ISO 9001 is an international standard for quality management systems (QMS) that provides a framework for organizations to demonstrate their commitment to quality and customer satisfaction. An audit checklist is a vital tool used to evaluate an organization's QMS against the requirements of ISO 9001. The checklist helps ensure that all aspects of the QMS are reviewed and assessed during an audit, providing a comprehensive and systematic approach to evaluating an organization's quality management system.
Mastering the ISO 9001 Audit Checklist: A Comprehensive Guide audit 9001 checklist
| 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 | ISO 9001 is an international standard for quality