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Audit modelAudit ISO 9001:2015 EN

Checklist to prepare for ISO 9001:2015 certification to protect consumers by ensuring international standards of safety, reliability and quality are met.

1. Context of the Organization

1. Understanding the organization and its context

1.1. 1.1.1. 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?
1.2. 1.1.2. Are these issues reviewed and monitored on a regular basis?
1.3. Notes

2. Understand the needs and expectations of stakeholders

2.1. 1.2. Have the needs and expectations of interested parties that are relevant to the QMS been determined?
2.2. Notes

3. QMS Scoping

3.1. 1.3. 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?
3.2. Notes

4. The Quality Management System and its processes

4.1. 1.4.1. Is your QMS established, and does it include a description of the processes required and their sequence and interaction?
4.2. 1.4.2. Have the criteria for managing these processes and their interaction been established?
4.3. 1.4.3. Have all responsibilities, methods, measurements and related performance indicators, needed to ensure the effective operation and control, been established?
4.4. Notes

2. Leadership

1. Leadership and commitment

1.1. 2.1. Has top management taken accountability for the effectiveness of the QMS?
1.2. Notes

2. Quality policy

2.1. 2.2. Have the policy and objectives for the QMS, which are compatible with the strategic direction of the organization, been established and communicated?
2.2. Notes

3. Roles, responsibilities and authorities within the organization

3.1. 2.3.1. Have the objectives been established at relevant departmental and individual levels with the business?
3.2. 2.3.2. Have the requirements for the QMS been integrated into the business processes and have management promoted awareness of the process approach?
3.3. 2.3.3. Have customer requirements and applicable statutory and regulatory requirements been determined, met and communicated throughout the organization?
3.4. 2.3.4. Have the risks and opportunities that are relevant to the QMS been established?
3.5. 2.3.5. Has the organization established and communicated the responsibilities and authorities for the effective operation of the QMS?
3.6. Notes

3. Planning

1. Actions to be taken in response to risks and opportunities

1.1. 3.1. Have the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended result(s) been established?
1.2. Notes

2. Quality objectives and planning to achieve them

2.1. 3.2. Has the organization planned actions to address these risks and opportunities and integrated them into the system processes?
2.2. Notes

3. Change planning

3.1. 3.3. Is there a defined process for the determining the need for changes to the QMS and managing their implementation?
3.2. Notes

4. Support (plan)

1. Resources

1.1. 4.1.1. 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)?
1.2. 4.1.2. Is monitoring or measuring is used for evidence of conformity of products and services to specified requirements?
1.3. Notes

2. Skills

2.1. 4.2. Has the organization determined the resources needed to ensure valid and reliable monitoring and measuring of results?
2.2. Notes

3. Awareness

3.1. 4.3. 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?
3.2. Notes

4. Communication

4.1. 4.4. 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?
4.2. Notes

5. Documented information

5.1. 4.5. Has the documented information required by the standard and necessary for the effective implementation and operation of the QMS been established?
5.2. Notes

5. Operation

1. Operational planning and control

1.1. 5.1.1. Is there a defined process for the provision of products and services that meet the requirements defined by the customer?
1.2. 5.1.2. Are there any changes planned?
1.3. 5.1.3. Are they carried out in a controlled way and actions taken to mitigate any adverse effects?
1.4. Notes

2. Determination of product and service requirements

2.1. 5.2.1. Are any outsourced processes managed and controlled?
2.2. 5.2.2. 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?
2.3. 5.2.3. Is this review conducted prior to the organisation’s commitment to supply products and services?
2.4. Notes

3. Design and development of products and services

3.1. 5.3.1. Do you design and develop products or services?
3.2. 5.3.2. Are these processes established and implemented in line with the requirements of the standard?
3.3. Notes

4. Control of products and services provided by external providers

4.1. 5.4.1. Do you ensure that externally provided processes, products, and services conform to specified requirements?
4.2. 5.4.2. Do you have criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers?
4.3. 5.4.3. 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?
4.4. Notes

5. Production and service provision

5.1. 5.5.1. Do you have effective methods of ensuring traceability during the operation process?
5.2. 5.5.2. Is property belonging to customers or external providers used in the provision of the product or service?
5.3. 5.5.3. Is this controlled effectively?
5.4. Notes

6. Release of products and services

6.1. 5.6.1. Is there a requirement for post-delivery activities associated with the products and services such as warranty, maintenance services, recycling or final disposal?
6.2. 5.6.2. Are these defined and managed?
6.3. Notes

7. Control of process output elements, non-conforming products

7.1. 5.7. Are any nonconforming process outputs managed so as to prevent their unintended use?
7.2. Notes

6. Performance Evaluation

1. Monitoring, measurement, analysis and evaluation

1.1. 6.1.1. Has the organisation determined what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation, to ensure valid results?
1.2. 6.1.2. Has it established when the results from monitoring and measurement shall be analyzed and evaluated?
1.3. 6.1.3. Have methods of monitoring customer perceptions of the provision of products and services been established?
1.4. 6.1.4. Has it determined the need or opportunities for improvements within the QMS and how these will be fed into management reviews?
1.5. Notes

2. Internal Audit

2.1. 6.2. Has the organisation established a process for an internal audit of the QMS?
2.2. Notes

3. Management review

3.1. 6.3. Has an approach to perform management reviews been established and implemented?
3.2. Notes

7. Improvement

1. Continuous improvement

1.1. 7.1. Has the company identified and selected opportunities for improvement and implemented the necessary actions to meet customer requirements and improve customer satisfaction?
1.2. Notes

2. Non-conformity and corrective actions

2.1. 7.2.1. Does the organisation operate appropriate processes for managing nonconformities and the related corrective actions?
2.2. 7.2.2. Has the organisation decided on how it will address the requirement to continually improve the suitability, adequacy, and effectiveness of the QMS?
2.3. Notes
Created at:2023-02-01T21:39:38.7376224

Updated on :2023-02-01T21:40:25.3140222

License : © Creative commons :
Attribution / Pas d'utilisation commerciale
CC-BY-NC AttributionPas d'utilisation commerciale

author :
Dastro Naute
Dastro Naute

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