Management Review Meeting Minutes Template - ISO 13485

Streamline your management review process with our ISO 13485:2016 Clause 5.6 Management Review Meeting Minutes Template. Regular management reviews are essential for ensuring the effectiveness of the Quality Management System (QMS), compliance with regulatory requirements, and continuous improvement in medical device manufacturing. This structured template helps organizations document key discussions, decisions, and action items, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

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

✔ Agenda & Discussion Points – Document reviews of quality objectives, regulatory updates, and risk management.

✔ QMS Performance Evaluation – Track audit results, CAPA status, and supplier performance.

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

✔ Action Items & Responsibilities Tracker – Assign tasks with deadlines to drive continuous improvement.

✔ Approval & Sign-Off Section – Ensure accountability and documentation for audit readiness.

✔ Editable Digital Format – Fully customizable for different organizational structures and review cycles.

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

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