FDA QMSR Logistics Management Policy, SOP & Forms

¥319,500

FDA QMSR Logistics Management Policy, SOP & Forms

FDA QMSR Logistics Management Policy, SOP & Forms

¥319,500

Logistics Management templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §7.5.5
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete logistics management template set for FDA QMSR compliance. Provides comprehensive procedures for product handling, storage, inventory management, and logistics operations to maintain product quality from production to delivery.

Regulatory Reference: ISO 13485:2016 §7.5.5 — Preservation of Product / Logistics

Why You Need This

ISO 13485:2016 §7.5.5 requires documented product preservation and logistics procedures. This template ensures your logistics operations protect product integrity and meet regulatory requirements.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Distribution Management SOP
📝 Form / Template DIST-001 Distribution Records UDI
📝 Form / Template DIST-002 Environmental Monitoring Record
📝 Form / Template DIST-003 Storage Area Inspection Record
📝 Form / Template DIST-004 Issuing Record
📝 Form / Template DIST-005 Quarantined Product Management Ledger
📝 Form / Template DIST-006 UDI Confirmation Record
📝 Form / Template DIST-007 UDI Verification Record
📝 Form / Template DIST-008 Traceability Record Implantable Devices
📝 Form / Template DIST-009 Delivery Condition Verification Record
📝 Form / Template DIST-010 Training Implementation Record
📝 Form / Template DIST-011 Training Effectiveness Evaluation Record
📝 Form / Template DIST-012 Risk Identification List
📝 Form / Template DIST-013 Data Integrity Checklist

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Key Requirements for Distribution Management
5.1 Management Responsibility for Distribution
5.2 Product Release and Shipment Approval
5.3 Order Review and Contract Requirements
5.4 Shelf Life and Expiration Date Management
5.5 Product Issuing and Dispatch Control
5.6 Delivery Service Provider Management and Customer Delivery
5.7 Verification of Delivery Services
5.8 Special Requirements for Implantable, Life-Sustaining, and Life-Supporting Devices
5.9 Monitoring of Distribution Management Activities
5.10 Management of Nonconforming Products, Returns, and Recalled Products
5.11 Risk Management
6. Training
6.1 Implementation of Training
6.2 Effectiveness Evaluation of Training
7. Record Management
7.1 Record Management and Retention
7.2 Electronic Record Systems and Data Integrity
8. References and Applicable Regulations
9. Supplementary Provisions

📋 Distribution Management SOP — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Identification
6. Storage Condition Management
7. UDI (Unique Device Identifier) Management
8. Receiving
9. Packaging for Shipment
10. Product Shipping and Dispatch
11. Issuing
12. Customer Delivery
13. Verification of Delivery Services
14. Special Requirements for Implantable and Life-Sustaining/Supporting Devices
15. Nonconforming Product Identification and Disposition
16. Handling
17. Abnormal Situation Handling
18. Reporting to Quality Assurance Manager
19. Risk Management for Distribution Process
20. Training for Distribution Personnel
21. Selection of Delivery Service Providers
22. Record Retention
23. Electronic Record Systems and Data Integrity Management
24. References and Applicable Regulations
25. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5.5 (Preservation of Product / Logistics)
  • 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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