Isolocity Gap Analysis

Gap Analysis

1.

Do you monitor internal and external issues and review regularly?

1 out of 74
2.

Have you identified and documented the stakeholders in your QMS?

2 out of 74
3.

Does top management have ownership over the success of the QMS?

3 out of 74
4.

Do you have an implemented QMS?

4 out of 74
5.

Do you identify and document risks and opportunities?

5 out of 74
6.

Do you create and implement plans to address risks and opportunities?

6 out of 74
7.

Are your operational processes documented?

7 out of 74
8.

Have your QMS processes been integrated into your overall business processes?

8 out of 74
9.

Does top management have ownership over the success of the QMS?

9 out of 74
10.

Does top management clearly assign and empower appropriate roles and responsibilities?

10 out of 74
11.

Does the identification and management of risks enable the QMS to achieve the intended results?

11 out of 74
12.

Does the identification and management of risks prevent/reduce undesirable outcomes?

12 out of 74
13.

Does the identification and management of risks cause continual improvement?

13 out of 74
14.

Do identified risks and opportunities have associated action plans?

14 out of 74
15.

Have appropriate quality objectives been established?

15 out of 74
16.

Is conformity of product/service supported by identifying, providing, and maintaining appropriate infrastructure?

16 out of 74
17.

Is conformity of product/service supported by ensuring reliable measurement and monitoring results?

17 out of 74
18.

Are knowledge requirements for conformity of product/service well identified?

18 out of 74
19.

Is competence of workers for conformity of product/service well identified?

19 out of 74
20.

When documenting information, are the documents labelled as required by your desired International Standard?

20 out of 74
21.

Is there a policy to control documents that is adhered to?

21 out of 74
22.

Is distribution, access, retrieval, and use addressed properly for controlled documents?

22 out of 74
23.

Are processes controlled properly in order to ensure quality of product/service?

23 out of 74
24.

Is there an active policy for communicating with clients regarding product/service?

24 out of 74
25.

Is there an active policy for communicating with clients regarding feedback?

25 out of 74
26.

If your product/service includes design, is your design process well defined and actively used?

26 out of 74
27.

Do you ensure your suppliers conform to specified requirements?

27 out of 74
28.

Do you monitor & evaluate suppliers' ability to meet specified requirements?

28 out of 74
29.

Are conditions for production/service controlled?

29 out of 74
30.

Do you identify the suitable process outputs to control conformity of product/service?

30 out of 74
31.

When unplanned changes are required for conformity of product/service, are they reviewed to ensure conformity?

31 out of 74
32.

Are changes documented to include information such as reviewer, approver, and actions?

32 out of 74
33.

Are changes reviewed at intervals to ensure product/service requirements are met?

33 out of 74
34.

Do you document proof of a change's effectiveness when closing its documentation?

34 out of 74
35.

Do you ensure a non-conforming product/service is prevented from being delivered to the client?

35 out of 74
36.

For non-conforming product/service do you complete a formalized corrective process?

36 out of 74
37.

Do you solicit customer feedback on conformance of product/service?

37 out of 74
38.

Do you compile and analyse the data obtained from monitoring?

38 out of 74
39.

Does your analysis ensure your QMS is effective?

39 out of 74
40.

Does your analysis prove that your planning has been effective?

40 out of 74
41.

Does your analysis assess the performance of your processes?

41 out of 74
42.

Does your analysis assess the performance of suppliers?

42 out of 74
43.

Does your analysis identify needs/opportunities for improvement in your QMS?

43 out of 74
44.

Is your analysis reviewed by top management?

44 out of 74
45.

Do you perform regular internal audits to ensure conformance to your own requirements?

45 out of 74
46.

Do you perform regular internal audits to ensure conformance to your preferred international standard?

46 out of 74
47.

Do you perform regular internal audits to ensure your QMS is being effectively used and maintained?

47 out of 74
48.

Does top management have regular reviews of the QMS to ensure suitability, adequacy, and effectiveness?

48 out of 74
49.

During management review, is the status of previously determined action items reviewed?

49 out of 74
50.

During management review, are internal/external issues reviewed relevant to the QMS strategic direction?

50 out of 74
51.

Are the following items covered in management review? non-conformities, corrective actions, monitoring results, audit results, customer satisfaction, supplier issues, other stakeholder issues, resources required for QMS compliance, process performance, conformity of product/service

51 out of 74
52.

During management review, is effectiveness of actions taken to address risks and opportunities addressed?

52 out of 74
53.

During management review, are opportunities for continual improvement identified?

53 out of 74
54.

Does the management review result in actions related to continual improvement?

54 out of 74
55.

Does the management review result in necessary changes to the QMS including resource needs?

55 out of 74
56.

Are the results of the management reviews documented?

56 out of 74
57.

Do you enhance customer satisfaction by finding & implementing opportunities for improvement?

57 out of 74
58.

Do you improve processes to prevent non-conforming products/services?

58 out of 74
59.

Do you improve products/services to meet known and predicted requirements?

59 out of 74
60.

Do you improve quality management system results?

60 out of 74
61.

When a complaint or non-conformity arises do you take action to correct it?

61 out of 74
62.

When a complaint or non-conformity arises do you deal with the consequences?

62 out of 74
63.

Do you review a non-conformity to prevent recurrence or occurrence elsewhere?

63 out of 74
64.

Do you determine the cause of a non-conformity to prevent recurrence or occurrence elsewhere?

64 out of 74
65.

Do you determine if similar non-conformities exist to prevent recurrence or occurrence elsewhere?

65 out of 74
66.

Do you implement all needed actions?

66 out of 74
67.

Do you review all corrective actions for effectiveness?

67 out of 74
68.

Do you make all necessary changes to your QMS?

68 out of 74
69.

Do you ensure corrective actions are appropriate for the non-conformity?

69 out of 74
70.

Do you document the nature of non-conformities and actions taken as a result?

70 out of 74
71.

Do you document the results of actions taken due to non-conformities?

71 out of 74
72.

Do you continually improve on your QMS?

72 out of 74
73.

Do the results of analysis and management review identify areas for improvement and support continual improvement?

73 out of 74
74.

Do you use tools or methods to investigate issues to support continual improvement?

74 out of 74

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