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?  

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General Requirements
 Where are the processes needed for the quality management system identified?
 Have the sequence and interaction of the processes been determined?
 What criteria and methods will be used for operation and control of the processes?
Management
 Where are the processes needed for the quality management system identified?
 Have the sequence and interaction of the processes been determined?
 What criteria and methods will be used for operation and control of the processes?
 How does management ensure that customer needs and expectations are determined,
converted into requirements and fulfilled?
 Does this include customer obligations related to the product-including regulatory?
 Does the quality policy include a commitment to continual improvement?
 Does it provide a framework for establishing and reviewing objectives?
 Do the quality objectives include a commitment to continual improvement?
 Do quality objectives include those needed to meet requirements for product?
 How does the management rep promote customer awareness?
 Does the quality manual include a description of the sequence and interaction of the
processes included in the quality management system?
 Does Management Review consider changes that could affect the quality system?
  Are there records of the output of management review? Do they include:
actions to improve the quality system and its processes
improvement of product related to customer requirements
Resources
 Can the organization demonstrate that resources are provided to address customer
satisfaction?
 Are they provided in a timely manner?
Human Resources
 Has the organization evaluated the effectiveness of training provided?
 Has the organization ensured that its employees are aware of the relevance and
importance of their activities and how they contribute to achievement of the quality
objectives?
Planning
 Has the organization planned for realization of product?
 Does it include product quality objectives?
 Does it include the need to establish processes and documentation, provide resources and
facilities specific to the product?
 Does the plan for measurement and monitoring to ensure conformity and achieve
improvement identify the need for and use of statistics?
Customer Requirements
Does the identification of customer requirements include product requirements not specified by the
customer, but necessary for the intended or specified use
obligations related to product, including regulatory and legal requirements
Review of product requirements
Does the organization confirm customer requirements when the customer does not provide a
documented statement of requirement?
Customer Communication
Has the organization identified and implemented arrangements for communication with customers
relating to:
 product information inquiries
 contracts or order handling including amendments
 customer feedback including complaints
Purchasing Control
How has the organization determined the extent of control of purchasing processes?
Is it dependent on the effect on subsequent realization processes and their output?
Customer Property
Has the organization applied the care of customer supplied property to intellectual property?
Preservation of Product
Has the organization validated any process where resulting output cannot be verified?
Does verification include:
 qualification of process
 qualification of equipment and personnel use of defined methodologies and procedures
requirements
 for records revalidation
Customer Satisfaction
 Is the organization monitoring information on customer satisfaction and dissatisfaction?
 Where are the methodologies for obtaining and using this information defined?
 Has the organization analyzed appropriate data to determine:
 suitability and effectiveness of the quality management system
 actions to improve the quality system and its processes
 improvement of product related to customer requirements