Management Review Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Management Review Procedure governs the management review process, management responsibilities, review inputs and outputs, review schedule and includes standardized forms to support all management review activity.

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Management Review Procedure

The Management Review Procedure governs the management review process, management responsibilities, review inputs and outputs, review schedule and includes standardized forms to support all management review activity.

Management Review Procedure - Overview

The Management Review Procedure covers the review of the suitability, adequacy and effectiveness of the quality system at defined intervals to ensure the quality system satisfies the requirements of 21 CFR Part 820, ISO 13485:2016 and MDR 2017/745. The Management Review Procedure includes multiple forms that address each element to be reviewed.

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.