Management Review Meeting Agenda Template - ISO 13485

Facilitate structured and audit-ready management review meetings with our ISO 13485:2016 Clause 5.6 Management Review Meeting Agenda Template. Regular management reviews are a critical requirement for ensuring the effectiveness of the Quality Management System (QMS), regulatory compliance, and continuous improvement in medical device manufacturing. This pre-formatted agenda template provides a clear structure to guide discussions, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Meeting Agenda Template – Covers key ISO 13485:2016 Clause 5.6 requirements.

✔ QMS Performance & Compliance Review – Evaluate audit findings, CAPA status, and supplier performance.

✔ Regulatory & Risk Management Updates – Ensure alignment with ISO 14971 and post-market surveillance requirements.

✔ Quality Objectives & Process Effectiveness – Assess progress toward KPIs and continuous improvement goals.

✔ Customer Feedback & Complaint Review – Discuss customer satisfaction and product non-conformities.

✔ Action Items & Responsibilities Section – Assign tasks with deadlines to ensure accountability.

✔ Editable Digital Format – Fully customizable for various business sizes and meeting frequencies.

This ready-to-use agenda template is ideal for quality managers, regulatory teams, and executive leadership, ensuring efficient, structured, and compliant management review meetings.

Download the ISO 13485:2016 Management Review Meeting Agenda Template today and improve QMS oversight and regulatory compliance!