Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

!Attention Points
* During [[management review|CFR 21-820.20c - Management review]] the procedures, instructions, forms and checklists should be discussed. The status of each item, its latest version and date may be attached to the report.
* During [[QSIT|Quality System Inspection Technique]] the following is subject to verification:
** A [[Quality Policiy]], [[Management Review|CFR 21-820.20c - Management review]] and quality audit  procedures, [[Quality Plan]] and quality system procedures and instructions are defined and documented
* A [[Quality Policy]] has been implemented
* The firms [[organizational structure|CFR 21-820.20b - Organization]] provides the management responsibilities, authorities and necessary resroueces
* A management representattive with appropriate purview has been identified
* Management review includes documented reviews of the suitability and effectviveness of the quality system
* [[Quality Audits]] and if appropriate reaudits of identified nonconformances are conducted.
bag
fda_public
created
Sat, 30 Jun 2012 15:09:53 GMT
creator
dirkjan
modified
Sat, 30 Jun 2012 15:09:53 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.20
FDA
Term
creator
dirkjan