Identification Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Identification Procedure governs the identification and the acceptance status of finished medical devices, components, materials, in-process devices, and returned devices manufactured by the company.

• MS Word Format

• Digital Content - Instant Download

ISO 13485:2016 Identification Procedure

The Identification Procedure governs the identification and the acceptance status of finished medical devices, components, materials, in-process devices, and returned devices manufactured by the company.

ISO 13485:2016 Identification Procedure Overview

The Identification Procedure ensures all products will be identified during all phases of manufacturing including receipt, production, distribution, and service.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.