External Standards Procedure | ISO 13485 | FDA QMSR

The External Standards Procedure defines how external standards, regulations and guidance are controlled and maintained.

Areas covered

Standards inventories, revision monitoring, departmental notification, applicability review and assessment of changes affecting products or submissions.

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

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.