[[Management with executive responsibility]] shall [[Establish]] its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

* [[Quality Policy]]
** Must be established by management with executive responsibility.
** Must be understood, implemented, and maintained at all levels of the organization.
* Must establish and maintain an adequate organizational structure, including Appropriate responsibility, authority, and interrelation of personnel
** Adequate resources
** Appointed management representative
* Management Review
** Management with executive responsibility shall review the suitability and effectiveness of the quality system
** At defined intervals
** With sufficient frequency
** According to established procedures
bag
fda_public
created
Sun, 24 Jun 2012 16:52:29 GMT
creator
dirkjan
modified
Sun, 24 Jun 2012 16:52:29 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.20
Term
creator
dirkjan