| Clause | Requirement Focus | Questions to Ask / Evidence to Look For | Evidence / Notes | Status | | :--- | :--- | :--- | :--- | :--- | | | Context & Interested Parties | Has the organization identified internal/external issues (SWOT, PESTLE) and the needs of interested parties? Is this review current? | | | | 4.4 | Process Approach | Can leadership explain the interaction between processes? Is the sequence and interaction defined (e.g., a process map)? | | | | 5.1 | Leadership & Commitment | Is Top Management taking accountability? Ask Management: "How do you ensure the QMS achieves its intended results?" "How do you promote customer focus?" | | | | 5.2 | Quality Policy | Is the policy available as documented information? Is it appropriate to the context? Do employees understand how the policy applies to their specific jobs? | | | | 5.3 | Organizational Roles | Are responsibilities and authorities assigned? Do staff members know their specific quality responsibilities? | | | | 6.1 | Actions to Address Risks | Are risks and opportunities identified? Have actions been taken to address them? Is the process integrated into the QMS? | | | | 6.2 | Quality Objectives | Are objectives measurable, monitored, and communicated? Are they consistent with the policy? Ask to see the current metrics. | | |
Beyond simply checking boxes, a robust audit checklist helps organizations: iso 9001 audit checklist
Mastering the ISO 9001 Audit Checklist: Your Essential Compliance Roadmap | Clause | Requirement Focus | Questions to
___________________ Date: ___________________ Area/Process Audited: ___________________ Audit Scope: ___________________ Is the sequence and interaction defined (e