Management Review templates for FDA QMSR compliance.
✅ Common Features Across All QMS Templates
🇺🇸 FDA QMSR (21 CFR Part 820)·
🌐 ISO 13485:2016 §5.6·
📝 MS Word (.docx)·
🔄 Immediate Use·
🎬 Video Guidance on YouTube
🌐 ISO 13485:2016 §5.6·
📝 MS Word (.docx)·
🔄 Immediate Use·
🎬 Video Guidance on YouTube
Overview
A complete management review template set for FDA QMSR compliance. Provides structured documentation for top management to systematically evaluate QMS effectiveness, resource adequacy, and strategic improvement opportunities.
Regulatory Reference: ISO 13485:2016 §5.6 — Management Review
Why You Need This
ISO 13485:2016 §5.6 requires top management to conduct regular QMS reviews. This template ensures your reviews cover all required inputs/outputs and are fully documented for FDA inspections.
What’s Included
| Document Type | Description |
|---|---|
| 📄 Policy Document | 1 file — Organizational policy & management framework |
| 📋 SOP / Procedure | MD-QMS-S101 Management Review Procedure |
| 📝 Forms | Management Review Meeting Minutes & Action Item Forms |
📋 Policy — Table of Contents
1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Policy Statements
5.1 Annual QMS Planning
5.2 Management Review Meeting Requirements
5.3 Management Review Inputs
5.4 Review and Deliberation
5.5 Management Review Outputs
5.6 Record Keeping
5.7 Absentee Handling
5.8 CAPA Initiation Criteria
6. References
7. Supplementary Provisions
📋 SOP — Table of Contents
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Annual QMS Planning
6. Management Review Meeting Preparation
7. Conducting Management Review Meeting
8. Management Review Inputs
9. Management Review Outputs
10. Documentation and Record Retention
11. Handling of Absentees
12. Ad-Hoc Management Review Meetings
13. CAPA Initiation Criteria
14. Related Forms
15. References
16. Supplementary Provisions
Key Features
- Fully aligned with ISO 13485:2016 §5.6 (Management Review)
- Written for immediate use — minimal customization required
- Structured for FDA QMSR (21 CFR Part 820) compliance
- Microsoft Word format (.docx) — easy to edit and adapt
- Professional quality suitable for FDA inspection review
- Includes all required procedural elements and record templates
Reviews
You must be a registered member to post a review.