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.