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3. Name three activities you must do under the “Act” part of your PDCA cycle?
10. Name some factors in determining the applicability of the requirements of the ISO 9001 standard to
your QMS?
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?
24. Provide some examples of risks or constraints related to use of resources in your organization?
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?
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?
40. Why do design verification and validation need to done more than once?
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?
47. What is product status, why is it needed and how is it different from product identification?
51. What should your plan for monitoring and measurement activities include?
55. In planning your internal audit program, what input information should you consider?
58. What factors should be considered in determining whether a corrective action is needed for a n/c?