[[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]]
bag
fda_public
created
Sat, 30 Jun 2012 14:33:28 GMT
creator
dirkjan
modified
Sat, 30 Jun 2012 14:33:28 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.20
FDA
Term
creator
dirkjan