Report no:
4820415 
7020531

Date:
21/03/2007

Prepared by:
Magnus Graham

BSI reference:
VIAMED-0009370214-000

Attached Report was delivered to the client and pasted into the template for uploading to PG.

Date:
21/03/2007

Prepared by:
Magnus Graham

BSI reference:
VIAMED-0009370214-000

Viamed Ltd 
15 Station Road 
Cross Hills 
Keighley 
West Yorkshire 
BD20 7DT 
United Kingdom	

BSI Continuing Assessment Visit Report

Introduction
This report relates to the Assessment Visit for Viamed Ltd held 21/03/2007. 

The assessment was based upon the Client’s Management System, reference Manual Issue 3.

During the assessment 3 nonconformities were identified. One of these is a major non-conformity.

Audit Objective – 
§	To assess the ongoing effectiveness of the management system in delivering the certified scope of activities and in meeting customer and regulatory requirements
Audit Scope –
§	Design, manufacture, repair, maintenance, servicing and supply of medical monitoring, ventilation and anaesthetic equipment including that carried out on customer premises. FS 28304 exp 20/11/2009
§	 The design and manufacture of microstim nerve stimulators, tom thumb resuscitator, thermacot, oxygen monitors, pulse oximeter probe s, temperature probes, breathing monitors, headboxes, oxygen tents, gas respiratory adapters, gas respiratory valves and phototherapy light shields CE01389 exp 22/8/2011
§	The design, manufacture and service of nerve stimulators, resuscitators,  oxygen monitors, pulse oximeter probes, temperature probes, breathing monitors, gas respiratory adapters, gas respiratory valves, APGAR timer, oxygen hoods and tents, and phototherapy light shields MD 78787 exp 26/01/2010
Audit Criteria – reference documents
§	ISO 9001:2000
§	MDD 93/42/EEC Annex II
§	ISO 13485:2003

This visit report forms part of BSI’s partnership approach in the assessment of your Management System.

The assessment was based on random samples and therefore nonconformities may exist which have not been identified.

If you wish to distribute copies of this report external to the organization, then all pages must be included.

Conclusion
A major nonconformity has been identified, and therefore a corrective action plan is required urgently.

The non-conformities identified indicate a breakdown in the management system to effectively control the activities for which it was intended.

Due to the severity of the non-conformities the continued validity of your certificate is at risk.

Immediate action is required to investigate the underlying cause of these non-conformities and implement effective, corrective action.

Please submit a plan to determine action, timescales and responsibilities for review, no later than the date specified in the section below (Non-Conformities).

The plan should be sent by fax to 01908 228109 or by e-mail to caps@bsi-global.com and reference the above Job number/s.

An additional assessment will be required to verify that the action plan has been effectively implemented as agreed. The date for the follow up visit is 11th June 2007.

Processes/Business Areas Assessed
Opening Meeting – Scope, Changes,	
Management Review of policy and objectives – performance, actions, internal audit plan and actions	
Regulatory Notifications	
Cots and Cabinet Product Design, supply, manufacture and Distribution
- Headboxes, oxygen tents and phototherapy light shields	
Closing Meeting	

Commentary
The opening meeting was used to define the scope and methods of the assessment.

Changes
The warehouse facility is in the process of being closed. Stock has been transferred to 15 Station Road. Controls over stocks and locations were reviewed at this assessment and the process applied at the Warehouse location has been directly transferred with conversion of office space to storage shelving. The quality manual is now held electronically. Procedures are being maintained in “Intrastats”. Indexing and cross enables tracing of product specifications and procedures. Consideration is being given to shortening of the Quality Manual to provide a brief guide to the system and it’s scope.

There have been no reportable incidents since the last assessment. Complaints records were sampled  (2 since last assessment) and vigilance decisions are consistent with the requirements of the directive.

Internal auditing has not been following the procedure defined. There are no reports of audits since 2006 however actions arising from audits and reviews of the system are recorded in the system. The need for a revised procedure has been identified as an action and a checklist document drafted. Chart 16 provides a flowchart of the requirements but refers to a matrix that is not in use.

The process for design and distribution of oxygen tents was traced for part 2310004. Technical documentation is being maintained and the declaration of conformity and the classification rationale have been established. The risk analysis for the product identified contamination risk and contamination controls deemed appropriate given the absence of complaints for this product. The product is purchased from a supplier in the US. Stock on the shelf did not include and CE or Viamed labelling. Labelling for despatch was demonstrated and includes a headed instruction leaflet with Viamed Ltd Information. The CE mark was not included in the labelling. There is no labelling specification for this product.
Goods inwards checks for the product are checked and records of the verification stored in the system with the identity of the individual responsible.

Non-Conformities
3 non-conformities were identified.  A corrective action plan is required by 29th March 2007.

Area	NCR Ref.	Description	Clause	
Internal Audits	MG01	The mechanism for recording internal audits has not been defined since migration of the procedure to Intrastats.	8.2.2	
Internal Audits	MG02	No audit reports have been generated since 2006. The matrix of audits required is no longer relevant.	8.2.2	
Labelling	MG03	Product 231004 has been despatched without inclusion of the CE mark symbol and notified body number. There is no definition of the packaging requirements for this product.	MDD Article 17, 5.2, 7.2.1	

Number of Employees (covered by Registrations at sites visited)
13

Assessment Team
On behalf of BSI the assessment was conducted by:
Magnus Graham	The principal staff involved on behalf of the company were:
Derek Lamb
John Lamb	

Next Visit Plan (Prepared in accordance with ISO19011: 2002)
Date	Time	Assessor	Business Area/Process	
11th Jun 2007	0900	M Graham	Opening Meeting – scope methods and changes	
	0915		Major N/C Investigation of root cause and extent of the issue	
	1000		Action Plan Completion and review of Effectiveness	
	1100		Internal Audit Process Changes	
	1130		Report Prep	
	1230		Closing Meeting	

Please note that cancellation within 30 days of an agreed visit date will incur a cancellation fee equivalent to the full daily rate.

BSI Registered Logo
BSI registered firm logos are still in use and in the process of being updated.

Signed for on behalf of BSI	Signed for on behalf of the client	
	Derek Lamb	
21/03/2007	21/03/2007	

Regulatory Compliance

BSI conditions of contract for this visit require that BSI be informed of all relevant regulatory non-compliance or incidents that require notification to any regulatory authority.  Acceptance of this report by the client signifies that all such issues have been disclosed as part of the assessment process and agreement that any such non-compliance or incidents occurring after this visit will be notified to the BSI client manager as soon as practical after the event.

eReport – Assessment Detail
A281108

Job Details
Job No	4820415	
Visit Type		
Visit Description	Continuing Assessment FS 28344	
Visit Duration	0.5 days	
Start Date	21/03/2007	

Job Details
Job No	7020531	
Visit Type		
Visit Description	Complete Continuing Assessment	
Visit Duration	0.5 days	
Start Date	21/03/2007	

Site Details
BSI Reference	VIAMED-0009370214-000	VIAMED-0009370214-000	
Company Name & Address	Viamed Ltd 
15 Station Road 
Cross Hills 
Keighley 
West Yorkshire 
BD20 7DT 
United Kingdom	
Contact Name	Mr Derek Lamb	
Telephone Number	01535 634542	
Fax Number	01535 635582	
e-mail Address	derek.lamb@viamed.co.uk	
Change to this section?		
Comments	     	

Billing Details
Purchase Order No. Required?		
Purchase Order No.	     	
Company Name & Address	Viamed Ltd 
15 Station Road 
Cross Hills 
Keighley 
West Yorkshire 
BD20 7DT 
United Kingdom	
Billing Contact	Mr Derek Lamb	
Billing Telephone Number	01535 634542	
Billing Fax Number	01535 635582	
Billing E-mail	derek.lamb@viamed.co.uk	
Change to this section?		
Comments:	     	

Certificate Details
Certificate	FS 28344	200028344	
Issue Date	15/06/1994	
Last Re-issue	09/06/2004	
Expiry Date	20/11/2009	
Management Standard	ISO 9001:2000	
Accreditation Marks	UKAS, RVA	
Management System	ISSUE 2 REV 3	
Management System Date	     	
Scope of Registration	Design, manufacture, repair, maintenance, servicing and supply of medical monitoring, ventilation and anaesthetic equipment including that carried out on customer premises.
	
Location Activities	 VIAMED-0009370214-000
Design, manufacture, repair, maintenance, servicing and supply of medical monitoring, ventilation and anaesthetic equipment including that carried out on customer premises.
	
Change to this section?		
Issue/Reissue required?		
Comments:	     	

Certificate Details
Certificate	CE 01389	200101389	
Issue Date	23/08/1996	
Last Re-issue	19/06/2006	
Expiry Date	22/08/2011	
Management Standard	MDD 93/42/EEC Annex II	
Accreditation Marks	     	
Management System	ISSUE 2 REV 3	
Management System Date	06/11/2002	
Scope of Registration	The design and manufacture of microstim nerve stimulators, tom thumb resuscitator, thermacot, oxygen monitors, pulse oximeter probe s, temperature probes, breathing monitors, headboxes, oxygen tents, gas respiratory adapters, gas respiratory valves and phototherapy light shields
	
Location Activities	 VIAMED-0009370214-000
     
	
Change to this section?		
Issue/Reissue required?		
Comments:	Management Standard Amended	

Certificate Details
Certificate	MD 78787	200478787	
Issue Date	27/01/2004	
Last Re-issue	30/10/2006	
Expiry Date	26/01/2010	
Management Standard	     	
Accreditation Marks	     	
Management System	     	
Management System Date	     	
Scope of Registration	The design, manufacture and service of nerve stimulators, resuscitators,  oxygen monitors, pulse oximeter probes, temperature probes, breathing monitors, gas respiratory adapters, gas respiratory valves, APGAR timer, oxygen hoods and tents, and phototherapy light shields
	
Location Activities	 VIAMED-0009370214-000
     
	
Change to this section?		
Issue/Reissue required?		
Comments:	     	

Written Corrective Actions
Written CAP Required?		
Date Required by:	29/03/2007 dd/mm/yyyy	
eReport – ADR Header Sheet – (Copy to be attached to ADRs)

Z	1	

SMO	Functional Location	SAP Material	

4820415	VIAMED-0009370214-000	200028344	

7020531	VIAMED-0009370214-000	200101389 
200478787	

Signed for on behalf of BSI	Signed for on behalf of the client	
	     	
21/03/2007	21/03/2007	

Regulatory Compliance

BSI conditions of contract for this visit require that BSI be informed of all relevant regulatory non-compliance or incidents that require notification to any regulatory authority.  Acceptance of this report by the client signifies that all such issues have been disclosed as part of the assessment process and agreement that any such non-compliance or incidents occurring after this visit will be notified to the BSI client manager as soon as practical after the event.

Checklist for medical device regulations – to be completed
every CAV
PCA099 page 1 of 1 issue 1
Client Managers should complete and send this checklist to BSI PC, attached
to the audit report. The boxes should refer to the page numbers of the ADR
(form A7) which contain the relevant details, or refer to the non-conformities, if
any are raised.

Report Number 4820415/7020531
Reference ADR page number
1. Checked whether there have been any vigilance reports or advisories since the last check.	Page 4

		
An II/V/VI, 3.1		
2. Complaint file sampled to check process for vigilance reporting.	Page 4

# 4.14.2		
3. Checked whether there have been any changes and additions to the QA system.	Page 1 and opening meeting

		
An II/V/VI, 3.4		
4. Checked whether there have been any changes and additions to the product range.	Page 1 and opening meeting

		
		
An II/V/VI, 3.4		
Checked at least one product-related
aspect from the following:	

5. Sample labelling checked against ER13	Page 5 – Major N/C

An I, ER 13		
6. Sample technical file checked for correct headings	Page 5

An VII, 3		
7. Final inspection and test checked for evidence that products meet intended performance	Page 7

		
8. Other product-related check, please specify:	

date of assessment 21st March 2007
signature of team leader Magnus Graham
The client does not receive this form as part of the audit report.