Management Review Procedure | ISO 13485 | FDA QMSR
Use this editable ISO 13485 Management Review Procedure and forms to plan, conduct and document reviews of a medical device quality management system at defined intervals.
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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.
QMS review inputs, decisions and follow-up
The procedure assigns management responsibilities, sets a review schedule, identifies review inputs and outputs, and documents decisions and follow-up actions. Its forms support a consistent record of the elements reviewed, resulting decisions and assigned actions.
Scheduled review of quality-system suitability, adequacy and effectiveness
Review inputs, outputs, decisions and action items
Management responsibilities and review records
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.
Related quality-system inputs
Review the Internal Audit Procedure for audit results, the CAPA Procedure for action follow-up, and the Complaint Trending Procedure for complaint patterns. These are separately sold documents for related workflows.
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 QMS Responsibilities and Management Review for workflow guidance, a checklist and common mistakes.
