Product Identification & Traceability Template - ISO 9001

Ensure accurate product identification and traceability throughout the medical device manufacturing process with our ISO 13485:2016 Clause 7.5 Product Identification & Traceability Procedure Template. Proper tracking of materials, components, and finished products is essential for maintaining regulatory compliance, product quality, and patient safety. This structured procedure template provides a systematic approach to implementing traceability measures, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Product Identification & Traceability Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Product Labeling & Identification Guidelines – Define how raw materials, in-process products, and finished devices are labeled.

✔ Batch & Serial Number Tracking System – Ensure full traceability from raw materials to finished products.

✔ Supply Chain & Manufacturing Process Integration – Maintain traceability through procurement, production, and distribution.

✔ UDI (Unique Device Identification) & Regulatory Compliance – Align with MDR, IVDR, and FDA UDI requirements.

✔ Non-Conformance & Recall Readiness Measures – Ensure quick response in case of product issues.

✔ Approval & Sign-Off Workflow – Assign responsibilities for traceability implementation and record-keeping.

✔ Editable Digital Format – Fully customizable for various medical device classifications and business needs.

This ready-to-use traceability procedure template is ideal for quality managers, regulatory teams, and production personnel, ensuring a structured, compliant, and effective identification system.

Download the ISO 13485:2016 Product Identification & Traceability Procedure Template today and improve your tracking and compliance processes!