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Gap Analysis

1. Do you monitor internal and external issues and review regularly?
2. Have you identified and documented the stakeholders in your QMS?
3. Does top management have ownership over the success of the QMS?
4. Do you have an implemented QMS?
5. Do you identify and document risks and opportunities?
6. Do you create and implement plans to address risks and opportunities?
7. Are your operational processes documented?
8. Have your QMS processes been integrated into your overall business processes?
9. Does top management have ownership over the success of the QMS?
10. Does top management clearly assign and empower appropriate roles and responsibilities?
11. Does the identification and management of risks enable the QMS to achieve the intended results?
12. Does the identification and management of risks prevent/reduce undesirable outcomes?
13. Does the identification and management of risks cause continual improvement?
14. Do identified risks and opportunities have associated action plans?
15. Have appropriate quality objectives been established?
16. Is conformity of product/service supported by identifying, providing, and maintaining appropriate infrastructure?
17. Is conformity of product/service supported by ensuring reliable measurement and monitoring results?
18. Are knowledge requirements for conformity of product/service well identified?
19. Is competence of workers for conformity of product/service well identified?
20. When documenting information, are the documents labelled as required by your desired International Standard?
21. Is there a policy to control documents that is adhered to?
22. Is distribution, access, retrieval, and use addressed properly for controlled documents?
23. Are processes controlled properly in order to ensure quality of product/service?
24. Is there an active policy for communicating with clients regarding product/service?
25. Is there an active policy for communicating with clients regarding feedback?
26. If your product/service includes design, is your design process well defined and actively used?
27. Do you ensure your suppliers conform to specified requirements?
28. Do you monitor & evaluate suppliers' ability to meet specified requirements?
29. Are conditions for production/service controlled?
30. Do you identify the suitable process outputs to control conformity of product/service?
31. When unplanned changes are required for conformity of product/service, are they reviewed to ensure conformity?
32. Are changes documented to include information such as reviewer, approver, and actions?
33. Are changes reviewed at intervals to ensure product/service requirements are met?
34. Do you document proof of a change's effectiveness when closing its documentation?
35. Do you ensure a non-conforming product/service is prevented from being delivered to the client?
36. For non-conforming product/service do you complete a formalized corrective process?
37. Do you solicit customer feedback on conformance of product/service?
38. Do you compile and analyse the data obtained from monitoring?
39. Does your analysis ensure your QMS is effective?
40. Does your analysis prove that your planning has been effective?
41. Does your analysis assess the performance of your processes?
42. Does your analysis assess the performance of suppliers?
43. Does your analysis identify needs/opportunities for improvement in your QMS?
44. Is your analysis reviewed by top management?
45. Do you perform regular internal audits to ensure conformance to your own requirements?
46. Do you perform regular internal audits to ensure conformance to your preferred international standard?
47. Do you perform regular internal audits to ensure your QMS is being effectively used and maintained?
48. Does top management have regular reviews of the QMS to ensure suitability, adequacy, and effectiveness?
49. During management review, is the status of previously determined action items reviewed?
50. During management review, are internal/external issues reviewed relevant to the QMS strategic direction?
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
52. During management review, is effectiveness of actions taken to address risks and opportunities addressed?
53. During management review, are opportunities for continual improvement identified?
54. Does the management review result in actions related to continual improvement?
55. Does the management review result in necessary changes to the QMS including resource needs?
56. Are the results of the management reviews documented?
57. Do you enhance customer satisfaction by finding & implementing opportunities for improvement?
58. Do you improve processes to prevent non-conforming products/services?
59. Do you improve products/services to meet known and predicted requirements?
60. Do you improve quality management system results?
61. When a complaint or non-conformity arises do you take action to correct it?
62. When a complaint or non-conformity arises do you deal with the consequences?
63. Do you review a non-conformity to prevent recurrence or occurrence elsewhere?
64. Do you determine the cause of a non-conformity to prevent recurrence or occurrence elsewhere?
65. Do you determine if similar non-conformities exist to prevent recurrence or occurrence elsewhere?
66. Do you implement all needed actions?
67. Do you review all corrective actions for effectiveness?
68. Do you make all necessary changes to your QMS?
69. Do you ensure corrective actions are appropriate for the non-conformity?
70. Do you document the nature of non-conformities and actions taken as a result?
71. Do you document the results of actions taken due to non-conformities?
72. Do you continually improve on your QMS?
73. Do the results of analysis and management review identify areas for improvement and support continual improvement?
74. Do you use tools or methods to investigate issues to support continual improvement?

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