| Clause | Checklist Question | Evidence to Look For | | :--- | :--- | :--- | | | Have external and internal issues relevant to the QMS been determined? | SWOT analysis, Meeting minutes, Market analysis reports. | | 5.2 | Is the Quality Policy appropriate to the purpose of the organization? | Posted policy statement, Employee interviews regarding understanding. | | 6.1 | Has the organization determined risks and opportunities? | Risk Register, Risk Assessment matrices. | | 7.2 | How is necessary competence determined? | Training matrices, Skill assessments, Job descriptions. | | 8.2 | How are customer requirements reviewed before committing? | Contracts, Quotations, Sales order review records. | | 8.5 | Are production/service processes controlled? | Work instructions, Checklists, Monitoring equipment logs. | | 9.1 | How is customer satisfaction monitored? | Survey results, Complaint logs, Feedback forms. | | 10.2 | When a nonconformity occurs, is corrective action taken to eliminate the cause? | CAR (Corrective Action Requests) forms, Root cause analysis documentation. |
Do not audit clause by clause in isolation. Audit by process.
ISO 9001:2015 follows the High-Level Structure (HLS). A comprehensive checklist must address the following clauses. audit 9001 checklist
| Ref | Question | Evidence | |-----|----------|----------| | 9.1 | Is QMS performance monitored, measured, analyzed, and evaluated? | KPI dashboards, trend analysis | | 9.1.2 | Is customer satisfaction monitored (surveys, complaints, feedback)? | Survey results, complaint logs, feedback analysis | | 9.2 | Are internal audits conducted at planned intervals; are auditors objective and competent? | Audit schedule, audit reports, auditor training records | | 9.3 | Is management review conducted at planned intervals, addressing QMS suitability, adequacy, effectiveness? | Management review minutes, action items |
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. | Clause | Checklist Question | Evidence to
A robust checklist is typically organized by the core clauses (4–10) of the ISO 9001:2015 standard. 1. Context of the Organization (Clause 4)
The audit checklist typically includes questions or statements that require a "yes" or "no" response, or a rating of compliance. Examples of questions include: | Inspection reports
Focus: Resources, Competence, and Communication. The checklist must verify:
| Ref | Question | Evidence | |-----|----------|----------| | 8.1 | Is operational planning and control implemented to meet product/service requirements? | Production plans, work instructions | | 8.2 | Are customer requirements reviewed before commitment (orders, contracts, tenders)? | Order review records, amendment logs | | 8.3 | If design applies: Is design & development planning, inputs, controls, outputs, and changes managed? | Design plan, review minutes, verification records | | 8.4 | Are external providers evaluated, monitored, and controlled based on their ability to supply? | Supplier approval list, performance scorecard, re-evaluation | | 8.4.2 | Are requirements for external providers clearly communicated? | Purchase orders, contracts, specifications | | 8.5 | Are production and service provision carried out under controlled conditions (e.g., work instructions, monitoring)? | Shop floor conditions, process controls | | 8.5.2 | Is traceability maintained where required? | Traceability records, batch/lot numbers | | 8.5.3 | Is customer or external provider property identified, verified, and protected? | Property log, damage reporting process | | 8.5.4 | Are preservation measures (handling, storage, packaging) in place? | Warehouse inspection, packaging standards | | 8.5.5 | Are post-delivery activities (warranty, maintenance, returns) defined and performed? | Service records, customer support logs | | 8.6 | Is product/service release only after verification of requirements? | Inspection reports, sign-offs, test certificates | | 8.7 | Are nonconforming outputs identified, controlled, and dispositioned (rework, scrap, concession)? | Nonconformance report, disposition log, rework records |