ISO 13485:2016 List of Mandatory Procedures


Our team of medical device consultants identified ISO 13485:2016 mandatory procedures and additional special procedures.. This procedures MUST be in place of any organization clamming ISO 13485 Implemented.

Below table explain the procedures for proper Implementation of ISO 13485:2016.

 

# Clause Mandatory Procedures Drafted by I 3 CONSULTING SOP / WI / PROTOCOL
1. 4.1.5 Outsourcing process  
2. 4.1.6 Validation of computer software in QMS
3. 4.2.4 Control of documents
4. 4.2.5 Control of records
5. 5.6.1 Management Review
6. 6.2 Training
7. 6.3 a Requirements for Maintenance
8. 6.3 b Infrastructure
9. 6.4.1 a Health, cleanliness and clothing
10. 6.4.1 a Work environment monitoring and control
11. 6.4.2 Control of contamination
12. 7.1 Risk Management in Product Realization
13. 7.2.2 Contract Review
14. 7.3.1 Design and development
7.3.8   Design and Development transfer to manufacturing
7.3.9   Control of design and development changes
15. 7.4.1 Purchasing process  
16. 7.5.1 Control of Production
4.2.3 c   Procedure for Manufacturing
4.2.3 c   Procedure for Packaging
4.2.3 c   Procedure for Storage
4.2.3 c   Procedure for Handling and Distribution
17. 7.5.2 Product Cleanliness  

 

18. 7.5.3 Installation activities and its verification
19. 7.5.4
4.2.3 f
Servicing Activities
20. 7.5.6 Validation of processes for production and service provision
21. 7.5.6 Validation of the application of the computer S/W in production and service provision
22. 7.5.7 Validation of Sterilization process
23. 7.5.8 Product identification
24. 7.5.8 Product return identification from normal production
25. 7.5.9.1 Product Traceability
26. 7.5.11 Product Preservation
7.5.11. b   Special conditions for Product Preservation
27. 7.6 Control of monitoring and measuring equipment  
28. 7.6 Calibration and verification of Monitoring and measuring equipment
29. 7.6 Validation of application software used for the monitoring and measuring.  
30. 8.2.1 Feedback System (including customer complaint)

 

31. 8.2.1 Post-Market Surveillance (PMS)
32. 8.2.1 Post – Market Clinical follow-up (PMCF)
33. 8.2.1 Clinical Evaluation
34. 8.2.2 Handling of Complaints
35. 8.2.3 Vigilance Control
36. 8.2.4 Internal Audit
37. 8.2.6
4.2.3 d
Monitoring and Measurement of Product
38. 8.3.1 Control of Nonconforming Product
39. 8.3.3 Advisory Notice
40. 8.3.4 Rework on Product
41. 8.4 Analysis of Data
42. 8.5.2
8.5.3
Corrective and Preventive Action (CAPA)