CFR 21-820.20e - Quality System Procedures

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 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 the following is subject to verification:
  • A Quality Policiy, 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 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.