SOP Management Review
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Use this SOP Management Review template to systematically document and conduct your organization's annual quality management system (QMS) review, ensuring compliance with ISO 13485:2016 and relevant regulatory requirements. This template guides you through collecting key performance indicators, analyzing QMS effectiveness, and documenting management review outcomes—essential before audits or when significant changes affect your QMS. Completing this document helps you identify opportunities for improvement, fulfill regulatory obligations, and demonstrate ongoing QMS suitability and effectiveness.