FDA QMSR Production and Service Provision Control Policy, SOP & Forms

¥319,500

FDA QMSR Production and Service Provision Control Policy, SOP & Forms

FDA QMSR Production and Service Provision Control Policy, SOP & Forms

¥319,500

Production and Service Provision Control templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
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🌐 ISO 13485:2016 §7.3.9
·
📝 MS Word (.docx)
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🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete design change management template set for FDA QMSR compliance. Provides structured procedures for evaluating, reviewing, verifying, and documenting all design changes to ensure continued safety and regulatory compliance.

Regulatory Reference: ISO 13485:2016 §7.3.9 — Control of Design and Development Changes

Why You Need This

ISO 13485:2016 §7.3.9 requires documented control of design changes. Uncontrolled design changes can invalidate regulatory approvals and compromise device safety. This template mitigates that risk.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S405 Design Change Management SOP
📝 Form / Template MD-QMS-F430 Design Change 4M Change Request Form
📝 Form / Template MD-QMS-F431 Change Application Form
📝 Form / Template MD-QMS-F432 Design Change 4M Change Order
📝 Form / Template MD-QMS-F433 Change Approval Rejection Decision Form

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Design Change / 4M Change Management
5.1 General Requirements
5.2 Determination of Significance
5.3 Pre-Implementation Requirements
5.4 Impact Assessment
5.5 Risk-Based Approach
5.6 Regulatory Reporting Obligations
5.7 Record Retention
5.8 Change Significance Evaluation Criteria
5.9 Classification: Design Change vs. 4M Change
5.10 Change Impact Assessment Checklist
6. CAPA Trigger Criteria
7. Design Transfer Process
7.1 Prerequisites for Design Transfer
7.2 Design Transfer Approval
7.3 Design Transfer Records
8. References
9. Supplementary Provisions

📋 MD-QMS-S405 Design Change Management SOP — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Change Significance Evaluation Criteria
6. Change Request
7. Change Implementation
7.1 Change Preparation
7.2 Design Transfer
8. Record Retention
9. Forms
10. References
11. Supplementary Provisions
Appendix 1: Examples of Changes and Responsible Departments

Key Features

  • Fully aligned with ISO 13485:2016 §7.3.9 (Control of Design and Development Changes)
  • 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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