| qms_version | 2.2.0 |
|---|---|
| sop_id | CSC PR.011 |
| sop_version | 2.0.3 |
| template_id | CSC F.003 |
| template_version | 2.0.3 |
| Template ID | CSC F.003 |
| Template Version | 2.0.3 |
| QMS Version | 2.2.0 |
| SOP ID | CSC PR.011 |
| SOP Version | 2.0.1 |
| Author | |
| Approval |
Overall QMS Assessment:
| Date of Review | |
| Participants |
|
| Signature |
| Date | Type | Focus | Status | Report |
|---|---|---|---|---|
Management review comments
| Date | Type | Focus | Status | Report |
|---|---|---|---|---|
Management review comments
| CAPA title | Date | Description | Status |
|---|---|---|---|
CAPA trend analysis
CAPA trend graphs
Management review comments
Management review comments
Management review comments
| Applied Regulation/Standards | Status |
|---|---|
| ISO 13485:2016+A11:2021 | |
| ISO 14971:2019 | |
| IEC 62304:2006 /Amd 2015 | |
| ISO 62366:2015 | |
| UK MDR:2002 |
Management review comments
Management review comments
Management review comments
| Name | Link | Status |
|---|---|---|
Management review comments
Management review comments
| Id | Title | KPI (metric) | Threshold | Value | Improvement measure | Evaluation of previous measures |
|---|---|---|---|---|---|---|
| CSC-PR-001 | Design and Development | Number of stakeholders contributing to requirements gathering | >3 | |||
| CSC-PR-002 | Clinical Risk Management System | Number of hazards identified (> 10 hazards per project), Number of stakeholders contributing to requirements gathering |
>10 hazards > 3 stakeholders |
|||
| CSC-PR-003 | Verification and Validation | Verification tests code coverage | > 90% code covered | |||
| CSC-PR-004 | Labelling | - | - | |||
| CSC-PR-005 | Monitoring and Surveillance | - | - | |||
| CSC-PR-006 | Feedback Management | Timeframes for initial response to feedback | within 10 working days | |||
| CSC-PR-007 | Uploading to XNAT | All imaging-related projects to store their imaging data in XNAT | - | |||
| CSC-PR-008 | MLOps | - | - | |||
| CSC-PR-009 | Third Party Software Validation | All third party software used for QMS and development is validated | - | |||
| CSC-PR-010 | Control of Non-Conforming Product | - | - | |||
| CSC-PR-011 | Management Review | Management reviews held annually | - | |||
| CSC-PR-012 | Integration and Deployment | - | - | |||
| CSC-PR-013 | Document and Record Control | Number of QMS records in the CSC-QMS GitHub repository or QPULSE | >95 % | |||
| CSC-PR-014 | Incident Reporting | All incidents reported within the timeframe specified by the applicable regulation | 1 | |||
| CSC-PR-015 | Human Resources Administration | All staff cross-trained | All staff | |||
| CSC-PR-016 | Corrective and Preventative Action | Resolution of CAPAs within their defined timeframes | - | |||
| CSC-PR-017 | Reviewing GitHub Pull Requests | GitHub Issues resolved within 60 days | 100% of issues | |||
| CSC-PR-018 | Purchasing and Purchase Verification | - | - | |||
| CSC-PR-019 | QIPS Registration | - | - | |||
| CSC-PR-020 | On-Boarding | All new staff to be formally onboarded | All staff | |||
| CSC-PR-021 | Change Management | - | - | |||
| CSC-PR-022 | Control of Q-Pulse Documents | - | - | |||
| CSC-PR-023 | Clinical Investigation | - | - | |||
| CSC-PR-024 | Sensitive Data Disclosure | - | - | |||
| CSC-PR-025 | Software Release Guidelines | - | - | |||
| CSC-PR-026 | Paired System Administration | - | - | |||
| CSC-PR-027 | Internal Quality Audit | Any issues raised at internal audit to be resolved within 3 months | 3 months |
Management review comments
| Q-Pulse Document Title | Q-Pulse ID | Revision | CSC QMS Process | Comment |
|---|---|---|---|---|
Management review comments
Management review comments
| Participants | Management, QMO |
| Input | Quality Policy, Quality Objectives |
| Output | Strategic Goals, Process KPIs |
Management review comments
Management review comments
Management review comments
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