Internal Audit Procedure | ISO 13485 | FDA QMSR

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The ISO 13485:2016 Internal Audit Procedure defines the process, methods and cycle for conducting internal audits.

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Internal Audit Procedure

The Internal Audit Procedure defines the process, methods of documenting and scheduling for conducting internal audits.

Internal Audit Procedure - Overview

The Internal Audit Procedure ensures audits are performed throughout the audit cycle to measure conformance to:

Product realization practices
Applicable standards and regulations.
Company’s standard operating procedures.

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.