Identification Procedure | ISO 13485 | FDA QMSR

Use this editable ISO 13485 Identification Procedure to define how materials, components, work in process, finished devices and returned devices are identified and how their acceptance status is shown.

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Supplied as one editable Microsoft Word document in a digital download.

Material identification and acceptance status

It sets out identification methods across receipt, production, distribution and service, connecting product and lot or serial identifiers to the relevant records.

The identification process follows material from receiving through work in process, finished goods and shipment, including acceptance, hold and sterilization status where relevant. Labels or other identifiers keep the product and its lot or serial number connected to the applicable records. The procedure also describes how returned and nonconforming items are distinguished so material with an unresolved status is not used or shipped inadvertently.

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.

Related material controls

Start with the Receiving and Identification of Materials Procedure for incoming deliveries. Use the Lot Inspection Procedure for documented lot acceptance decisions and the Returned Goods Procedure for products arriving back from the field.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Receiving Inspection, First Article Inspection and Lot Acceptance for workflow guidance, a checklist and common mistakes.