ISO 9001: 2015 Mock Audit Checklist Part 1

1. Understanding the organization and its context: Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.

2. Understanding the organization and its context: Verify how these issues affect the ability to achieve the intended result of the QMS.

3. Understanding the organization and its context: Verify how the organization monitors and reviews information about these internal and external issues.

4. Understanding the needs and expectations of interested parties: Verify how organization determined relevant interested parties to QMS.

5. Understanding the needs and expectations of interested parties: Verify how the organization has determined the relevant needs and expectations of interested parties.

6. Understanding the needs and expectations of interested parties: Verify how the organization has determined the impact or potential impact of the interested parties.

7. Understanding the needs and expectations of interested parties: Verify how the organization monitors and reviews information about interested parties and their relevant requirements

8. Determining the scope of the quality management system: Verify the QMS scope considers the following:

9. Determining the scope of the quality management system: External and internal issues.

10. Determining the scope of the quality management system: The requirements of relevant interested parties.

11. Determining the scope of the quality management system: The products and services of the organization.

12. Determining the scope of the quality management system: Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization.

13. Determining the scope of the quality management system: If the organization has determined any of the requirements of the ISO 9001:2015 standard not to be applicable, show me how conformity of products and services are not affected by this.

14. Determining the scope of the quality management system: Verify QMS scope is documented.

15. Determining the scope of the quality management system: Verify scope states what products and services are covered by the QMS and how it justies instances where requirements cannot be applied.

16. Quality management system and its processes: Show how the processes have been determined and how they interact.

17. Quality management system and its processes: Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.

18. Quality management system and its processes: Verify the sequence and interaction of of the processes.

19. Quality management system and its processes: Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes

20. Quality management system and its processes: Verify how resources are determined and allocated

21. Quality management system and its processes: Verify how responsibilities and authorities are determined.

22. Quality management system and its processes: Verify how risks and opportunities are considered and what actions are taken to address them.

23. Quality management system and its processes: Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.

24. Quality management system and its processes: Verify how opportunities for improvement for the QMS and its processes are determined.

25. Quality management system and its processes: Reviewed documented information created to support the operation of its processes.

26. Leadership and commitment: Top management is identified

27. Leadership and commitment: Verify top management demonstrates leadership and commitment by

28. Leadership and commitment: Taking accountability for QMS effectiveness

29. Leadership and commitment: Ensuring the QMS policy and objectives are established and are compatible with strategic direction and context of organization

30. Leadership and commitment: Ensuring the QMS is integrated into organization's business processes

31. Leadership and commitment: Promoting the use of the process approach and risk-based thinking

32. Leadership and commitment: Ensuring resources are available

33. Leadership and commitment: Communicating the importance of effective QMS and of conforming to its requirements

34. Leadership and commitment: Ensuring intended outcomes

35. Leadership and commitment: Engaging, directing and supporting persons to contribute to the effectiveness of the QMS

36. Leadership and commitment: Promoting continuous improvement

37. Leadership and commitment: Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility

38. Leadership and commitment: Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that

39. Leadership and commitment: customer and applicable statutory and regulatory requirements are determined, understood and consistently met.

40. Leadership and commitment: the risks and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.

41. Leadership and commitment: the focus of enhancing customer satisfaction is maintained.

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