Product Preservation templates for FDA QMSR compliance.
✅ Common Features Across All QMS Templates
🇺🇸 FDA QMSR (21 CFR Part 820)
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🌐 ISO 13485:2016 §7.5.11
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📝 MS Word (.docx)
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🔄 Immediate Use
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🎬 Video Guidance on YouTube
·
🌐 ISO 13485:2016 §7.5.11
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube
Overview
A complete product preservation template set for FDA QMSR compliance. Covers product handling, storage conditions, shelf-life management, and preservation procedures to maintain product quality and safety throughout the product lifecycle.
Regulatory Reference: ISO 13485:2016 §7.5.11 — Preservation of Product
Why You Need This
ISO 13485:2016 §7.5.11 requires documented product preservation procedures. Improper preservation can lead to product degradation, sterility failures, and costly recalls.
What’s Included
| Document Type | Description |
|---|---|
| 📄 Policy Document | 1 file — Organizational policy & management framework |
| 📋 SOP / Procedure | MD-QMS-S11001 Product Storage SOP |
| 📝 Form / Template | MD-QMS-F11001 Storage Condition Monitoring Records |
| 📝 Form / Template | MD-QMS-F1101 Temperature and Humidity Record Confirmation Chart |
📋 Policy — Table of Contents
1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Product Preservation Principles
6. Storage Requirements
7. Handling Requirements
8. Protection Requirements
9. Identification Requirements
10. Outsourced Storage
11. References
12. Supplementary Provisions
📋 MD-QMS-S11001 Product Storage SOP — Table of Contents
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Product Identification
6. Product Handling
7. Product Storage
7.1 Raw Materials and Components Storage
7.2 Work-in-Process Storage
7.3 Finished Product Storage
7.4 Repaired Product Storage
7.5 Returned Product Storage
7.6 Aviation Security Area Storage
7.7 Pre-Release and Post-Release Storage Segregation
8. Product Protection
9. Inventory Management
10. Nonconforming Product Control
11. Outsourced Storage Management
12. Records Management
13. References
14. Supplementary Provisions
Key Features
- Fully aligned with ISO 13485:2016 §7.5.11 (Preservation of Product)
- 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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