 Check Paypal For Orders 17 Feb 2016
Process: 5944 Responsibility Allocation : Chasing Lost Customers 08 Mar 2016
Process: 3 Responsibility Allocation : Meeting And Greeting Visitors To The Company 16 Feb 2016
Process: 4 Responsibility Allocation : Assisting With Refreshments For Visitors 16 Feb 2016
Process: 7676 PDFing Of Invoices Viamed 17 Mar 2016
Process: 9 Distribution Of Faxes 16 Feb 2016
Process: 7696 Send VIAMED Delivery Notifications 28 Apr 2016
Process: 5857 Customer Service Logs 17 Feb 2016
Process: 5893 Answering Website Questions 25 Feb 2016
Process: 7678 Check Catalog 360 Circle For Quotes And Orders 08 Apr 2016
Process: 15 Filing and Archiving 16 Feb 2016
Process: 5899 Proforma And Quote Chasing 25 Feb 2016
Process: 7710 Responsibility Allocation : Proforma And Quote Processing 29 Jun 2016
Process: 7707 Send Purchase Orders To Suppliers 13 Jun 2016
Process: 14 Fax Paper 16 Feb 2016
Process: 5882 Responsibility Allocation : Send Post To Humanmed 24 Feb 2016
Process: 7734 Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 5850 Purchase Order Log 17 Feb 2016
Process: 7693 Collect Repair Filing From Warehouse 22 Apr 2016
Process: 7677
Process: 21 Office Sales Projects 16 Feb 2016
Process: 8 Responsibility Allocation : Order And Status Liaison With Customers 16 Feb 2016
Process: 12 Responsibility Allocation : Sales And Technical Information Processing 16 Feb 2016
Process: 16 Responsibility Allocation : Photocopying 16 Feb 2016
Process: 17
Process: 20 Processing Of Mail Shots 16 Feb 2016
Process: 5896 Responsibility Allocation : Ensuring ORD`s Are Taken To Goods Out And Invoices Are Retrieved 25 Feb 2016
Process: 5897 Responsibility Allocation : Franking Mail 25 Feb 2016
Process: 5901 Link Call Log Contacts To The CRM 02 Mar 2016
Process: 5913 Check For Humanmed Orders In Logistics Mailbox 03 Mar 2016
Process: 5947 Responsibility Allocation : Search For Distributors 08 Mar 2016
Process: 6958 Responsibility Allocation : Shipped Order Queries 09 Mar 2016
Process: 7686 Thorough Checking Of Awaiting Action Tray - Priority 8s 21 Apr 2016
Process: 7699 Shred Sensitive Paperwork In JL Office 19 May 2016
Process: 7705 Checking For Uploaded Files 08 Jun 2016
Process: 7709 Delivered not Invoiced 28 Jun 2016
Process: 7712 Review Inward Payments 01 Jul 2016
Process: 7735 Ensure SOR`s Are Followed Up 01 Sep 2016
Process: 7751 VST Purchase Order Log 02 Nov 2016
Process: 7758 Check For GHX Orders 17 Jan 2017
Process: 7760 Send Service Offers 31 Jan 2017
Process: 7761 Send VST Delivery Notifications 01 Feb 2017
Process: 7783 PDF VST Invoices And Purchase Orders 10 Feb 2017
Process: 7792 Shipped Order Success Report 13 Mar 2017
Process: 7795 Answering UK Web Questions 27 Apr 2017
Process: 7822 Review Oxylink Stock 26 Jul 2017
Process: 5876 E.Commerce Cardea And Multiquote 17 Feb 2016
Process: 5873 Distributor Contract Reviews 17 Feb 2016
Process: 5885 Responsibility Allocation : Monthly Reports 24 Feb 2016
Process: 6938 Responsibility Allocation : Customer Database Updates 09 Mar 2016
Process: 6940 Responsibility Allocation : Customer Ongoing task List 09 Mar 2016
Process: 6956 Responsibility Allocation : Sales Order Issues 09 Mar 2016
Process: 5866 UPS Shipping Fuel Surcharge 17 Feb 2016
Process: 6952 Responsibility Allocation : Lost in Shipping Claims 09 Mar 2016
Process: 6971 Responsibility Allocation : Freight Courier Cost Request 09 Mar 2016
Process: 7692 Responsibility Allocation : Take Complete Repair Paperwork To Office 22 Apr 2016
Process: 7796 Review Franking Label Errors 08 May 2017
Process: 6916 Responsibility Allocation : Service exisiting 09 Mar 2016
Process: 6917 Responsibility Allocation : Service extension 09 Mar 2016
Process: 7863 Maintain Repair Codes List 05 Oct 2017
Process: 7872 Embargo Countries NOT Allowed To Sell To 16 Oct 2017
Process: 7890 New UPS Rates Needs Checking 24 Oct 2017
Process: 7893 VST Price Lists 28 Oct 2017
Process: 7894 VST Customer Agreements 28 Oct 2017
Process: 7901 UPS Exceptions Checkup 20 Apr 2018
Process: 7957 Warehouse Requests 29 May 2020
Process: 7959 Audit 16 Sales And Marketing Viamed 28 Sep 2020
Process: 7970 Proforma And Quote Chasing Ryan 31 Aug 2021
Process: 7971 Proforma And Quote Chasing Steve Hardaker 31 Aug 2021
Process: 7988 Verification Contact Details Internal CRM 07 Feb 2022
Process: 7989 Verification Contact Details Accounts 07 Feb 2022
Process: 7990 Verification Invoice Details Accounts 07 Feb 2022
Process: 8020 Checking Proformas And Quotes Vandagraph To The Bank 05 Dec 2022
Process: 8023 Vandagraph Check Shopify Order Delivery Notifications 17 Feb 2023
Process: 8026 Automotive Competitor Price Review 10 Mar 2023
Process: 8033 Sales Forecasts 30 Oct 2023
Process: 8061 Reconcile Invoices In B2B Router 03 Jan 2024
ID163469 Audit 02 Contract Review and Sales Order Processing Viamed
Process: 5 Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 36 Emailing Of Invoices 16 Feb 2016
Process: 5892 Checking EBay And Amazon For Orders And Messages 25 Feb 2016
Process: 5894 Checking Of Active List 25 Feb 2016
Process: 7 Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 5943 Check Cardea And Multiquote 08 Mar 2016
Process: 5891 Processing Of Repair Quotes And Orders 25 Feb 2016
Process: 2 Answering Telephones 16 Feb 2016
Process: 37 West Yorkshire Ambulance Stock 16 Feb 2016
Process: 5945 Responsibility Allocation : Sending Samples 08 Mar 2016
Process: 5946 Responsibility Allocation : Sending Sale Or Returns 08 Mar 2016
Process: 5948 Adding New Accounts To Opera 08 Mar 2016
Process: 5949 Filling Credit Card Slips 08 Mar 2016
Process: 5895 Responsibility Allocation : Completing Office Job List 25 Feb 2016
Process: 5875 Check Paypal For Orders 17 Feb 2016
Process: 7675 Responsibility Allocation : Ordering Demo Stock For Humanmed Reps 11 Mar 2016
Process: 5944 Responsibility Allocation : Chasing Lost Customers 08 Mar 2016
Process: 3 Responsibility Allocation : Meeting And Greeting Visitors To The Company 16 Feb 2016
Process: 4 Responsibility Allocation : Assisting With Refreshments For Visitors 16 Feb 2016
Process: 7676 PDFing Of Invoices Viamed 17 Mar 2016
Process: 7696 Send VIAMED Delivery Notifications 28 Apr 2016
Process: 5893 Answering Website Questions 25 Feb 2016
Process: 7678 Check Catalog 360 Circle For Quotes And Orders 08 Apr 2016
Process: 5899 Proforma And Quote Chasing 25 Feb 2016
Process: 7710 Responsibility Allocation : Proforma And Quote Processing 29 Jun 2016
Process: 14 Fax Paper 16 Feb 2016
Process: 5882 Responsibility Allocation : Send Post To Humanmed 24 Feb 2016
Process: 7715 Audit 02 Contract Review Viamed 24 Aug 2016
Process: 7734 Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 7677
Process: 6954 Back Orders Review - By Customer 09 Mar 2016
Process: 8 Responsibility Allocation : Order And Status Liaison With Customers 16 Feb 2016
Process: 5896 Responsibility Allocation : Ensuring ORD`s Are Taken To Goods Out And Invoices Are Retrieved 25 Feb 2016
Process: 5897 Responsibility Allocation : Franking Mail 25 Feb 2016
Process: 5913 Check For Humanmed Orders In Logistics Mailbox 03 Mar 2016
Process: 5947 Responsibility Allocation : Search For Distributors 08 Mar 2016
Process: 6958 Responsibility Allocation : Shipped Order Queries 09 Mar 2016
Process: 7686 Thorough Checking Of Awaiting Action Tray - Priority 8s 21 Apr 2016
Process: 7709 Delivered not Invoiced 28 Jun 2016
Process: 7712 Review Inward Payments 01 Jul 2016
Process: 7735 Ensure SOR`s Are Followed Up 01 Sep 2016
Process: 7758 Check For GHX Orders 17 Jan 2017
Process: 7761 Send VST Delivery Notifications 01 Feb 2017
Process: 7783 PDF VST Invoices And Purchase Orders 10 Feb 2017
Process: 7795 Answering UK Web Questions 27 Apr 2017
Process: 7822 Review Oxylink Stock 26 Jul 2017
Process: 7791 Price List Check 10 Mar 2017
Process: 7763 Audit 02 Contract Review VST 08 Feb 2017
Process: 7808 Ensure All Invoice Correctly Tagged 02 Jun 2017
Process: 5872 Check Sale Or Returns Export 17 Feb 2016
Process: 5871 Check Sale Or Returns 17 Feb 2016
Process: 5876 E.Commerce Cardea And Multiquote 17 Feb 2016
Process: 7782 Remove Started But Not Used Order Numbers 08 Feb 2017
Process: 6956 Responsibility Allocation : Sales Order Issues 09 Mar 2016
Process: 6921 Responsibility Allocation : Customer pricing agreements 09 Mar 2016
Process: 6922
Process: 6959 Responsibility Allocation : Sales Forward Orders Review 09 Mar 2016
Process: 7801 VST Price Review 17 May 2017
Process: 5905 Responsibility Allocation : Price Checking 02 Mar 2016
Process: 6950
Process: 7697 Yearly Pricing Review 09 May 2016
Process: 7670 Humanmed general Issues 09 Mar 2016
Process: 7872 Embargo Countries NOT Allowed To Sell To 16 Oct 2017
Process: 7893 VST Price Lists 28 Oct 2017
Process: 7894 VST Customer Agreements 28 Oct 2017
Process: 7936 B2B Router / Peppol Responsibilitys 19 Jun 2019
Process: 7941 Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found. 23 Sep 2019
Process: 7953 Vandagraph Delivery Notifications 26 May 2020
Process: 7954 Vandagraph Email Of Invoices 26 May 2020
Process: 7955 Vandagraph Shipper SignOff Collection 26 May 2020
Process: 7970 Proforma And Quote Chasing Ryan 31 Aug 2021
Process: 7971 Proforma And Quote Chasing Steve Hardaker 31 Aug 2021
Process: 8005 Verification Of SRS Information added 17 Feb 2022
Process: 7988 Verification Contact Details Internal CRM 07 Feb 2022
Process: 7989 Verification Contact Details Accounts 07 Feb 2022
Process: 8020 Checking Proformas And Quotes Vandagraph To The Bank 05 Dec 2022
Process: 8023 Vandagraph Check Shopify Order Delivery Notifications 17 Feb 2023
Process: 8027 Update Pricing For Viamed Shopify 11 Apr 2023
Process: 8028 Viamed Shopify Sales Report Export 11 Apr 2023
Process: 8033 Sales Forecasts 30 Oct 2023
Process: 8061 Reconcile Invoices In B2B Router 03 Jan 2024
Process: 8071 Checked Repair Quotes Have Been Sent To Customers 03 Jan 2024
Process: 8080 Review Back To Stock Report On Shopify 10 Sep 2024
ID132118 VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd
Process: 7743 Customer Complaints Paper File 26 Sep 2016
Process: 7671 Humanmed Non Conformances 09 Mar 2016
Process: 6931 Customer Complaints 09 Mar 2016
Process: 7839 Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7838 Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7070 Management Review 09 Mar 2016
Process: 7840 Review VST Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7841 Review VST Feedback - Customer Complaints 23 Sep 2017
Process: 7842 Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7843 Review VST Product Feedback Negative 23 Sep 2017
Process: 7174
Process: 7175
Process: 7179
Process: 7874 Review For Latest Version Med Dev 2.12. 18 Oct 2017
Process: 7954 Vandagraph Email Of Invoices 26 May 2020
Process: 7979 Review The Template Of The QC 21 Form To Ensure It Is Current And Valid 12 Nov 2021
Process: 8068 Request Feedback From Unique Customer For 2 Months Prior 03 Jan 2024
Process: 8070 Website Order VM-2160 VET Feedback 03 Jan 2024
ID137933 VOP 07 Stock Control, Handling, Control of Labelling, Storage, Movement
Process: 6973 Responsibility Allocation : Stock Transfers. (QC19) 09 Mar 2016
Process: 7675 Responsibility Allocation : Ordering Demo Stock For Humanmed Reps 11 Mar 2016
Process: 5872 Check Sale Or Returns Export 17 Feb 2016
Process: 5871 Check Sale Or Returns 17 Feb 2016
Process: 5855 Purchase Order Requirements Teledyne 17 Feb 2016
Process: 5858 Opera Stock Adjustments 17 Feb 2016
Process: 5868 Return Goods To Suppliers 17 Feb 2016
Process: 5935 Stock Allocations 05 Mar 2016
Process: 6829 Supplier Review - Outstanding orders 09 Mar 2016
Process: 6832 Supplier Review Future orders 09 Mar 2016
Process: 6840
Process: 6848
Process: 6850 Current Stock Levels 09 Mar 2016
Process: 6945 Missing Stock or Adjustments 09 Mar 2016
Process: 6955 Production Requirements 09 Mar 2016
Process: 7046 Responsibility Allocation : Stock Purchasing 09 Mar 2016
Process: 7051 Responsibility Allocation : Control of nonconforming product 09 Mar 2016
Process: 7673 Check Expiry Dated Stock 09 Mar 2016
Process: 7679 Check Stock Requirements Supplier Teledyne 18 Apr 2016
Process: 7680 Check Stock Requirements Supplier Envitec 18 Apr 2016
Process: 7681 Check Stock Requirements Supplier Posey 18 Apr 2016
Process: 7682 Check Stock Requirements Supplier Bluepoint 18 Apr 2016
Process: 7687 Vandagraph Duckets 21 Apr 2016
Process: 7688
Process: 7689 Move Stock From QA Shelf To Stock Shelf Monday 21 Apr 2016
Process: 7694 Move Stock From QA Shelf To Stock Shelf Tuesday 28 Apr 2016
Process: 7695 Top Up Quick Shipping Shelves 28 Apr 2016
Process: 7708 Acorn 0014904 17 Jun 2016
Process: 7798 Orders And Items Shipped Per Month 10 May 2017
Process: 6961 Responsibility Allocation : VIAMED Stock Meeting Purchase Order Requirements 09 Mar 2016
Process: 7683 Check Stock For Proforma 18 Apr 2016
Process: 6968 Responsibility Allocation : VIAMED Stock Meeting Repairs Review - General 09 Mar 2016
Process: 6949 Responsibility Allocation : VIAMED Stock Meeting QA Processing 09 Mar 2016
Process: 6948 Responsibility Allocation : VIAMED Stock Meeting Stock Processing 09 Mar 2016
Process: 6947 Responsibility Allocation : VIAMED Stock Meeting Stock Queries 09 Mar 2016
Process: 7830 Review Q.A. Failures Report 18 Sep 2017
Process: 7864 ESD Work Stations 07 Oct 2017
Process: 7873 On Site Environment Review 18 Oct 2017
Process: 7866 Oxygen Cylinder Check 13 Oct 2017
Process: 7897 Daily O2 Sensors Returns 04 Jan 2018
Process: 7909 EAN GTIN Online Database 06 Aug 2018
Process: 7943 Review Stocks Of 8000004 01 Oct 2019
Process: 7944 Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST 09 Oct 2019
Process: 7962 VST Supplier QA Results 28 Oct 2020
Process: 7967 VST Stock Count For End April 01 Jul 2021
Process: 7969 Weee Waste Reporting 23 Aug 2021
Process: 8006 Verification Warehouse Unidentified Stock 17 Feb 2022
Process: 8008 Verification Warehouse Hand Sanitiser 21 Feb 2022
Process: 8009 Verification Stock Items And Locations 21 Feb 2022
Process: 8010 Verification Of Ebay Stock 21 Feb 2022
Process: 8011 Verification Of Demo Stock 21 Feb 2022
Process: 7996 Verification Repairs Older Repairs 07 Feb 2022
Process: 8002 Verification Todays Goods In 17 Feb 2022
Process: 8004 Verification Of Non Conforming Products 17 Feb 2022
Process: 8024 Discontinue/Supersede Stock 01 Mar 2023
Process: 8060 Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST Phils Issue 03 Jan 2024
ID159461 Audit 16 Sales and Marketing Viamed
Process: 21 Office Sales Projects 16 Feb 2016
Process: 17
Process: 40 Responsibility Allocation : Calender 16 Feb 2016
Process: 5870 Book Arab Health 17 Feb 2016
Process: 19 Maintaining Leaflet Stocks 16 Feb 2016
Process: 20 Processing Of Mail Shots 16 Feb 2016
Process: 5873 Distributor Contract Reviews 17 Feb 2016
Process: 5885 Responsibility Allocation : Monthly Reports 24 Feb 2016
Process: 5883 Responsibility Allocation : Monthly Sales Report 24 Feb 2016
Process: 6888 Viamed Automotive UK 09 Mar 2016
Process: 6898 GHX Web Pricing 09 Mar 2016
Process: 5884 Responsibility Allocation : Monthly Report 24 Feb 2016
Process: 5886 Responsibility Allocation : Monthly Report 24 Feb 2016
Process: 6891 Responsibility Allocation : Exhibitions Co-ordinator 09 Mar 2016
Process: 7909 EAN GTIN Online Database 06 Aug 2018
Process: 7920 Sales Warnings 20 Dec 2018
Process: 7927 Contract Pricing Review 14 Feb 2019
Process: 7926 Sales Forecasts Export 22 Jan 2019
Process: 7921 VST Bags And Grey Sensor 03 Jan 2019
Process: 7925 Providing Ebay Feedback 16 Jan 2019
Process: 7916 Google Webmaster Tools 16 Oct 2018
Process: 7931 Competitor Pricing 14 Mar 2019
Process: 7949 Sales Projects Send To Sales Team 04 Mar 2020
Process: 7947 8010004 - JJ-CCR Oxygen Sensor Orders 04 Mar 2020
Process: 7948 8010006 - REVo Oxygen Sensor Orders 04 Mar 2020
Process: 7950 Envitec Oxygen Sensor Parts Stock Check 05 Mar 2020
Process: 7959 Audit 16 Sales And Marketing Viamed 28 Sep 2020
Process: 7960 Audit 16 Sales And Marketing VST 28 Sep 2020
Process: 8031 Tenders Review UN 02 Aug 2023
Process: 8046 Shopify Add Words 29 Dec 2023
Process: 8056 Add Calendar To Order 29 Dec 2023
Process: 8062 Vandagraph Shopify Payouts Report 03 Jan 2024
Process: 8068 Request Feedback From Unique Customer For 2 Months Prior 03 Jan 2024
Process: 8049 Book Medica 29 Dec 2023
Process: 8057 Emergency Services Show 29 Dec 2023
Process: 8058 Preparation For Medica 03 Jan 2024
Process: 8059 Preparation For Medica Leaflets 03 Jan 2024
Process: 8063 Send Calendars To Sylvia Gallagher 03 Jan 2024
Process: 8065 Review Shopify Website For Missing Images 03 Jan 2024
Process: 8066 Review Search Terms - Shopify 03 Jan 2024
Process: 8069 Viamed Shopify: Office Hours 03 Jan 2024
Process: 8075 Tenders Review UK 14 Feb 2024
ID75943 VOP 20 Goods in Purchases, Returns, Repairs, Inspection / Rejection
Process: 5938 Responsibility Allocation : Receive Goods 05 Mar 2016
Process: 5898 Processing Depleted Sensors 25 Feb 2016
Process: 5879 Responsibility Allocation : Customer Returning Goods On Our UPS Account 18 Feb 2016
Process: 7826 Goods In Processes 06 Sep 2017
Process: 7859 Check POR Files For Items Delivered But Not Removed From File 02 Oct 2017
Process: 7976 Decontamination Of Incoming Products And Repairs 08 Nov 2021
ID103501 VM3COP20.01 Post In Distributing the Post
Process: 11 Distribution Of Post 16 Feb 2016
Process: 5882 Responsibility Allocation : Send Post To Humanmed 24 Feb 2016
ID162725 Audit 08 Training, Competence and Human Resources Viamed
Process: 7720 Audit 08 Training Viamed 24 Aug 2016
Process: 6839 Responsibility Allocation : Personnel Holidays and Time Adjustments 09 Mar 2016
Process: 5881 Training Records Review 18 Feb 2016
Process: 5904 Taking On New Staff 02 Mar 2016
Process: 5936 Wages Calculations 05 Mar 2016
Process: 6837 Personnel Requirements and Training 09 Mar 2016
Process: 6851 Review Accident Book 09 Mar 2016
Process: 6877 Responsibility Allocation : Alarm Key Holders 09 Mar 2016
Process: 6906 Responsibility Allocation : Time Working Away 09 Mar 2016
Process: 6928 Responsibility Allocation : Eye Tests 09 Mar 2016
Process: 7074
Process: 7759 Health Declaration Sheet 23 Jan 2017
Process: 7768 Audit 08 Training VST 08 Feb 2017
Process: 5934 Responsibility Allocation : Staff Training 05 Mar 2016
Process: 38 Audits Up to Date and Confirm next years Audit schedule 16 Feb 2016
Process: 6841 Responsibility Allocation : Grants 09 Mar 2016
Process: 7070 Management Review 09 Mar 2016
Process: 7713 Review Roles And Responsibilitys 17 Aug 2016
Process: 7883 Appraisal 23 Oct 2017
Process: 7884 Pay Review 23 Oct 2017
Process: 7908 Private Information Data 27 Jul 2018
Process: 7907 Annual Review Doc Management 27 Jul 2018
Process: 7937 Diversity Impact Assessment 27 Jun 2019
Process: 7951 Server Review 05 Mar 2020
Process: 7982 Check There Are No Changes To Employment Law 21 Nov 2021
Process: 7983 To Check On Line And See If There Have Been Any Changes To Gdpr We Need To Be Aware Of. 21 Nov 2021
Process: 8054 Team Building Event - June 29 Dec 2023
Process: 8055 Christmas/Team Building Event - December 29 Dec 2023
Process: 8067 Training Refresh Issues To Send / Questions To Write 03 Jan 2024
Process: 8082 HSE Workplace Safety Environment And Harassment Risk Assessment Questionnaire 23 Oct 2024
Process: 8081 Anti Harassment Awareness And Prevention 18 Oct 2024
ID159483 Audit 19 Health and Safety, Working Conditions and Building Fabric Issues Viamed
Process: 5941 Responsibility Allocation : Replace Main Server 07 Mar 2016
Process: 45 Responsibility Allocation : Main Server Status 16 Feb 2016
Process: 46 Responsibility Allocation : Backup Server Status 16 Feb 2016
Process: 7704 Responsibility Allocation : Computer Failure Diagnostics 24 May 2016
Process: 5856 Cleaning The Kitchen 17 Feb 2016
Process: 7729 Audit 19 Health And Saftey Viamed 24 Aug 2016
Process: 5853 Vacuuming Of The Office, Hall And Meeting Room 17 Feb 2016
Process: 5900 Cleaning Of Office Windows 25 Feb 2016
Process: 39 Enviromental Policy Document Review 16 Feb 2016
Process: 7741 Review Ethical Policy 14 Sep 2016
Process: 5878 Empty Office Bins 18 Feb 2016
Process: 5912 Responsibility Allocation : Main Recycle Bins 03 Mar 2016
Process: 7821 Controlled Waste Description And Transfer 15 Jun 2017
Process: 7820 North Yorkshire Council Waste Tranfer 15 Jun 2017
Process: 5906 Empty Paper Bins 03 Mar 2016
Process: 7805 Empty Kitchen Bins 22 May 2017
Process: 5909 Empty Warehouse Bins 03 Mar 2016
Process: 7042 Responsibility Allocation : Work Environment 09 Mar 2016
Process: 7706 Update Virus Software And Scan For Viruses 10 Jun 2016
Process: 7802 Clean Kitchen Sides 22 May 2017
Process: 7803 Dishwashing 22 May 2017
Process: 7804 Sweep Kitchen Floor 22 May 2017
Process: 7806 Watering Plants 22 May 2017
Process: 7807
Process: 7777 Audit 19 Health And Saftey VST 08 Feb 2017
Process: 54 Responsibility Allocation : Gents Toilets 17 Feb 2016
Process: 5907 Hoover Warehouse 03 Mar 2016
Process: 5908 Sweep Warehouse 03 Mar 2016
Process: 5910 Clean Duckets 03 Mar 2016
Process: 5911 Clear Cardboard 03 Mar 2016
Process: 7687 Vandagraph Duckets 21 Apr 2016
Process: 7698 Clean Toilets 17 May 2016
Process: 6849 First Aid 09 Mar 2016
Process: 6855 Risk Assessment HSE 09 Mar 2016
Process: 6856 Fire Alarms 09 Mar 2016
Process: 7092
Process: 56 Warehouse Outside Heating Guard 17 Feb 2016
Process: 5919 Check Out Side Drain 05 Mar 2016
Process: 5921 Clearing Water Downstairs 05 Mar 2016
Process: 7120 General Maintenance Requirements 09 Mar 2016
Process: 7742 Boiler Check 26 Sep 2016
Process: 7756 Carbon Monoxide Alarm 05 Jan 2017
Process: 48 Responsibility Allocation : Internet 16 Feb 2016
Process: 49 Responsibility Allocation : Wifi 16 Feb 2016
Process: 50 Responsibility Allocation : Guest Access Wifi 16 Feb 2016
Process: 51 Responsibility Allocation : Printers 16 Feb 2016
Process: 5903 Responsibility Allocation : Weather Station 02 Mar 2016
Process: 7121 Responsibility Allocation : General Computer Maintenance 09 Mar 2016
Process: 7178 Responsibility Allocation : Systems Innovation 09 Mar 2016
Process: 6843
Process: 7835 Electrics Need Checking 20 Sep 2017
Process: 7836 Central Heating For Winter 20 Sep 2017
Process: 7847 Health And Safety Review 26 Sep 2017
Process: 7864 ESD Work Stations 07 Oct 2017
Process: 7867 Bandsaw Checklist 13 Oct 2017
Process: 7868 Pillar Drill Checklist 13 Oct 2017
Process: 7869 Hand Drill Checklist 13 Oct 2017
Process: 7891 Fire Alarm Evacuation Drill 25 Oct 2017
Process: 7896 Tree In Car Park 22 Dec 2017
Process: 7910 Review CCTV Warning Signs 20 Sep 2018
Process: 7928 Fire Test Points Checking 21 Feb 2019
Process: 7929 Emergency Lighting And Fire Extinguishers 21 Feb 2019
Process: 7911 Review Security Of The Special Category Personal Data 20 Sep 2018
Process: 7961 R D Room - Tidy, Empty Bins, Remove Cups. Caution Around Oxygen Supply 05 Oct 2020
Process: 7982 Check There Are No Changes To Employment Law 21 Nov 2021
Process: 7999 Building Risk Assesments 08 Feb 2022
Process: 8038 Defrost Fridge / Freezer 29 Dec 2023
Process: 8039 Weee Report Due Vandagraph Annual 29 Dec 2023
Process: 8043 Turn Off Outside Tap On The Warehouse 29 Dec 2023
Process: 8045 Radiators - Bleed Radiators In Vandagraph Room In Warehouse And Loft In Offices 29 Dec 2023
Process: 8047 Electric Testing 29 Dec 2023
Process: 8048 Workshop Toilet Is To Be Cleaned And Rubbish To Be Binned 29 Dec 2023
Process: 8044 PAT Test 29 Dec 2023
ID29373 VM3COP02.02 VST Company Responsibilitys organisation chart structure
Process: 5877 Review Company Data 17 Feb 2016
ID159485 Audit 21 Audit of Audit Viamed
Process: 7731 Audit 21 Audit Of Audit Viamed 24 Aug 2016
Process: 7779 Audit 21 Audit Of Audit VST 08 Feb 2017
Process: 38 Audits Up to Date and Confirm next years Audit schedule 16 Feb 2016
Process: 7093 BSI Audits Calander 09 Mar 2016
Process: 7670 Humanmed general Issues 09 Mar 2016
Process: 7862 Review The Audit Calender Screen 04 Oct 2017
ID159383 Audit 22 Post Market Survellance Viamed
Process: 7732 Audit 22 Post Market Survellance Viamed 24 Aug 2016
Process: 43 Responsibility Allocation : Product Post Market Survelance 16 Feb 2016
Process: 7780 Audit 22 Post Market Survellance VST 08 Feb 2017
Process: 6889 Responsibility Allocation : Post Market Surveilance 09 Mar 2016
Process: 7809 Pro-Active Marketing 06 Jun 2017
Process: 7810 Research Activities 06 Jun 2017
Process: 5863 Responsibility Allocation : Sales Meetings UK 17 Feb 2016
Process: 5864 Responsibility Allocation : Sales Meeting EX 17 Feb 2016
Process: 7973 VST Product Performance - Customers 27 Oct 2021
Process: 7974 VST Product Performance - Suppliers 27 Oct 2021
Process: 8014 Review VIAMED Product Feedback Positive 25 Jul 2022
Process: 8015 Review VST Product Feedback Positive 25 Jul 2022
Process: 8016 Review VIAMED Customer Feedback Positive 25 Jul 2022
Process: 8017 Review VST Customer Feedback Positive 25 Jul 2022
Process: 8070 Website Order VM-2160 VET Feedback 03 Jan 2024
Process: 8076 Medica Review 21 Feb 2024
ID126137 Viamed Management Review Blank Minutes 20xx
Process: 7846 ISO System Management Review Viamed 26 Sep 2017
ID74728 QC 21 Non Conformance Form
Process: 7138 Non Conformance Issues Any New QC21 Forms 09 Mar 2016
Process: 7979 Review The Template Of The QC 21 Form To Ensure It Is Current And Valid 12 Nov 2021
ID166222 VOP 12 Training
Process: 7750 Meeting With Management 14 Oct 2016
Process: 7793 Team Review Meeting 16 Mar 2017
Process: 5934 Responsibility Allocation : Staff Training 05 Mar 2016
Process: 7833 Importance Of Effective Quality Management 20 Sep 2017
Process: 7845 7.1.4 Environment Of Operations 25 Sep 2017
Process: 7883 Appraisal 23 Oct 2017
ID14696
Process: 6972 UPS Shipping Fuel Surcharge 09 Mar 2016
ID17155 VM3COP03.05 Procedures for customer returning goods on our UPS account number
Process: 5879 Responsibility Allocation : Customer Returning Goods On Our UPS Account 18 Feb 2016
ID159437 Audit 07 Handling and Storage Viamed
Process: 6973 Responsibility Allocation : Stock Transfers. (QC19) 09 Mar 2016
Process: 7719 Audit 07 Handling And Storage Viamed 24 Aug 2016
Process: 7767 Audit 07 Handling And Storage VST 08 Feb 2017
Process: 5858 Opera Stock Adjustments 17 Feb 2016
Process: 5935 Stock Allocations 05 Mar 2016
Process: 6840
Process: 6850 Current Stock Levels 09 Mar 2016
Process: 6945 Missing Stock or Adjustments 09 Mar 2016
Process: 7046 Responsibility Allocation : Stock Purchasing 09 Mar 2016
Process: 7051 Responsibility Allocation : Control of nonconforming product 09 Mar 2016
Process: 7673 Check Expiry Dated Stock 09 Mar 2016
Process: 7688
Process: 7689 Move Stock From QA Shelf To Stock Shelf Monday 21 Apr 2016
Process: 7694 Move Stock From QA Shelf To Stock Shelf Tuesday 28 Apr 2016
Process: 7695 Top Up Quick Shipping Shelves 28 Apr 2016
Process: 7873 On Site Environment Review 18 Oct 2017
Process: 7866 Oxygen Cylinder Check 13 Oct 2017
Process: 7903 Empty Warehouse Depleted Sensor Bin 17 Jul 2018
Process: 7904 Check Weeee Waste Pallet And Sensor Bin 17 Jul 2018
Process: 7902 Empty Depleted Sensor Bin From The Offic 17 Jul 2018
Process: 7942 Do We Have Service Manual / QA For All Our Stock Coming In. 23 Sep 2019
Process: 7940 Review The Tom Thumb Grease Date 18 Sep 2019
Process: 7944 Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST 09 Oct 2019
Process: 8008 Verification Warehouse Hand Sanitiser 21 Feb 2022
Process: 8002 Verification Todays Goods In 17 Feb 2022
Process: 8004 Verification Of Non Conforming Products 17 Feb 2022
Process: 8024 Discontinue/Supersede Stock 01 Mar 2023
Process: 8060 Sealant, Glues, Greases, Sprays, Gases And Tapes You Use In Production, Service And Repairs For Viamed And VST Phils Issue 03 Jan 2024
ID168580 VOP 06 Measurement Control Viamed VST, Calibration, QA Stock
Process: 7718 Audit 06 Calibration Viamed 24 Aug 2016
Process: 7091 Calibration Index 09 Mar 2016
Process: 7998 Verification Calibrated Equipment 08 Feb 2022
Process: 8044 PAT Test 29 Dec 2023
ID159459 Audit 15 Production Viamed
Process: 7727 Audit 15 Production Viamed 24 Aug 2016
Process: 7736 Production Start Job List 03 Sep 2016
Process: 7737 Production In Production List 03 Sep 2016
Process: 7738 Production Statistics 03 Sep 2016
Process: 7775 Audit 15 Production VST 08 Feb 2017
Process: 6845 Responsibility Allocation : Quarantine Production 09 Mar 2016
Process: 6955 Production Requirements 09 Mar 2016
Process: 7169 Responsibility Allocation : Production 09 Mar 2016
Process: 7170 Responsibility Allocation : Production Production Schedule 09 Mar 2016
Process: 7171 Responsibility Allocation : Production Production Problems 09 Mar 2016
Process: 7072 Responsibility Allocation : Manufacturing Processes 09 Mar 2016
Process: 8000 Verification Production Paperwork 08 Feb 2022
Process: 8037 Projects / Products HSE Requirements 29 Dec 2023
Process: 8064 Production Of JJCCR Cables 03 Jan 2024
ID31032 VOP 16 Health and Safety, Company Personnel Manual
Process: 7821 Controlled Waste Description And Transfer 15 Jun 2017
Process: 7820 North Yorkshire Council Waste Tranfer 15 Jun 2017
Process: 6851 Review Accident Book 09 Mar 2016
Process: 7759 Health Declaration Sheet 23 Jan 2017
Process: 6849 First Aid 09 Mar 2016
Process: 6855 Risk Assessment HSE 09 Mar 2016
Process: 6856 Fire Alarms 09 Mar 2016
Process: 7092
Process: 56 Warehouse Outside Heating Guard 17 Feb 2016
Process: 5919 Check Out Side Drain 05 Mar 2016
Process: 5921 Clearing Water Downstairs 05 Mar 2016
Process: 7120 General Maintenance Requirements 09 Mar 2016
Process: 7742 Boiler Check 26 Sep 2016
Process: 7756 Carbon Monoxide Alarm 05 Jan 2017
Process: 7835 Electrics Need Checking 20 Sep 2017
Process: 7836 Central Heating For Winter 20 Sep 2017
Process: 7847 Health And Safety Review 26 Sep 2017
Process: 7867 Bandsaw Checklist 13 Oct 2017
Process: 7868 Pillar Drill Checklist 13 Oct 2017
Process: 7869 Hand Drill Checklist 13 Oct 2017
Process: 7928 Fire Test Points Checking 21 Feb 2019
Process: 7999 Building Risk Assesments 08 Feb 2022
Process: 8082 HSE Workplace Safety Environment And Harassment Risk Assessment Questionnaire 23 Oct 2024
Process: 8081 Anti Harassment Awareness And Prevention 18 Oct 2024
ID31008 VOP 11 Equipment Control, Office, Warehouse, Pcs and Equipment
Process: 5939 Responsibility Allocation : Email ISP Routing 05 Mar 2016
Process: 5941 Responsibility Allocation : Replace Main Server 07 Mar 2016
Process: 45 Responsibility Allocation : Main Server Status 16 Feb 2016
Process: 46 Responsibility Allocation : Backup Server Status 16 Feb 2016
Process: 52 Software Verification Clear Down Backup Emails 16 Feb 2016
Process: 53 Emails 16 Feb 2016
Process: 7672 Off Site Backup 09 Mar 2016
Process: 6813 Management Meeting Turnover Report 09 Mar 2016
Process: 7700 Domain Name Management 19 May 2016
Process: 7701 AWS Amazon Web Services 23 May 2016
Process: 7704 Responsibility Allocation : Computer Failure Diagnostics 24 May 2016
Process: 48 Responsibility Allocation : Internet 16 Feb 2016
Process: 49 Responsibility Allocation : Wifi 16 Feb 2016
Process: 50 Responsibility Allocation : Guest Access Wifi 16 Feb 2016
Process: 51 Responsibility Allocation : Printers 16 Feb 2016
Process: 5903 Responsibility Allocation : Weather Station 02 Mar 2016
Process: 6838 Opera Negative Stock 09 Mar 2016
Process: 7121 Responsibility Allocation : General Computer Maintenance 09 Mar 2016
Process: 7124 Responsibility Allocation : Intrastats 09 Mar 2016
Process: 7125 Responsibility Allocation : Intrastats Urgent Problems 09 Mar 2016
Process: 7126 Intrastats Requested Page updates 09 Mar 2016
Process: 7127 Responsibility Allocation : Intrastats Unfinished in progress Processes 09 Mar 2016
Process: 7128 Responsibility Allocation : Intrastats Future Features needed 09 Mar 2016
Process: 7129 Intrastats Cross Reference Database Tables Updates 09 Mar 2016
Process: 7178 Responsibility Allocation : Systems Innovation 09 Mar 2016
Process: 7739 Intrastats Amendment Log 12 Sep 2016
Process: 7755 Fast Hosts Invoice 08 Dec 2016
Process: 44 Secure Socket Level Certificate 16 Feb 2016
Process: 7668 Responsibility Allocation : Upgrading Intrastats ISO Quality system 09 Mar 2016
Process: 7832 Cleardown Emailed Invoices 20 Sep 2017
Process: 7823 Saftey Tester Data 02 Aug 2017
Process: 8038 Defrost Fridge / Freezer 29 Dec 2023
Process: 8043 Turn Off Outside Tap On The Warehouse 29 Dec 2023
Process: 8045 Radiators - Bleed Radiators In Vandagraph Room In Warehouse And Loft In Offices 29 Dec 2023
Process: 8047 Electric Testing 29 Dec 2023
Process: 8048 Workshop Toilet Is To Be Cleaned And Rubbish To Be Binned 29 Dec 2023
Process: 8044 PAT Test 29 Dec 2023
ID137919 VOP 09 Repairs and Servicing
Process: 7684 Repairs Ready For Quote 18 Apr 2016
Process: 7685 Repairs Ready For Invoice 18 Apr 2016
Process: 7690 Ship Repairs 21 Apr 2016
Process: 7752 SRS Folder 22 Nov 2016
Process: 6847 Responsibility Allocation : Quarantine Repairs 09 Mar 2016
Process: 6862 Current Repairs 09 Mar 2016
Process: 7048 Control of monitoring and measuring devices 09 Mar 2016
Process: 7674 Check Repairs Ready For Invoice List 10 Mar 2016
Process: 7814 Responsibility Allocation : Viamed Repairs 06 Jun 2017
Process: 7811 Responsibility Allocation : General Area 06 Jun 2017
Process: 7812 Responsibility Allocation : Vandagraph Repairs 06 Jun 2017
Process: 7813 Responsibility Allocation : VST Repairs 06 Jun 2017
Process: 7815 Responsibility Allocation : Product Types To Relevant Person 06 Jun 2017
Process: 7942 Do We Have Service Manual / QA For All Our Stock Coming In. 23 Sep 2019
Process: 7940 Review The Tom Thumb Grease Date 18 Sep 2019
Process: 7985 OverDue Servicing 03 Feb 2022
Process: 7993 Verification Warranty Repairs Customer Approval 07 Feb 2022
Process: 7994 Verification Repairs Paperwork Completed 07 Feb 2022
Process: 7995 Verification Visual Check Repair Shelf 07 Feb 2022
Process: 7996 Verification Repairs Older Repairs 07 Feb 2022
Process: 7997 Verification Repair Qa Reports 07 Feb 2022
Process: 8005 Verification Of SRS Information added 17 Feb 2022
Process: 8022 Vandagraph Repair Review 06 Feb 2023
Process: 8071 Checked Repair Quotes Have Been Sent To Customers 03 Jan 2024
ID166168 Audit 09 Goods Inward and Product Identity Viamed
Process: 5938 Responsibility Allocation : Receive Goods 05 Mar 2016
Process: 7721 Audit 09 Goods Inward And Product Identity Viamed 24 Aug 2016
Process: 7826 Goods In Processes 06 Sep 2017
Process: 7792 Shipped Order Success Report 13 Mar 2017
Process: 7769 Audit 09 Goods Inward And Product Identity VST 08 Feb 2017
Process: 6969 Responsibility Allocation : VIAMED Stock Meeting `Goods In` Review 09 Mar 2016
Process: 57 Temporary Stock Notices 17 Feb 2016
Process: 5854 Stock FAQ Admin List 17 Feb 2016
Process: 7181 Responsibility Allocation : Product Catagories 09 Mar 2016
Process: 6894 Product Cross References 09 Mar 2016
Process: 6838 Opera Negative Stock 09 Mar 2016
Process: 7830 Review Q.A. Failures Report 18 Sep 2017
Process: 7859 Check POR Files For Items Delivered But Not Removed From File 02 Oct 2017
Process: 7897 Daily O2 Sensors Returns 04 Jan 2018
Process: 7898 Stamp Deliveries 30 Jan 2018
Process: 7903 Empty Warehouse Depleted Sensor Bin 17 Jul 2018
Process: 7914 Proofs of Delivery 02 Oct 2018
Process: 7915 Reserve Stock Review 02 Oct 2018
Process: 7917 Human Med Purchase Order 18 Oct 2018
Process: 7923 Review Of Credits Received From Suppliers 08 Jan 2019
Process: 7943 Review Stocks Of 8000004 01 Oct 2019
Process: 7957 Warehouse Requests 29 May 2020
Process: 7962 VST Supplier QA Results 28 Oct 2020
Process: 7967 VST Stock Count For End April 01 Jul 2021
Process: 7976 Decontamination Of Incoming Products And Repairs 08 Nov 2021
Process: 8006 Verification Warehouse Unidentified Stock 17 Feb 2022
Process: 8009 Verification Stock Items And Locations 21 Feb 2022
Process: 8010 Verification Of Ebay Stock 21 Feb 2022
Process: 8011 Verification Of Demo Stock 21 Feb 2022
ID31072 VOP 08 Production, Reworks, New Production
Process: 7736 Production Start Job List 03 Sep 2016
Process: 7737 Production In Production List 03 Sep 2016
Process: 7738 Production Statistics 03 Sep 2016
Process: 6845 Responsibility Allocation : Quarantine Production 09 Mar 2016
Process: 7169 Responsibility Allocation : Production 09 Mar 2016
Process: 7170 Responsibility Allocation : Production Production Schedule 09 Mar 2016
Process: 7171 Responsibility Allocation : Production Production Problems 09 Mar 2016
Process: 7072 Responsibility Allocation : Manufacturing Processes 09 Mar 2016
Process: 6962 Responsibility Allocation : VIAMED Stock Meeting Returns Overview 09 Mar 2016
Process: 8000 Verification Production Paperwork 08 Feb 2022
Process: 8037 Projects / Products HSE Requirements 29 Dec 2023
Process: 8064 Production Of JJCCR Cables 03 Jan 2024
ID165205 VM3COP20.31 Export Order Processing
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
ID20049 VM3COP03.01 Order Processing Priorities
Process: 5 Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
ID165199 VM3COP20.30 UK Order Processing
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
ID22266 VM3COP03.07 Humanmed Order Checking
Process: 7 Responsibility Allocation : Checking Of Sales Orders 16 Feb 2016
Process: 7734 Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
ID24775 VM3COP03.08 Humanmed Order Processing
Process: 5 Responsibility Allocation : Processing Of Sales Orders 16 Feb 2016
Process: 7734 Responsibility Allocation : Humanmed Order Processing 25 Aug 2016
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
ID159399 Audit 01 Picking packing Viamed
Process: 7714 Audit 01 Picking Packing Viamed 24 Aug 2016
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
Process: 5859 Review Un-shipped Parcels 17 Feb 2016
Process: 6970
Process: 7691 Ship Sale Or Returns 21 Apr 2016
Process: 7796 Review Franking Label Errors 08 May 2017
Process: 7797 Check Order Are Being Picked In Priority Order 10 May 2017
Process: 7798 Orders And Items Shipped Per Month 10 May 2017
Process: 7762 Audit 01 Picking Packing VST 08 Feb 2017
Process: 7860 Goods Out Picking 03 Oct 2017
Process: 8027 Update Pricing For Viamed Shopify 11 Apr 2023
ID34889 VM3COP20.32 Order Checking
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
ID166158 Audit 11 Repairs, Servicing and Returns Viamed
Process: 5898 Processing Depleted Sensors 25 Feb 2016
Process: 5879 Responsibility Allocation : Customer Returning Goods On Our UPS Account 18 Feb 2016
Process: 5857 Customer Service Logs 17 Feb 2016
Process: 7724 Audit 11 Repairs And Service Viamed 24 Aug 2016
Process: 7684 Repairs Ready For Quote 18 Apr 2016
Process: 7685 Repairs Ready For Invoice 18 Apr 2016
Process: 7690 Ship Repairs 21 Apr 2016
Process: 7748 Check Repair Orders 10 Oct 2016
Process: 7749 Check Repair Quotes 10 Oct 2016
Process: 7752 SRS Folder 22 Nov 2016
Process: 7760 Send Service Offers 31 Jan 2017
Process: 7772 Audit 11 Repairs And Service VST 08 Feb 2017
Process: 6847 Responsibility Allocation : Quarantine Repairs 09 Mar 2016
Process: 6862 Current Repairs 09 Mar 2016
Process: 7138 Non Conformance Issues Any New QC21 Forms 09 Mar 2016
Process: 7674 Check Repairs Ready For Invoice List 10 Mar 2016
Process: 7692 Responsibility Allocation : Take Complete Repair Paperwork To Office 22 Apr 2016
Process: 6916 Responsibility Allocation : Service exisiting 09 Mar 2016
Process: 6917 Responsibility Allocation : Service extension 09 Mar 2016
Process: 7823 Saftey Tester Data 02 Aug 2017
Process: 7905 Generate RMA Box, Link Items And Add Faults 17 Jul 2018
Process: 7906 Request RMA Based On The RMA Boxes 17 Jul 2018
Process: 7993 Verification Warranty Repairs Customer Approval 07 Feb 2022
Process: 7994 Verification Repairs Paperwork Completed 07 Feb 2022
Process: 7995 Verification Visual Check Repair Shelf 07 Feb 2022
Process: 7996 Verification Repairs Older Repairs 07 Feb 2022
Process: 7997 Verification Repair Qa Reports 07 Feb 2022
Process: 8022 Vandagraph Repair Review 06 Feb 2023
Process: 8052 Check Supplier Returns 29 Dec 2023
ID69812 VM3COP27.31 Processing Proforma Invoices and Quotations
Process: 7710 Responsibility Allocation : Proforma And Quote Processing 29 Jun 2016
ID13695 VM3COP20.05 New Orders - How to enter into Opera Viamed
Process: 7936 B2B Router / Peppol Responsibilitys 19 Jun 2019
ID21314
Process: 6828
ID159455 Audit 14 Complaints and Corrective Actions Viamed
Process: 7726 Audit 14 Complaints And Corrective Actions Viamed 24 Aug 2016
Process: 6828
Process: 7743 Customer Complaints Paper File 26 Sep 2016
Process: 7774 Audit 14 Complaints And Corrective Actions VST 08 Feb 2017
Process: 6865 Responsibility Allocation : Non Conformance Effectiveness 09 Mar 2016
Process: 7199 Non Conformities Review Viamed 09 Mar 2016
Process: 7671 Humanmed Non Conformances 09 Mar 2016
Process: 6931 Customer Complaints 09 Mar 2016
Process: 7839 Review VIAMED Feedback - Customer Complaints 23 Sep 2017
Process: 7838 Review VIAMED Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7840 Review VST Feedback - Customer Feedback Negative 23 Sep 2017
Process: 7841 Review VST Feedback - Customer Complaints 23 Sep 2017
Process: 7842 Review VIAMED Product Feedback Negative 23 Sep 2017
Process: 7843 Review VST Product Feedback Negative 23 Sep 2017
Process: 7849 Review Product Failures New Codes 28 Sep 2017
Process: 7934 Test Website Questions 02 May 2019
Process: 7965 VST Feedback 29 Oct 2020
Process: 7264 Responsibility Allocation : VST Management Meeting Non Conformance Issues 09 Mar 2016
ID159427 Audit 04 Accounts and Finance Viamed
Process: 7702 Responsibility Allocation : Vandagraph Pay Pay Issue Refund 23 May 2016
Process: 7703 Vandagraph Pay Pal Retrieve Funds 23 May 2016
Process: 5915 Opera Sales Ledger Close 05 Mar 2016
Process: 7740 Weights Per Region Needed To Submit EC Sales List 13 Sep 2016
Process: 5929 HMRC Intrastats Sales Data 05 Mar 2016
Process: 7799 Opera Purchase Ledger Close 11 May 2017
Process: 7800 Opera Nominal Ledger Close 11 May 2017
Process: 5937 Review the Delivered Not Invoiced Reports 05 Mar 2016
Process: 5865 Vandagraph Loan 17 Feb 2016
Process: 5867 Accounts On Stop 17 Feb 2016
Process: 5874 Childcare Vouchers Edenred 17 Feb 2016
Process: 5914 End Of Year Reports For Accountants 04 Mar 2016
Process: 5916 Bank Details Opera reports entered Intrastats 05 Mar 2016
Process: 5917 Fill in Cashbook / Bank Rec for previous Month 05 Mar 2016
Process: 5918 Journals for the End of Month accounts 05 Mar 2016
Process: 5920 Responsibility Allocation : Cheques To Bank - Fill in Paying in Book 05 Mar 2016
Process: 5922 Credit Cards Expenses Calculations 05 Mar 2016
Process: 5923 Credits Note Processing 05 Mar 2016
Process: 5924 Export Cheques sent by Currency Lodgement 05 Mar 2016
Process: 5925 Customs Clearance 05 Mar 2016
Process: 5926 Responsibility Allocation : Petty Cash Expenses receipts and cash 05 Mar 2016
Process: 5927 Responsibility Allocation : Accounts Filing 05 Mar 2016
Process: 5928 Responsibility Allocation : Filing Cabinets 05 Mar 2016
Process: 5930 VAT Return Viamed 05 Mar 2016
Process: 5931 Purchase Invoices in to Opera 05 Mar 2016
Process: 5932 Remit Processing and entry into Opera 05 Mar 2016
Process: 5933 Responsibility Allocation : Sales Accounts Reminders 05 Mar 2016
Process: 5942 Chase the Debtors viamed 08 Mar 2016
Process: 6819 Supplier Payments and Invoice processing 09 Mar 2016
Process: 6822
Process: 6876 Issues for Accountants - P11D Form re Benefits to Revenue and Customs 09 Mar 2016
Process: 6946 Accounts Debtors Review - Export 09 Mar 2016
Process: 6951 Accounts Debtors Review - UK 09 Mar 2016
Process: 7192
Process: 7084 Responsibility Allocation : Accounts Issues 09 Mar 2016
Process: 7195 Responsibility Allocation : Loans between companies 09 Mar 2016
Process: 7788 Petty Cash Reconciliation 02 Mar 2017
Process: 7789 Withdraw Funds From Paypal 02 Mar 2017
Process: 7817 Issues For Accountants - Check suggested invoice report in operas 13 Jun 2017
Process: 7818 Issues For Accountants - Check Purchasing Journals to see if VAT handled correctly Previous Month 13 Jun 2017
Process: 7819 Issues For Accountant - Check Contra account 8000 and clear it 13 Jun 2017
Process: 7824 Chase The Debtors VST 27 Aug 2017
Process: 7708 Acorn 0014904 17 Jun 2016
Process: 5869 Responsibility Allocation : Legal Company Car Registration 17 Feb 2016
Process: 7831 Intrastats Debtors And Creditor Figures 18 Sep 2017
Process: 7885 Audit 04 Accounts and Finance Viamed 23 Oct 2017
Process: 7899 Region Checker 06 Feb 2018
Process: 7900 Royal Mail - Mail Retention Form 29 Mar 2018
Process: 7901 UPS Exceptions Checkup 20 Apr 2018
Process: 7920 Sales Warnings 20 Dec 2018
Process: 7927 Contract Pricing Review 14 Feb 2019
Process: 7919 Send Debtors Overview To Derek 06 Dec 2018
Process: 7924 PDFing Of Invoices Vandagraph 11 Jan 2019
Process: 7932 Check Debtors Report 15 Mar 2019
Process: 7933 Purchasing Invoice Processing 22 Mar 2019
Process: 7935 PCI DSS Compliance 03 Jun 2019
Process: 7938 VAT Return Vandagraph 22 Jul 2019
Process: 7939 VAT Return VST 22 Jul 2019
Process: 7945 Xero Review Sales Contacts 05 Feb 2020
Process: 7946 Xero Merge Customers That Are Duplicates 05 Feb 2020
Process: 7952 Check Xero To Barclays Bank Statements End On Month GBP, USD And Euro Viamed 06 Mar 2020
Process: 7958 Exchange Rate In To Intrastats 03 Sep 2020
Process: 7966 Xero Sync 10 Mar 2021
Process: 7968 Shred CC Slips 06 Aug 2021
Process: 7984 Check For Viking Invoices 19 Jan 2022
Process: 8007 Verification Credit Notes 17 Feb 2022
Process: 7986 Check Creditors 03 Feb 2022
Process: 7990 Verification Invoice Details Accounts 07 Feb 2022
Process: 8012 VAT Return Viamed Properties 06 Apr 2022
Process: 8019 Audit 04 Accounts And Finance VST 14 Sep 2022
Process: 8021 Check Xero Bank For The Year To The Barclays Bank Account 06 Jan 2023
Process: 8035 USA Tax Book Sales 14 Dec 2023
Process: 8042 PAYE Needs Paying URGENT 29 Dec 2023
Process: 8077 Download HMRC Reports 18 Jun 2024
Process: 8085 **Stock Figure - Correct Xero To Intrastats 16 Dec 2024
ID159449 Audit 12 CE Files Viamed
Process: 7725 Audit 12 CE Files Viamed 24 Aug 2016
Process: 7773 Audit 12 CE Files VST 08 Feb 2017
Process: 24 Responsibility Allocation : Compliance ISO Standards 16 Feb 2016
Process: 7172 Responsibility Allocation : CE Technical Files 09 Mar 2016
Process: 7071 Post Market Surveillance 09 Mar 2016
ID137913 VOP 15 Data and Information Analysis
Process: 8074 Carbon Reduction Planning 26 Jan 2024
ID73132 VM3COP20.29 Checking the Purchase Order Log
Process: 5850 Purchase Order Log 17 Feb 2016
ID17070 VM3COP27.34 Sending Purchase Orders to Suppliers
Process: 7707 Send Purchase Orders To Suppliers 13 Jun 2016
ID168080 Audit 06 Calibration VIAMED
Process: 7718 Audit 06 Calibration Viamed 24 Aug 2016
Process: 7048 Control of monitoring and measuring devices 09 Mar 2016
Process: 7091 Calibration Index 09 Mar 2016
Process: 7766 Audit 06 Calibration VST 08 Feb 2017
Process: 7998 Verification Calibrated Equipment 08 Feb 2022
ID164829 VOP 22 Picking and Packing Dispatch and Goods Out
Process: 5945 Responsibility Allocation : Sending Samples 08 Mar 2016
Process: 5946 Responsibility Allocation : Sending Sale Or Returns 08 Mar 2016
Process: 7825 Responsibility Allocation : Order Picking 06 Sep 2017
Process: 5859 Review Un-shipped Parcels 17 Feb 2016
Process: 6954 Back Orders Review - By Customer 09 Mar 2016
Process: 6970
Process: 7691 Ship Sale Or Returns 21 Apr 2016
Process: 7748 Check Repair Orders 10 Oct 2016
Process: 7749 Check Repair Quotes 10 Oct 2016
Process: 7797 Check Order Are Being Picked In Priority Order 10 May 2017
Process: 6969 Responsibility Allocation : VIAMED Stock Meeting `Goods In` Review 09 Mar 2016
Process: 7860 Goods Out Picking 03 Oct 2017
ID159493 Audit 24 Service Logs Viamed
Process: 5857 Customer Service Logs 17 Feb 2016
Process: 7760 Send Service Offers 31 Jan 2017
Process: 7889 Audit 24 Servicing Viamed 24 Oct 2017
Process: 7985 OverDue Servicing 03 Feb 2022
ID24509 VM3COP20.27 Annual Services for Resuscitation Cabinets
Process: 5857 Customer Service Logs 17 Feb 2016
ID75624 VM3COP23.00 EAN13 Barcodes to Stock and the Online Databases
Process: 7909 EAN GTIN Online Database 06 Aug 2018
ID8712 DO NOT USE VM3COP09 Repairs
Process: 7684 Repairs Ready For Quote 18 Apr 2016
Process: 7685 Repairs Ready For Invoice 18 Apr 2016
Process: 7814 Responsibility Allocation : Viamed Repairs 06 Jun 2017
ID13703 VM3COP20.03 Repair Procedures Goods in
Process: 5891 Processing Of Repair Quotes And Orders 25 Feb 2016
ID17485 VM3COP20.47 Collecting Repair Paperwork
Process: 7693 Collect Repair Filing From Warehouse 22 Apr 2016
ID159465 Audit 17 Internal Audits Viamed
Process: 7728 Audit 17 Internal Audits Viamed 24 Aug 2016
Process: 7776 Audit 17 Internal Audits VST 08 Feb 2017
Process: 7972 ISO System Management Review Vst 26 Oct 2021
ID124938 VOP 10 Non Conformance, Corrective and Preventive Actions
Process: 7199 Non Conformities Review Viamed 09 Mar 2016
Process: 7069 Responsibility Allocation : Corrective Actions 09 Mar 2016
Process: 7849 Review Product Failures New Codes 28 Sep 2017
Process: 7874 Review For Latest Version Med Dev 2.12. 18 Oct 2017
Process: 7264 Responsibility Allocation : VST Management Meeting Non Conformance Issues 09 Mar 2016