CFR 21-820.20c - Management review

Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

Attention points

• Problems and issues identified should be written down in the Management Review Report.
• The review should identify any changes to the quality policy procedure
• Each review should be numbered with a logical numbering system
• The report might have sections:
  • Quality System
  • Quality Procedure
  • Quality Plan
  • Qualtity System Procedures
• Only include those issues that significantly impact the Quality System