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ISO 9001 Audit Checklist Generator

ISO 9001:2015 clauses 4–10 · Evidence-based questions per clause
Printable with checkboxes and notes fields · No signup required
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Section 4 — Context of the Organization 4 clauses
Section 5 — Leadership 3 clauses
Section 6 — Planning 3 clauses
Section 7 — Support 7 clauses
Section 8 — Operation 8 clauses
Section 9 — Performance Evaluation 4 clauses
Section 10 — Improvement 3 clauses
ISO 9001:2015 Audit Checklist

Each question is designed to elicit objective evidence — not yes/no answers. Record what you observed, who you spoke to, and what documents you reviewed.

Classifying Findings

Major NC Systematic failure or absence of a required element. Affects the QMS's ability to achieve intended outcomes.
Minor NC Isolated lapse. System intent is evident but execution failed in a specific instance.
Observation Conforming, but a weakness that could become a nonconformity if not addressed.
Opportunity Beyond compliance. A suggestion for improvement that exceeds standard requirements.

After the Audit

Communicate findings in the closing meeting, document in an audit report, and track through the CAPA process. Major nonconformities require root cause analysis and verified corrective action before closure.

Next step

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