FDA QMSR Identification Policy, SOP & Forms

¥319,500

FDA QMSR Identification Policy, SOP & Forms

FDA QMSR Identification Policy, SOP & Forms

¥319,500

Identification and Traceability templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §7.5.9
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete traceability management template set for FDA QMSR compliance. Provides comprehensive procedures for implantable device traceability, UDI management, and maintaining device history records as required by FDA QMSR.

Regulatory Reference: ISO 13485:2016 §7.5.9 — Traceability

Why You Need This

ISO 13485:2016 §7.5.9 and FDA QMSR impose specific traceability requirements for implantable devices. This template ensures complete traceability from components and raw materials through finished product to the end user.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S6501 Traceability Management SOP
📝 Form / Template F6501-01 Incoming Inspection Record
📝 Form / Template F6501-02 Manufacturing Record
📝 Form / Template F6501-03 DHR Compilation Checklist
📝 Form / Template F6501-06 Manufacturing Record Enhanced Implantable
📝 Form / Template F6501-07 Retrospective Investigation Report

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
XXXXXX
XXXXXX
References
Supplementary Provisions
Purpose
Scope
Normative References
Definitions
Traceability
General Principles
Scope and Extent of Traceability
Ensuring Traceability
Traceability Records
Retrospective Investigation (Traceability Execution)
References
Supplementary Provisions

📋 MD-QMS-S6501 Traceability Management SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Procedure
References
Supplementary Provisions
Purpose
Scope
Definitions
Roles and Responsibilities
Traceability Assurance Procedure
Enhanced Traceability Procedure for Implantable Devices
Traceability Record Management
Retrospective Investigation Procedure
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5.9 (Traceability)
  • 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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