Gap Analysis ISO 9001 Checklist
Manufacturing
This Gap Analysis ISO 9001 Checklist can help you prepare for ISO 9001:2015 certification. Use this to evaluate if the Context of the organization, Planning, Operation, Quality control, and Product improvement complies with the ISO standard. It will also help determine the needs of consumers and your opportunities for improvements within the QMS.
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Audit

Context of the Organization

Have all external and internal issues that are relevant to your organization’s purpose and the achievement of customer satisfaction and the organization’s strategic direction been determined?
Yes
No
N/A
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Are these issues reviewed and monitored on a regular basis?
Yes
No
N/A
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Have the needs and expectations of interested parties that are relevant to the QMS been determined?
Yes
No
N/A
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Was the scope of your QMS determined whilst taking into account all the external and internal issues, the needs of interested parties and the scope your products and services?
Yes
No
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Is your QMS established, and does it include a description of the processes required and their sequence and interaction?
Yes
No
N/A
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Have the criteria for managing these processes and their interaction been established?
Yes
No
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Have all responsibilities, methods, measurements and related performance indicators, needed to ensure the effective operation and control, been established?
Yes
No
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Leadership

Has top management taken accountability for the effectiveness of the QMS?
Yes
No
N/A
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Have the policy and objectives for the QMS, which are compatible with the strategic direction of the organization, been established and communicated?
Yes
No
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Have the objectives been established at relevant departmental and individual levels with the business?
Yes
No
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Have the requirements for the QMS been integrated into the business processes and have management promoted awareness of the process approach?
Yes
No
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Have customer requirements and applicable statutory and regulatory requirements been determined, met and communicated throughout the organization?
Yes
No
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Have the risks and opportunities that are relevant to the QMS been established?
Yes
No
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Has the organization established and communicated the responsibilities and authorities for the effective operation of the QMS?
Yes
No
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Planning

Have the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended result(s) been established?
Yes
No
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Has the organization planned actions to address these risks and opportunities and integrated them into the system processes?
Yes
No
N/A
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Is there a defined process for the determining the need for changes to the QMS and managing their implementation?
Yes
No
N/A
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Support

Has the organization determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS (including people, environmental and infrastructure requirements)?
Yes
No
N/A
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Is monitoring or measuring is used for evidence of conformity of products and services to specified requirements?
Yes
No
N/A
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Has the organization determined the resources needed to ensure valid and reliable monitoring and measuring of results?
Yes
No
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Has the organization determined the knowledge necessary for the operation of its processes and the achievement of conformity of products and services and implemented a lessons learned process?
Yes
No
N/A
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Has the organization ensured that those persons who can affect the performance of the QMS are competent on the basis of appropriate education, training, or experience or taken action to ensure that those persons can acquire the necessary competence?
Yes
No
N/A
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Has the documented information required by the standard and necessary for the effective implementation and operation of the QMS been established?
Yes
No
N/A
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Operation

Is there a defined process for the provision of products and services that meet the requirements defined by the customer?
Yes
No
N/A
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Are there any changes planned?
Yes
No
N/A
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Are they carried out in a controlled way and actions taken to mitigate any adverse effects?
Yes
No
N/A
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Are any outsourced processes managed and controlled?
Yes
No
N/A
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Is there a defined process for reviewing and communicating with customers in relation to information relating to products and services, enquiries, contracts or order handling?
Yes
No
N/A
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Is this review conducted prior to the organisation’s commitment to supply products and services?
Yes
No
N/A
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Do you design and develop products or services?
Yes
No
N/A
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Are these processes established and implemented in line with the requirements of the standard?
Yes
No
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Do you ensure that externally provided processes, products, and services conform to specified requirements?
Yes
No
N/A
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Do you have criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers?
Yes
No
N/A
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Is the provision of products and services carried out in controlled conditions which include: • the availability of documented information that defines the characteristics of the products and services? • the availability of documented information that defines the activities to be performed and the results to be achieved? • monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met? • the people carrying out the tasks are competent?
Yes
No
N/A
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Do you have effective methods of ensuring traceability during the operation process?
Yes
No
N/A
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Is property belonging to customers or external providers used in the provision of the product or service?
Yes
No
N/A
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Is this controlled effectively?
Yes
No
N/A
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Is there a requirement for post-delivery activities associated with the products and services such as warranty, maintenance services, recycling or final disposal?
Yes
No
N/A
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Are these defined and managed?
Yes
No
N/A
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Are any nonconforming process outputs managed so as to prevent their unintended use?
Yes
No
N/A
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Performance Evaluation

Has the organisation determined what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation, to ensure valid results?
Yes
No
N/A
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Has it established when the results from monitoring and measurement shall be analyzed and evaluated?
Yes
No
N/A
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Have methods of monitoring customer perceptions of the provision of products and services been established?
Yes
No
N/A
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Has it determined the need or opportunities for improvements within the QMS and how these will be fed into management reviews?
Yes
No
N/A
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Has the organisation established a process for an internal audit of the QMS?
Yes
No
N/A
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Has an approach to perform management reviews been established and implemented?
Yes
No
N/A
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Improvement

Has the organisation determined and selected opportunities for improvement and implemented the necessary actions to meet customer requirements and enhance customer satisfaction?
Yes
No
N/A
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Does the organisation operate appropriate processes for managing nonconformities and the related corrective actions?
Yes
No
N/A
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Has the organisation decided on how it will address the requirement to continually improve the suitability, adequacy, and effectiveness of the QMS?
Yes
No
N/A
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Completion

Recommendations
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Signature

Inspector's Full Name and Signature
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