# Management Review Report
**Company:** Viamed
**Type:** Role: ISO and Compliance Controller
**Report Date:** 27 Jul 2026
---
## Index
1. ISO and Compliance Controller (ID #28)
1. **Conclusion / Executive Summary**
---
---
## Role: ISO and Compliance Controller (ID #28)
**Reports To:** Managing Director → Share Holder
**Assigned Employees:** Derek Lamb, Derek Lamb, Derek Lamb, Derek Lamb
**Processes Assigned:** 33 (25 active, 8 responsibility-only)
### Role Risk Indicators - ISO and Compliance Controller
- **25** linked processes
- **1** overdue rolling tasks/audits
- **1** processes not reviewed >24 months
- **7** processes with only one trained user
- **15** processes with no audit configured
### Dependency / Single-Point-of-Failure Risk
- Derek Lamb linked to 100% (25 of 25) of role processes - single point of failure risk
- 7 process(es) have only 1 trained employee - no backup coverage
---
### Process ID #7093 — BSI Audits Calander
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Audit Issues | Derek Lamb 26 Sep 2017 |
| Outputs to the Process | Completed Audits | Derek Lamb 26 Sep 2017 |
| Risks to the Process | Audits dont get completed | Derek Lamb 26 Sep 2017 |
| Steps to Minimise Process Risks | rolling Issue 725 | Derek Lamb 26 Sep 2017 |
| Scope / Definition of Process / Objective | Review of outstanding Audits | Derek Lamb 26 Sep 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 26 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 26 Sep 2017 |
| Measurable Objective | Check what audit issues are outstanding and if they are within reasonable terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal audits and management review meeting. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 21 Audit of Audit Viamed (Doc ID: 159485)
- Audit 21 Audit of Audit VST (Doc ID: 159487)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #725**
- **Subject:** BSI Audits Calander
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Check No Top Level Audits are Overdue
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 384683 | BSI Audits Calander (725) | 01 Jan 2026 | 09 Apr 2026 | 98 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 09 Apr 2026 14:31 | Meeting Completion | Derek Lamb | | |
| | - 02 Jan 2026 09:20 | Completed | Derek Lamb | all update and done for 2025 | |
| 350935 | BSI Audits Calander (725) | 01 Jan 2025 | 31 Mar 2025 | 89 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 31 Mar 2025 16:02 | Meeting Completion | Derek Lamb | | |
| | - 23 Jan 2025 09:44 | | Derek Lamb | alldone for 2024 | |
---
### Process ID #7941 — Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found.
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | leaflets and letter headed paper
website
BSi logo | Helen Lamb 23 Sep 2019 |
| Outputs to the Process | correct paperwork available | Helen Lamb 23 Sep 2019 |
| Risks to the Process | that we may miss something and risk BSI non conformance | Helen Lamb 23 Sep 2019 |
| Steps to Minimise Process Risks | Regular review and Issues when needed. | Helen Lamb 23 Sep 2019 |
| Scope / Definition of Process / Objective | Check Leaflets, Letterhead and other paperwork to see if the correct BSI logo is in use. Remove and dispose of all old items if found.
Ask Catrin to review the website for old leaflets. | Helen Lamb 23 Sep 2019 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 13 Nov 2021 |
| Severity of Risk (1-5) | 3.Serious | Helen Lamb 23 Sep 2019 |
| Measurable Objective | Check and make sure no old stock of paperwork - Leaflets, Letterhead etc is present. | Helen Lamb 23 Sep 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 02 Nov 2021 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness,of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=3) | |
**Interested Parties**
- ISO Auditing Bodies
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Helen Lamb)
- Helen Lamb (trained by Helen Lamb)
**Associated Documents**
- Audit 02 Contract Review and Sales Order Processing Viamed (Doc ID: 163469)
- Audit 02 Contract Review and Sales Order Processing VST (Doc ID: 163467)
- VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records (Doc ID: 120321)
**Rolling Task #1005**
- **Subject:** Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found.
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Check we do not have any old leaflets or letterhead. Get Catrin to check website for old leaflets.
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 371479 | Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found. (1005) | 01 Aug 2025 | 05 Aug 2025 | 4 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 01 Aug 2025 09:37 | | Derek Lamb | no bsi logos on paperwork | |
| | - 01 Aug 2025 09:37 | Completed | Derek Lamb | no bsi logos on paperwork | |
| 336871 | Check Leaflets, Letterhead And Other Paperwork To See If The Correct BSI Logo Is In Use. Remove All Old If Found. (1005) | 01 Aug 2024 | 01 Aug 2024 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 01 Aug 2024 11:33 | | Derek Lamb | done, | |
| | - 01 Aug 2024 11:33 | Completed | Derek Lamb | done, | |
---
### Process ID #5890 — Check Website ISO Documents
**Last Reviewed:** 01 Jul 2026 by Derek Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Web site | Derek Lamb 22 Aug 2016 |
| Outputs to the Process | confirmation the online documents are our latest versions | Derek Lamb 22 Aug 2016 |
| Risks to the Process | customers download out of date documents. | Derek Lamb 22 Aug 2016 |
| Steps to Minimise Process Risks | rolling Issue to check the online documents | Derek Lamb 22 Aug 2016 |
| Scope / Definition of Process / Objective | Ensure the online available copies of our ISO standards are upto date | Derek Lamb 22 Aug 2016 |
| Likelihood of Risk (1-5) | 3.Occasional | Derek Lamb 12 Jun 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 12 Jun 2017 |
| Measurable Objective | Check rolling issues are completed within terms. Also check the web site to the current documentation. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Derek Lamb 23 Oct 2020 |
| Covid / Pandemic Notes | not applicable | Derek Lamb 01 Jul 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=3, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
**Interested Parties**
- ISO Auditing Bodies
- VST OEM Customers
- VST OEM Customers
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Catrin Hird (trained by Derek Lamb)
**Associated Documents**
- Audit 10 Documentation Control Viamed (Doc ID: 159363)
- Audit 10 Documentation Control VST (Doc ID: 159361)
- VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records (Doc ID: 120321)
**Rolling Task #463**
- **Subject:** Check Website ISO Documents
- **Target User:** Catrin Hird
- **Recurrence:** 1 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Check the documents are still in date and valid
**Rolling Audit #464**
- **Subject:** Check Website ISO Documents
- **Target User:** Derek Lamb
- **Recurrence:** 6 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
AUDIT Ensure the Task is being Completed
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 402522 | Check Website ISO Documents (463) | 10 Jul 2026 | | Outstanding (17 days) | Catrin Hird |
| | **History Log:** | | | | |
| | - 14 Jul 2026 09:42 | Completed | Catrin Hird | All up to date, checked BSI membership certificate in the hall which is out of date - added a request amend issue to DL to check if we have received (by post) an up to date one. 190590 - runs out August so presuming not. | |
| 401387 | Check Website ISO Documents (464) | 01 Jul 2026 | 09 Jul 2026 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 01 Jul 2026 12:43 | Completed | Derek Lamb | all upto dater | |
| 399592 | Check Website ISO Documents (463) | 10 Jun 2026 | 12 Jun 2026 | 2 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Jun 2026 11:01 | Completed | Catrin Hird | Done, insurance renewal expected July | |
| 396859 | Check Website ISO Documents (463) | 11 May 2026 | 14 May 2026 | 3 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 12 May 2026 14:09 | Completed | Catrin Hird | Done | |
| | - 12 May 2026 14:09 | Read | Catrin Hird | | |
| 394252 | Check Website ISO Documents (463) | 10 Apr 2026 | 16 Apr 2026 | 6 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 18 Dec 643996 20:15 | Read | Catrin Hird | | |
| | - 15 Apr 2026 13:42 | Completed | Catrin Hird | Done | |
| 391266 | Check Website ISO Documents (463) | 10 Mar 2026 | 16 Mar 2026 | 6 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Mar 2026 09:38 | Completed | Catrin Hird | Done | |
| 388419 | Check Website ISO Documents (463) | 10 Feb 2026 | 13 Feb 2026 | 3 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Feb 2026 11:33 | Completed | Catrin Hird | Done | |
| 385597 | Check Website ISO Documents (463) | 12 Jan 2026 | 19 Jan 2026 | 7 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 05 Jun 643987 21:48 | Read | Catrin Hird | | |
| | - 13 Jan 2026 11:22 | Completed | Catrin Hird | Done | |
| 384653 | Check Website ISO Documents (464) | 01 Jan 2026 | 08 Jan 2026 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Jan 2026 09:23 | Completed | Derek Lamb | uptodate and valid | |
| 383039 | Check Website ISO Documents (463) | 10 Dec 2025 | 22 Dec 2025 | 12 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 16 Dec 2025 10:11 | Completed | Catrin Hird | Done | |
| 380373 | Check Website ISO Documents (463) | 10 Nov 2025 | 20 Nov 2025 | 10 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 11 Nov 2025 12:15 | Completed | Catrin Hird | Done | |
| 377684 | Check Website ISO Documents (463) | 10 Oct 2025 | 16 Oct 2025 | 6 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 16 Oct 2025 08:37 | Completed | Catrin Hird | Done | |
| 374977 | Check Website ISO Documents (463) | 10 Sep 2025 | 12 Sep 2025 | 2 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Sep 2025 09:29 | Completed | Catrin Hird | Done | |
| 372237 | Check Website ISO Documents (463) | 11 Aug 2025 | 12 Sep 2025 | 32 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 04 Sep 2025 12:26 | Completed | Catrin Hird | Done | |
| 369445 | Check Website ISO Documents (463) | 10 Jul 2025 | 18 Jul 2025 | 8 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Jul 2025 10:14 | | Catrin Hird |
Done | |
| | - 10 Jul 2025 10:14 | Completed | Catrin Hird |
Done | |
| 368461 | Check Website ISO Documents (464) | 01 Jul 2025 | 03 Jul 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 01 Jul 2025 11:39 | | Derek Lamb | certificates upto date | |
| | - 01 Jul 2025 11:39 | Completed | Derek Lamb | certificates upto date | |
| 366646 | Check Website ISO Documents (463) | 10 Jun 2025 | 19 Jun 2025 | 9 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 17 Jun 2025 13:31 | | Catrin Hird |
Done | |
| | - 17 Jun 2025 13:31 | Completed | Catrin Hird |
Done | |
| 363944 | Check Website ISO Documents (463) | 12 May 2025 | 15 May 2025 | 3 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 13 May 2025 09:25 | | Catrin Hird |
Done | |
| | - 13 May 2025 09:25 | Completed | Catrin Hird |
Done | |
| 361189 | Check Website ISO Documents (463) | 10 Apr 2025 | 14 Apr 2025 | 4 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 10 Apr 2025 08:57 | | Catrin Hird |
Done
Done | |
| | - 10 Apr 2025 08:57 | Completed | Catrin Hird |
Done
Done | |
| 357941 | Check Website ISO Documents (463) | 10 Mar 2025 | 13 Mar 2025 | 3 days | Catrin Hird |
| | **History Log:** | | | | |
| | - 12 Mar 2025 10:28 | | Catrin Hird |
Done | |
| | - 12 Mar 2025 10:28 | Completed | Catrin Hird |
Done | |
---
### Process ID #7743 — Customer Complaints Paper File
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Issues Customer Complaints, and non conformance reviews.
See Customer Complaints VM3COP for further details | Derek Lamb 21 Feb 2017 |
| Outputs to the Process | File is kept upto date | Derek Lamb 21 Feb 2017 |
| Risks to the Process | Customer Complaints could be missed or not filed correctly | Helen Lamb 02 Nov 2021 |
| Steps to Minimise Process Risks | Digital system
Regular reviews and issues and management meeting | Helen Lamb 02 Nov 2021 |
| Scope / Definition of Process / Objective | Major Customer Complaints get escalated to Paper Customer Complaints file.
Check the File is being Maintained and any relevant documentation is in the File. | Derek Lamb 21 Feb 2017 |
| Likelihood of Risk (1-5) | 2.Remote | Derek Lamb 12 Jun 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 12 Jun 2017 |
| Measurable Objective | Look at the paper file see when reviewed last. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 02 Nov 2021 |
| Verification / Effectiveness | This task is verified for effectiveness during internal audit and management review. | Helen Lamb 02 Nov 2021 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=2, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.1.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.6.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.6.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.6.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 7.2.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 7.2.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.3.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.3.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.5.3
- Filter 90012015: 5.1.2
- VIAMED ISO 13485:2008 Manual: 4.1.a
- VIAMED ISO 13485:2008 Manual: 4.1.b
- VIAMED ISO 13485:2008 Manual: 4.1.c
- VIAMED ISO 13485:2008 Manual: 5.1.A
- VIAMED ISO 13485:2008 Manual: 5.1.A
- VIAMED ISO 13485:2008 Manual: 6.1
- VIAMED ISO 13485:2008 Manual: 7.2.1
- VIAMED ISO 13485:2008 Manual: 7.2.1.A
- VIAMED ISO 13485:2008 Manual: 7.2.1.A
- VIAMED ISO 13485:2008 Manual: 7.2.3
- VIAMED ISO 13485:2008 Manual: 7.2.3.C
- VIAMED ISO 13485:2008 Manual: 7.2.3.C
- VIAMED ISO 13485:2008 Manual: 7.2.3.C
- VIAMED ISO 13485:2008 Manual: 7.2.3.C
- VIAMED ISO 13485:2008 Manual: 7.5.4
- VIAMED ISO 13485:2008 Manual: 8.3
- VIAMED ISO 13485:2008 Manual: 8.3
- VIAMED ISO 13485:2008 Manual: 8.5.1
- VIAMED ISO 13485:2008 Manual: 8.5.1
- VIAMED ISO 13485:2008 Manual: 8.5.2
- VIAMED ISO 13485:2008 Manual: 8.5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- ISO 9001 Vandagraph Sensor Technologies Manual: 4.1.a
- ISO 9001 Vandagraph Sensor Technologies Manual: 4.1.b
- ISO 9001 Vandagraph Sensor Technologies Manual: 4.1.c
- ISO 9001 Vandagraph Sensor Technologies Manual: 5.1.A
- ISO 9001 Vandagraph Sensor Technologies Manual: 5.1.A
- ISO 9001 Vandagraph Sensor Technologies Manual: 6.1
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.1
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.1.A
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.1.A
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.3
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.3.C
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.3.C
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.3.C
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.2.3.C
- ISO 9001 Vandagraph Sensor Technologies Manual: 7.5.4
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.3
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.3
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.5.1
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.5.1
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.5.2
- ISO 9001 Vandagraph Sensor Technologies Manual: 8.5.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Customer
- MHRA
- VST OEM Customers
- VST OEM Customers
**Linked Companies**
- Viamed
- VST
- Vandagraph
**Trained Staff (1)**
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 14 Complaints and Corrective Actions Viamed (Doc ID: 203281)
- Audit 14 Complaints and Corrective Actions VST (Doc ID: 159453)
- Chart 27 Customer Complaints Chart 27 (Doc ID: 8700)
- QC 11 Customer Complaints Index (Doc ID: 6098)
- QC 12 Customer Complaints Report form QC12 (Doc ID: 6096)
- VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd (Doc ID: 132118)
- VOP 19 FeedBack Customer Complaints Vigilance and Notifications VST Ltd (Doc ID: 217154)
**Rolling Task #75**
- **Subject:** Review Paper Customer Complaints File
- **Target User:** Derek Lamb
- **Recurrence:** 6 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Review Paper Customer Complaints File
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 392734 | Review Paper Customer Complaints File (75) | 25 Mar 2026 | 26 Mar 2026 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Mar 2026 11:54 | Completed | Derek Lamb | no new complaints | |
| 376214 | Review Paper Customer Complaints File (75) | 25 Sep 2025 | 02 Oct 2025 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Sep 2025 09:02 | Completed | Derek Lamb | nothing new in the file | |
| 359497 | Review Paper Customer Complaints File (75) | 25 Mar 2025 | 25 Mar 2025 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Mar 2025 10:29 | | Derek Lamb | reviewed in audit last week all upto date nothing new | |
| | - 25 Mar 2025 10:29 | Completed | Derek Lamb | reviewed in audit last week all upto date nothing new | |
| 341930 | Review Paper Customer Complaints File (75) | 25 Sep 2024 | 17 Oct 2024 | 22 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 16 Oct 2024 15:42 | | Derek Lamb |
Done | |
| | - 16 Oct 2024 15:42 | Completed | Derek Lamb |
Done | |
---
### Process ID #7895 — FDA Device Establishment Registration
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | FDA Website
Rolling Issue | Derek Lamb 29 Oct 2017 |
| Outputs to the Process | Continued Registration | Derek Lamb 29 Oct 2017 |
| Risks to the Process | unable to sell in U.S.A | Derek Lamb 29 Oct 2017 |
| Steps to Minimise Process Risks | rolling task | Derek Lamb 29 Oct 2017 |
| Scope / Definition of Process / Objective | To conitune our FDA registration
(for the Apgar timer) | Derek Lamb 29 Oct 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 29 Oct 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 29 Oct 2017 |
| Measurable Objective | Check we are listed on the FDA Website, | Derek Lamb 16 Aug 2018 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness,of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Interested Parties**
- Internal Systems
- Regulations
- ISO Auditing Bodies
**Linked Companies**
- Viamed
**Trained Staff (1)**
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- FDA Registration Owner Number (Doc ID: 7026)
**Rolling Task #825**
- **Subject:** FDA Device Establishment Registration
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed To Link
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 379689 | FDA Device Establishment Registration (825) | 03 Nov 2025 | 06 Nov 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 03 Nov 2025 10:31 | Completed | Derek Lamb | no registration required | |
| 345614 | FDA Device Establishment Registration (825) | 01 Nov 2024 | 11 Nov 2024 | 10 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 01 Nov 2024 12:55 | | Derek Lamb | No FDA Products | |
| | - 01 Nov 2024 12:55 | Completed | Derek Lamb | No FDA Products | |
---
### Process ID #7744 — FDA Device Establishment Registration And Listing
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Rolling Issue to determine if we wish to renew - based off sales
Emails from the FDA with current instructions and Time lines.
FDA User Website FDA Product listing Website
MDall Website for reviewing current listing | Derek Lamb 21 Feb 2017 |
| Outputs to the Process | Paperwork is generally posted to the FDA, *note paperwork is supplied by the FDA. | Derek Lamb 21 Feb 2017 |
| Risks to the Process | Its harder to initially get on teh register than maintaining it.
Inability to sell products in North America | Derek Lamb 21 Feb 2017 |
| Steps to Minimise Process Risks | Rolling Issue | Helen Lamb 22 Jul 2019 |
| Scope / Definition of Process / Objective | FDA registration and the CMDCAS products
In order to sell in the USA / Canada Markets products need to be registered with the FDA. | Derek Lamb 21 Feb 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 12 Jun 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 12 Jun 2017 |
| Measurable Objective | Check rolling issues are completed within terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 02 Nov 2021 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness,of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 7.1.5.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 7.1.6
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 7.5.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 7.5.3.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 8.3.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 9.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 4.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 7.1.5.2
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 7.1.6
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 7.5.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 7.5.3.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 8.3.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.2.1
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
**Linked Companies**
- Viamed
**Trained Staff (1)**
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records (Doc ID: 120321)
**Rolling Task #565**
- **Subject:** FDA Device Establishment Registration And Listing
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Need to decide if we continuing with FDA registration and the CMDCAS products
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 376478 | FDA Device Establishment Registration And Listing (565) | 29 Sep 2025 | 02 Oct 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 29 Sep 2025 09:56 | Completed | Derek Lamb | No fda products registration not required | |
| 342290 | FDA Device Establishment Registration And Listing (565) | 30 Sep 2024 | 03 Oct 2024 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 30 Sep 2024 09:54 | | Derek Lamb | no fda products or cmdcas to register | |
| | - 30 Sep 2024 09:54 | Completed | Derek Lamb | no fda products or cmdcas to register | |
---
### Process ID #8036 — Future Issues Review
**Last Reviewed:** 22 Jun 2026 by Derek Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Show All Unlinked to Process list
processes | Helen Lamb 03 Jan 2024 |
| Outputs to the Process | An empty list
effective processes that cover all areas of the company | Helen Lamb 03 Jan 2024 |
| Risks to the Process | that we might miss and issue | Helen Lamb 03 Jan 2024 |
| Steps to Minimise Process Risks | regular issues to make sure everything is covered | Helen Lamb 03 Jan 2024 |
| Scope / Definition of Process / Objective | To review any new rolling future issues check they have a processed it is linked to. Make sure it not duplicated | Helen Lamb 03 Jan 2024 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 03 Jan 2024 |
| Severity of Risk (1-5) | 1.Negligible | Helen Lamb 03 Jan 2024 |
| Measurable Objective | To review any new rolling future issues
In - Add View Scheduled/Rolling Issues - Show All Unlinked to Process
check list is empty | Helen Lamb 03 Jan 2024 |
| Training Method Required | hands on | Helen Lamb 03 Jan 2024 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Helen Lamb 03 Jan 2024 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 03 Jan 2024 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Interested Parties**
- ISO Auditing Bodies
**Linked Companies**
- Vandagraph
- Viamed
- Viamed Properties
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1234**
- **Subject:** Future Issues Review
- **Target User:** Derek Lamb
- **Recurrence:** 6 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed To review any new rolling future issues
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 400573 | Future Issues Review (1234) | 22 Jun 2026 | 09 Jul 2026 | 17 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Jun 2026 12:51 | Completed | Derek Lamb | lots new going in due to the reviews and subsequent actions, lets do a proper review in july,
Done | |
| | - 22 Jun 2026 12:42 | Read | Derek Lamb | | |
| 384086 | Future Issues Review (1234) | 22 Dec 2025 | 29 Dec 2025 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 23 Dec 2025 12:59 | Completed | Derek Lamb | no new issues added without a process | |
| 367656 | Future Issues Review (1234) | 20 Jun 2025 | 26 Jun 2025 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Jun 2025 16:43 | | Derek Lamb | done | |
| | - 25 Jun 2025 16:43 | Completed | Derek Lamb | done | |
| 350308 | Future Issues Review (1234) | 20 Dec 2024 | 27 Dec 2024 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 20 Dec 2024 09:33 | | Derek Lamb | non required converting to a process | |
| | - 20 Dec 2024 09:33 | Completed | Derek Lamb | non required converting to a process | |
---
### Process ID #7833 — Importance Of Effective Quality Management
**Last Reviewed:** 02 Apr 2026 by Derek Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Reminder Issue | Derek Lamb 20 Sep 2017 |
| Outputs to the Process | Read only Issue sent to All current Employees so they acknowledge the importance of the Quality Management System | Derek Lamb 20 Sep 2017 |
| Risks to the Process | people may become careless | Helen Lamb 22 Jul 2019 |
| Steps to Minimise Process Risks | Keep up to date with issues. | Helen Lamb 22 Jul 2019 |
| Scope / Definition of Process / Objective | To Remind Staff of the Importance of the ISO systems and they should be following the procedures | Derek Lamb 20 Sep 2017 |
| Likelihood of Risk (1-5) | 2.Remote | Derek Lamb 20 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 20 Sep 2017 |
| Measurable Objective | Check rolling issues are completed within terms. Check issues. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Procedural , Required Reading and Hands on | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | regular reviews and issues | Helen Lamb 28 Jul 2025 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=2, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.5.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.2
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.2
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives (Doc ID: 164833)
- VM3COP00.00 VOP00.00 VST Quality Statement policy and objectives (Doc ID: 164813)
- VOP 12 Training (Doc ID: 166222)
**Rolling Task #732**
- **Subject:** Importance Of Effective Quality Management ISO
- **Target User:** Derek Lamb
- **Recurrence:** 6 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Post Read Only Issue to all Staff
Reminder to All staff
VST is ISO 9001:2015 Registered.
Viamed is ISO 13485:2016 Registered.
Its important you follow procedures and raise non conformances if things go wrong.
Please re-read VM3COP00.00
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 393306 | Importance Of Effective Quality Management ISO (732) | 01 Apr 2026 | 09 Apr 2026 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Apr 2026 12:45 | Completed | Derek Lamb | was sent in october | |
| 376738 | Importance Of Effective Quality Management ISO (732) | 01 Oct 2025 | 09 Oct 2025 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 03 Oct 2025 09:32 | Completed | Derek Lamb | Done | |
| | - 03 Oct 2025 09:31 | | Derek Lamb | New Related Issue #377051 | |
| 360188 | Importance Of Effective Quality Management ISO (732) | 01 Apr 2025 | 15 May 2025 | 44 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 13 May 2025 15:06 | | Derek Lamb | this gets done in october | |
| | - 13 May 2025 15:06 | Completed | Derek Lamb | this gets done in october | |
| 342445 | Importance Of Effective Quality Management ISO (732) | 01 Oct 2024 | 10 Oct 2024 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 03 Oct 2024 09:29 | | Derek Lamb | done | |
| | - 03 Oct 2024 09:29 | Completed | Derek Lamb | done | |
---
### Process ID #6866 — Internal Process Verification Complete Systems Review
**Last Reviewed:** 03 Nov 2021 by Derek Lamb
**Process Maturity:** 2 of 6 (33%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | No |
| Recent Completion Evidence | No |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | review of all the system processes | Derek Lamb 26 Sep 2017 |
| Outputs to the Process | Confirm the system is suitable for purpose | Derek Lamb 26 Sep 2017 |
| Risks to the Process | Review not carried out | Helen Lamb 02 Nov 2021 |
| Steps to Minimise Process Risks | Keep up to date with issues. | Helen Lamb 22 Jul 2019 |
| Scope / Definition of Process / Objective | Review the Internal Process and Verification`s are suitable for the current standards
PROCESS NOW CANCELLED AS REPEAT OF AUDIT 20 | Derek Lamb 03 Nov 2021 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 26 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 26 Sep 2017 |
| Measurable Objective | Check rolling issues are completed within terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness,of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | | |
| HSE Implications | | |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Government E.G. HMRC
- Physical Sites
- Regulations
**Linked Companies**
- Viamed
- VST
**Trained Staff (1)**
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 20 Process verification to Managment Viamed (Doc ID: 159389)
- Audit 20 Process verification to Managment VST (Doc ID: 159391)
- Internal process verification (Doc ID: 8948)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Task Completion History (Last 2 Years, Max 20 Items)**
*No completed tasks in the last 2 years.*
---
### Process ID #8107 — ISO And Compliance Controller Review
**Last Reviewed:** 16 Jul 2026 by Helen Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | ISO and Compliance Controller management review report.
Current role, title and process allocations.
Internal and external audit schedules and findings.
Rolling ISO, regulatory and compliance tasks.
Process risk assessments and measurable objectives.
Training records and backup staff coverage.
Controlled document records, certificates and website documents.
Customer complaint and non-conformance records.
Regulatory registrations, declarations and reporting obligations where applicable.
Management review records and relevant changes to standards, regulations, products or company activities. | Helen Lamb 16 Jul 2026 |
| Outputs to the Process | Confirmation that ISO and compliance responsibilities remain correctly allocated and adequately controlled.
Confirmation of any required changes to process ownership, trained staff, backup arrangements, objectives, risk assessments, audits or task frequencies.
Identification of overdue, obsolete, incomplete or unsupported compliance activities.
Separate actions, issues, audits or non-conformances raised where further investigation or correction is required.
Evidence that senior management has reviewed the continuing suitability and effectiveness of the company’s ISO and compliance controls. | Helen Lamb 16 Jul 2026 |
| Risks to the Process | A required ISO, regulatory or compliance activity may be missed, completed late or not supported by adequate evidence.
The review may become a routine administrative exercise rather than identifying significant compliance weaknesses.
Excessive dependency on one person may result in missed deadlines, loss of knowledge or inadequate cover during absence.
Processes may remain active after the associated regulatory or commercial requirement has ceased.
Certificates, controlled documents, website information or regulatory registrations may become out of date.
Missing objectives, risk assessments or audit links may prevent the effectiveness of a process from being properly assessed.
Repeated review of individual issues may obscure wider trends or systemic weaknesses.
Significant findings may be noted in the review but not converted into traceable corrective actions. | Helen Lamb 16 Jul 2026 |
| Steps to Minimise Process Risks | Complete the role review at least every six months using the generated management report.
Focus on exceptions, trends, overdue controls, regulatory relevance and systemic weaknesses rather than repeating individual issue investigations.
Review each process shown as overdue, not recently reviewed, without a measurable objective or without adequate trained cover.
Confirm whether processes relating to historic registrations, products or regulatory markets remain applicable.
Develop practical backup knowledge for critical compliance processes currently dependent on one person.
Ensure that controlled documents, certificates and public-facing compliance information are regularly checked and remain current.
Raise each significant finding as a separate, traceable action, audit, issue or non-conformance.
Review outstanding actions at the management meeting and during the next ISO and Compliance Controller review. | Helen Lamb 16 Jul 2026 |
| Scope / Definition of Process / Objective | New Process as of 14 / 05 / 2026.
Roles Titles Processes and Procedures ADMIN Viamed
End column of ISO And Compliance Controller Responsibilitys Review
Print to PDF,
To provide a structured, top-down review of the responsibilities and processes assigned to the ISO and Compliance Controller.
The review considers whether the company’s ISO, regulatory and compliance activities remain appropriately allocated, current, adequately controlled and supported by suitable evidence.
It includes oversight of audits, controlled documents, certificates, regulatory registrations, customer complaints, scheduled compliance tasks, management-system records and related process responsibilities.
This review does not repeat the detailed investigation of every task, complaint, audit or issue. Those records are reviewed through their individual operational, audit and closure processes. The purpose of this review is to identify wider gaps, overdue controls, resource dependencies and systemic compliance risks. | Helen Lamb 16 Jul 2026 |
| Likelihood of Risk (1-5) | 2.Remote | Helen Lamb 16 Jul 2026 |
| Severity of Risk (1-5) | 4.Critical | Helen Lamb 16 Jul 2026 |
| Measurable Objective | Complete the ISO and Compliance Controller responsibility review at least every six months.
Confirm that all active compliance processes have an appropriate owner, current risk information, a suitable objective where required, recent completion evidence and adequate trained staff coverage.
Review all overdue compliance tasks, processes not reviewed within the required period, missing objectives and processes dependent on a single trained person.
Ensure that significant findings are recorded as separate actions, issues, audits or non-conformances with an allocated owner and target date. | Helen Lamb 16 Jul 2026 |
| Training Method Required | Procedural training, required reading and hands-on training with an experienced ISO and compliance representative.
Training should include use of the management review report, interpretation of process risk indicators, internal audit requirements, document control, complaint and non-conformance escalation, regulatory obligations and the distinction between an administrative warning and an actual compliance failure.
Backup staff should receive practical training on the critical activities they may be required to perform during absence or disruption. | Helen Lamb 16 Jul 2026 |
| Verification / Effectiveness | Effectiveness is verified by confirming that the review is completed at the required frequency and that significant compliance exceptions are identified, assessed and converted into traceable actions where necessary.
Internal audits, external certification audits and management review provide additional verification that the assigned processes remain effective.
The process is considered effective where scheduled compliance activities are completed within appropriate timescales, documents and registrations remain current, identified actions are followed through, and no significant compliance failure occurs because information was available but not acted upon.
Trends in overdue activities, processes without backup cover and repeated audit findings should be compared between successive reviews. | Helen Lamb 16 Jul 2026 |
| Covid / Pandemic Notes | The review can be completed remotely using Intrastats and the associated electronic documents and records.
A pandemic or other major disruption may affect staff availability, audit arrangements, regulatory response times, certificate renewal or access to physical records.
Critical compliance responsibilities should therefore have sufficient electronic access and backup staff cover to continue during disruption. | Helen Lamb 16 Jul 2026 |
| Risk / Benefit Report | The benefit of this process is that it provides a consolidated senior-level review of the company’s ISO, regulatory and compliance responsibilities and helps ensure that required activities remain current, evidenced and appropriately controlled.
The principal risks are over-reliance on one individual, the volume and variety of compliance processes, and the possibility that a significant exception may be overlooked within a large report.
The benefits outweigh the risks, provided the review focuses on exceptions and systemic concerns and any significant finding is converted into a separately allocated and traceable action. | Helen Lamb 16 Jul 2026 |
| HSE Implications | No significant direct health and safety risk arises from carrying out the review itself.
However, the review may identify compliance obligations affecting products, staff, premises, customers or members of the public. Any health and safety concern identified must be referred to the Health and Safety Controller and recorded through the appropriate risk-assessment or issue process. | Helen Lamb 16 Jul 2026 |
| **Calculated Risk Code** | **Unacceptable** (Frequency=2, Severity=4) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.5
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.5
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Customer
- MHRA
- Regulations
- Staff
- Government E.G. HMRC
- Supplier
- VST OEM Customers
- VST Supplier
- External Partners
**Linked Companies**
- Viamed
- VST
- Vandagraph
**Trained Staff (3)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
- Michael Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- managerment reviews - Roles Reviews (Doc ID: 220072)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1328**
- **Subject:** ISO And Compliance Controller Review
- **Target User:** Derek Lamb
- **Recurrence:** 6 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Review the ISO and Compliance Controller management report from a top-down perspective.
Confirm that the assigned responsibilities, processes, trained staff and backup arrangements remain suitable.
Review all significant exceptions, including overdue tasks, processes not recently reviewed, missing measurable objectives, missing risk information and processes with only one trained person.
Confirm that regulatory registrations, certificates, controlled documents, audit arrangements and public-facing compliance information remain applicable and current.
Do not repeat the detailed review of individual tasks, complaints, audits or issues unless the report indicates a systemic concern.
Raise a separate action, issue, audit or non-conformance where further investigation or correction is required.
Record an overall conclusion on whether the company
**Rolling Audit #1365**
- **Subject:** ISO And Compliance Controller Review
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Audit To be Completed New Process as of 14 / 05 / 2026.
Check the task is carried out
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 403964 | ISO And Compliance Controller Review (1328) | 27 Jul 2026 | | Outstanding (0 days) | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Jul 2026 09:30 | Read | Derek Lamb | | |
| 399990 | ISO And Compliance Controller Review (1328) | 15 Jun 2026 | 17 Jun 2026 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 17 Jun 2026 11:11 | Completed | Derek Lamb | New Review, calender has now been set, details still need populating, | |
| 397363 | ISO And Compliance Controller Review (1328) | 14 May 2026 | 14 May 2026 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 14 May 2026 17:10 | Completed | Derek Lamb | Done | |
| | - 14 May 2026 17:09 | Read | Derek Lamb | | |
---
### Process ID #6871 — ISO14001 Environmental management systems
**Last Reviewed:** 16 Jun 2026 by Derek Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | If we went for this, we would have the standard and its documentation | Helen Lamb 02 Nov 2021 |
| Outputs to the Process | If we went for this, we would have a effective Environmental management systems | Helen Lamb 02 Nov 2021 |
| Risks to the Process | If we went for this, the risks would be incomplete data or ineffective system | Helen Lamb 02 Nov 2021 |
| Steps to Minimise Process Risks | If we went for this, we would carry out regular review and meetings | Helen Lamb 02 Nov 2021 |
| Scope / Definition of Process / Objective | Not yet Applied
Rolling Issue to see if we should apply this standard in the future | Derek Lamb 26 Sep 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 26 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 26 Sep 2017 |
| Measurable Objective | If we went for this, we would have documentation to measure our processes against | Helen Lamb 02 Nov 2021 |
| Training Method Required | If we went for this it would be Hands on Learning from experienced staff | Helen Lamb 02 Nov 2021 |
| Verification / Effectiveness | If we went for this we would assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness,of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit. | Helen Lamb 02 Nov 2021 |
| Covid / Pandemic Notes | If we went for this.
This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 02 Nov 2021 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
**Interested Parties**
- ISO Auditing Bodies
- Staff
- Physical Sites
- Internal Systems
- Customer
- Supplier
**Linked Companies**
- Viamed
- VST
**Trained Staff (1)**
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #748**
- **Subject:** ISO14001 Environmental management systems
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Review if we should be trying to go for this standard
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 376379 | ISO14001 Environmental management systems (748) | 26 Sep 2025 | 02 Oct 2025 | 6 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 30 Sep 2025 12:00 | Completed | Helen Lamb | At present i do not think anything has changed. We do not have the time to go for this and we do not currently ned it,
Done | |
| | - 26 Sep 2025 08:54 | Update | Derek Lamb | we revew each year if we need this | |
| 342081 | ISO14001 Environmental management systems (748) | 26 Sep 2024 | 03 Oct 2024 | 7 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 26 Sep 2024 12:01 | | Helen Lamb | ok i agree. | |
| | - 26 Sep 2024 12:01 | Completed | Helen Lamb | ok i agree. | |
---
### Process ID #7199 — Non Conformities Review Viamed
**Last Reviewed:** 19 Feb 2026 by Derek Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Non Conformance Issue History | Derek Lamb 20 Sep 2017 |
| Outputs to the Process | To Fix / Stop a non conformance reoccurring | Derek Lamb 20 Sep 2017 |
| Risks to the Process | Non comformances go unfixed | Derek Lamb 07 Oct 2021 |
| Steps to Minimise Process Risks | Reports to highlight Nonconformances | Derek Lamb 07 Oct 2021 |
| Scope / Definition of Process / Objective | To review any non conformances created during the previous month, and produce a non conformance report.
Review history of non conformances and see if there has been any improvement. | Derek Lamb 20 Sep 2017 |
| Likelihood of Risk (1-5) | 2.Remote | Derek Lamb 12 Nov 2021 |
| Severity of Risk (1-5) | 2.Minor | Derek Lamb 12 Nov 2021 |
| Measurable Objective | look at the past non conformance review and make sure it has been issued within three months | Helen Lamb 29 Aug 2018 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Derek Lamb 23 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=2, Severity=2) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.1.5
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- Internal Systems
- MHRA
- ISO Auditing Bodies
**Linked Companies**
- Viamed
**Trained Staff (2)**
- Helen Lamb (trained by Derek Lamb)
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 14 Complaints and Corrective Actions Viamed (Doc ID: 203281)
- Audit 14 Complaints and Corrective Actions VST (Doc ID: 159453)
- VM3COP27.46 Non Conformance review (How Too) (Doc ID: 70247)
- VM3COP27.46 Non Conformance review (How Too) (Doc ID: 76237)
- VOP 10 Non Conformance, Corrective and Preventive Actions (Doc ID: 215244)
**Rolling Task #283**
- **Subject:** Non conformance review history Viamed
- **Target User:** Helen Lamb
- **Recurrence:** 1 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Check the history of the last Non conformance review, check actions are being carried out,
and non conformances are not reoccurring.
Review the Order Invoice Error Logs (link in issue) for increases in errors. Areas that are errors that are our mistake and not due to changes instigated by the customer. Note any problem areas in report.
Review Customer Complaint and Non Conformance Review Screen check back over the previous month since last review to see if anything internal / staff / process related needs to be highlighted.
Go to Add an issue, search non con and review any issues since the last review for internal / staff / process related issues that needs to be highlighted.
Note any problems in the issue and send to Derek to review
**Rolling Audit #284**
- **Subject:** Non conformance review history Viamed
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Check the below review is being carried out
Check the history of the last Non conformance review,
check actions are being carried out,
and non conformances are not reoccurring
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 401785 | Non conformance review history Viamed (283) | 06 Jul 2026 | | Outstanding (21 days) | Helen Lamb |
| | **History Log:** | | | | |
| | - 13 Jul 2026 17:13 | Completed | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st July 26.
These are all being reviewed, nothing else of concern or to be investigated or reported on in Non Con issues. Issue 401567 - 0110229 sensor failure return to supplier.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - Only minor issue, nothing to worry about. Non Conformance, complaints and feedback headers nothing new. Nothing else not already reviewed in the non conformance log all just general working errors.
Nothing else not already covered, no concerns. No problems. No issues not already reviewed above in log. No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above
Done | |
| | - 13 Jul 2026 17:09 | Read | Helen Lamb | | |
| 399196 | Non conformance review history Viamed (283) | 05 Jun 2026 | 12 Jun 2026 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Jun 2026 16:25 | Completed | Derek Lamb | thankyou | |
| | - 08 Jun 2026 15:52 | Update | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st June 26.
These are all being reviewed, nothing else of concern or to be investigated or reported on in Non Con issues. Issue 398549 - 0110137 sensor failure return to supplier. Issue 397996 - 0110132 sensor failure return to supplier.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - Only minor issue, nothing to worry about.
Non Conformance, complaints and feedback headers, Issues 398329 V1000 erratic keypad selection for BPM - ongoing. 398639 products came in with a very old date code, returning to supplier. 398852 QA Failures High Numbers. Nothing else not already reviewed in the non conformance log all just general working errors. Nothing else not already covered, no concerns. No problems.
No issues not already reviewed above in log. No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 396370 | Non conformance review history Viamed (283) | 05 May 2026 | 14 May 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 12 May 2026 12:29 | Completed | Derek Lamb | thankyou | |
| | - 12 May 2026 12:03 | Update | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st May 26.
These are all being reviewed, nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - Only minor issue, nothing to worry about.
Non Conformance, complaints and feedback headers, Issues for Shipped items returned no Cap so no problems. Issue 393955 UFO 130-2 sensor leak failure 8th April 26. Speaking to Teledyne as leaked sensor has affected the machine they were in. Ongoing cannot see a reply yet. To follow up.
Nothing not already reviewed in the non conformance log all just general working errors
Nothing else not already covered, no concerns. No problems and Nothing of concern.
Non Conformance issues review screen. No issues not already reviewed above in log. No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 393572 | Non conformance review history Viamed (283) | 06 Apr 2026 | 22 Apr 2026 | 16 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 30 Dec 643996 10:18 | Read | Helen Lamb | | |
| | - 17 Apr 2026 11:25 | Completed | Derek Lamb | thankyou | |
| 390871 | Non conformance review history Viamed (283) | 05 Mar 2026 | 22 Apr 2026 | 48 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 17 Jul 643993 21:54 | Read | Helen Lamb | | |
| | - 06 Mar 2026 13:58 | Completed | Derek Lamb | thankyou | |
| 387858 | Non conformance review history Viamed (283) | 05 Feb 2026 | 22 Apr 2026 | 76 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 26 Oct 643990 10:50 | Read | Helen Lamb | | |
| | - 15 Oct 643990 03:07 | Read | Derek Lamb | | |
| 387730 | Non conformance review history Viamed (284) | 04 Feb 2026 | 10 Feb 2026 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 06 Feb 2026 09:40 | Completed | Derek Lamb | task is upto date just the current one due | |
| 384914 | Non conformance review history Viamed (283) | 05 Jan 2026 | 22 Apr 2026 | 107 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 20 Apr 643987 23:45 | Read | Helen Lamb | | |
| | - 12 Jan 2026 10:14 | Completed | Derek Lamb | thankyou | |
| 382670 | Non conformance review history Viamed (283) | 05 Dec 2025 | 22 Apr 2026 | 138 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Dec 2025 12:41 | Field Update | Helen Lamb | Next Action By updated to: Derek Lamb | |
| | - 22 Dec 2025 12:41 | Field Update | Helen Lamb | Next Action By updated to: Derek Lamb | |
| 380043 | Non conformance review history Viamed (283) | 05 Nov 2025 | 22 Apr 2026 | 168 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Nov 2025 16:32 | Completed | Derek Lamb | thankyou | |
| | - 07 Nov 2025 15:18 | Update | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st November 25.
We have a non conformances QC21 form Issues 378839 sensors labelled wrong in goods in. Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - only one data entry error no other issue, nothing to worry about.
Non Conformance, complaints and feedback headers Positive Feedback 377363 07/10/25 2810049 - feedback via ebay and 378028 14/10/25 Flowsensor A Reprocessing Survey: Medtrest LLC. Nothing else new not already covered.
Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 377121 | Non conformance review history Viamed (283) | 06 Oct 2025 | 22 Apr 2026 | 198 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Oct 2025 10:52 | Completed | Derek Lamb | Thankyou | |
| | - 06 Oct 2025 13:56 | Update | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st October 25.
We have two non conformances from BSI minors. Issues 375173 and 375175.
Issue 375262 Extra sensors sent in error. QC21 form sent investigated and signed off.
Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - only one data entry error no other issue, nothing to worry about.
Non Conformance, complaints and feedback headers 376408 26/09/25 Mediq purchase order PVM4595 short delivery, 377072 03/10/25 Positive Feedback from Beyond Borders CID34730 and 375667 18/09/25 Leidos MOD David Ford Positive Feedback. First is only negative feedback and not our mistake.
Nothing else new, no concerns. Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 374604 | Non conformance review history Viamed (283) | 05 Sep 2025 | 22 Apr 2026 | 229 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 05 Sep 2025 15:05 | Completed | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st September 25. Nothing Of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - only one data entry error no other issue, nothing to worry about.
Non Conformance, complaints and feedback headers issue re not fulfilling orders on website. Staff have been reminded to do this.
Nothing new no concerns. Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above
Done | |
| 371760 | Non conformance review history Viamed (283) | 05 Aug 2025 | 22 Apr 2026 | 260 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Aug 2025 14:18 | Completed | Derek Lamb | thankyou | |
| | - 08 Aug 2025 11:53 | Field Update | Helen Lamb | Next Action By updated to: Derek Lamb | |
| 369024 | Non conformance review history Viamed (283) | 07 Jul 2025 | 22 Apr 2026 | 289 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 Jul 2025 10:24 | | Derek Lamb |
Done | |
| | - 18 Jul 2025 10:24 | Completed | Derek Lamb |
Done | |
| 366217 | Non conformance review history Viamed (283) | 05 Jun 2025 | 22 Apr 2026 | 321 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 06 Jun 2025 09:49 | | Derek Lamb | thankyou | |
| | - 06 Jun 2025 09:49 | Completed | Derek Lamb | thankyou | |
| 363193 | Non conformance review history Viamed (283) | 05 May 2025 | 22 Apr 2026 | 352 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 19 May 2025 16:51 | | Derek Lamb | thankyou | |
| | - 19 May 2025 16:51 | Completed | Derek Lamb | thankyou | |
| 360739 | Non conformance review history Viamed (283) | 07 Apr 2025 | 22 Apr 2026 | 380 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 08 Apr 2025 12:56 | | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st April 25.
Issue 360064 account issue from customer. Resolve nothing ongoing, Issue360344 (360357) high failure rate 0110107.
Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - No issue, nothing to worry about.
Non Conformance, complaints and feedback headers nothing else and nothing of concerns.
Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| | - 08 Apr 2025 12:56 | Completed | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st April 25.
Issue 360064 account issue from customer. Resolve nothing ongoing, Issue360344 (360357) high failure rate 0110107.
Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - No issue, nothing to worry about.
Non Conformance, complaints and feedback headers nothing else and nothing of concerns.
Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 357468 | Non conformance review history Viamed (283) | 05 Mar 2025 | 22 Apr 2026 | 413 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 17 Mar 2025 19:33 | | Derek Lamb | thankyou | |
| | - 17 Mar 2025 19:33 | Completed | Derek Lamb | thankyou | |
| 354618 | Non conformance review history Viamed (283) | 05 Feb 2025 | 22 Apr 2026 | 441 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 10 Feb 2025 12:21 | | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st Jan 25. Issue 352880 wrong sensors in boxes still ongoing from last review. 354351 high failure rate on 0110361 R22AHJR sensors no cap.
Nothing new to add, just resolving.
Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - a lot of address amends but some are customer and only a few are input error based. No issue, nothing to worry about.
Non Conformance, complaints and feedback headers 351507 a request for PMS, 353625 Ceratherm cases incorrectly drilled - ongoing, 351010 + 354400 0110361 QA Data Requires Risk / Non Conformance Review Dec 2024, 351194 + 351875Incorrect oxygen sensors in boxes, 353250, 353881, 354144, 354707, 355001 auto issues. Everything underway nothing else and nothing of concerns.
Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| | - 10 Feb 2025 12:21 | Completed | Helen Lamb | Checked back through all Non Conformance issues (not automatically generated) to 1st Jan 25. Issue 352880 wrong sensors in boxes still ongoing from last review. 354351 high failure rate on 0110361 R22AHJR sensors no cap.
Nothing new to add, just resolving.
Nothing else of concern or to be investigated or reported on in Non Con issues.
Review VIAMED Feedback - Product Feedback Negative (741) nothing new.
Review VIAMED Feedback - Product Feedback Positive (1189) nothing new.
Review VIAMED Feedback - Customer Feedback Negative (739) nothing new.
Review VIAMED Feedback - Customer Feedback Positive (1188) nothing new.
Review VIAMED Feedback - Customer Complaints (737) nothing new.
Order Invoice Error Logs - a lot of address amends but some are customer and only a few are input error based. No issue, nothing to worry about.
Non Conformance, complaints and feedback headers 351507 a request for PMS, 353625 Ceratherm cases incorrectly drilled - ongoing, 351010 + 354400 0110361 QA Data Requires Risk / Non Conformance Review Dec 2024, 351194 + 351875Incorrect oxygen sensors in boxes, 353250, 353881, 354144, 354707, 355001 auto issues. Everything underway nothing else and nothing of concerns.
Non Conformance issues review screen - No issues not already reviewed above in log.
No other feedback issues relating to non conformances that need to be monitored or reviewed.
Derek please review the above | |
| 354495 | Non conformance review history Viamed (284) | 04 Feb 2025 | 13 Feb 2025 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 06 Feb 2025 16:28 | | Derek Lamb | task is upto date | |
| | - 06 Feb 2025 16:28 | Completed | Derek Lamb | task is upto date | |
---
### Process ID #7071 — Post Market Surveillance
**Last Reviewed:** 15 Sep 2025 by Helen Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Intrastats and current regulations. | Derek Lamb 30 Aug 2017 |
| Outputs to the Process | Notified body notification
Updated post market surveillance on products.
updates risk assessments. | Derek Lamb 30 Aug 2017 |
| Risks to the Process | Loss of certifications
Unforeseen product risks. | Derek Lamb 30 Aug 2017 |
| Steps to Minimise Process Risks | Rolling tasks and Issue. This process is audited. | Derek Lamb 30 Aug 2017 |
| Scope / Definition of Process / Objective | The process by which re view and risk assess all product files, check that no Products / Designs have changed significantly to warrant informing any notified bodies eg. MDD / BSI / CMDCAS or any other related Body. | Helen Lamb 15 Sep 2025 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 13 Nov 2021 |
| Severity of Risk (1-5) | 3.Serious | Derek Lamb 12 Nov 2021 |
| Measurable Objective | Check Audit completed. Look at the issue for the completed document. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Derek Lamb 23 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=3) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
**Interested Parties**
- Internal Systems
- Customer
- ISO Auditing Bodies
- MHRA
- VST OEM Customers
- VST OEM Customers
- VST Supplier
- VST Supplier
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Helen Lamb)
- Steve Nixon (trained by Helen Lamb)
**Associated Documents**
- Audit 12 CE Files Viamed (Doc ID: 181242)
- Audit 12 CE Files VST (Doc ID: 159451)
- Audit 23 Analysis of Data Viamed (Doc ID: 158752)
- Audit 23 Analysis of Data VST (Doc ID: 158748)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #50**
- **Subject:** Product / Design Changes, are any Post Market Surveillance reviews due
- **Target User:** Derek Lamb
- **Recurrence:** 2 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Check that no Products / Designs have changed significantly to warrant informing MDR / Bsi or any other related Body.
First Check the Stockbox -> QA Fails Review (Slow Page) in case there are any products that have a New repair code that requires a risk assesment
Reprint the Risk Assessment Questions update the file in the index
Carry out the Technical File PMS Post Market Surveillance. Form for Each OBL and Viamed Product
Rename the file to include Periodic Safety Update Report in the title
Using procedure VM3COP27.11
then VM3COP18
for each product range required
**Rolling Audit #14**
- **Subject:** Audit 22 Post Market Survellance Viamed
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Audit 22 BSI Audits Calendar BSI Audit Post Marketing Surveillance
BEFORE starting the Audit you need to update the Processes attached to the Audit.
Find the doc in the Document Index Admin Document -
Copy and Paste List Processes Per Title replacing them in the current audit.
Review Last years Audit see if its still suitable
Carry out the Audit, reviewing and commenting on the ISO route map first.
Any follow on issues must be identified with Observation Issue or a Non Conformance Issue.
If the issue is a Non Conformance a QC21 form must be filled in, as per the QC21 form procedure, and investigated as such.
If there are any non Conformances from the Audit, create a follow up / related Issue including all of the following -
With a time for Completion
Immediate Action Plan
Corrective Action Plan
Corrective Action
Confirmation of Resolution
If its a major / critical non conformance complete form QC 18
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 398803 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Jun 2026 | 04 Jun 2026 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Jun 2026 10:42 | Completed | Derek Lamb | non due | |
| 396003 | Audit 22 Post Market Survellance Viamed (14) | 30 Apr 2026 | | Outstanding (88 days) | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 May 2026 08:51 | Completed | Derek Lamb | Internal Audit Report
Audit 22 ? Post Market Surveillance (PMS) ? Viamed
The internal audit reviewed the effectiveness and implementation of the Viamed Post Market Surveillance (PMS) process, including linked processes, rolling audit tasks, management review integration, process maturity indicators, risk assessments, and supporting completion evidence. The audit also reviewed alignment with ISO 13485:2016 and ISO 9001:2015 requirements.
Audit Scope
The audit covered:
Audit 22 ? Post Market Surveillance Viamed
Linked PMS monitoring and review processes
Rolling audit and review tasks
Completion history and audit trail records
Process maturity and risk indicators
Integration into the Quality Management System
Related ISO route map clauses
Evidence of ongoing review and monitoring activities
The audit confirmed that the PMS process is actively managed through the Intrastats system using rolling reviews, recurring monitoring tasks, linked audits, and management review activities.
Audit Findings
Positive Findings
1. Established PMS Monitoring Structure
The audit identified a structured and established framework for recurring PMS activities. Rolling audits and recurring review tasks are embedded within the management system and linked directly to responsible personnel. Evidence was present showing active monitoring of:
Post Market Surveillance activities
Pro-active marketing reviews
Research activities
Medica exhibition reviews
Sales and marketing monitoring activities
This demonstrates that PMS activities are treated as an ongoing operational process rather than a one-off review exercise.
2. Strong Integration into the QMS
The PMS process is integrated into the wider Quality Management System through direct linkage to ISO 13485 and ISO 9001 route maps. The audit confirmed linkage to clauses relating to:
Monitoring and measurement
Internal auditing
Process review
Verification of effectiveness
Management review activities
The process includes documented risk assessments, defined responsibilities, trained personnel, and recurring effectiveness verification.
3. Effective Rolling Audit and Task System
The rolling task and rolling audit structure provides a strong and traceable audit trail. Completion notes, review commentary, and issue updates are retained within the system, providing evidence of:
Ongoing monitoring
Management oversight
Traceability
Continuous review activity
Staff engagement with the process
Completion history demonstrated recurring review activity throughout 2024?2026.
4. Good Process Maturity Levels
Most linked processes reviewed demonstrated good maturity levels with evidence of:
Completed risk assessments
Assigned backup staff
Current reviews
Measurable objectives
Verification of effectiveness
Recent completion evidence
Several processes reviewed achieved full maturity scores of 100%.
5. Evidence of Active Market and Customer Monitoring
The audit identified evidence of ongoing proactive monitoring activities including:
Website and social media updates
Product awareness campaigns
Customer communication reviews
Exhibition and trade event reviews
CRM and marketing analysis
Product trend monitoring
This supports the effectiveness of the PMS process in gathering and reviewing post-market information and customer feedback.
Observations
Observation 1 ? Dependency on Key Personnel
The audit identified a significant dependency on key individuals within the PMS process structure.
Document risk indicators showed:
Derek Lamb linked to 92% of reviewed processes
Steve Nixon linked to 83% of reviewed processes
This creates a potential business continuity and knowledge retention risk should key personnel become unavailable. Additional cross-training and process distribution should continue to be developed as part of resilience planning.
Observation 2 ? Limited Backup Coverage
One linked process was identified as having only one trained user assigned. While no immediate issue was identified, this represents limited operational resilience and should be monitored.
Observation 3 ? Audit Coverage Gaps
The audit summary identified several areas for improvement:
Eight linked processes currently have no audit configured
One process had not been reviewed for more than 24 months
One process was missing a measurable objective
These were not considered major nonconformances during this review; however, they should be progressively addressed through continual improvement activities.
Observation 4 ? Extended Completion Times
Some recurring review tasks demonstrated extended completion periods beyond expected review intervals, particularly within proactive marketing and research review activities. While evidence of review activity was present, timeliness of completion should continue to be monitored.
Conclusion
Based on the evidence reviewed, the Viamed Post Market Surveillance process is considered to be operationally effective and suitably integrated into the organisation?s Quality Management System.
The audit demonstrated:
Active recurring monitoring activities
Structured rolling audit controls
Integration into management review processes
Traceable completion and review records
Defined responsibilities and linked ISO clauses
Ongoing review of customer feedback and market activities
Evidence of continual monitoring and oversight
No major nonconformances were identified during this audit.
Several observations were identified relating primarily to:
Dependency on key personnel
Limited backup staff coverage
Incomplete audit coverage on some linked processes
Delays in completion of some recurring activities
These observations do not currently prevent the PMS process from functioning effectively but should be addressed through ongoing continual improvement and business resilience planning.
Overall, the audit provides evidence that the Viamed Post Market Surveillance system is active, monitored, and functioning in line with the intended requirements of the organisation?s internal Quality Management System and applicable ISO standards.
Done | |
| | - 27 May 2026 08:51 | Read | Derek Lamb | | |
| 393408 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Apr 2026 | 09 Apr 2026 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Apr 2026 12:42 | Completed | Derek Lamb | 3 left, non due | |
| 387420 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Feb 2026 | 05 Feb 2026 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Feb 2026 13:50 | Completed | Derek Lamb | Non due now,
Tom Thumb displayed a new risk to review:
[ 1666 ]0310030 Does Fault Code Replaced adjustable valve spring Type Fault present a risk
Applys
Pre Mitigation Risk level (harm)
Negligible Inconvenience or Temporary discomfort
Pre Mitigation Chance of Risk
Improbable 1 %
Reasoning if not obvious, Or factors mitigating risk or solution
Spring was replaced in a regular service, means the calibration was possibly at its limits,
no risk.
Replaced adjustable valve spring
Number Recorded 1 Total 1692 0.06 %
Post Risk level (harm)
Negligible Inconvenience found in service
Post Chance of Risk
Improbable 1 % | |
| 382316 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Dec 2025 | 04 Dec 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 03 Dec 2025 10:18 | Completed | Derek Lamb | nothing needs revieweing | |
| 376811 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Oct 2025 | 02 Oct 2025 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Oct 2025 09:12 | Completed | Derek Lamb | no reviews due | |
| 371605 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 04 Aug 2025 | 05 Aug 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 04 Aug 2025 11:02 | | Derek Lamb | non required, only 3 live ones left | |
| | - 04 Aug 2025 11:02 | Completed | Derek Lamb | non required, only 3 live ones left | |
| 365768 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Jun 2025 | 05 Jun 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Jun 2025 16:35 | | Derek Lamb |
Done | |
| | - 02 Jun 2025 16:35 | Completed | Derek Lamb |
Done | |
| 362859 | Audit 22 Post Market Survellance Viamed (14) | 30 Apr 2025 | 27 Feb 2026 | 303 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 27 Feb 2026 14:49 | Meeting Completion | Derek Lamb | | |
| | - 27 May 2025 15:34 | | Derek Lamb |
Done | |
| 360316 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Apr 2025 | 07 Apr 2025 | 5 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Apr 2025 09:19 | | Derek Lamb | Heat Shields Viamed Product (I)
No extra informtion in this file for the last few years time to stop the annual review and reflag as old product.
Oxygen Tents/Hoods Tanda Viamed Product (IIa)
No extra informtion in this file for the last few years time to stop the annual review and reflag as old product.
| |
| | - 02 Apr 2025 09:19 | Completed | Derek Lamb | Heat Shields Viamed Product (I)
No extra informtion in this file for the last few years time to stop the annual review and reflag as old product.
Oxygen Tents/Hoods Tanda Viamed Product (IIa)
No extra informtion in this file for the last few years time to stop the annual review and reflag as old product.
| |
| 354298 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 03 Feb 2025 | 06 Feb 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 03 Feb 2025 13:33 | | Derek Lamb | Apgar Timer 2
Microstim MkIII
Resuscitation Cabinet
archive to old products,
nothing new in the system, nolonger doing PMS unless new information comes to light | |
| | - 03 Feb 2025 13:33 | Completed | Derek Lamb | Apgar Timer 2
Microstim MkIII
Resuscitation Cabinet
archive to old products,
nothing new in the system, nolonger doing PMS unless new information comes to light | |
| 348370 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Dec 2024 | 04 Dec 2024 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Dec 2024 09:38 | | Derek Lamb | All files green, i suspect our scope will be updated and the files can be removed from the checking list | |
| | - 02 Dec 2024 09:38 | Completed | Derek Lamb | All files green, i suspect our scope will be updated and the files can be removed from the checking list | |
| 342569 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Oct 2024 | 10 Oct 2024 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 04 Oct 2024 17:43 | | Derek Lamb | all curenttly upto date, and no new risks hgighlighted | |
| | - 04 Oct 2024 17:43 | Completed | Derek Lamb | all curenttly upto date, and no new risks hgighlighted | |
| 336946 | Product / Design Changes, are any Post Market Surveillance reviews due (50) | 02 Aug 2024 | 05 Aug 2024 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 05 Aug 2024 11:51 | Meeting Completion | Derek Lamb | | |
| | - 05 Aug 2024 11:09 | | Derek Lamb | mothing needing review until december | |
---
### Process ID #7978 — Regulatory Requirements and Review of QC21 form template
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Regulatory bodies
Internal documentation
QC 21 form | Helen Lamb 15 Aug 2022 |
| Outputs to the Process | Up to date documentation | Helen Lamb 11 Nov 2021 |
| Risks to the Process | That we will miss updates | Helen Lamb 11 Nov 2021 |
| Steps to Minimise Process Risks | Regular review and issues | Helen Lamb 11 Nov 2021 |
| Scope / Definition of Process / Objective | To Regulatory Requirements and a Review of QC21 form template. To ensure they are up to date to the current standards
review Qc 21 Form to ensure it is still appropriate and valid | Helen Lamb 15 Aug 2022 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 11 Nov 2021 |
| Severity of Risk (1-5) | 3.Serious | Helen Lamb 11 Nov 2021 |
| Measurable Objective | That the issue has been carried out and the documentation has been reviewed annually. | Helen Lamb 11 Nov 2021 |
| Training Method Required | Hands on by with experience staff | Helen Lamb 11 Nov 2021 |
| Verification / Effectiveness | This task is verified for effectiveness during external audits and BSI visits. | Helen Lamb 15 Nov 2021 |
| Covid / Pandemic Notes | Not affected by Covid 19 or other national or international crisis | Helen Lamb 15 Aug 2022 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=3) | |
**Interested Parties**
- Regulations
- Internal Systems
**Linked Companies**
- Viamed
- VST
**Trained Staff (1)**
- Derek Lamb (trained by Helen Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #48**
- **Subject:** Regulatory Requirements
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Ensure all Regulatory requirements are up to date, Check those that relate to the MDR for our discontinued products that are still with in their lifespans.
Check the QC21 form template is still ok to use and doesn`t need any updates
Complete the Document up to date reviews on all documents.
European Commission harmonised standards to check documentation upto date
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 379031 | Regulatory Requirements (48) | 27 Oct 2025 | 30 Oct 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Oct 2025 09:48 | Completed | Derek Lamb | QC21 form template reveiwed Valid until 28 Jul 2026 | |
| 345055 | Regulatory Requirements (48) | 28 Oct 2024 | 21 Nov 2024 | 24 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 Nov 2024 13:08 | | Derek Lamb | just 9001 has a new addition | |
| | - 18 Nov 2024 13:08 | Completed | Derek Lamb | just 9001 has a new addition | |
---
### Process ID #8089 — Review Any Outstanding QC 21 Forms To Sign Off
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | QC 21 forms
Issues | Helen Lamb 07 Feb 2025 |
| Outputs to the Process | QC 21 forms underway and completed | Helen Lamb 07 Feb 2025 |
| Risks to the Process | Forms started might be missed, left un completed | Helen Lamb 07 Feb 2025 |
| Steps to Minimise Process Risks | regular reviews of all open QC21 forms and their issues. | Helen Lamb 07 Feb 2025 |
| Scope / Definition of Process / Objective | Review Any Outstanding QC 21 Forms. If completed, sign it off.
Review it to make sure all parts are completed satisfactorily | Helen Lamb 07 Feb 2025 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 07 Feb 2025 |
| Severity of Risk (1-5) | 3.Serious | Helen Lamb 07 Feb 2025 |
| Measurable Objective | QC 21 forms underway and completed.
Make sure completed or being worked on. | Helen Lamb 07 Feb 2025 |
| Training Method Required | Hands on by experienced members of staff | Helen Lamb 07 Feb 2025 |
| Verification / Effectiveness | regular reviews of the QC21 forms and the rolling issue. | Helen Lamb 07 Feb 2025 |
| Covid / Pandemic Notes | This is not affected by any national or international emergency or pandemic. | Helen Lamb 07 Feb 2025 |
| Risk / Benefit Report | There is a risk of an uncompleted form being missed. This process is here to reduce the likelihood of this ever happening.
No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=3) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.6.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 8.2.4
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 8.7.1
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 14 Complaints and Corrective Actions Viamed (Doc ID: 203281)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1276**
- **Subject:** Review Any Outstanding QC 21 Forms To Sign Off
- **Target User:** Derek Lamb
- **Recurrence:** 1 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Review Any Outstanding QC 21 Forms
**Rolling Audit #1277**
- **Subject:** Review Any Outstanding QC 21 Forms To Sign Off
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
This is an audit to check the task is being completed.
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 402203 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Jul 2026 | 09 Jul 2026 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Jul 2026 14:10 | Completed | Derek Lamb | just teh 2 bsi ones, but still monitoring the labels, | |
| 400447 | Review Any Outstanding QC 21 Forms To Sign Off (1277) | 19 Jun 2026 | | Outstanding (38 days) | Helen Lamb |
| 399381 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 08 Jun 2026 | 12 Jun 2026 | 4 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Jun 2026 13:48 | Completed | Derek Lamb | no new qc 21 forms | |
| 396693 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 May 2026 | 28 May 2026 | 21 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 May 2026 07:46 | Completed | Derek Lamb | no new forms | |
| 393703 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Apr 2026 | 16 Apr 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 09 Apr 2026 14:38 | Completed | Derek Lamb | nothing for sign off | |
| 391167 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 09 Mar 2026 | 19 Mar 2026 | 10 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 16 Mar 2026 14:14 | Completed | Derek Lamb | no new qc21 forms | |
| 388347 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 09 Feb 2026 | 10 Feb 2026 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 09 Feb 2026 10:55 | Completed | Derek Lamb | couple viamed ones to do, schedule to sort with helen this week | |
| 385242 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Jan 2026 | 19 Jan 2026 | 12 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Jan 2026 10:56 | Completed | Derek Lamb | Done | |
| 382860 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 08 Dec 2025 | 22 Dec 2025 | 14 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 12 Dec 2025 15:41 | Completed | Derek Lamb | bsi ones and the mislabeled sensors,
Done | |
| 380303 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Nov 2025 | 20 Nov 2025 | 13 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Nov 2025 10:28 | Completed | Derek Lamb | Done | |
| 378839 | QC 21 Non Conformance Report - We have labelled 25 Maxtec MAX55E 0110452 sensors as MAX250E 01104294, in goods in. | 22 Oct 2025 | 12 Jan 2026 | 82 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 15 Dec 643993 07:20 | Read | Derek Lamb | | |
| | - 15 Oct 643990 06:16 | Read | Derek Lamb | | |
| 377333 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Oct 2025 | 09 Oct 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Oct 2025 15:35 | Completed | Derek Lamb | bsi ones, and 1 other thats bene completed | |
| 375175 | BSI Non Conformance 2700663-202509-N2 | 11 Sep 2025 | | Outstanding (318 days) | Helen Lamb |
| | **History Log:** | | | | |
| | - 15 Dec 643993 07:20 | Read | Derek Lamb | | |
| | - 04 Dec 643993 04:37 | Read | Derek Lamb | | |
| 375173 | BSI Non Conformance 2700663-202509-N1 | 11 Sep 2025 | | Outstanding (318 days) | Helen Lamb |
| | **History Log:** | | | | |
| | - 15 Dec 643993 07:20 | Read | Derek Lamb | | |
| | - 04 Dec 643993 04:36 | Read | Derek Lamb | | |
| 374782 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 08 Sep 2025 | 12 Sep 2025 | 4 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 11 Sep 2025 17:34 | Completed | Derek Lamb | reviewed in BSI ISO meeting, need a way to single out the qc 21 forms | |
| 372047 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Aug 2025 | 07 Aug 2025 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Aug 2025 09:18 | Completed | Derek Lamb | none to sign off | |
| 369096 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 Jul 2025 | 10 Jul 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 Jul 2025 10:47 | | Derek Lamb | no new qc 21 forms | |
| | - 07 Jul 2025 10:47 | Completed | Derek Lamb | no new qc 21 forms | |
| 367537 | Review Any Outstanding QC 21 Forms To Sign Off (1277) | 19 Jun 2025 | 26 Jun 2025 | 7 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 19 Jun 2025 09:36 | | Helen Lamb |
Done | |
| | - 19 Jun 2025 09:36 | Completed | Helen Lamb |
Done | |
| 366523 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 09 Jun 2025 | 12 Jun 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 11 Jun 2025 14:49 | | Derek Lamb | no new forms | |
| | - 11 Jun 2025 14:49 | Completed | Derek Lamb | no new forms | |
| 363452 | Review Any Outstanding QC 21 Forms To Sign Off (1276) | 07 May 2025 | 08 May 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 07 May 2025 07:35 | | Derek Lamb | no new qc 21 forms | |
| | - 07 May 2025 07:35 | Completed | Derek Lamb | no new qc 21 forms | |
---
### Process ID #7980 — Review Gov Website For Applicable Required Standards ISO9001
**Last Reviewed:** 17 Nov 2025 by Derek Lamb
**Process Maturity:** 4 of 6 (67%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | No |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | ISO 9001 standard reviews | Helen Lamb 15 Nov 2021 |
| Outputs to the Process | up to date ISO 9001 standard | Helen Lamb 15 Nov 2021 |
| Risks to the Process | A regulartory update could be missed, so we are not assessing to the correct version of the standard | Helen Lamb 15 Nov 2021 |
| Steps to Minimise Process Risks | regular task reviews so these are keep up to date | Helen Lamb 15 Nov 2021 |
| Scope / Definition of Process / Objective | Review the Government Website For Applicable Required Standards ISO 9001
Check if any other standards have been introduced that may have an affect on the company
www.gov.uk
European Commission harmonised standards to check documentation upto date
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm | Derek Lamb 15 Nov 2021 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 15 Nov 2021 |
| Severity of Risk (1-5) | 2.Minor | Helen Lamb 15 Nov 2021 |
| Measurable Objective | Check the issue has been done and the review date | Helen Lamb 15 Nov 2021 |
| Training Method Required | Hands on by experianced member of staff | Derek Lamb 15 Nov 2021 |
| Verification / Effectiveness | This task is verified for effectiveness during external audits and BSI visits. | Helen Lamb 15 Nov 2021 |
| Covid / Pandemic Notes | this is not affected by Covid 19 or other national or international crisis | Helen Lamb 15 Nov 2021 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=2) | |
**Interested Parties**
- ISO Auditing Bodies
- Government E.G. HMRC
**Linked Companies**
- VST
**Trained Staff (1)**
- Derek Lamb (trained by Helen Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1103**
- **Subject:** Review Gov Website For Applicable Required Standards ISO9001
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Process needs updating and completing
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 381016 | Review Gov Website For Applicable Required Standards ISO9001 (1103) | 17 Nov 2025 | 20 Nov 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 17 Nov 2025 14:58 | Completed | Derek Lamb | 9001 and 13485 all upto date | |
| | - 17 Nov 2025 14:37 | Completed | Derek Lamb | 90001 and 13485 both still current | |
| 347193 | Review Gov Website For Applicable Required Standards ISO9001 (1103) | 18 Nov 2024 | 21 Nov 2024 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 Nov 2024 10:13 | | Derek Lamb | only iso 9001 has been updated | |
| | - 18 Nov 2024 10:13 | Completed | Derek Lamb | only iso 9001 has been updated | |
---
### Process ID #5887 — Review ISO/EN Documents
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Uninfied Stardards Web Site
Intrastats
Document index.
Technical Files | Derek Lamb 12 Jun 2017 |
| Outputs to the Process | Update of Required standards,
Updated Technical Files | Derek Lamb 12 Jun 2017 |
| Risks to the Process | Shipping products and or services with below regulations and or standards | Derek Lamb 12 Jun 2017 |
| Steps to Minimise Process Risks | Rolling Issue
Review on Stanards / Legislation
Regular review of Technical file sections to research each affected standards when updated | Derek Lamb 12 Jun 2017 |
| Scope / Definition of Process / Objective | To Keep Products and Services up-to date with current regulations and standards | Derek Lamb 12 Jun 2017 |
| Likelihood of Risk (1-5) | 2.Remote | Derek Lamb 12 Jun 2017 |
| Severity of Risk (1-5) | 2.Minor | Derek Lamb 12 Jun 2017 |
| Measurable Objective | Check rolling issues are completed within terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during external BSI audit. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=2, Severity=2) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Regulations
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- (trained by Derek Lamb)
**Associated Documents**
- Audit 03 Design Control Viamed (Doc ID: 210973)
- Audit 03 Design Control VST (Doc ID: 211516)
- Viamed Certification ISO 13485:2016 MD78787 (Doc ID: 176874)
- Viamed ISO 13485:2016 Scope (Doc ID: 168096)
- VM3COP02.01 Exclusions to Viamed ISO13485:2016 boundaries of ISO (Doc ID: 74571)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
- VST - ISO 9001:2015 Certificate FM 607767 (Doc ID: 218795)
- VST ISO 9001:2015 Scope (Doc ID: 164901)
**Rolling Task #235**
- **Subject:** Review ISO documents
- **Target User:** Derek Lamb
- **Recurrence:** 3 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
ISO -> Document up-to date reviews
Review list.
Ensure any out of date documents as renamed as out of date.
If required purchase new version and review changes.
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 400782 | Review ISO documents (235) | 24 Jun 2026 | 09 Jul 2026 | 15 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Jun 2026 11:34 | Completed | Derek Lamb | no iso specific docs out of date | |
| 392613 | Review ISO documents (235) | 24 Mar 2026 | 02 Apr 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Mar 2026 11:23 | Completed | Derek Lamb | Done | |
| 384218 | Review ISO documents (235) | 24 Dec 2025 | 02 Jan 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 29 Dec 2025 10:15 | Completed | Derek Lamb | just 2 supplier documents to be chased, all other ducoments ok | |
| 376083 | Review ISO documents (235) | 24 Sep 2025 | 25 Sep 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Sep 2025 13:00 | Completed | Derek Lamb | iso documents upto date, and online | |
| 367884 | Review ISO documents (235) | 24 Jun 2025 | 03 Jul 2025 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Jun 2025 16:36 | | Derek Lamb |
Done | |
| | - 26 Jun 2025 16:36 | Completed | Derek Lamb |
Done | |
| 359363 | Review ISO documents (235) | 24 Mar 2025 | 25 Mar 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Mar 2025 11:17 | | Derek Lamb |
Done | |
| | - 25 Mar 2025 11:17 | Completed | Derek Lamb |
Done | |
| 350509 | Review ISO documents (235) | 24 Dec 2024 | 27 Dec 2024 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Dec 2024 12:25 | | Derek Lamb | documents upto date, just waiing from bsi on new viamed iso | |
| | - 27 Dec 2024 12:25 | Completed | Derek Lamb | documents upto date, just waiing from bsi on new viamed iso | |
| 341793 | Review ISO documents (235) | 24 Sep 2024 | 17 Oct 2024 | 23 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 16 Oct 2024 12:48 | | Derek Lamb | reviewed
iso 9001 has an amendemtn, nothing to buy | |
| | - 16 Oct 2024 12:48 | Completed | Derek Lamb | reviewed
iso 9001 has an amendemtn, nothing to buy | |
**Effectiveness Reviews**
| Date | Reviewer | Memo |
|------|----------|------|
| 26 Jun 2023 | Derek Lamb | First Run 24 Sep 2014
Last Run 24 Mar 2023
Number Runs 35
Usually Completed with 2 Updates 88.57 % of the time - 100% would be a Perfect Score
Usually Completed within 3 Days 28.57 % of the time - Rating subject to Process
Source Date
Updates
Issue# 6 (17.14%)
Days to Complete 1 =># 3 (8.57%)
Days to Complete 16 =># 3 (8.57%)
Days to Complete 48 =># 2 (5.71%)
Days to Complete 7 =># 2 (5.71%)
Days to Complete 6 =># 2 (5.71%)
Days to Complete 10 =># 1 (2.86%)
Days to Complete 0 =># 1 (2.86%)
Days to Complete 21 =># 1 (2.86%)
Days to Complete 9 =># 1 (2.86%)
Days to Complete 5 =># 1 (2.86%)
Days to Complete 14 =># 1 (2.86%)
Days to Complete 15 =># 1 (2.86%)
Days to Complete 203 =># 1 (2.86%)
Days to Complete 330 =># 1 (2.86%)
Days to Complete 127 =># 1 (2.86%)
Days to Complete 217 =># 1 (2.86%)
Days to Complete 139 =># 1 (2.86%)
Days to Complete 56 =># 1 (2.86%)
Days to Complete 50 =># 1 (2.86%)
Days to Complete 29 =># 1 (2.86%)
Days to Complete 279 =># 1 (2.86%)
Days to Complete 35 =># 1 (2.86%) |
| 16 May 2023 | Derek Lamb | First Run 24 Sep 2014
Last Run 24 Mar 2023
Number Runs 35
Usually Completed with 2 Updates 88.57 % of the time - 100% would be a Perfect Score
Usually Completed within 3 Days 28.57 % of the time - Rating subject to Process
Source Date
Updates
Issue# 6 (17.14%)
Days to Complete 1 =># 3 (8.57%)
Days to Complete 16 =># 3 (8.57%)
Days to Complete 48 =># 2 (5.71%)
Days to Complete 7 =># 2 (5.71%)
Days to Complete 6 =># 2 (5.71%)
Days to Complete 10 =># 1 (2.86%)
Days to Complete 0 =># 1 (2.86%)
Days to Complete 21 =># 1 (2.86%)
Days to Complete 9 =># 1 (2.86%)
Days to Complete 5 =># 1 (2.86%)
Days to Complete 14 =># 1 (2.86%)
Days to Complete 15 =># 1 (2.86%)
Days to Complete 203 =># 1 (2.86%)
Days to Complete 330 =># 1 (2.86%)
Days to Complete 127 =># 1 (2.86%)
Days to Complete 217 =># 1 (2.86%)
Days to Complete 139 =># 1 (2.86%)
Days to Complete 56 =># 1 (2.86%)
Days to Complete 50 =># 1 (2.86%)
Days to Complete 29 =># 1 (2.86%)
Days to Complete 279 =># 1 (2.86%)
Days to Complete 35 =># 1 (2.86%) |
| 16 May 2023 | Derek Lamb | First Run 24 Sep 2014
Last Run 24 Mar 2023
Number Runs 35
Usually Completed with 2 Updates 88.57 % of the time - 100% would be a Perfect Score
Usually Completed within 3 Days 28.57 % of the time - Rating subject to Process
Source Date
Updates
Issue# 6 (17.14%)
Days to Complete 1 =># 3 (8.57%)
Days to Complete 16 =># 3 (8.57%)
Days to Complete 48 =># 2 (5.71%)
Days to Complete 7 =># 2 (5.71%)
Days to Complete 6 =># 2 (5.71%)
Days to Complete 10 =># 1 (2.86%)
Days to Complete 0 =># 1 (2.86%)
Days to Complete 21 =># 1 (2.86%)
Days to Complete 9 =># 1 (2.86%)
Days to Complete 5 =># 1 (2.86%)
Days to Complete 14 =># 1 (2.86%)
Days to Complete 15 =># 1 (2.86%)
Days to Complete 203 =># 1 (2.86%)
Days to Complete 330 =># 1 (2.86%)
Days to Complete 127 =># 1 (2.86%)
Days to Complete 217 =># 1 (2.86%)
Days to Complete 139 =># 1 (2.86%)
Days to Complete 56 =># 1 (2.86%)
Days to Complete 50 =># 1 (2.86%)
Days to Complete 29 =># 1 (2.86%)
Days to Complete 279 =># 1 (2.86%)
Days to Complete 35 =># 1 (2.86%) |
| 16 May 2023 | Derek Lamb | First Run 24 Sep 2014
Last Run 24 Mar 2023
Number Runs 35
Usually Completed with 2 Updates 88.57 % of the time - 100% would be a Perfect Score
Usually Completed within 3 Days 28.57 % of the time - Rating subject to Process
Source Date
Updates
Issue# 6 (17.14%)
Days to Complete 1 =># 3 (8.57%)
Days to Complete 16 =># 3 (8.57%)
Days to Complete 48 =># 2 (5.71%)
Days to Complete 7 =># 2 (5.71%)
Days to Complete 6 =># 2 (5.71%)
Days to Complete 10 =># 1 (2.86%)
Days to Complete 0 =># 1 (2.86%)
Days to Complete 21 =># 1 (2.86%)
Days to Complete 9 =># 1 (2.86%)
Days to Complete 5 =># 1 (2.86%)
Days to Complete 14 =># 1 (2.86%)
Days to Complete 15 =># 1 (2.86%)
Days to Complete 203 =># 1 (2.86%)
Days to Complete 330 =># 1 (2.86%)
Days to Complete 127 =># 1 (2.86%)
Days to Complete 217 =># 1 (2.86%)
Days to Complete 139 =># 1 (2.86%)
Days to Complete 56 =># 1 (2.86%)
Days to Complete 50 =># 1 (2.86%)
Days to Complete 29 =># 1 (2.86%)
Days to Complete 279 =># 1 (2.86%)
Days to Complete 35 =># 1 (2.86%) |
---
### Process ID #7981 — Review Process Updates For Risk To Systems
**Last Reviewed:** 26 Feb 2026 by Derek Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Intrastats processes | Helen Lamb 30 Dec 2021 |
| Outputs to the Process | Up to date system regularly reviewed | Helen Lamb 30 Dec 2021 |
| Risks to the Process | Monthly review could be missed
changes to process could be missed | Helen Lamb 30 Dec 2021 |
| Steps to Minimise Process Risks | regular issues and reviews | Helen Lamb 30 Dec 2021 |
| Scope / Definition of Process / Objective | To review monthly any changes, to any processes, for risks to ISO systems. | Helen Lamb 30 Dec 2021 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 30 Dec 2021 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 30 Dec 2021 |
| Measurable Objective | completed issues and up to date list | Helen Lamb 30 Dec 2021 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 30 Dec 2021 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Helen Lamb 30 Dec 2021 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 30 Dec 2021 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Interested Parties**
- ISO Auditing Bodies
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1104**
- **Subject:** Review Process Updates For Risk To Systems
- **Target User:** Derek Lamb
- **Recurrence:** 1 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed To Review monthly any changes to running processes for risks to ISO systems.
Review the Updated Process Screen and review for any associated risks, and confirm the updated process is still effective to its objective.
**Rolling Audit #1105**
- **Subject:** Review Process Updates For Risk To Systems
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Audit To be Completed To Review monthly any changes to running processes for risks to ISO systems.
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 403518 | Review Process Updates For Risk To Systems (1104) | 22 Jul 2026 | | Outstanding (5 days) | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Jul 2026 11:47 | Completed | Derek Lamb | Done, linked all the new manager reviews | |
| 400562 | Review Process Updates For Risk To Systems (1104) | 22 Jun 2026 | 09 Jul 2026 | 17 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Jun 2026 11:47 | Completed | Derek Lamb | Done | |
| | - 22 Jun 2026 11:46 | Read | Derek Lamb | | |
| 398055 | Review Process Updates For Risk To Systems (1104) | 22 May 2026 | 28 May 2026 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 May 2026 08:49 | Completed | Derek Lamb | was hundreds to sign off, but we added a new to tag field, IMP for processes im going to review more in depth at board meetings, this triggered all processes, to need a review, so just signed them off on mass this time | |
| 395255 | Review Process Updates For Risk To Systems (1104) | 22 Apr 2026 | 23 Apr 2026 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Apr 2026 15:37 | Completed | Derek Lamb | done | |
| 392501 | Review Process Updates For Risk To Systems (1104) | 23 Mar 2026 | 02 Apr 2026 | 10 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Mar 2026 11:22 | Completed | Derek Lamb | Done | |
| 389724 | Review Process Updates For Risk To Systems (1104) | 23 Feb 2026 | 02 Mar 2026 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Feb 2026 14:49 | Completed | Derek Lamb | Done | |
| 386570 | Review Process Updates For Risk To Systems (1104) | 22 Jan 2026 | 23 Jan 2026 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 23 Jan 2026 08:34 | Completed | Derek Lamb | Reviewed feedback no action required | |
| 384075 | Review Process Updates For Risk To Systems (1104) | 22 Dec 2025 | 29 Dec 2025 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 23 Dec 2025 13:15 | Completed | Derek Lamb | Updated Process(s) Review
23 Dec 2025 Derek Lamb
NOTHING TO SIGN OFF | |
| 381582 | Review Process Updates For Risk To Systems (1104) | 24 Nov 2025 | 27 Nov 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Nov 2025 11:08 | Completed | Derek Lamb | Done | |
| 379711 | Review Process Updates For Risk To Systems (1105) | 03 Nov 2025 | 06 Nov 2025 | 3 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 04 Nov 2025 11:07 | Completed | Helen Lamb | Done | |
| 378776 | Review Process Updates For Risk To Systems (1104) | 22 Oct 2025 | 30 Oct 2025 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Oct 2025 09:53 | Completed | Derek Lamb | Stock Items Requiring Repair Code Clean Up
All Product repairs have Clean Codes No Work Required
Done | |
| 375881 | Review Process Updates For Risk To Systems (1104) | 22 Sep 2025 | 22 Sep 2025 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Sep 2025 10:40 | Completed | Derek Lamb | added a mome box so tons appeared, closed them all will then see real changes next time
Done | |
| 373396 | Review Process Updates For Risk To Systems (1104) | 22 Aug 2025 | 28 Aug 2025 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Aug 2025 17:14 | Completed | Derek Lamb | Done | |
| 370449 | Review Process Updates For Risk To Systems (1104) | 22 Jul 2025 | 24 Jul 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Jul 2025 12:58 | | Derek Lamb |
Done | |
| | - 22 Jul 2025 12:58 | Completed | Derek Lamb |
Done | |
| 367790 | Review Process Updates For Risk To Systems (1104) | 23 Jun 2025 | 26 Jun 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Jun 2025 16:28 | | Derek Lamb |
Done | |
| | - 25 Jun 2025 16:28 | Completed | Derek Lamb |
Done | |
| 365019 | Review Process Updates For Risk To Systems (1104) | 22 May 2025 | 29 May 2025 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 May 2025 13:44 | | Derek Lamb | will do next month, 4 new ones, not 100% sure they started yet so will give them time | |
| | - 22 May 2025 13:44 | Completed | Derek Lamb | will do next month, 4 new ones, not 100% sure they started yet so will give them time | |
| 362152 | Review Process Updates For Risk To Systems (1104) | 22 Apr 2025 | 24 Apr 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 22 Apr 2025 16:14 | | Derek Lamb |
Done | |
| | - 22 Apr 2025 16:14 | Completed | Derek Lamb |
Done | |
| 359424 | Review Process Updates For Risk To Systems (1104) | 24 Mar 2025 | 25 Mar 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Mar 2025 11:09 | | Derek Lamb |
Done | |
| | - 25 Mar 2025 11:09 | Completed | Derek Lamb |
Done | |
| 356384 | Review Process Updates For Risk To Systems (1104) | 24 Feb 2025 | 28 Feb 2025 | 4 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Feb 2025 12:25 | | Derek Lamb |
Done | |
| | - 24 Feb 2025 12:25 | Completed | Derek Lamb |
Done | |
| 353236 | Review Process Updates For Risk To Systems (1104) | 22 Jan 2025 | 23 Jan 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 23 Jan 2025 08:37 | | Derek Lamb | reviewed | |
| | - 23 Jan 2025 08:37 | Completed | Derek Lamb | reviewed | |
---
### Process ID #7888 — Review Processes Linked To VOPs And Audits
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Intrastats Processes To Audits and VOPs Screen | Derek Lamb 24 Oct 2017 |
| Outputs to the Process | All active Processes are linked to Audits and Vops | Derek Lamb 24 Oct 2017 |
| Risks to the Process | process can go un-monitored | Derek Lamb 24 Oct 2017 |
| Steps to Minimise Process Risks | rolling task to link appropriately | Derek Lamb 24 Oct 2017 |
| Scope / Definition of Process / Objective | Ensure All Sub Processes are linked to a VOP and an Audit. | Derek Lamb 24 Oct 2017 |
| Likelihood of Risk (1-5) | 3.Occasional | Derek Lamb 24 Oct 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 24 Oct 2017 |
| Measurable Objective | review list | Helen Lamb 22 Jul 2019 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Derek Lamb 23 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=3, Severity=1) | |
**Interested Parties**
- Internal Systems
**Linked Companies**
- VST
- Viamed Properties
- Viamed
- Vandagraph
- Human Med
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #818**
- **Subject:** Review Processes Linked To VOPs And Audits
- **Target User:** Derek Lamb
- **Recurrence:** 1 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed Ensure All Sub Processes are linked to a VOP and an Audit.
Document index File Groups
Intrastats Processes To Audits and VOPs Screen
**Rolling Audit #819**
- **Subject:** Review Processes Linked To VOPs And Audits
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
** Audit Review ** Ensure the task is being done and check no blanks in the system
Task To be Completed Ensure All Sub Processes are linked to a VOP and an Audit. Intrastats Processes To Audits and VOPs Screen
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 403817 | Review Processes Linked To VOPs And Audits (818) | 24 Jul 2026 | | Outstanding (3 days) | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Jul 2026 09:52 | Completed | Derek Lamb | all linked, no work to do | |
| 400811 | Review Processes Linked To VOPs And Audits (818) | 24 Jun 2026 | 09 Jul 2026 | 15 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Jun 2026 15:33 | Completed | Derek Lamb | none to link | |
| 398160 | Review Processes Linked To VOPs And Audits (818) | 25 May 2026 | 28 May 2026 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 May 2026 10:42 | Completed | Derek Lamb | Done | |
| 395515 | Review Processes Linked To VOPs And Audits (818) | 24 Apr 2026 | 30 Apr 2026 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Apr 2026 09:22 | Completed | Derek Lamb | Done | |
| 392638 | Review Processes Linked To VOPs And Audits (818) | 24 Mar 2026 | 02 Apr 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Mar 2026 13:53 | Completed | Derek Lamb | all upto date | |
| 389853 | Review Processes Linked To VOPs And Audits (818) | 24 Feb 2026 | 02 Mar 2026 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Feb 2026 14:42 | Completed | Derek Lamb | Done | |
| 386863 | Review Processes Linked To VOPs And Audits (818) | 26 Jan 2026 | 29 Jan 2026 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Jan 2026 08:42 | Completed | Derek Lamb | done | |
| 384247 | Review Processes Linked To VOPs And Audits (818) | 24 Dec 2025 | 02 Jan 2026 | 9 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 29 Dec 2025 10:17 | Completed | Derek Lamb | nothing new in the list | |
| 382587 | Review Processes Linked To VOPs And Audits (819) | 04 Dec 2025 | 02 Jan 2026 | 29 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 30 Dec 2025 15:12 | Completed | Helen Lamb | all filled in
Done | |
| 381572 | Review Processes Linked To VOPs And Audits (818) | 24 Nov 2025 | 27 Nov 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Nov 2025 09:32 | Completed | Derek Lamb | Done | |
| 378975 | Review Processes Linked To VOPs And Audits (818) | 24 Oct 2025 | 30 Oct 2025 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Oct 2025 09:52 | Completed | Derek Lamb | Done | |
| 376113 | Review Processes Linked To VOPs And Audits (818) | 24 Sep 2025 | 25 Sep 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Sep 2025 12:59 | Completed | Derek Lamb | Done | |
| 373501 | Review Processes Linked To VOPs And Audits (818) | 25 Aug 2025 | 28 Aug 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 Aug 2025 16:41 | Completed | Derek Lamb | non to link | |
| 370706 | Review Processes Linked To VOPs And Audits (818) | 24 Jul 2025 | 24 Jul 2025 | 0 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Jul 2025 15:48 | | Derek Lamb | nothing new to link, | |
| | - 24 Jul 2025 15:48 | Completed | Derek Lamb | nothing new to link, | |
| 367910 | Review Processes Linked To VOPs And Audits (818) | 24 Jun 2025 | 26 Jun 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Jun 2025 09:08 | | Derek Lamb |
Done | |
| | - 25 Jun 2025 09:08 | Completed | Derek Lamb |
Done | |
| 365278 | Review Processes Linked To VOPs And Audits (818) | 26 May 2025 | 29 May 2025 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 27 May 2025 12:26 | | Derek Lamb |
Done | |
| | - 27 May 2025 12:26 | Completed | Derek Lamb |
Done | |
| 362430 | Review Processes Linked To VOPs And Audits (818) | 24 Apr 2025 | 02 May 2025 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 28 Apr 2025 16:00 | | Derek Lamb |
Done | |
| | - 28 Apr 2025 16:00 | Completed | Derek Lamb |
Done | |
| 359412 | Review Processes Linked To VOPs And Audits (818) | 24 Mar 2025 | 25 Mar 2025 | 1 day | Derek Lamb |
| | **History Log:** | | | | |
| | - 25 Mar 2025 11:09 | | Derek Lamb |
Done | |
| | - 25 Mar 2025 11:09 | Completed | Derek Lamb |
Done | |
| 356374 | Review Processes Linked To VOPs And Audits (818) | 24 Feb 2025 | 28 Feb 2025 | 4 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Feb 2025 12:09 | | Derek Lamb |
Done | |
| | - 24 Feb 2025 12:09 | Completed | Derek Lamb |
Done | |
| 353562 | Review Processes Linked To VOPs And Audits (818) | 24 Jan 2025 | 30 Jan 2025 | 6 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 24 Jan 2025 09:18 | | Derek Lamb |
Done | |
| | - 24 Jan 2025 09:18 | Completed | Derek Lamb |
Done | |
---
### Process ID #7977 — Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting
**Last Reviewed:** 08 Aug 2025 by Derek Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Agenda
Meetings and management review can also raise areas that have been missed | Helen Lamb 11 Nov 2021 |
| Outputs to the Process | A comprehensive management review / Board meeting agenda and therefore meeting | Helen Lamb 11 Nov 2021 |
| Risks to the Process | That we will miss a header and something important will not be discussed. | Helen Lamb 11 Nov 2021 |
| Steps to Minimise Process Risks | Regular reviews and discussions in the Meeting itself, to ensure the agenda is up to date and relevant. | Helen Lamb 11 Nov 2021 |
| Scope / Definition of Process / Objective | To review the Agenda of the Management review. Make sure no headers are missed that should be being discussed.
Make sure Objectives are appropriate and effective. | Helen Lamb 11 Nov 2021 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 13 Nov 2021 |
| Severity of Risk (1-5) | 2.Minor | Helen Lamb 11 Nov 2021 |
| Measurable Objective | A completed issue
Management review carried out effectively. | Helen Lamb 11 Nov 2021 |
| Training Method Required | Hands on by experienced member of staff | Helen Lamb 11 Nov 2021 |
| Verification / Effectiveness | This Management review is assessed for effectiveness in detail by BSI when they do their annual visit.
Reviewed by the board during and after the management review. | Helen Lamb 11 Nov 2021 |
| Covid / Pandemic Notes | This is not affected by Covid 19 or any other national or international crisis | Helen Lamb 11 Nov 2021 |
| Risk / Benefit Report | The addition of this task is aimed at reducing the risk of missing a header. If a header is missed the risk would be to miss discussing something important. | Helen Lamb 11 Nov 2021 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=2) | |
**Interested Parties**
- Internal Systems
- ISO Auditing Bodies
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Helen Lamb)
- Helen Lamb (trained by Helen Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #1100**
- **Subject:** Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Review the Agenda of the Management review for Viamed and VST and make sure we do not need any other headers and to check that we have up to date and appropriate objectives. Once reviewed check with the Managing directors that they do not have anything further that should be added.
**Rolling Audit #1101**
- **Subject:** Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Audit of the task
Check it has been completed and check you have been consulted by the member of staff carrying out the task
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 376499 | Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting (1101) | 29 Sep 2025 | 09 Oct 2025 | 10 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 26 Dec 643993 13:10 | Read | Derek Lamb | | |
| | - 03 Oct 2025 09:25 | Completed | Derek Lamb | agenda approve in issue 371466
Done | |
| 371677 | Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting (1100) | 04 Aug 2025 | 01 Sep 2025 | 28 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 21 Aug 2025 07:51 | Completed | Derek Lamb | attached to issue for the board meeting thankyou | |
| | - 20 Aug 2025 17:36 | Field Update | Helen Lamb | Next Action By updated to: Derek Lamb | |
| 342309 | Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting (1101) | 30 Sep 2024 | 11 Nov 2024 | 42 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 29 Oct 2024 15:37 | | Derek Lamb | | |
| | - 29 Oct 2024 15:37 | Completed | Derek Lamb | | |
| 337146 | Review The Agenda For The Management Review / Board Meeting Prior To The Annual Meeting (1100) | 05 Aug 2024 | 22 Nov 2024 | 109 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 13 Nov 2024 16:21 | | Helen Lamb |
Done | |
| | - 13 Nov 2024 16:21 | Completed | Helen Lamb |
Done | |
---
### Process ID #7828 — Review The Quality Policy Viamed
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Rolling Issue to trigger a review,
Quality policy in the system | Derek Lamb 16 Sep 2017 |
| Outputs to the Process | Completed Task to history and document marked as reviewed or marked for update and issue left alive. | Derek Lamb 16 Sep 2017 |
| Risks to the Process | That the policy will go out of date | Helen Lamb 22 Jul 2019 |
| Steps to Minimise Process Risks | Keep up to date with issues. | Helen Lamb 22 Jul 2019 |
| Scope / Definition of Process / Objective | To review the Quality policy and check it is still valid and upto date. | Derek Lamb 16 Sep 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 16 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 16 Sep 2017 |
| Measurable Objective | Check rolling issues are completed within terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Procedural , Required Reading and Hands on | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness, of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit and management review meeting. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 6.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.2
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 6.2.1
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Government E.G. HMRC
- Physical Sites
- Regulations
**Linked Companies**
- Viamed
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 20 Process verification to Managment Viamed (Doc ID: 159389)
- Audit 20 Process verification to Managment VST (Doc ID: 159391)
- VM3COP00.00 VOP00.00 Viamed Quality Statement policy and objectives (Doc ID: 164833)
- VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records (Doc ID: 120321)
**Rolling Task #723**
- **Subject:** Review The Quality Policy Viamed
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 373496 | Review The Quality Policy Viamed (723) | 25 Aug 2025 | 02 Oct 2025 | 38 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 02 Oct 2025 09:37 | Meeting Completion | Derek Lamb | | |
| | - 27 Aug 2025 16:55 | Completed | Derek Lamb | reviewed, still current | |
| 339136 | Review The Quality Policy Viamed (723) | 27 Aug 2024 | 08 Jan 2025 | 134 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Jan 2025 11:56 | Meeting Completion | Derek Lamb | | |
| | - 10 Sep 2024 10:41 | | Derek Lamb |
Done | |
---
### Process ID #7827 — Review The Quality Policy VST
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Rolling Issue to trigger a review,
Quality policy in the system | Derek Lamb 16 Sep 2017 |
| Outputs to the Process | Completed Task to history and document marked as reviewed or marked for update and issue left alive. | Derek Lamb 16 Sep 2017 |
| Risks to the Process | that policy will go out of date | Helen Lamb 22 Jul 2019 |
| Steps to Minimise Process Risks | Keep up to date with issues. | Helen Lamb 22 Jul 2019 |
| Scope / Definition of Process / Objective | To review the Quality policy and check it is still valid and upto date. | Derek Lamb 16 Sep 2017 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 16 Sep 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 16 Sep 2017 |
| Measurable Objective | Check rolling issues are completed within terms. | Helen Lamb 22 Jul 2019 |
| Training Method Required | Procedural , Required Reading and Hands on | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | We assess the previous issues for any problems or anomalies. Upon final completion of this task any trends, problems or anomalies will be picked up and if needed a separate issue generate so an investigation can be carried out.
The final completion of any issue, resulting in a query over the effectiveness, of any task or mini audit, will also be reported on in an issue upon final completion of that task or mini audit and management review meeting. | Helen Lamb 26 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 5.3
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.1.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 5.2.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 6.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.1.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 5.2.2
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 6.2.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- ISO Auditing Bodies
- Internal Systems
- Government E.G. HMRC
- Physical Sites
- Regulations
**Linked Companies**
- VST
**Trained Staff (2)**
- Helen Lamb (trained by Derek Lamb)
- Derek Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 20 Process verification to Managment Viamed (Doc ID: 159389)
- Audit 20 Process verification to Managment VST (Doc ID: 159391)
- VM3COP00.00 VOP00.00 VST Quality Statement policy and objectives (Doc ID: 164813)
- VOP 01 Documentation and Records, Control, Creation, Storage, Retrieval, Revision Control and Online Records (Doc ID: 120321)
**Rolling Task #301**
- **Subject:** Review the Quality policy VST
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Review the Quality policy and check it still meets the objectives
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 373457 | Review the Quality policy VST (301) | 25 Aug 2025 | 06 Feb 2026 | 165 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 06 Feb 2026 09:24 | Meeting Completion | Derek Lamb | | |
| | - 27 Aug 2025 17:10 | Completed | Derek Lamb | still current and valid | |
| 339089 | Review the Quality policy VST (301) | 27 Aug 2024 | 08 Jan 2025 | 134 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 08 Jan 2025 13:02 | Meeting Completion | Derek Lamb | | |
| | - 09 Sep 2024 09:54 | | Derek Lamb |
Done | |
---
### Process ID #7979 — Review The Template Of The QC 21 Form To Ensure It Is Current And Valid
**Last Reviewed:** 28 Jul 2025 by Helen Lamb
**Process Maturity:** 5 of 6 (83%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | No |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | QC 21 Form
BSI Assessments | Helen Lamb 12 Nov 2021 |
| Outputs to the Process | Completed and compliant forms | Helen Lamb 12 Nov 2021 |
| Risks to the Process | that we will miss sections that we need to be effective | Helen Lamb 12 Nov 2021 |
| Steps to Minimise Process Risks | regular reviews and assessments | Helen Lamb 12 Nov 2021 |
| Scope / Definition of Process / Objective | To review the QC 21 form to make sure it is fit for purpose and covers all the areas we need to assess when filling in this form | Helen Lamb 12 Nov 2021 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 12 Nov 2021 |
| Severity of Risk (1-5) | 2.Minor | Helen Lamb 12 Nov 2021 |
| Measurable Objective | To ensure we have a valid and up to date form that can be used to accurately and effectively review Non Conformances, internally and externally. That includes risk and effectiveness. | Helen Lamb 12 Nov 2021 |
| Training Method Required | Hands on with experienced members of staff | Helen Lamb 12 Nov 2021 |
| Verification / Effectiveness | these will be verified each time they are use and when we submit them to BSI they will also review the form as well as the contents of it. | Helen Lamb 12 Nov 2021 |
| Covid / Pandemic Notes | this in not affected by Covid 19 pandemic or any national or international crisis | Helen Lamb 12 Nov 2021 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=2) | |
**Interested Parties**
- Internal Systems
- ISO Auditing Bodies
- Government E.G. HMRC
**Linked Companies**
- Viamed
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Helen Lamb)
- Helen Lamb (trained by Helen Lamb)
**Associated Documents**
- Audit 18 Management Review Viamed (Doc ID: 159471)
- Audit 18 Management Review VST (Doc ID: 159473)
- QC 21 Non Conformance Form (Doc ID: 74728)
- VOP 19 Feedback Customer Complaints Vigilance and Notifications Viamed Ltd (Doc ID: 132118)
**Rolling Task #1102**
- **Subject:** Review The Template Of The QC 21 Form To Ensure It Is Current And Valid
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
To ensure we have a valid and up to date form that can be used to accurately and effectively review Non Conformances, internally and externally. That includes risk and effectiveness.
Have we got all areas needed covered in this form
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 403954 | Review The Template Of The QC 21 Form To Ensure It Is Current And Valid (1102) | 27 Jul 2026 | | Outstanding (0 days) | Derek Lamb |
| 370978 | Review The Template Of The QC 21 Form To Ensure It Is Current And Valid (1102) | 28 Jul 2025 | 04 Aug 2025 | 7 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 28 Jul 2025 15:22 | | Derek Lamb |
Done | |
| | - 28 Jul 2025 15:22 | Completed | Derek Lamb |
Done | |
| 336469 | Review The Template Of The QC 21 Form To Ensure It Is Current And Valid (1102) | 29 Jul 2024 | 13 Aug 2024 | 15 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 31 Jul 2024 11:29 | | Derek Lamb |
Done | |
| | - 31 Jul 2024 11:29 | Completed | Derek Lamb |
Done | |
---
### Process ID #28 — Supplier Review
**Last Reviewed:** 09 Feb 2026 by Helen Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Supplier review intrastats screen, showing our current suppliers.
Supplier websites for ISO certificates
Email systems for supplier whom dont have certificates online. | Derek Lamb 22 Aug 2016 |
| Outputs to the Process | Supplier Grading | Derek Lamb 22 Aug 2016 |
| Risks to the Process | Supplier certificates go out of date, or they lose ISO standards and we`re unaware | Derek Lamb 22 Aug 2016 |
| Steps to Minimise Process Risks | rolling task to do the supplier review | Derek Lamb 22 Aug 2016 |
| Scope / Definition of Process / Objective | Check our supplier are still certified to ISO 9001 or ISO 13485,
and do a review of their internal grading. | Derek Lamb 22 Aug 2016 |
| Likelihood of Risk (1-5) | 1.Improbable | Derek Lamb 12 Jun 2017 |
| Severity of Risk (1-5) | 1.Negligible | Derek Lamb 12 Jun 2017 |
| Measurable Objective | Check the supplier review page make sure none are more then a month out of date. | Helen Lamb 29 Aug 2018 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 01 Oct 2019 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Derek Lamb 23 Oct 2020 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Oct 2020 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=1) | |
**Linked ISO Sections**
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 4.2.1
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO13485:2016: 7.4.2
- Quality Management System Route Map to Documents and Procedures Viamed Ltd ISO9001:2015: 4.4.1
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.1.3
- Quality Management System Route Map to Documents and Procedures VST Ltd ISO9001:2015+A1: 9.3.2
**Interested Parties**
- Supplier
- Physical Sites
- Internal Systems
- VST Supplier
- VST Supplier
- VST Supplier
**Linked Companies**
- Human Med
- Vandagraph
- Viamed
- Viamed Properties
- VST
**Trained Staff (3)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
- Steve Nixon (trained by Derek Lamb)
**Associated Documents**
- Audit 05 Purchasing suppliers Viamed (Doc ID: 159433)
- Audit 05 Purchasing suppliers VST (Doc ID: 159435)
- VOP 05 Supplier Control, Supplier Review, Purchase Orders, Supplier Returns and Rejection (Doc ID: 227177)
- VOP 05 Vandagraph Sensor Technologies Ltd Supplier Management, Purchasing and Supplier Performance, Purchase Orders, Supplier Returns and Rejection (Doc ID: 227171)
- VOP 13 Process Monitoring, System Reviews, Audits, Management Reviews Analysis Data PMS Post Market (Doc ID: 210961)
**Rolling Task #15**
- **Subject:** Supplier Review
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Need To do full Supplier Review.
Need to add to the review - getting supplier agreements added as a file,
confirming they will notify us of changes and/or vigilance notifications.
**Rolling Audit #610**
- **Subject:** Supplier Review
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
*** AUDIT *** Ensure the Task is being Completed
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 388313 | Supplier Review (610) | 09 Feb 2026 | 10 Feb 2026 | 1 day | Helen Lamb |
| | **History Log:** | | | | |
| | - 21 Jun 643990 17:20 | Read | Helen Lamb | | |
| | - 09 Feb 2026 17:28 | Completed | Helen Lamb | Done | |
| 371304 | Supplier Review (15) | 31 Jul 2025 | 12 Sep 2025 | 43 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 04 Sep 2025 14:50 | Completed | Derek Lamb | updated the supplier review page,
supplier has to be within review 12month to place orders, or the commit button not active,
have 1 in the list out of sync with that but i have a feeling its historic and cross over of when the button timer went live | |
| | - 31 Jul 2025 08:18 | Re-Read | Derek Lamb | | |
| 355046 | Supplier Review (610) | 10 Feb 2025 | 13 Feb 2025 | 3 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 10 Feb 2025 10:48 | | Helen Lamb |
Done | |
| | - 10 Feb 2025 10:48 | Completed | Helen Lamb |
Done | |
| 336693 | Supplier Review (15) | 31 Jul 2024 | 08 Aug 2024 | 8 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 06 Aug 2024 16:06 | | Derek Lamb | checked the supplier review, the new system of blocking orders until a valid upto date supplier review is working well,
the whole system is about to undergo a change and have increase correspondace with suppliers | |
| | - 06 Aug 2024 16:06 | Completed | Derek Lamb | checked the supplier review, the new system of blocking orders until a valid upto date supplier review is working well,
the whole system is about to undergo a change and have increase correspondace with suppliers | |
---
### Process ID #7998 — Verification Calibrated Equipment
**Last Reviewed:** 18 Nov 2025 by Derek Lamb
**Process Maturity:** 6 of 6 (100%)
| Measure | Status |
|--------|--------|
| Has Risk Assessment | Yes |
| Has Audit | Yes |
| Has Measurable Objective | Yes |
| Has Backup Staff | Yes |
| Reviewed <12 Months | Yes |
| Recent Completion Evidence | Yes |
**Risk Assessment**
| Risk Item | Notes / Value | Last Updated |
|-----------|---------------|---------------|
| Input to the Process | Test equipment
Calibration Index
Date sticker | Helen Lamb 12 Nov 2024 |
| Outputs to the Process | Completed list and up to date calibrated equipment
Equipment identified with a CE0 label and a date sticker | Helen Lamb 12 Nov 2024 |
| Risks to the Process | Equipment missed from the list
Goods could have been tested with equipment that has not been calibrated.
Or the date may not be attached. | Helen Lamb 12 Nov 2024 |
| Steps to Minimise Process Risks | regular reviews and checking of test equipment.
Checking the equipment for a date label on calibration | Helen Lamb 12 Nov 2024 |
| Scope / Definition of Process / Objective | Verify Equipment used is logged and up to date in the ISO calibration Index and that they have a date of calibration sticker on it. | Helen Lamb 12 Nov 2024 |
| Likelihood of Risk (1-5) | 1.Improbable | Helen Lamb 23 Feb 2022 |
| Severity of Risk (1-5) | 3.Serious | Helen Lamb 23 Feb 2022 |
| Measurable Objective | Check the ISO calibration Index is up to date.
Check the test areas for any Calibration equipment that does not have an ISO Calibration CE Sticker. Workshop, R and D room, Vandagraph areas, QA bench
Visual check for the date sticker on all calibrated equipment. | Helen Lamb 12 Nov 2024 |
| Training Method Required | Hands on Learning from experienced staff | Helen Lamb 23 Feb 2022 |
| Verification / Effectiveness | This task is verified for effectiveness during internal rolling audit issues. | Helen Lamb 23 Feb 2022 |
| Covid / Pandemic Notes | This process is not affected by Covid 19 or other extreme national or international circumstance / crisis. | Helen Lamb 23 Feb 2022 |
| Risk / Benefit Report | No Action | Helen Lamb 28 Jul 2025 |
| HSE Implications | No health and safety implications | Helen Lamb 28 Jul 2025 |
| **Calculated Risk Code** | **No Action** (Frequency=1, Severity=3) | |
**Interested Parties**
- Internal Systems
- Physical Sites
- Customer
- Supplier
- VST OEM Customers
- VST Supplier
**Linked Companies**
- Viamed
- Vandagraph
- VST
**Trained Staff (2)**
- Derek Lamb (trained by Derek Lamb)
- Helen Lamb (trained by Derek Lamb)
**Associated Documents**
- Audit 06 Calibration VIAMED (Doc ID: 186878)
- Audit 06 VST Ltd Calibration (Doc ID: 221522)
- VOP 06 Measurement Control Viamed VST, Calibration, QA Stock (Doc ID: 168580)
**Rolling Task #1141**
- **Subject:** Verification Calibrated Equipment
- **Target User:** Helen Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed
Verify Equipment used is logged and upto date in the ISO calibration Index.
Check Test areas for any Calibration equipment that does not have an ISO Calibration CE Sticker.
**Rolling Audit #1142**
- **Subject:** Verification Calibrated Equipment
- **Target User:** Derek Lamb
- **Recurrence:** 12 Month(s) 0 Week(s) 0 Day(s)
- **Notes:** System Generated
Task To be Completed Verify Equipment used is logged and uptodate in the ISO calibration Index
**Task Completion History (Last 2 Years, Max 20 Items)**
| ID | Subject | Created | Completed | Days to Complete | Investigated By |
|----|---------|---------|----------|------------------|----------------|
| 396904 | Verification Calibrated Equipment (1141) | 11 May 2026 | 14 May 2026 | 3 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 12 May 2026 12:28 | Completed | Helen Lamb | all equipment found has a label either CE or only for indication only. Rolling task for this also 547, 1142 up to date no problems | |
| 381129 | Verification Calibrated Equipment (1142) | 18 Nov 2025 | 20 Nov 2025 | 2 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 Nov 2025 11:05 | Completed | Derek Lamb | task is upto date | |
| 363990 | Verification Calibrated Equipment (1141) | 12 May 2025 | 15 May 2025 | 3 days | Helen Lamb |
| | **History Log:** | | | | |
| | - 13 May 2025 16:15 | | Helen Lamb |
Done | |
| | - 13 May 2025 16:15 | Completed | Helen Lamb |
Done | |
| 347197 | Verification Calibrated Equipment (1142) | 18 Nov 2024 | 21 Nov 2024 | 3 days | Derek Lamb |
| | **History Log:** | | | | |
| | - 18 Nov 2024 10:47 | | Derek Lamb | task done ok | |
| | - 18 Nov 2024 10:47 | Completed | Derek Lamb | task done ok | |
### Responsibility-Only Processes (8)
*These processes represent allocated responsibilities only - no rolling task or audit is required, so they are excluded from the main report metrics and conclusion.*
- **#5889:** Audit And Task - Audit (last reviewed: 13 Sep 2024)
- **#7172:** CE Technical Files (last reviewed: 02 Jan 2024)
- **#29:** CMDCAS Updates And Licences (last reviewed: 29 Oct 2021)
- **#24:** Compliance ISO Standards (last reviewed: 11 Nov 2021)
- **#7069:** Corrective Actions (last reviewed: 10 Oct 2017)
- **#7200:** ISO Issues (last reviewed: 25 Oct 2017)
- **#6865:** Non Conformance Effectiveness (last reviewed: 10 Oct 2017)
- **#7264:** VST Management Meeting Non Conformance Issues (last reviewed: 28 Jul 2025)
---
---
## Conclusion / Executive Summary
*Auto-calculated summary of findings across the report.*
### Coverage
- **1** roles reviewed
- **50** active processes reviewed
- **16** responsibility-only processes (excluded from metrics, listed per role)
### Key Risks
- **2** process(es) with 'Unacceptable' calculated risk code:
- Process #8107: ISO And Compliance Controller Review
- Process #8107: ISO And Compliance Controller Review
- **2** overdue rolling task(s) / audit(s) across all roles
### Overdue Reviews
- **2** process(es) not reviewed in over 24 months
### Dependency Warnings
- [ISO and Compliance Controller] Derek Lamb linked to 100% (25 of 25) of role processes - single point of failure risk
- [ISO and Compliance Controller] Derek Lamb linked to 100% (25 of 25) of role processes - single point of failure risk
### Missing Audits
- **30** process(es) with no audit configured (excluding responsibility-only)
### Missing Measurable Objectives
- All processes have measurable objectives defined
### Trained Staff Coverage
- **14** process(es) with only one trained user (no backup)
### Process Maturity Overview
- **2** of 50 processes (4%) scored below 4 of 6 maturity checks
### Per-Role Risk Indicator Summary
| Role | Processes | Overdue | >24mo Review | Solo Trained | No Trained | Missing Obj | No Audit |
|------|-----------|---------|--------------|--------------|------------|-------------|----------|
| ISO and Compliance Controller | 25 | 1 | 1 | 7 | 0 | 0 | 15 |
| ISO and Compliance Controller | 25 | 1 | 1 | 7 | 0 | 0 | 15 |
---
*End of Management Review Report - Viamed*