Internal Audit Procedure | ISO 13485 | FDA QMSR

Plan and perform independent medical device quality-system audits with this editable ISO 13485 Internal Audit Procedure. It covers auditor qualification and independence, audit schedules and criteria, checklists, evidence, findings, reports and corrective-action follow-up.

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

Independent quality-system audit planning and follow-up

The audit cycle measures conformance to the organization's quality system requirements and identifies areas that need corrective action.

The audit program begins with a schedule and defined scope, criteria and auditor assignment. Auditors gather evidence, document findings and issue a formal report to quality management. The procedure then connects audit nonconformities to follow-up and corrective action, with reports retained in an audit file. It supplies a repeatable path from planning an independent assessment to confirming that findings have been addressed.

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.

For investigating and tracking an audit finding through corrective action, see the CAPA Procedure.

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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 Internal Audits vs External Medical Device Facility Inspections for workflow guidance, a checklist and common mistakes.