ISO 9001 2008 PROCESS-BASED QMS DEVELOPMENT PLAN

12. MANAGEMENT REVIEW process development plan

ISO

ASSIGNED TO

start

finish

C

Implement your management review process

1

Develop documents that you can use to implement
your organization’s management review process.

4.2.1

2

Provide the resources that your management review process needs.

4.1

3

Provide resources needed to support your review process.

4.1

4

Provide the resources needed to implement review process.

6.1

5

Provide the resources needed to maintain review process.

6.1

6

Provide the resources needed to improve review process.

6.1

7

Provide resources needed to continually
improve your management review process.

6.1

8

Provide resources needed to monitor your review process.

4.1

9

Provide the information that your management review process needs.

4.1

10

Provide the infrastructure that your management review process
needs in order to ensure that products meet requirements.

6.3

11

Provide the physical spaces that your review process needs.

6.3

12

Provide the workspaces that your review process needs.

6.3

13

Provide the equipment that your review process needs.

6.3

14

Provide the hardware that your review process needs.

6.3

15

Provide the software that your review process needs.

6.3

16

Provide the utilities that your review process needs.

6.3

17

Provide the support services that your review process needs.

6.3

18

Provide the transportation services that are needed.

6.3

19

Provide the communications services that are needed.

6.3

20

Provide the information services that are needed.

6.3

21

Provide the work environment that your management review
process needs in order to meet quality requirements.

6.4

22

Provide the physical working conditions that must exist
in order to ensure that product requirements are met.

6.4

23

Provide the environmental working conditions that must
exist in order to ensure that product requirements are met.

6.4

24

Provide training, or take other suitable steps, to ensure that
management reviews meet competence requirements.

6.2.2

25

Make sure that your management reviewers understand
your quality policy and know exactly how to apply it.

5.3

26

Explain how management reviews can help your
organization to achieve its quality objectives.

6.2.2

27

Make your management reviewers aware of how their
activities can affect your organization’s ability to meet
product requirements and how important their efforts are.

6.2.2

28

Carry out management review under controlled conditions.

7.5.1

29

Carry out management reviews of your QMS at planned intervals.

5.6.1

30

Review the ongoing suitability of your organization’s QMS.

5.6.1

31

Review the ongoing adequacy of your organization’s QMS.

5.6.1

32

Review the ongoing effectiveness of your organization’s QMS.

5.6.1

33

Evaluate improvement opportunities.

5.6.1

34

Assess the need to make changes.

5.6.1

35

Assess the need to change your QMS.

5.6.1

36

Assess the need to change your quality policy.

5.6.1

37

Ensure that your quality policy is periodically
reviewed to make sure that it is still suitable.

5.3

38

Assess the need to change your quality objectives.

5.6.1

39

Maintain a record of your management reviews.

5.6.1

40

Examine information about your QMS (inputs).

5.6.2

41

Examine previous management reviews.

5.6.2

42

Examine the results of previous audits.

5.6.2

43

Examine feedback from customers.

5.6.2

44

Examine product conformity data.

5.6.2

45

Examine process performance information.

5.6.2

46

Examine internal process performance.

5.6.2

47

Examine outsourced process performance.

5.6.2

48

Examine the status of previous remedial actions.

5.6.2

49

Examine the status of previous corrective actions.

5.6.2

50

Examine the status of previous preventive actions.

5.6.2

51

Examine opportunities to improve.

5.6.2

52

Examine previous follow up actions.

5.6.2

53

Generate management review decisions and
actions (outputs) to improve your organization.

5.6.3

54

Generate decisions and actions to improve your QMS.

5.6.3

55

Generate management review decisions and
actions to improve the suitability of your QMS.

5.6.3

56

Generate management review decisions and
actions to improve the adequacy of your QMS.

5.6.3

57

Generate management review decisions and
actions to improve the effectiveness of your QMS.

5.6.3

58

Generate decisions and actions to improve
the effectiveness of your QMS processes.

5.6.3

59

Generate decisions and actions to improve
the effectiveness of internal processes.

5.6.3

60

Generate decisions and actions to improve
the effectiveness of outsourced processes.

5.6.3

61

Generate decisions and actions to improve your products.

5.6.3

62

Generate management review decisions and actions to
 improve product’s ability to meet customer requirements.

5.6.3

63

Generate management review decisions and actions
(outputs) to change your general quality orientation.

5.6.3

64

Generate management review decisions
and actions to change your quality policy.

5.6.3

68

Generate management review decisions
and actions to change your quality objectives.

5.6.3

66

Generate management review decisions
and actions to address resource needs.

5.6.3

67

Make sure that your management review people
are trying to achieve their own quality objectives.

5.4.1

68

Implement a corrective action procedure.

8.5.2

69

Use your procedure to review actual nonconformities.

8.5.2

70

Use procedure to review customer complaints.

8.5.2

71

Use your procedure to identify and study causes.

8.5.2

72

Use your procedure to identify and study effects.

8.5.2

73

Use your procedure to develop corrective actions.

8.5.2

74

Use your procedure to evaluate the need for action.

8.5.2

75

Use your procedure to take corrective action.

8.5.2

76

Use your procedure to record corrective action.

8.5.2

77

Use procedure to record corrective action results.

8.5.2

78

Use your procedure to review the effectiveness
of previous corrective actions.

8.5.2

79

Implement your preventive action procedure.

8.5.3

80

Use your procedure to identify and
define potential nonconformities.

8.5.3

81

Use your procedure to determine the
causes of potential nonconformities.

8.5.3

82

Use your procedure to trace the
effects of potential nonconformities.

8.5.3

83

Use your procedure to evaluate the
need for preventive action.

8.5.3

84

Use your procedure to develop actions to prevent
the occurrence of potential nonconformities.

8.5.3

85

Use your procedure to take preventive action.

8.5.3

86

Use your procedure to record preventive action.

8.5.3

87

Use procedure to record preventive action results.

8.5.3

88

Use your procedure to review the effectiveness
of previous preventive actions.

8.5.3

89

Plan how your QMS will be continually improved.

8.1

90

Continually improve your QMS.

8.1

91

Improve the effectiveness of your QMS.

8.5.1

92

Use data analysis to make improvements.

8.5.1

93

Use quality policy to make improvements.

8.5.1

94

Use quality objectives to make improvements.

8.5.1

95

Use audit results to make improvements.

8.5.1

96

Use management reviews to make improvements.

8.5.1

97

Use corrective actions to make improvements.

8.5.1

98

Take corrective actions whenever your
QMS fails to achieve planned results.

8.2.3

99

Make sure that your corrective actions ensure
that QMS requirements are being met.

8.2.3

100

Use preventive actions to make improvements.

8.5.1