FREE TEMPLATE · ISO 9001:2015
ISO 9001 Internal Audit Checklist
A comprehensive 32-point internal audit checklist covering every clause of ISO 9001:2015 — from context of the organization through continuous improvement. Built by a quality executive who has led real certification audits across aerospace and automotive.
This checklist is designed for internal auditors and quality managers preparing for ISO 9001:2015 certification or surveillance audits. Each question maps directly to a clause requirement and includes the objective evidence you should look for.
How to use: Work through each clause section. For every question, verify objective evidence (documents, records, interviews, observations). Mark Conformity (C), Nonconformity (NC), or Opportunity for Improvement (OFI). Any "NC" finding should trigger your CAPA process.
CLAUSE 4 Context of the Organization
Understanding your organization, its environment, and the needs of interested parties.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 1 | 4.1 External & Internal Issues: Has the organization identified the external and internal issues that affect its ability to achieve QMS results? | Documented context analysis, management review minutes, SWOT records | CNCOFI |
| 2 | 4.2 Needs of Interested Parties: Are requirements of relevant interested parties (customers, regulators, employees, suppliers) identified and monitored? | Stakeholder register, customer requirement matrices, compliance lists | CNCOFI |
| 3 | 4.3 Scope of QMS: Is the QMS scope clearly defined, documented, and aligned with products, services, and strategic direction? | QMS scope statement, quality manual, documented boundaries | CNCOFI |
| 4 | 4.4 QMS Processes: Are processes determined with sequence, interaction, criteria, methods, resources, responsibilities, risks? | Process maps, turtle diagrams, process interaction charts | CNCOFI |
CLAUSE 5 Leadership
Top management commitment, quality policy, and organizational roles.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 5 | 5.1 Leadership Commitment: Can top management demonstrate active involvement and accountability for the QMS? | Management review minutes, resource allocation, leadership participation | CNCOFI |
| 6 | 5.1.2 Customer Focus: Does leadership ensure customer requirements are determined, understood, and met? | Customer satisfaction data, complaint trends, contract reviews | CNCOFI |
| 7 | 5.2 Quality Policy: Is a documented quality policy communicated, understood, and applied throughout the organization? | Posted policy, employee interviews, policy review records | CNCOFI |
| 8 | 5.3 Roles & Authorities: Are QMS roles, responsibilities, and authorities assigned, communicated, and understood? | Org chart, job descriptions, RACI matrices, delegation records | CNCOFI |
CLAUSE 6 Planning
Actions to address risks, opportunities, and quality objectives.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 9 | 6.1 Risks & Opportunities: Are risks and opportunities determined for each QMS process with planned actions? | Risk registers, FMEA documents, risk treatment plans | CNCOFI |
| 10 | 6.2 Quality Objectives: Are measurable objectives established, aligned with policy, communicated, and monitored? | SMART objectives, KPI dashboards, objective review minutes | CNCOFI |
| 11 | 6.3 Planning of Changes: Are QMS changes carried out systematically, considering purpose and consequences? | Change management procedures, MOC records, impact assessments | CNCOFI |
CLAUSE 7 Support
Resources, competence, awareness, communication, and documented information.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 12 | 7.1.1 Resources: Are necessary resources (people, infrastructure, environment) determined and provided? | Resource plans, budget allocations, capability studies | CNCOFI |
| 13 | 7.1.5 Monitoring & Measurement: Are measuring instruments identified, calibrated, verified, and maintained? | Calibration schedule, gage R&R studies, calibration certificates | CNCOFI |
| 14 | 7.2 Competence: Is necessary competence of personnel determined, verified, and maintained? | Competency matrices, training records, qualification certificates | CNCOFI |
| 15 | 7.3 Awareness: Are persons aware of quality policy, objectives, their contribution, and implications of nonconformity? | Employee interviews, training materials, toolbox talk records | CNCOFI |
| 16 | 7.4 Communication: Are internal and external QMS communications defined — what, when, with whom, how? | Communication plans, meeting minutes, escalation matrices | CNCOFI |
| 17 | 7.5 Documented Information: Is documented information controlled for creation, review, update, approval, distribution, retention? | Document control procedures, master lists, revision histories | CNCOFI |
CLAUSE 8 Operation
Product and service requirements, design, purchasing, production, and release.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 18 | 8.2 Customer Requirements: Are customer requirements determined, reviewed, and confirmed before commitment to deliver? | Contract review records, order acknowledgment procedures | CNCOFI |
| 19 | 8.3 Design & Development: Are design inputs, outputs, reviews, verification, validation, and changes controlled? | Design plans, review minutes, V&V reports, engineering changes | CNCOFI |
| 20 | 8.4 External Providers: Are suppliers evaluated, selected, monitored, and re-evaluated based on ability to meet requirements? | Approved supplier lists, audit reports, supplier scorecards | CNCOFI |
| 21 | 8.5.1 Production Control: Is production under controlled conditions — documented info, monitoring, qualified personnel, equipment? | Control plans, work instructions, operator qualifications | CNCOFI |
| 22 | 8.5.2 Identification & Traceability: Are outputs identified and traceable, including conforming/nonconforming status? | Labeling procedures, batch tracking, nonconforming tags | CNCOFI |
| 23 | 8.5.4 Preservation: Are outputs preserved during processing, storage, handling, and delivery? | Packaging specs, storage conditions, FIFO procedures | CNCOFI |
| 24 | 8.6 Release of Products: Are products not released until planned arrangements are completed with authorized documentation? | Final inspection records, test reports, release authorization | CNCOFI |
| 25 | 8.7 Nonconforming Outputs: Are nonconforming outputs identified, segregated, and dispositioned with documented evidence? | NCRs, quarantine procedures, disposition records, concessions | CNCOFI |
CLAUSE 9 Performance Evaluation
Monitoring, measurement, analysis, internal audit, and management review.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 26 | 9.1.1 Monitoring & Measurement: Are monitoring methods, timing, and results analysis defined and implemented? | KPI dashboards, measurement plans, data analysis reports | CNCOFI |
| 27 | 9.1.2 Customer Satisfaction: Is customer satisfaction monitored and acted upon as a QMS performance measure? | Satisfaction surveys, complaint analysis, feedback logs | CNCOFI |
| 28 | 9.2 Internal Audit: Are internal audits conducted at planned intervals by competent independent auditors with results reported? | Audit schedule, audit reports, auditor qualifications, corrective action tracking | CNCOFI |
| 29 | 9.3 Management Review: Are management reviews held at planned intervals with all required inputs and outputs documented? | Management review minutes, agenda with all inputs, action items tracked | CNCOFI |
CLAUSE 10 Improvement
Nonconformity, corrective action, and continuous improvement.
| # | Audit Question | Objective Evidence | Status |
|---|---|---|---|
| 30 | 10.1 General Improvement: Does the organization determine and select opportunities for improvement and implement necessary actions? | Improvement project logs, Kaizen records, innovation pipelines, lessons learned | CNCOFI |
| 31 | 10.2 Nonconformity & Corrective Action: When a nonconformity occurs, is it reacted to, evaluated for need of corrective action, root-caused, implemented, and verified for effectiveness? | 8D reports, 5-Whys analysis, CAPA tracking, effectiveness verification records, fishbone diagrams | CNCOFI |
| 32 | 10.3 Continual Improvement: Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS? | Improvement trend data, maturity assessments, benchmark results, PDCA cycle evidence | CNCOFI |
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