Audit 9001 Checklist

A well-constructed ISO 9001 audit checklist is the backbone of an effective quality audit. It ensures compliance with the standard, drives organizational improvement, and mitigates risk. For an audit to be successful, the checklist must be tailored to the organization's specific context, size, and complexity, rather than being a generic copy of the standard's requirements.

| Ref | Question | Evidence / Y/N / Notes | |-----|----------|------------------------| | 4.1 | Has the organization determined external and internal issues relevant to its purpose and strategic direction? | List of issues (SWOT, PESTLE) | | 4.2 | Have relevant interested parties (customers, suppliers, regulators) been identified, along with their requirements? | Stakeholder matrix, requirement records | | 4.3 | Is the scope of the QMS defined, documented, and justified for any exclusions (e.g., design if not applicable)? | Scope statement, exclusion justification | | 4.4 | Are processes, their interactions, inputs, outputs, criteria, methods, resources, risks, and opportunities documented and managed? | Process map, turtle diagrams, procedure list | audit 9001 checklist