Understanding ISO 9001:2015 eCourse
1. Why should your QMS be regularly monitored
2. What does “interrelated processes”
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
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
12. What are performance
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
19. What is risk and how is it related to
20. Explain what “desirable effects”
21. What should quality objectives focus
22. How are quality objectives related to risk
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
30. What is the difference between education and
31. What are risks related to
32. What factors determine the extent of
33. Name some controls required for maintaining
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
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
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
49. Can services be exposed to preservation
50. Name some controls over post-delivery
51. What should your plan for monitoring and
measurement activities include?
52. What three ways can an n/c
53. What is measurement and how is it different
54. What should the scope of customer feedback
55. In planning your internal audit program,
what input information should you consider?
56. What is breakthrough
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
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"Understanding ISO 9001"2015 eCourse"