Quality System Procedures
According to the guidance, the authority expects the applicant to submit a copy of the quality system procedure(s) developed and implemented by the entity. The said procedure(s) should cover such aspects as:
- Quality audit or internal audit procedure(s);
- Management review procedure(s);
- Outline the structure of the quality system documentation.
The requirement to have the aforementioned written procedure is also set forth by regulation 820.20(e). The latter prescribes the structure such policy should have, namely:
- Title and scope of application;
- Table of contents;
- Definitions (if needed);
- Outline the structure of the quality manual or quality system documentation;
- Quality policy and objectives;
- Organizational structure and responsibilities or authority;
- References to basic quality system procedures;
- Guide or appendix for supportive data (if needed).