FDA QMSR Measuring Equipment Management Policy, SOP & Forms

¥319,500

FDA QMSR Measuring Equipment Management Policy, SOP & Forms

FDA QMSR Measuring Equipment Management Policy, SOP & Forms

¥319,500

Measuring Equipment Management templates for FDA QMSR compliance.

Quantity

SOLD OUT

✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §8.2.2
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete complaint handling template set for FDA QMSR compliance. Provides structured procedures for receiving, investigating, and reporting customer complaints, including MDR/vigilance reporting decision guidance.

Regulatory Reference: ISO 13485:2016 §8.2.2 — Complaint Handling

Why You Need This

ISO 13485:2016 §8.2.2 and FDA QMSR require robust complaint handling and MDR reporting procedures. Poor complaint management is a leading cause of FDA warning letters and consent decrees.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S1401 Complaint Handling SOP
📝 Form / Template MD-QMS-F1401 苦情および評価報告書
📝 Form / Template MD-QMS-F1401 Complaint and Evaluation Report 1
📝 Form / Template MD-QMS-K14 苦情管理規程
📝 Form / Template MD-QMS-S1401 苦情管理手順書

📋 Policy — Table of Contents

Revision History
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Policy
5.1 Complaint Classification
5.2 Complaint Receipt and Documentation
5.3 Evaluation and Investigation Requirements
5.4 Regulatory Reporting
5.5 Timelines
5.6 Complaint Files
5.7 Record Retention
5.8 Trend Analysis and Reporting
6. References
7. Supplementary Provisions

📋 MD-QMS-S1401 Complaint Handling SOP — Table of Contents

Revision History
1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Complaint Receipt
6. Complaint Evaluation
7. Investigation Determination
8. Investigation
9. Corrective Action Disposition
10. Risk Analysis Review
11. Customer Response
12. CAPA Determination
13. SCAR Process (Supplier Issues)
14. Complaint Data Analysis and Reporting
15. Complaint File Management
16. Forms
17. References
18. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §8.2.2 (Complaint Handling)
  • 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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