External Standards Procedure | ISO 13485 | FDA QMSR

The External Standards Procedure describes how to list, monitor and maintain external standards and regulations. When a revision is identified, the responsible functions assess its effect on products, specifications, testing and regulatory documentation.

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Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.

External requirement monitoring and change assessment

The procedure starts with a controlled inventory of external standards. Document Control obtains standards, checks for revisions and notifies affected departments when a version changes. Engineering, quality and regulatory personnel then assess whether the update affects a product, test, specification or submission, and arrange revisions where needed. This links a changed external requirement to a documented internal review instead of treating a new publication as an automatic document update.

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.

After assessing a revised external requirement, manage affected internal document changes with the Engineering Change Notice Procedure and issue approved revisions under the Document Control Procedure. All three are included in the Document Control Procedure Bundle.

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 Medical Device Document Control: From Approval to Record Retention for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in ISO 13485 Document Control Procedure Bundle. Explore the bundle for the related documents.