NOTE #1: This template is designed to provide a structural outline. It is recommended to use Excel or Sheets instead of MS Word for optimal use.
NOTE #2: Consider each sub-section below as a separate tab in your spreadsheet.
General Review
Overall QMS Evaluation:
NOTE: Assess the overall adequacy, suitability, and effectiveness of the quality management system in meeting regulatory requirements. Also, evaluate the significance and impact of individual processes on product safety. Summarize the measures taken as a result of this review.
| Review Date | XYZ (…) |
| Participants (Name, Role) |
XYZ (…) |
| Signature | XYZ (…) |
Process Review
NOTE: You may want to create a separate tab in your spreadsheet for each process and incorporate data from previous management reviews for comparison.
| SOP | Key Performance Indicator | Review Input | Management Assessment | Improvement Measures | Review of Previous Measures |
|---|---|---|---|---|---|
| Corrective and Preventive Action (CAPA) | Timely action plan execution (goal: max. 1 week) | Last year: average 3 days | Process followed and meets compliance standards | None | N/A |
| Change Management | |||||
| Document and Record Control | |||||
| Software Development | |||||
| Management Review | |||||
| (…) |