ISO 9001:2015 Audit Checklist
A comprehensive checklist covering all clauses of ISO 9001:2015. Perfect for internal audits, gap analysis, and certification preparation.
ISO 9001 Audit Checklist
Clause-by-clause ISO 9001 checklist for internal audits, supplier reviews, and gap analysis.
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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 covers everything you need.
The checklist is provided in editable Microsoft Word and Excel formats, 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 over 100 individual audit questions:
| Clause | Title | Questions | Focus Areas |
|---|---|---|---|
| Clause 4 | Context of the Organization | 12 items | Understanding internal/external issues, interested parties, scope, and QMS processes. |
| Clause 5 | Leadership | 15 items | Leadership commitment, quality policy, organisational roles and responsibilities. |
| Clause 6 | Planning | 10 items | Actions to address risks and opportunities, quality objectives, and planning of changes. |
| Clause 7 | Support | 18 items | Resources, competence, awareness, communication, and documented information. |
| Clause 8 | Operation | 25 items | Operational planning, requirements, design, external providers, production, release, and nonconforming outputs. |
| Clause 9 | Performance Evaluation | 14 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
Complete clause-by-clause audit checklist with 100+ questions
Gap Analysis Checklist
Identify gaps between your current system and ISO 9001 requirements
Supplier Audit Checklist
Evaluate your suppliers against ISO 9001 requirements
Compliance Checklist
Verify ongoing compliance with all ISO 9001:2015 requirements
How to Use the Checklist
- Download the checklist in your preferred format (Word or 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.