Management Review SOP – ISO 13485, MDSAP & FDA QMSR

Management review is one of the most frequently cited findings in ISO 13485 audits and FDA inspections — yet it’s often mishandled due to poor documentation or inadequate procedure design.

This Management Review SOP package gives your quality team an audit-ready framework to plan, conduct, document, and follow up on management reviews — fully aligned with ISO 13485:2016 (Clause 5.6), MDSAP, and FDA QMSR (21 CFR Part 820).

What’s included:

• P-01 Management Review Procedure — step-by-step instructions covering review frequency, required inputs (complaint data, audit results, CAPA status, PMS data, regulatory changes), outputs, responsibilities, and record requirements
• F01-1 Management Review Report Template — pre-formatted, editable Word template with all mandatory sections, ready to complete and sign

Designed for: Quality managers, regulatory affairs professionals, and management representatives at medical device companies seeking ISO 13485 certification, preparing for MDSAP audits, or transitioning to FDA QMSR compliance.

Why buy instead of writing it yourself? Writing a compliant management review procedure from scratch takes 4–8 hours of a regulatory professional’s time. This package is immediately usable, written by an experienced ISO 13485 Lead Auditor and former Notified Body auditor — reflecting current notified body expectations, not just the text of the standard.

✓ Instant download after purchase ✓ Fully editable Word format ✓ Compatible with ISO 13485:2016, MDSAP, FDA QMSR ✓ Updated April 2026 ✓ Used by quality teams across EU, US and Canada

FAQ

Q: Is this SOP ready to use or does it need customization? A: It is ready to use out of the box. Minor customization (company name, logo, document numbering) is recommended to match your QMS structure.

Q: Does this cover FDA QMSR (21 CFR Part 820) requirements? A: Yes. The procedure is aligned with the 2024 FDA QMSR, which harmonizes with ISO 13485:2016.

Q: Is this suitable for small medical device companies? A: Yes. The procedure is scalable and suitable for companies of any size, including startups seeking initial ISO 13485 certification.

Q: In what format is the document delivered? A: All documents are delivered in fully editable Microsoft Word (.docx) format.