Design Change Management templates for FDA QMSR compliance.
✅ Common Features Across All QMS Templates
🇺🇸 FDA QMSR (21 CFR Part 820)
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🌐 ISO 13485:2016 §7.4
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📝 MS Word (.docx)
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🔄 Immediate Use
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🎬 Video Guidance on YouTube
·
🌐 ISO 13485:2016 §7.4
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube
Overview
A complete purchasing control template set for FDA QMSR compliance. Covers supplier evaluation, qualification, monitoring, and purchasing information requirements to ensure that externally provided products and services meet your quality requirements.
Regulatory Reference: ISO 13485:2016 §7.4 — Purchasing
Why You Need This
ISO 13485:2016 §7.4 requires documented supplier controls and purchasing procedures. Supply chain failures are a significant source of medical device defects and regulatory citations.
What’s Included
| Document Type | Description |
|---|---|
| 📄 Policy Document | 1 file — Organizational policy & management framework |
| 📋 SOP / Procedure | MD-QMS-S601 Purchasing Control SOP |
| 📋 SOP / Procedure | MD-QMS-S602 SOP Verification of Purchased Products |
| 📝 Form / Template | MD-QMS-F602 Supplier Evaluation Re-evaluation Record |
| 📝 Form / Template | MD-QMS-F603 Supplier Audit Record |
| 📝 Form / Template | MD-QMS-F604 Incoming Inspection Test Record |
| 📝 Form / Template | MD-QMS-F605 Rejected Purchased Product Disposition Record |
| 📝 Form / Template | MD-QMS-F606 Purchased Product Change Impact Assessment |
📋 Policy — Table of Contents
Purpose
Scope
Normative References
Definitions
Ensuring Quality of Purchased Products
Supplier Control Categories
Supplier Control Category Assignments
Degree of Control by Category
New Supplier Qualification
Information Gathering
Supplier Candidate Audit
Supplier Candidate Evaluation
Evaluation Rating Criteria
Supplier Selection
Supplier Contracting
Purchasing
Communicating Purchasing Information to Suppliers
Ordering Purchased Products
Verification of Purchased Products
Supplier Corrective Action Request (SCAR)
Supplier Management
Supplier Re-evaluation
Supplier Audit
Supplier Data Collection and Analysis
Records
CAPA Initiation Criteria
References
Supplementary Provisions
📋 MD-QMS-S601 Purchasing Control SOP — Table of Contents
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Supplier and Supplier Candidate List Management
5.1 Registration of New Supplier Candidates
5.2 Maintenance of the Supplier and Supplier Candidate List
6. New Supplier Qualification (Information Gathering, Audit, Evaluation, Selection, and Contracting)
6.1 Information Gathering
6.2 Supplier Candidate Audit
6.3 Supplier Candidate Evaluation
6.4 Supplier Selection
6.5 Supplier Contracting
7. Purchasing Execution
7.1 Communication of Purchasing Information to Suppliers
7.2 Purchase Ordering
7.3 Verification of Purchased Products
8. Ongoing Supplier Management
8.1 Supplier Performance Monitoring
8.2 Periodic QMS Verification of Registered Manufacturers
8.3 Periodic Supplier Re-evaluation
8.4 Supplier Auditing
9. Supplier Corrective Action Request (SCAR)
10. Response to Supplier-Reported Information
11. Record Retention
12. Supplier Data Collection and Analysis
13. CAPA Initiation Criteria
14. Forms
15. References
16. Supplementary Provisions
📋 MD-QMS-S602 SOP Verification of Purchased Products — Table of Contents
Purpose
Scope
Definitions
Roles and Responsibilities
Development of Incoming Inspection Procedures
Performing Incoming Inspection
Disposition of Nonconforming Purchased Products
Handling Unapproved Changes to Purchased Products
Periodic Reporting of Incoming Inspection Results
Forms
References
Supplementary Provisions
Key Features
- Fully aligned with ISO 13485:2016 §7.4 (Purchasing)
- 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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