This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) and ISO 13485:2016 §4.2 Documented Information.

What’s Included

Policy & Procedure

• 📄 Document_Control_Policy.docx
• 📄 Document_Control_Procedure.docx

Forms / Records

• 📄 F201 Document Request Form
• 📊 F202 Master Document List
• 📄 F203 Periodic Document Review Record
• 📊 F204 Obsolete Document List
• 📊 F205 External Document List
• 📄 F207 Form Template

Templates

• 📄 F206 Document Template
• 📄 F208 Deliverable Documentation Template

Table of Contents (Policy Document)

• 1. Purpose / 2. Scope / 3. Normative References / 4. Definitions
• 5. QMS Document Hierarchy
• 6. Document Control Responsibilities
• 7. QMS Document Management
  • 7.1 Principles, 7.2 Creation, 7.3 Identification, 7.4 Review & Approval, 7.5 Training
  • 7.6 Distribution, 7.7 Master Document List, 7.8 Printed Documents Management
  • 7.9 Controlled vs Uncontrolled, 7.10 Periodic Review, 7.11 Revision, 7.12 Obsolescence
  • 7.13 Obsolete Documents Management, 7.14 Device-Specific Procedures
  • 7.15 Document Storage (Method, Retention Period)
• 8. Record Management (Principles, Creation, Approval, Version Control, Storage, Retention, Disposal)
• 9. References / 10. Supplementary Provisions