Step 1: ISO 9001 Create Your Audit Checklist

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Clause 4: Context of the Organization

Understanding internal and external factors affecting quality management.

(4.1) Has the organization determined internal and external issues affecting its QMS?

(4.2) Are the needs and expectations of interested parties identified?

(4.3) Is the scope of the QMS documented and maintained?

(4.4) Are QMS processes defined, documented, and implemented?

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Clause 5: Leadership

Top management commitment to the QMS.

(5.1) Does top management demonstrate leadership and commitment to the QMS?

(5.2) Is a quality policy established, communicated, and understood?

(5.3) Are responsibilities and authorities for the QMS assigned and communicated?

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Clause 6: Planning

Identifying and addressing risks and opportunities.

(6.1) Are risks and opportunities identified and addressed?

(6.2) Are quality objectives established and measurable?

(6.3) Is there a process for planning changes to the QMS?

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Clause 7: Support

Providing adequate resources for the QMS.

(7.1) Are adequate resources provided for the QMS?

(7.2) Are employees competent and trained for their roles?

(7.3) Is documented information properly controlled (created, updated, stored)?

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Clause 8: Operation

Ensuring operational control to meet requirements.

(8.1) Are operational controls in place to meet customer and regulatory requirements?

(8.2) Are customer communication and contract review processes effective?

(8.3) Are external providers and suppliers evaluated for compliance?

(8.4) Are controls in place to prevent nonconforming product or service delivery?

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Clause 9: Performance Evaluation

Monitoring and measuring QMS effectiveness.

(9.1) Is there a process for monitoring and measuring QMS effectiveness?

(9.2) Are customer satisfaction levels monitored?

(9.3) Are internal audits conducted at planned intervals?

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Clause 10: Improvement

Identifying nonconformities and taking corrective action.

(10.1) Are nonconformities identified and corrective actions taken?

(10.2) Is there a process for continual improvement of the QMS?

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