Dirkjan: Created page with "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..."

2020-08-25T07:18:24Z

Created page with "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..."

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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 [[CFR 21-820.20c - Management review|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 [[Quality System Inspection Technique|QSIT]] the following is subject to verification:
** A [[Quality Policiy|Quality Policiy]], [[CFR 21-820.20c - Management review|Management Review]] and quality audit procedures, [[Quality Plan|Quality Plan]] and quality system procedures and instructions are defined and documented
* A [[Quality Policy|Quality Policy]] has been implemented
* The firms [[CFR 21-820.20b - Organization|organizational structure]] 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|Quality Audits]] and if appropriate reaudits of identified nonconformances are conducted.
[[Category:fda]]

[[Category:CFR]]

[[Category:CFR 21-820.20]]

[[Category:FDA]]

[[Category:Term]]

CFR 21-820.20e - Quality System Procedures - Revision history

Dirkjan: Created page with "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..."