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Review and Update Your QMS with 50 Mandatory SOPs

as per ISO 13485:2016
The checklist helps an organisation to quickly review and update their mandatory SOPs as per ISO 13485:2016. The
mentioned clauses (procedures) are applicable to all medical device or in vitro diagnostics manufacturer.

Irrespective of industry or product type an organisation must have the basic mandatory SOPs as per ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes. Although many a times some
of the clauses may not be applicable to an organisation, where the organisation is expected to declare the same and
include the clause in ‘exclusions’.

For example: Procedure for Document Control may be applicable to all manufacturers while sterilization may not be
applicable to a SaMD. Similarly, Procedure for servicing may not be applicable to a consumables ‘Single Use Only’ devices.

SL.
NO. REQUIREMENT CHECK BOX APPLICABLE CLAUSE

4.1.6,
1. Procedure for the validation of the application of computer software 7.5.6,
7.6

2. Procedure to assure a risk-based approach is implemented 4.1.2

3. Procedure on how to write a SOP and its contents 4.2.1

4. Procedure for Document Control 4.2.4

5. Procedure for a Medical Device File 4.2.3

6. Procedure for Record control 4.2.5

7. Procedure to identify and meet quality objectives 5.4.1

8. Procedure that defines responsibility and authority of top management within the 5.5.1
organisation

9. Procedure for Internal communication for all processes and the effectiveness of the 5.5.3
quality management system.

10. Procedure for management review 5.6.1

11. Procedure for competence, training and awareness 6.2

12. Procedure for a Recruitment Process 6.2

13. Procedure for Effectiveness Matrix 6.2

14. Procedure to meet requirements of the maintenance activities 6.3

15. Procedure to meet requirements for the work environment 6.4.1

16. Procedure to monitor and control the work environment 6.4.1

17. Procedure to meet requirements for health, cleanliness and clothing of personnel 6.4.1

18. Procedure for arrangements for the control of contaminated or potentially 6.4.2
contaminated product.

19. Procedure to meet requirements for control of sterile medical device contamination 6.4.2

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SL.
NO. REQUIREMENT CHECK BOX APPLICABLE CLAUSE

20. Processes for risk management in product realization 7.1

21. Procedure for post-delivery activities including product recall 7.2.1

22. Procedure to Review Customer Orders 7.2.2

23. Procedure for communicating with customers 7.2.3

24. Procedure for design and development 7.3.1

25. Procedure for change control at Design and development – Review and Approval 7.3.9

26. Procedure for Outsourcing and controls 7.4.1

27. Procedure for purchasing 7.4.1

28. Procedure for Receiving, Inspection and testing 7.4.3

29. Procedure and methods for the control of production 7.5.1

30. Procedure to meet requirements for cleanliness of product 7.5.2

31. Procedure for medical device installation and acceptance criteria for verification of 7.5.3
installation

32. Procedure for servicing activities of medical device 7.5.4

33. Procedures for validation of processes (systems) 7.5.6

34. Procedure for the validation of processes for sterilization 7.5.7

35. Procedure for product identification 7.5.8

36. Procedure for traceability 7.5.9.1

37. Procedure to identify, protect and safe guard Customer property 7.5.10

38. Procedure for preserving the conformity of product 7.5.11

39. Procedure for Validation of processes (Validation Master Plan) 7.5.6

40. Procedure for monitoring and measuring of equipment’s 7.6

41. Procedure for calibration of equipment and process 7.6

42. Procedure for customer feedback gathering 8.2.1

43. Procedure for complaint handling 8.2.2

44. Procedure for Internal Audit 8.2.4

45. Procedure for Control of non-conforming product 8.3.1

46. Procedure for issuing advisory notices 8.3.3

47. Procedure for rework 8.3.4

48. Procedure for analysis of data 8.4

49. Procedure for corrective actions 8.5.2

50. Procedure for preventive actions 8.5.3

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REFERENCE:

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

For further queries or support, please contact: marketing@compliancequest.com

Doc. CQEQMS-004, Ver1.0, eff. April 4th, 2021

About ComplianceQuest
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and inefficiencies while protecting customers, employees, suppliers and brand.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today.

Visit www.compliancequest.com • Email us at marketing@compliancequest.com • Call us at 408-458-8343

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