1. Why should your QMS be regularly monitored and evaluated?

2. What does “interrelated processes” mean?

3. Name three activities you must do under the “Act” part of your
PDCA cycle?

4. How is “risk-based thinking” integrated into the ISO 9001

standard?

5. How does an organization provide assurance of conformity to

requirements?

6. What factors should be considered in designing and

implementing your QMS?

7. What is meant by an organization’s “strategic direction”?

8. How do you determine if a contextual factor is relevant to your

organization?

9. When does an interested party become relevant to your QMS?

10. Name some factors in determining the applicability of the

requirements of the ISO 9001 standard to your QMS?

11. What should the documented statement of QMS scope

include?

12. What are performance indicators?

13. How does the organization’s context affect its quality policy and
objectives?

14. What is meant by integrating the QMS requirements into the

organization’s business activities?

15. How does top management provide support to personnel to

contribute to QMS effectiveness?

16. Name some measures to gauge the effectiveness of customer

focus?

17. What does it mean for the quality policy to support the
organization’s strategic direction?
18. In this standard, who performs the management
representative’s responsibilities that existed in the previous version
of the ISO 9001
standard?

19. What is risk and how is it related to uncertainty?

20. Explain what “desirable effects” mean?

21. What should quality objectives focus on?

22. How are quality objectives related to risk management?

23. List some activities required for effective planning of change

control?

24. Provide some examples of risks or constraints related to use of

resources in your organization?

25. What factors should be considered in determining infrastructure

resources?

26. What is ergonomics and provide examples of factors to be

considered?

27. How are monitoring and measurement resources used for

reference purposes controlled?

28. What is the difference between calibrating and verifying a

measurement and monitoring resource?

29. Name some risks related to organizational knowledge?

30. What is the difference between education and skills?

31. What are risks related to communication?

32. What factors determine the extent of documented

information?

33. Name some controls required for maintaining documented

information?

34. What are contingency actions and why should your customers
be notified?
35. What are contingency actions and why should your customers
be notified?

36. Why is it important to review customer requirements before

committing to accept their orders?

37. When should you include Design and development (DD) in your
QMS scope?

38. Why should customers and users be involved in the DD process

and how should it take place?

39. Why is information from previous DD useful?

40. Why do design verification and validation need to done more

than once?

41. What type of DD output information should be provided to

other processes or departments?

42. What processes and documents do DD changes impact?

43. What should be considered in defining the controls over

externally provided products and services?

44. What is the difference between general verification and QA

verification of purchased product?

45. What should a review of purchasing information include and

how should it be evidenced?

46. What documented information should be maintained and

retained on process validation?

47. What is product status, why is it needed and how is it different

from product identification?

48. What risks is customer property exposed to?

49. Can services be exposed to preservation risks?

50. Name some controls over post-delivery activities?

51. What should your plan for monitoring and measurement

activities include?
52. What three ways can an n/c arise?

53. What is measurement and how is it different from monitoring?

54. What should the scope of customer feedback information

include?

55. In planning your internal audit program, what input information

should you consider?

56. What is breakthrough improvement?

57. What is the difference between n/c, correction and corrective

action?

58. What factors should be considered in determining whether a

corrective action is needed for a n/c?

59. What is meant by suitability of the QMS?