ISO 9001:2015 Audit Checklist
A clause-by-clause checklist covering the requirement clauses (4–10) of ISO 9001:2015. Built for internal audits, gap analysis, and certification preparation.
ISO 9001 Audit Checklist
Clause-by-clause ISO 9001:2015 audit checklist with conformance dashboard, plus a gap analysis workbook.
- 2 editable files · 2 Excel
- Instant download after payment, plus an email copy of your links
- Single-organisation licence: use across all your sites and staff
- 90-day money-back guarantee
These files follow ISO 9001:2015. ISO 9001:2026 was published on 16 September 2026; certificates to the previous edition remain valid until 30 September 2029. Transition guidance
See every file in the download (2)
- Internal Audit ChecklistExcel
- Gap AnalysisExcel
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The full Excel checklist scores all 112 questions automatically, with charts, a root-cause chart and a readiness dashboard.
Preview sample documents
Sample pages from the ISO 9001 Complete Document Kit, showing the structure and writing style. Only the files listed in the purchase box above are in this product.
Quality Manual
Section 8.5 — Production and service provision
The organization carries out production and service provision under controlled conditions. Controlled conditions include the availability of documented information defining the characteristics of the products and the results to be achieved, suitable monitoring and measuring resources, and the use of competent people.
Identification and traceability
Outputs are identified by suitable means throughout production and service provision, and their status with respect to monitoring and measurement requirements is identified. Where traceability is a requirement, the organization controls the unique identification of outputs and retains the documented information needed to maintain traceability.
Release of products and services
Planned arrangements are completed satisfactorily before release, and the release of products and services to the customer does not proceed until then, unless otherwise approved by a relevant authority. Documented information provides traceability to the person authorizing release.
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About This Checklist
Our ISO 9001:2015 audit checklist provides a complete, clause-by-clause assessment tool for evaluating your Quality Management System against the requirements of ISO 9001:2015. Whether you're conducting an internal audit, performing a gap analysis, or preparing for your certification audit, this checklist gives you a structured set of questions to work through.
The checklist is provided as an editable Microsoft Excel workbook, allowing you to easily customise it for your organisation's specific needs. You may also find our supplier audit checklist helpful for evaluating external providers under Clause 8.4.
Checklist Coverage by Clause
The checklist covers all requirement clauses (4–10) of ISO 9001:2015 with 112 individual audit questions:
| Clause | Title | Questions | Focus Areas |
|---|---|---|---|
| Clause 4 | Context of the Organization | 19 items | Understanding internal/external issues, interested parties, scope, and QMS processes. |
| Clause 5 | Leadership | 16 items | Leadership commitment, quality policy, organisational roles and responsibilities. |
| Clause 6 | Planning | 9 items | Actions to address risks and opportunities, quality objectives, and planning of changes. |
| Clause 7 | Support | 20 items | Resources, competence, awareness, communication, and documented information. |
| Clause 8 | Operation | 30 items | Operational planning, requirements, design, external providers, production, release, and nonconforming outputs. |
| Clause 9 | Performance Evaluation | 10 items | Monitoring and measurement, internal audit, and management review. |
| Clause 10 | Improvement | 8 items | Nonconformity, corrective action, and continual improvement. |
What's Included
Internal Audit Checklist
Clause-by-clause Excel audit checklist with 112 questions
Conformance Dashboard
Dashboard sheet with charts and a root-cause chart that update as you record results
Gap Analysis Workbook
Single-sheet gap analysis form to record gaps between your current system and ISO 9001:2015 requirements
How to Use the Checklist
- Download the checklist and gap analysis workbooks (Excel)
- Customise the questions to suit your organisation's specific processes
- Conduct your audit by working through each clause systematically
- Record your findings, evidence, and any nonconformities
- Report your audit results to management
- Follow up on corrective actions and verify their effectiveness
How to Use This Checklist for an Effective Audit
A well-conducted internal audit begins with preparation. Before you open the checklist, review the scope of the audit and identify which processes, departments, or clauses you intend to cover. Gather relevant documented information such as procedures, previous audit reports, and corrective action records so you have context before you start asking questions.
During the audit, work through each clause systematically. For every checklist item, look for objective evidence that the requirement has been implemented and is being maintained. Evidence can include records, documents, observations, and interviews with staff. Record your findings clearly, noting whether each item is conforming, nonconforming, or represents an opportunity for improvement.
After completing the checklist, compile your findings into an audit report and present the results to management. Prioritise any nonconformities by severity and agree on corrective actions with realistic deadlines. Schedule a follow-up review to verify that corrective actions have been implemented effectively and that the underlying root causes have been addressed. Using this structured approach ensures your audits add genuine value to your quality management system rather than becoming a box-ticking exercise.