ISO 13485 Quality Management System Documentation

This ITVC reference list contains 45 documentation topics. It does not mean every organization must issue exactly 45 separate documents. Determine mandatory requirements, applicability, activities and risks, and create or integrate documents accordingly.

45 reference documentation topics

1. Quality policy
2. Quality objectives
3. Quality manual
4. Document and data control procedure
5. Records control procedure
6. Management review procedure
7. Recruitment procedure
8. Training procedure
9. Equipment maintenance procedure
10. Equipment repair procedure
11. Work environment management procedure
12. Protective equipment and personal hygiene controls
13. Contract review procedure
14. Supplier evaluation procedure
15. Purchasing procedure
16. Incoming inspection procedure
17. Material and assembly component specifications
18. Product specifications
19. First product approval procedure
20. Process technology instructions
21. Manufacturing procedure
22. Assembly procedure
23. Product inspection procedure
24. Product batch identification procedure
25. Product labelling and packaging procedure
26. Product cleanliness and contamination control procedure
27. Product sterilization procedure
28. After-sales service procedure
29. Product traceability procedure
30. Product recall procedure
31. Product risk assessment procedure
32. 4M change management procedure
33. Special process control procedure
34. Raw material and finished goods warehouse receipt and dispatch procedure
35. Customer property management procedure
36. Product regulatory compliance evaluation procedure
37. Inspection and measuring equipment control procedure
38. Customer complaint handling procedure
39. Internal audit procedure
40. Nonconforming product control procedure
41. Corrective action procedure
42. Preventive action procedure
43. Job descriptions for each position
44. Competency requirements for each position
45. Other relevant documents

ISO13485:2016