FDA QMSR Product Recall Policy

¥319,500

FDA QMSR Product Recall Policy

FDA QMSR Product Recall Policy

¥319,500

Product Recall Policy template for FDA QMSR compliance.

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §8.5.1
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete product recall policy template for FDA QMSR compliance. Provides structured procedures for initiating, executing, and closing product recalls and field safety corrective actions (FSCAs) to protect patient safety.

Regulatory Reference: ISO 13485:2016 §8.5.1 — Improvement / Post-Market Field Safety

Why You Need This

FDA QMSR and ISO 13485:2016 §8.5.1 require documented recall and corrective action procedures. Without a tested recall plan, companies face significant delays in executing safety-critical field actions.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
Policy Principles
Roles and Responsibilities
Recall Initiation and Decision-Making
Recall Scope Determination
Regulatory Notification
Customer Notification and Communication
Recall Implementation and Product Recovery
Product Disposition
Root Cause Investigation and CAPA
Recall Termination and Closure
Documentation and Record Retention
Training
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §8.5.1 (Improvement / Post-Market Field Safety)
  • 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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