Management Review

Overview

Management Review is a formal evaluation of the quality management system conducted by senior leadership.

It ensures that the system remains suitable, effective, and aligned with regulatory expectations and organizational objectives.

Regulatory Framework

Requirements for management review appear in FDA 21 CFR 820.20, FDA 21 CFR 211.180(e), ISO 13485, ISO 9001, and EU GMP guidance.

These frameworks expect documented review meetings and clear evidence of leadership oversight.

Inputs

Typical inputs include audit findings, complaint trends, CAPA status, supplier performance, quality metrics, and regulatory updates.

These inputs allow leadership to evaluate the overall performance of the quality system.

Outputs

Outputs often include improvement initiatives, resource allocation decisions, and risk mitigation actions.

Documented follow‑up ensures that actions are implemented.

Inspection Perspective

Inspectors evaluate whether management reviews are meaningful rather than purely administrative exercises.

They often look for evidence that leadership decisions lead to measurable improvements.

Conclusion

Management review demonstrates leadership commitment to quality and ensures that strategic decisions support regulatory compliance and patient safety.

Terms related to Management Review

Management Review connects to many other quality concepts. Explore related terms to build a complete picture.

• Internal Audit
• CAPA
• Risk Management