FDA QMSR Purchasing Control Policy, SOP & Forms

¥319,500

FDA QMSR Purchasing Control Policy, SOP & Forms

FDA QMSR Purchasing Control Policy, SOP & Forms

¥319,500

Purchasing 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 §8.3
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete nonconforming product control template set for FDA QMSR compliance. Provides structured procedures for identifying, segregating, evaluating, and dispositioning nonconforming products to prevent inadvertent use or shipment.

Regulatory Reference: ISO 13485:2016 §8.3 — Control of Nonconforming Product

Why You Need This

ISO 13485:2016 §8.3 requires documented nonconformance control. This template ensures nonconforming products are properly controlled and that all dispositions are fully documented for regulatory review.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Nonconforming Product Control Procedure
📝 Form / Template MD-QMS-F1201 不適合品報告書
📝 Form / Template MD-QMS-F1201 Nonconforming Product Report
📝 Form / Template MD-QMS-K12 不適合品管理規程
📝 Form / Template MD-QMS-S1201 不適合品管理手順書

📋 Policy — Table of Contents

Revision History
1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Policy Statements
5.1 General Requirements
5.2 Nonconforming Product Manager
5.3 Identification and Segregation
5.4 Documentation
5.5 Severity Classification
5.6 Evaluation and Investigation
5.7 Notification of Responsible Parties
5.8 Disposition Options
5.8.1 Pre-Delivery Nonconforming Product
5.8.2 Post-Delivery Nonconforming Product
5.9 Records
5.10 Corrective and Preventive Action
5.11 Supplier-Caused Nonconformities
5.12 Returned Product
5.13 Data Analysis and Reporting
6. References
7. Supplementary Provisions

📋 Nonconforming Product Control Procedure — Table of Contents

Revision History
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Nonconforming Product Detection and Reporting
6. Nonconforming Product Evaluation and Disposition Planning
7. Notification to Responsible Parties
8. Recall and Advisory Notice Evaluation
9. Investigation Execution (if required)
10. Nonconforming Product Disposition Execution
10.1 Return to Supplier and SCAR Issuance
10.2 Rework Disposition
10.3 Concession (Use-As-Is) Disposition
10.4 Scrap Disposition
11. Final Review and Closure
12. Nonconforming Product Data Analysis
13. Forms
14. References
15. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §8.3 (Control of Nonconforming Product)
  • 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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