| 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 |
________ Auditor(s): ________ Next audit date (planned): ________
Has the scope of the QMS been clearly defined and documented? audit 9001 checklist
The ISO 9001 audit checklist is a fundamental tool used to verify that an organization’s Quality Management System (QMS) aligns with the requirements of the ISO 9001:2015 standard. It serves as a roadmap for auditors to ensure objective evidence is gathered, non-conformities are identified, and opportunities for improvement are highlighted. This report outlines the purpose of the checklist, a structural breakdown based on the standard’s clauses, and best practices for its execution.
An audit checklist is a valuable tool for evaluating an organization's QMS against the requirements of ISO 9001. By using a structured and systematic approach, auditors can ensure that all aspects of the QMS are reviewed and assessed, providing a comprehensive evaluation of an organization's quality management system. By identifying areas of non-conformance and opportunities for improvement, organizations can take corrective action to enhance their QMS and improve overall performance. | Ref | Question | Evidence | |-----|----------|----------|
☐ Conforming ☐ Conforming with minor nonconformities ☐ Nonconforming (major nonconformities)
You cannot audit every record. The checklist should guide the auditor to select a representative sample (e.g., "Select the last 5 purchase orders and verify they were approved according to the procedure"). | Audit schedule, audit reports, auditor training records
ISO 9001:2015 follows the High-Level Structure (HLS). A comprehensive checklist must address the following clauses.