Management Review Procedure Template ISO 13485

Streamline your management review process and ensure Quality Management System (QMS) compliance with our ISO 13485:2016 Clause 5.6 Management Review Procedure Template. Regular management reviews are essential for evaluating QMS effectiveness, addressing risks, and ensuring continuous improvement in medical device manufacturing. This structured procedure template provides a systematic approach for planning, conducting, and documenting management reviews, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Management Review Procedure – Covers key ISO 13485:2016 Clause 5.6 requirements.

✔ Review Meeting Planning & Frequency Guidelines – Establish structured review schedules and responsibilities.

✔ QMS Performance & Compliance Evaluation – Assess audit results, CAPA status, and regulatory updates.

✔ Risk Management & Continuous Improvement Planning – Align with ISO 14971 risk assessment requirements.

✔ Customer Feedback & Complaint Handling Review – Ensure a proactive approach to product quality and safety.

✔ Action Item Tracking & Follow-Up Monitoring – Assign responsibilities for implementing improvements.

✔ Audit-Ready Documentation & Record Keeping – Maintain structured records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various business models and QMS requirements.

This ready-to-use management review procedure template is ideal for quality managers, regulatory teams, and senior leadership, ensuring a structured, compliant, and effective review process.

Download the ISO 13485:2016 Management Review Procedure Template today and enhance your QMS oversight and regulatory compliance!