This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) and ISO 13485:2016. It includes the policy, SOP, and supporting forms drawn from over 30 years of FDA inspection experience.

What’s Included

Policy

• 📄 MD-QMS-K4i_Design_Change_Management_Policy.docx

Procedure (SOP)

• 📄 MD-QMS-S405_Design_Change_Management_SOP.docx

Forms

• 📄 MD-QMS-F430_Design_Change_4M_Change_Request_Form.docx
• 📄 MD-QMS-F431_Change_Application_Form.docx
• 📄 MD-QMS-F432_Design_Change_4M_Change_Order.docx
• 📄 MD-QMS-F433_Change_Approval_Rejection_Decision_Form.docx

Table of Contents (Policy Document)

• 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