ISO 9001 checklist per chapter
This ISO 9001 checklist goes through all requirements of chapters 4 to 10, clause by clause, with the evidence an auditor expects. Use it as a gap analysis at the start of your project, or as a final check before the external audit. The clause numbers follow ISO 9001 and have stayed almost the same in the new 2026 version . Where 2026 differs, this is stated. Explanations per chapter are in the requirements of ISO 9001.
How to use this checklist: copy the tables into Excel and add a “status” column (yes, partly, no) and an “action” column. Each line marked “no” or “partly” becomes an action with an owner and a date. Chapters 1 to 3 contain no requirements and are therefore not included.
On this page
Context, interested parties, scope and processes.
Chapter 4: ContextLeadership, policy, risks and objectives.
Chapters 5 and 6Resources, competence, documents and operation.
Chapters 7 and 8Measuring, audits, management review and improvement.
Chapters 9 and 10Chapter 4: Context of the organisation
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 4.1 | Internal and external issues determined, including whether climate change is relevant | Context analysis or SWOT with impact |
| 4.2 | Relevant interested parties and their requirements determined and monitored | Interested parties analysis |
| 4.3 | Scope established, exclusions justified | Scope statement as documented information |
| 4.4 | Processes, sequence, inputs, outputs, owners, criteria and measurements determined | Process landscape and process descriptions |
Chapter 5: Leadership
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 5.1.1 | Top management shows commitment and takes responsibility for the QMS | Interview with management, minutes, resources made available |
| 5.1.1 (2026) | Top management promotes a quality culture and ethical behaviour | Code of conduct, examples from team meetings, reporting culture |
| 5.1.2 | Customer focus: customer and legal requirements known, customer satisfaction central | Customer satisfaction figures in management meetings |
| 5.2 | Quality policy established, communicated and available | Quality policy with signature |
| 5.3 | Roles, responsibilities and authorities assigned | Organisation chart, job descriptions, RACI |
Chapter 6: Planning
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 6.1.1 | Risks and opportunities determined on the basis of context and interested parties | Risk analysis |
| 6.1.2 | Actions planned to address risks, effectiveness assessed | Measures with owner and evaluation |
| 6.1.3 (2026) | Actions to take advantage of opportunities (a separate clause in 2026) | List of opportunities with decisions |
| 6.2 | Measurable quality objectives with a plan: what, who, when, how measured | Objectives plan with progress |
| 6.3 | Changes to the QMS planned and carried out in a controlled way | Change proposal, impact analysis, evaluation after implementation |
In ISO 9001:2026 clause 6.3 has been expanded. You must also record how you communicate, monitor and assess changes afterwards.
Chapter 7: Support
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 7.1.2 | Sufficient people | Staffing and capacity planning |
| 7.1.3 | Suitable infrastructure (buildings, machines, IT) | Maintenance plan, fault log |
| 7.1.4 | Suitable work environment | RI&E (risk inventory and evaluation), workplace inspections |
| 7.1.5 | Measuring equipment calibrated or verified, where necessary | Calibration overview with certificates |
| 7.1.6 | Organisational knowledge determined and maintained | Knowledge base, induction programme, handover documents |
| 7.2 | Competences determined, competence demonstrated, actions evaluated | Competence matrix, diplomas |
| 7.3 | Employees know the policy, the objectives, their contribution and the implications of not conforming | Interviews on the shop floor, induction checklist |
| 7.4 | Internal and external communication determined | Communication overview: what, when, with whom |
| 7.5 | Documented information created, approved, controlled and retained | Document register, version control |
Chapter 8: Operation
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 8.1 | Operational planning and control of processes | Process descriptions, plans, criteria |
| 8.2.1 | Communication with customers (information, complaints, customer property) | Complaints register, customer contact agreements |
| 8.2.2 | Requirements for products and services determined | Quotes, specifications |
| 8.2.3 | Customer requirements reviewed before you commit to supply | Signed order review or checklist |
| 8.2.4 | Changes to requirements implemented and communicated | Amended order confirmation, additional work form |
| 8.3 | Design and development controlled (only if you design) | Design plan, reviews, verification, validation |
| 8.4 | External providers selected, evaluated and monitored | Supplier evaluation |
| 8.5.1 | Production and service provision under controlled conditions | Work instructions, releases, competent people |
| 8.5.2 | Identification and traceability where necessary | Batch or serial numbers, project codes |
| 8.5.3 | Customer or external provider property managed | Register of customer materials, reports of damage |
| 8.5.4 | Preservation of output (storage, packaging, transport) | Storage instructions |
| 8.5.5 | Post-delivery activities | Warranty and service agreements |
| 8.5.6 | Changes in production controlled | Change register with approval |
| 8.6 | Release of products and services after checks | Final inspection, signed release |
| 8.7 | Nonconforming output identified and controlled | Register of nonconforming product and decision |
Chapter 9: Performance evaluation
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 9.1.1 | Determined what, how and when you measure and analyse | KPI overview with source and frequency |
| 9.1.2 | Customer satisfaction monitored | Customer satisfaction measurement |
| 9.1.3 | Data analysed and evaluated | Trend analyses, dashboards |
| 9.2 | Internal audits planned and carried out, findings followed up | Audit programme and reports, see internal audit |
| 9.3 | Management review with mandatory input and output | Minutes of the management review |
Chapter 10: Improvement
| Clause | Requirement | Evidence the auditor wants to see |
|---|---|---|
| 10.1 | Improvement opportunities determined and actions carried out | Improvement list, projects, measured effect |
| 10.2 | Nonconformities corrected, cause investigated, action evaluated | Nonconformity register with root cause analysis |
| 10.3 (2015) | Continual improvement of the QMS | Management review, trends over several years |
In ISO 9001:2026, clause 10.3 is merged with clause 10.1 into one clause on continual improvement. In substance, the auditor asks for the same evidence. You can read more about root cause analysis at nonconformities and improvement.
Which version of ISO 9001 do you use for this checklist?
ISO 9001:2026 was published on 16 September 2026. Existing certificates based on the 2015 version remain valid during the three-year transition period. The chapter structure has stayed the same, so this checklist works for both. For a transition, pay particular attention to the items marked “2026”, and read the revision of ISO 9001.
A checklist with only “yes” tells an auditor very little. For each line, fill in where the evidence is: a file name or location. Then you can show exactly what you mean during the audit.
Next step
Put the open points from this checklist into your step-by-step plan, and plan an internal audit once most items are marked “yes”. You will find more templates, such as an internal audit checklist, in the tools.
Sources
- NEN-EN-ISO 9001:2026 : Dutch edition of the new version
- NEN-EN-ISO 9001:2015
- LRQA - ISO 9001:2026 is published : publication date and transition period