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How to use this checklist
The questions follow the structure of ISO 9001:2015. They do not replace the standard, but they help you not to miss anything important during the audit. For every question, look for objective evidence – an approved document, a record or an interview with the people responsible. A “yes” without evidence is not a yes in an audit.
- 1
Define the scope
Choose the processes and clauses that your audit programme schedules for this audit. Not every audit needs to cover every clause.
- 2
Review evidence in advance
Read the controlled documents of the area and the results of the last audit, so you ask the right questions in the interview.
- 3
Ask questions and check evidence
Note what you saw for each question. Write deviations as findings with requirement, evidence and observation.
- 4
Turn results into actions
Every nonconformity becomes a corrective action with root cause analysis and an effectiveness check – for example in CAPA management.
Audit questions by clause
Clause 4 – Context of the organization
Clause 5 – Leadership
Clause 6 – Planning
Clause 7 – Support
Clause 8 – Operation
Clause 9 – Performance evaluation
Clause 10 – Improvement
How to write audit findings
A good finding is immediately understandable to the audited department. It states the requirement, the evidence reviewed and the deviation – without judgement and without prescribing the solution.
| Element | Example |
|---|---|
| Requirement | ISO 9001, 7.5.3: current documents must be available at the point of use. |
| Evidence | Final inspection workstation, line 2, on 12 September. |
| Observation | Inspection instruction PA-021 version 3 was posted; version 4 has been valid since 1 August. |
| Grading | Minor nonconformity – single case, low impact, but a systemic cause is possible. |
Download the checklist as PDF
Print-ready with tick boxes – ideal for your next audit or team meeting. Free; we also email you the link.
Frequently asked questions
How often must an ISO 9001 internal audit take place?
The standard does not prescribe a fixed interval. It requires planned intervals based on the importance of processes, changes and previous results. In practice, every process is audited at least once within the three-year certification cycle, and important processes every year.
Can I adapt the checklist to my company?
Yes, you should. Add company-specific questions, for example about customer requirements or critical process steps. Do not remove questions without a reason – requirements that do not apply should be justified in the scope.
Can I use the checklist for supplier audits?
As a framework, yes. For supplier audits you typically add questions about your specific quality requirements, inspection certificates and traceability.