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Gap Analysis
1.
Do you monitor internal and external issues and review regularly?
Yes
No
2.
Have you identified and documented the stakeholders in your QMS?
Yes
No
3.
Does top management have ownership over the success of the QMS?
Yes
No
4.
Do you have an implemented QMS?
Yes
No
5.
Do you identify and document risks and opportunities?
Yes
No
6.
Do you create and implement plans to address risks and opportunities?
Yes
No
7.
Are your operational processes documented?
Yes
No
8.
Have your QMS processes been integrated into your overall business processes?
Yes
No
9.
Does top management have ownership over the success of the QMS?
Yes
No
10.
Does top management clearly assign and empower appropriate roles and responsibilities?
Yes
No
11.
Does the identification and management of risks enable the QMS to achieve the intended results?
Yes
No
12.
Does the identification and management of risks prevent/reduce undesirable outcomes?
Yes
No
13.
Does the identification and management of risks cause continual improvement?
Yes
No
14.
Do identified risks and opportunities have associated action plans?
Yes
No
15.
Have appropriate quality objectives been established?
Yes
No
16.
Is conformity of product/service supported by identifying, providing, and maintaining appropriate infrastructure?
Yes
No
17.
Is conformity of product/service supported by ensuring reliable measurement and monitoring results?
Yes
No
18.
Are knowledge requirements for conformity of product/service well identified?
Yes
No
19.
Is competence of workers for conformity of product/service well identified?
Yes
No
20.
When documenting information, are the documents labelled as required by your desired International Standard?
Yes
No
21.
Is there a policy to control documents that is adhered to?
Yes
No
22.
Is distribution, access, retrieval, and use addressed properly for controlled documents?
Yes
No
23.
Are processes controlled properly in order to ensure quality of product/service?
Yes
No
24.
Is there an active policy for communicating with clients regarding product/service?
Yes
No
25.
Is there an active policy for communicating with clients regarding feedback?
Yes
No
26.
If your product/service includes design, is your design process well defined and actively used?
Yes
No
27.
Do you ensure your suppliers conform to specified requirements?
Yes
No
28.
Do you monitor & evaluate suppliers' ability to meet specified requirements?
Yes
No
29.
Are conditions for production/service controlled?
Yes
No
30.
Do you identify the suitable process outputs to control conformity of product/service?
Yes
No
31.
When unplanned changes are required for conformity of product/service, are they reviewed to ensure conformity?
Yes
No
32.
Are changes documented to include information such as reviewer, approver, and actions?
Yes
No
33.
Are changes reviewed at intervals to ensure product/service requirements are met?
Yes
No
34.
Do you document proof of a change's effectiveness when closing its documentation?
Yes
No
35.
Do you ensure a non-conforming product/service is prevented from being delivered to the client?
Yes
No
36.
For non-conforming product/service do you complete a formalized corrective process?
Yes
No
37.
Do you solicit customer feedback on conformance of product/service?
Yes
No
38.
Do you compile and analyse the data obtained from monitoring?
Yes
No
39.
Does your analysis ensure your QMS is effective?
Yes
No
40.
Does your analysis prove that your planning has been effective?
Yes
No
41.
Does your analysis assess the performance of your processes?
Yes
No
42.
Does your analysis assess the performance of suppliers?
Yes
No
43.
Does your analysis identify needs/opportunities for improvement in your QMS?
Yes
No
44.
Is your analysis reviewed by top management?
Yes
No
45.
Do you perform regular internal audits to ensure conformance to your own requirements?
Yes
No
46.
Do you perform regular internal audits to ensure conformance to your preferred international standard?
Yes
No
47.
Do you perform regular internal audits to ensure your QMS is being effectively used and maintained?
Yes
No
48.
Does top management have regular reviews of the QMS to ensure suitability, adequacy, and effectiveness?
Yes
No
49.
During management review, is the status of previously determined action items reviewed?
Yes
No
50.
During management review, are internal/external issues reviewed relevant to the QMS strategic direction?
Yes
No
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
Yes
No
52.
During management review, is effectiveness of actions taken to address risks and opportunities addressed?
Yes
No
53.
During management review, are opportunities for continual improvement identified?
Yes
No
54.
Does the management review result in actions related to continual improvement?
Yes
No
55.
Does the management review result in necessary changes to the QMS including resource needs?
Yes
No
56.
Are the results of the management reviews documented?
Yes
No
57.
Do you enhance customer satisfaction by finding & implementing opportunities for improvement?
Yes
No
58.
Do you improve processes to prevent non-conforming products/services?
Yes
No
59.
Do you improve products/services to meet known and predicted requirements?
Yes
No
60.
Do you improve quality management system results?
Yes
No
61.
When a complaint or non-conformity arises do you take action to correct it?
Yes
No
62.
When a complaint or non-conformity arises do you deal with the consequences?
Yes
No
63.
Do you review a non-conformity to prevent recurrence or occurrence elsewhere?
Yes
No
64.
Do you determine the cause of a non-conformity to prevent recurrence or occurrence elsewhere?
Yes
No
65.
Do you determine if similar non-conformities exist to prevent recurrence or occurrence elsewhere?
Yes
No
66.
Do you implement all needed actions?
Yes
No
67.
Do you review all corrective actions for effectiveness?
Yes
No
68.
Do you make all necessary changes to your QMS?
Yes
No
69.
Do you ensure corrective actions are appropriate for the non-conformity?
Yes
No
70.
Do you document the nature of non-conformities and actions taken as a result?
Yes
No
71.
Do you document the results of actions taken due to non-conformities?
Yes
No
72.
Do you continually improve on your QMS?
Yes
No
73.
Do the results of analysis and management review identify areas for improvement and support continual improvement?
Yes
No
74.
Do you use tools or methods to investigate issues to support continual improvement?
Yes
No
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