FDA QMSR SCAR (Supplier Corrective Action Request) Policy, SOP & Forms

¥319,500

FDA QMSR SCAR (Supplier Corrective Action Request) Policy, SOP & Forms

FDA QMSR SCAR (Supplier Corrective Action Request) Policy, SOP & Forms

¥319,500

SCAR 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 §7.5.8
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete identification and traceability template set for FDA QMSR compliance. Provides structured procedures for identifying products throughout production and maintaining the traceability records required under ISO 13485:2016.

Regulatory Reference: ISO 13485:2016 §7.5.8 — Identification and Traceability

Why You Need This

ISO 13485:2016 §7.5.8 requires documented identification and traceability procedures. These are essential for effective product recalls and post-market surveillance under FDA QMSR.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S6001 Identification and Traceability SOP
📝 Form / Template F6001-01 Material Identification Tag
📝 Form / Template F6001-02 Material Label
📝 Form / Template F6001-03 Manufacturing Record
📝 Form / Template F6001-04 Return Product Tag
📝 Form / Template F6001-05 Repair Slip
📝 Form / Template F6001-06 Shipping Record
📝 Form / Template F6001-07 Nonconformance Tag
📝 Form / Template F6001-08 Process Deviation Label
📝 Form / Template F6001-09 Color Control Reference Chart

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
Identification and Traceability
Risk-Based Approach to Identification and Traceability
Product Identification
Status Identification
Traceability
Unique Device Identification (UDI)
Implantable Medical Device Requirements
Identification Methods
Color Control
Electronic Records and Data Integrity
Segregation and Identification of Nonconforming, Returned, and Process Deviation Products
Outsourced Process Controls
References
Supplementary Provisions

📋 MD-QMS-S6001 Identification and Traceability SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Material Identification
Incoming Material Identification
Work-in-Process Identification
Product Identification
Finished Product Identification
UDI / UPC Labeling
Packaging and Shipping Box Identification
Returned Product and Repair Item Identification
Returned Product Identification
Repair Item Identification
Service Parts Identification
Shipping and Traceability Records
Implantable Medical Device Traceability
Status Identification
Color Control
Pre-Inspection Status Identification
Post-Inspection Status Identification
Pre/Post Release Status Identification
Installation and Servicing Status Identification
Nonconforming and Deviation Product Identification
Nonconforming Product Identification
Process Deviation Product Identification
Anomalous Equipment / Instruments Identification
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5.8 (Identification and 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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