FDA QMSR Identification & Traceability Policy, SOP & Forms | qmsdoc.com

Identification and Traceability templates for FDA QMSR compliance.

Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.

Download Sample Preview (PDF)

This editable Microsoft Word template set covers ISO 13485:2016 §7.5.8 Identification and §7.5.9 Traceability, plus FDA UDI (21 CFR Part 830) and Implantable device requirements.

What’s Included

Policy

📄 MD-QMS-K60_Identification_and_Traceability_Policy.docx

SOP

📄 MD-QMS-S6001_Identification_and_Traceability_SOP.docx
📄 F6001-05_Repair_Slip.docx

Table of Contents (Policy Document)

Purpose / Scope / Normative References / Definitions
Identification and Traceability
- Risk-Based Approach
- 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

Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.

📄 Preview the Document Before You Buy

Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.

Table of Contents — FDA QMSR Identification Policy, SOP & Forms

Purpose
Scope
Definitions
Roles and Responsibilities
Procedure
References
Supplementary Provisions

4-page sample preview
Cover · TOC · Sample sections
Watermarked PDF

Download Sample Preview (PDF)

Reviews

You must be a registered member to post a review.

What’s Included

Policy

SOP

Forms / Tags / Labels

Table of Contents (Policy Document)

📄 Preview the Document Before You Buy

Table of Contents — FDA QMSR Identification Policy, SOP & Forms

Related products

FDA QMSR Purchasing Controls Policy, SOP & Forms

FDA QMSR Complaint Handling Policy, SOP & Forms

FDA QMSR Control of Monitoring & Measuring Equipment Policy, SOP & Forms

FDA QMSR Control of Documents Policy, SOP & Forms

FDA QMSR Internal Audit Policy, SOP & Forms

FDA QMSR Production and Service Provision Control Policy, SOP & Forms

Quality Manual Template Set – FDA QMSR & ISO 13485 Compliant (MD-QMS-01)

FDA QMSR Work Environment Management Procedure & Forms

FDA QMSR Corrections, Removals & Recall Policy

FDA QMSR Control of Design and Development Changes Policy, SOP & Forms

CAPA Policy, SOP & Forms – FDA QMSR Compliant Template Set (MD-QMS-03)

FDA QMSR Process Validation Template Set