Complete CAPA (Corrective and Preventive Action) documentation package for FDA QMSR compliance. Includes policy, SOP, and ready-to-use forms aligned with FDA 21 CFR 820.198 and ISO 13485:2016.
✅ Common Features Across All QMS Templates
🇺🇸 FDA QMSR (21 CFR Part 820)
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🌐 ISO 13485:2016 §8.5.2
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📝 MS Word (.docx)
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🔄 Immediate Use
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🎬 Video Guidance on YouTube
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🌐 ISO 13485:2016 §8.5.2
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube
Overview
A complete CAPA (Corrective and Preventive Action) management template set designed for FDA QMSR compliance. Provides everything needed to systematically identify, investigate, and resolve quality issues—preventing recurrence and driving continuous improvement in your medical device QMS.
Regulatory Reference: ISO 13485:2016 §8.5.2 — Corrective and Preventive Action
Why You Need This
FDA QMSR (21 CFR Part 820) and ISO 13485:2016 §8.5.2 require documented CAPA procedures. Inadequate CAPA systems are consistently among the top FDA 483 observations. This template gives you audit-ready documentation from day one.
What’s Included
| Document Type | Description |
|---|---|
| 📄 Policy Document | 1 file — Organizational policy & management framework |
| 📋 SOP / Procedure | MD-QMS-S1701 CAPA SOP |
| 📝 Form / Template | CAPA Form (English & Japanese) |
| 📝 Form / Template | CAT Meeting Minutes |
📋 Policy — Table of Contents
1. Purpose
2. Scope
3. Definitions
4. CAPA Management Principles
5. CAPA Management Responsibility
6. CAPA Information Sources
7. CAPA Escalation Criteria
8. CAPA Severity Classification
9. CAPA Identification Number
10. CAPA Progress Management
10.1 CAPA Log
10.2 Corrective Action Team (CAT)
11. Procedure Overview
12. References
13. Supplementary Provisions
📋 SOP — Table of Contents
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Procedure
5.1 Problem Identification
5.2 Root Cause Investigation
5.3 Action Planning and Verification
5.4 Action Implementation
5.5 Communication and Training
5.6 Closure Approval
5.7 Effectiveness Verification
5.8 Documentation and Records
5.9 Data Analysis and Reporting
6. CAPA Progress Management
7. References
8. Supplementary Provisions
Key Features
- Fully aligned with ISO 13485:2016 §8.5.2 (Corrective and Preventive Action)
- 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
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