ISO 9001 Audit Checklist
Check whether your QMS complies with ISO standards.
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How to Use This Checklist
- Review the checklist items against your QMS processes and documented information.
- Interview process owners and top management to gather evidence for each question.
- Record findings against each item using the answer choices: Conforms, Nonconformity, Opportunity for improvement, or Not applicable.
- Agree corrective actions for any nonconformities and assign responsibility.
- Follow up to verify that actions were implemented and effective.
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Introduction
An ISO 9001 audit examines how your quality management system (QMS) actually works, not just whether documents exist. It tests whether you have identified the internal and external issues that affect your organisation, understood the needs and expectations of interested parties, defined the scope of your QMS, and established the processes that deliver your products and services. This checklist walks through the clauses of the standard in sequence, so you can gather evidence, record findings, and decide where action is needed.
Context of the organisation
Start by showing how your organisation determines the external and internal issues relevant to its purpose and strategic direction, and how those issues affect the ability of the QMS to achieve its intended results. You should also show how this information is monitored and reviewed, because the context is not static. Next, look at interested parties. Who are the relevant interested parties for the QMS? What are their relevant needs and expectations? What are the actual or potential impacts of these parties on the QMS? And how do you monitor and review information about them and their requirements? The scope of the QMS must take into account external and internal issues, the requirements of relevant interested parties, and your products and services. Check that the scope is documented, and that where a requirement of ISO 9001:2015 is determined not to be applicable, you can show that this does not affect the conformity of products and services. Finally, review the processes of the QMS: their inputs and outputs, the sequence and interaction between them, the criteria, methods, measurements and related performance indicators needed to operate and control them, the resources assigned, and who is responsible and authorised. Confirm how risks and opportunities are addressed, how processes are monitored, measured and evaluated, how changes are implemented when needed to achieve intended results, how improvement opportunities are identified, and what documented information supports the operation of these processes.
Leadership
Top management must demonstrate leadership and commitment, and this section tests whether that is visible in practice. Evidence includes taking responsibility for the effectiveness of the QMS, ensuring the quality policy and objectives are established and compatible with the strategic direction and context, and integrating the QMS into the organisation's business processes. You should also see promotion of the process approach and risk-based thinking, assurance that resources are available, communication of the importance of an effective QMS and of conforming to its requirements, and support for people who contribute to its effectiveness. Leadership should promote continual improvement and support other management roles to demonstrate leadership in their areas of responsibility. Customer focus is part of this. Check that top management demonstrates it by ensuring customer requirements and applicable legal and regulatory requirements are determined, understood and consistently met; that risks and opportunities affecting product and service conformity and the ability to enhance customer satisfaction are determined and addressed; and that the focus on enhancing customer satisfaction is maintained. The quality policy must be appropriate to the purpose and context, support strategic direction, provide a framework for setting quality objectives, include a commitment to satisfy applicable requirements, and include a commitment to continual improvement of the QMS. Confirm that it is maintained as documented information, that it is communicated, understood and applied within the organisation, and that it is available to relevant interested parties. Finally, check that responsibilities and authorities for relevant roles are assigned and communicated. This includes top management assigning responsibility and authority to ensure the QMS conforms to ISO 9001:2015, that processes deliver their intended results, and that reporting on QMS performance and improvement opportunities reaches top management. Also confirm that promotion of customer focus is ensured across the organisation, and that the integrity of the QMS is maintained when changes are planned and implemented.
Planning
Planning in ISO 9001 covers risks and opportunities, quality objectives, and changes to the QMS. For risks and opportunities, examine how the organisation determined them and what actions it takes to address them. For quality objectives, check that objectives are set for relevant functions, levels and processes; that they are measurable and consistent with the quality policy; that they are monitored, communicated and updated as appropriate; and that the organisation has determined what will be done, what resources are needed, who is responsible, when it will be completed, and how results will be evaluated. When changes to the QMS are planned, the organisation is expected to consider their purpose and any potential consequences, the availability of resources, the allocation or reallocation of responsibilities and authorities, and how the integrity of the QMS will be maintained. Record whether planned changes are carried out in a controlled manner.
Support
Support covers the resources and conditions needed to operate the QMS. Resources: review how the organisation determines and provides the resources needed to establish, implement, maintain and continually improve the QMS. This includes people, infrastructure, the environment for the operation of processes, monitoring and measuring resources, and organisational knowledge. Competence: determine the necessary competence of people doing work that affects the performance and effectiveness of the QMS, ensure they are competent on the basis of education, training or experience, and take action to acquire any needed competence. Keep documented information as evidence of competence. Awareness: ensure people are aware of the quality policy, their contribution to the effectiveness of the QMS, and the implications of not conforming with QMS requirements. Communication: determine what to communicate, when to communicate, with whom, how, and who communicates on matters relevant to the QMS. Documented information: maintain documented information required by ISO 9001 and by the organisation, and ensure it is properly controlled — available and suitable for use where and when it is needed, and protected from loss of integrity, improper use, or loss of confidentiality. Review the controls for distribution, access, retrieval and use, storage and preservation, version control, retention, and disposition. When creating and updating documented information, confirm appropriate identification and description, format and media, review and approval for suitability and adequacy.
Evaluation, improvement and findings
This section of the checklist gathers the findings from your review. Work through the questions and record each as one of the following: - **Conforms** — evidence shows the requirement is met. - **Nonconformity** — the requirement is not met, or is not effective. - **Opportunity for improvement** — the requirement is met, but there is a way to make it work better. - **Not applicable** — the requirement genuinely does not apply to your scope, with a justification recorded. For every nonconformity, agree a corrective action, assign an owner and a due date, and follow up to verify that the action was implemented and effective. Findings and their follow-up should be reviewed as part of management review, alongside performance and improvement opportunities, so that the QMS continues to improve.
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