FDA QMSR Distribution Management Policy, SOP & Forms

¥319,500

FDA QMSR Distribution Management Policy, SOP & Forms

FDA QMSR Distribution Management Policy, SOP & Forms

¥319,500

Distribution 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 §4.2.3 / §4.2.4
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete document and record control template set for FDA QMSR compliance. Ensures all quality documents are properly created, reviewed, approved, distributed, and maintained—forming the backbone of a compliant QMS.

Regulatory Reference: ISO 13485:2016 §4.2.3 / §4.2.4 — Control of Documents and Records

Why You Need This

ISO 13485:2016 §4.2.3 and §4.2.4 require documented procedures for controlling documents and records. Document control deficiencies are among the most cited FDA inspection findings.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Document Control Procedure
📝 Form / Template MD-QMS-F201 Document Request Form
📝 Form / Template MD-QMS-F203 Periodic Document Review Record
📝 Form / Template MD-QMS-F206 Document Template
📝 Form / Template MD-QMS-F207 Form Template
📝 Form / Template MD-QMS-F208 Deliverable Documentation Template

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. QMS Document Hierarchy
6. Document Control Responsibilities
7. QMS Document Management
7.1 Principles of QMS Document Management
7.2 Document Creation
7.3 Document Identification
7.4 Document Review and Approval
7.5 Document Training
7.6 Document Distribution
7.7 Master Document List
7.8 Management of Printed QMS Documents
7.9 Identification of Controlled and Uncontrolled Documents
7.10 Periodic Document Review
7.11 Document Revision
7.12 Document Obsolescence
7.13 Management of Obsolete Documents
7.14 Management of Device-Specific Procedures
7.15 Document Storage
7.15.1 Storage Method
7.15.2 Retention Period
8. Record Management
8.1 Principles of Record Management
8.2 Record Creation
8.3 Record Approval
8.4 Record Version Control
8.5 Record Correction
8.6 Record Identification
8.7 Record Retrieval and Access
8.8 Record Storage
8.8.1 Storage Method
8.8.2 Retention Period
9. External Document Management
10. Electronic Document Management Compliance
11. References
12. Supplementary Provisions

📋 Document Control Procedure — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. QMS Document Management
5.1 Document Creation or Revision Request
5.2 Document Creation/Revision, Review, and Approval
5.3 Original Document Management
5.4 Document Creation/Revision Training
5.5 QMS Document Distribution
5.5.1 For Electronic Original Documents
5.5.2 For Paper Original Documents
5.6 Periodic Document Review
5.7 Document Obsolescence
5.8 External Document Management
6. Record Management
6.1 Record Creation
6.1.1 Paper-Based Record Creation
6.1.2 Electronic Record Creation
6.2 Record Correction
6.3 Record Storage and Protection
6.3.1 Paper-Based Storage and Protection
7. Forms
8. References
9. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §4.2.3 / §4.2.4 (Control of Documents and Records)
  • 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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