ISO 9001:2015 Internal Audit Checklist

Audit Programme & Planning

Verify the audit is planned, scoped, and conducted by objective auditors.

• Is an internal audit programme established that defines frequency, methods, responsibilities, and reporting? *
• Do audit criteria and scope for this audit reflect the importance of the processes and results of prior audits? *
• Are auditors independent of the activity being audited to ensure objectivity and impartiality? *
• Audit date *
• Process / area audited *

Context & Leadership (Cl. 4–5)

• Have relevant internal and external issues and interested party needs been determined and monitored? *
• Is the scope of the QMS documented and consistent with the organization's products and services? *
• Has top management demonstrated leadership and commitment, including a communicated quality policy? *
• Are roles, responsibilities, and authorities assigned and communicated? *

Planning & Support (Cl. 6–7)

• Are risks and opportunities addressed and integrated into QMS processes? *
• Are quality objectives established at relevant functions, measurable, and supported by plans? *
• Are resources, competence, awareness, and infrastructure adequate and evidenced? *
• Are monitoring and measuring resources fit for purpose and traceable where required? *

Operation (Cl. 8)

• Are operational processes planned and controlled with defined acceptance criteria? *
• Are customer and product requirements determined and reviewed before commitment? *
• Is production and service provision controlled under suitable conditions with identification and traceability? *
• Is nonconforming output identified and controlled to prevent unintended use? *

Performance Evaluation & Improvement (Cl. 9–10)

• Are QMS performance and customer satisfaction monitored, measured, analysed, and evaluated? *
• Is corrective action taken to eliminate the causes of nonconformities and prevent recurrence? *
• Are opportunities for improvement to the QMS identified and pursued? *

Findings & Close-out

• Number of nonconformities raised *
• Are audit results reported to relevant management and retained as documented information? *
• Auditor summary of findings
• Lead auditor signature *