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Gap Analysis ISO 9001 Checklist
Section 1: Title Information
1. Client / Site
2. Conducted on (Date and Time)
3. Inspected by
4. Location
Section 2: Audit Overview
1. Have all external and internal issues relevant to the organization's purpose and customer satisfaction been identified?
Yes
No
N/A
2. If yes, are these issues reviewed regularly?
Yes
No
N/A
3. Have the needs and expectations of interested parties relevant to the QMS been identified?
Yes
No
N/A
4. Was the scope of the QMS determined considering all relevant issues and needs?
Yes
No
N/A
5. Is your QMS established and does it describe the required processes and their interactions?
Yes
No
N/A
6. Have criteria for managing these processes and their interactions been established?
Yes
No
N/A
7. Have all responsibilities, methods, measurements, and performance indicators needed for effective operation been established?
Yes
No
N/A
Section 3: Leadership Responsibilities
1. Has top management taken accountability for the effectiveness of the QMS?
Yes
No
N/A
2. Have the policy and objectives for the QMS been established and communicated?
Yes
No
N/A
3. Have objectives been set at relevant departmental and individual levels?
Yes
No
N/A
4. Have QMS requirements been integrated into business processes and promoted?
Yes
No
N/A
5. Have customer and applicable statutory requirements been determined and communicated?
Yes
No
N/A
6. Have relevant risks and opportunities been established?
Yes
No
N/A
7. Has the organization communicated responsibilities for effective QMS operation?
Yes
No
N/A
Section 4: Planning Actions
1. Have risks and opportunities to ensure the QMS achieves its intended results been established?
Yes
No
N/A
2. Has the organization planned actions to address these risks and integrated them into processes?
Yes
No
N/A
3. Is there a defined process for determining the need for changes to the QMS?
Yes
No
N/A
Section 5: Resource Management
1. Has the organization provided resources needed for QMS establishment and improvement?
Yes
No
N/A
2. Is monitoring used for evidence of conformity of products and services?
Yes
No
N/A
3. Has the organization determined resources for valid and reliable monitoring?
Yes
No
N/A
4. Has the organization determined necessary knowledge for process operation?
Yes
No
N/A
5. Has the organization ensured competence of those affecting QMS performance?
Yes
No
N/A
6. Has the necessary documented information for effective QMS implementation been established?
Yes
No
N/A
Section 6: Operational Processes
1. Is there a defined process for providing products and services that meet customer requirements?
Yes
No
N/A
2. Are any changes planned and carried out in a controlled way?
Yes
No
N/A
3. Are outsourced processes managed and controlled?
Yes
No
N/A
4. Is there a defined process for reviewing and communicating with customers?
Yes
No
N/A
5. Is this review conducted prior to commitment to supply products and services?
Yes
No
N/A
6. Do you design and develop products or services?
Yes
No
N/A
Section 7: Performance Evaluation
1. Has the organization determined what needs to be monitored and the methods for it?
Yes
No
N/A
2. Has it established when monitoring results shall be analyzed?
Yes
No
N/A
3. Have methods for monitoring customer perceptions been established?
Yes
No
N/A
4. Has the organization established a process for internal audits of the QMS?
Yes
No
N/A
5. Has an approach for management reviews been established?
Yes
No
N/A
Section 8: Improvement Actions
1. Has the organization determined opportunities for improvement and implemented actions?
Yes
No
N/A
2. Does the organization operate processes for managing nonconformities?
Yes
No
N/A
3. Has the organization decided how to address continual improvement of the QMS?
Yes
No
N/A
Section 9: Completion Notes
1. Recommendations