List of Mandatory Documented Information

No. Clause Clause No.

1. Scope of the QMS 4.3
2. QMS and its processes 4.4.2
3. Quality policy 5.2.2
4. Quality objectives 6.2.1
5. Monitoring and measuring resources (Records) 7.1.5.1
6. Competence (Record) 7.2
7. Operational planning and control, (Document & record) 8.1 (e)
8. Review of the requirements for products and services (Records) 8.2.3.2
9. Design and development planning (Record) 8.3.2
10. Design and development inputs (Record) 8.3.3
11. Design and development controls (Record) 8.3.4 f
12. Design and development outputs (Record) 8.3.5
13. Design and development changes (Record) 8.3.6
14. Control of externally provided processes, products and services (Record) 8.4.1
15. Control of production and service provision (Document/Record) 8.5.1
16. Identification and Traceability (Record) 8.5.2
17. Property belonging to customers or external providers (Record) 8.5.3
18. Control of changes (Record) 8.5.6
19. Release of products and services (Record) 8.6
20. Control of nonconforming outputs (Record) 8.7.2
21. Monitoring, measurement analysis and evaluation (Record) 9.1.1
22. Internal audit program (Document/Record) 9.2.2
23. Results of internal audits (Record) 9.2.2
24. Results of the management review (Record) 9.3.3
25. Results of corrective actions (Record) 10.2.2