Management Review

Top management's planned review of the quality management system at set intervals, to confirm that the system remains suitable, adequate, and effective.

Where it is written: ISO 13485:2016 clause 5.6, Management review
Old rule: 21 CFR 820.20(c), in Part 820 before February 2, 2026

Avoid This Mistake

Since February 2, 2026, a management review failure falls under 21 CFR 820.10(a), not 820.20(c).

Related terms

Quality Management System QMSR

All Terms