Iso 9001 2015 Gap Analysis Checklist

This ISO 9001-2015 self-assessment form is an auditing tool that will help you to identify gaps between your existing Quality Management System and the requirements of ISO 9001:2015. Assess your existing policies, processes or procedures and flag key non-conformance areas. Understanding the status of your existing QMS will be a key driver for the subsequent implementation approach.​

ISO 9001-2015 Gap Analysis Checklist



Understanding The Organisation

1. Does your company determine the external and internal issues that are relevant to your purpose and strategic direction?


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2. Do you consider the relevant issues that affect your ability to achieve the intended results of the QMS?


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3. Does your company monitor and review the information related to the external and internal issues?


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4. With consideration given to their impact or potential impact on your company's ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, do you determine: The interested parties that are relevant to the QMS? The requirements of these interested parties that are relevant to the QMS?


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5. Does your company monitor and review the information about these interested parties and their relevant requirements?


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6. To establish the scope of the QMS, does your company determine the boundaries and applicability of the QMS?


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7. When determining the scope of the QMS, do you consider the: External and internal issues; Requirements of relevant interested parties; The products and services of your company?


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8. When a requirement of ISO 9001:2015 can be applied, is the requirement applied by your company?


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9. When requirements cannot be applied and in order to claim conformity to ISO 9001:2015, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected?


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10. Is the scope of the QMS available and maintained as documented information?


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11. Does the scope state the products and services covered by the QMS?


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12. Does your company provide justification for any instance where a requirement of the standard cannot be applied?


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13. As required by the standard, do you establish, document, implement, maintain, and continually improve the QMS?


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14. Does your company determine the processes needed for the QMS, their interactions and applications throughout your company?


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15. That is, for the QMS processes do you determine the: Inputs required and the outputs expected from the processes? Sequence and interaction of the processes? Criteria, methods, including measurements and related performance indicators needed to ensure the effective operation and control of the processes? Resources needed and ensure their availability? Assignment of the responsibilities and authorities for these processes? Risk and opportunities and plans to implement the appropriate actions to address them? Methods for monitoring, measuring and evaluation of processes and if needed, the changes to processes to ensure that they achieve intended results? Opportunities for improvement of the processes and the QMS?


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16. Does your company maintain the necessary documented information to support the operation of processes?


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17. Does your company retain the necessary documented information to provide the confidence that the processes are being carried out as planned?


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Leadership

1. Does top management demonstrate leadership and commitment with respect to the QMS by: Taking accountability of the effectiveness of the QMS? Ensuring that the quality policy and quality objectives are established for the QMS and are compatible with the strategic directions direction and the contact of the organisation? Ensuring that the quality policy is communicated, understood and applied within the company? Ensuring the integration of the QMS requirements into the company's business processes? Promoting awareness of the process approach? Ensuring that the resources needed for the QMS are available?


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2. Communicating the importance of effective quality management and of conforming to the QMS requirements?


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3. Ensuring that the QMS achieves its intended results?


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4. Engaging, directing and supporting persons to contribute to the effectiveness of the QMS?


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5. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?


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6. Does top management demonstrate leadership and commitment with respect to customer focus by ensuring that the: Customer requirements and applicable statutory and regulatory requirements are determined and met? Risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed? Focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements are maintained? Focus on enhancing customer satisfaction is maintained?


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7. Has your top management established, implemented and maintained a quality policy that: Is appropriate to the purpose and context of the organisation? Provides a framework for setting and reviewing quality objectives? Includes a commitment to satisfy applicable requirements? Includes a commitment to continual improvement of the QMS?


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8. Is your quality policy: Communicated, understood and applied within your company? Available as documented information? Available to relevant interested parties?


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9. Does the top management ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the company?


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10. Does top management assign the responsibility and authority for: Ensuring that the QMS conforms to the requirements of ISO 9001:2015 standards? Ensuring that the processes are delivering their intended outputs? Reporting on the performance of the QMS on opportunities for improvement and for reporting to the top management? Ensuring the promotion of customer focus throughout your company? Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?


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Planning

1. When planning for the QMS, does your company consider the issues referred to earlier in the audit as well as determining the risks and opportunities that need to be addressed?