ISO 9001:2015
Quality Management System
Internal Audit Checklist
Organization:
Audit Date:
Lead Auditor:
Audit Ref No.:
Auditee(s):
Scope/Area:
Instructions for Use
This checklist covers all clauses of ISO 9001:2015 (Clauses 4–10). For each audit item, review the stated requirement, gather objective evidence as guided, assign a rating, and record findings in the notes column.
Use the rating codes below. Attach supporting evidence references (document numbers, interview notes) to each finding.
Rating Legend
✓ Conforming
OFI Opportunity
MNC Minor NC
MJC Major NC
N/A Not Applicable
☐ Not Yet Audited
Clause 4: Context of the Organization
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
4.1
The organization has determined external and internal issues relevant to its purpose and strategic direction.
Review SWOT/PESTLE analysis, strategic plans, management meeting minutes.
☐
4.1
External and internal issues are monitored and reviewed to reflect changes in context.
Check for regular review records (e.g., management review outputs).
☐
4.2
Interested parties relevant to the QMS have been identified.
Review stakeholder register or equivalent document.
☐
4.2
Requirements of relevant interested parties have been determined and are monitored.
Verify requirements list is documented and updated.
☐
4.3
The scope of the QMS is defined, documented, and available.
Review scope statement; verify exclusions are justified.
☐
4.3
Applicable requirements and processes are identified within the defined scope.
Confirm scope aligns with products/services offered.
☐
4.4
Processes needed for the QMS are established, implemented, and maintained.
Review process maps or turtle diagrams for all key processes.
☐
4.4
Process inputs, outputs, sequence, interactions, and responsibilities are defined.
Check process documentation for owners and KPIs.
☐
4.4
Risks and opportunities for processes are determined and addressed.
Verify risk registers reference process-level risks.
☐
Clause 5: Leadership
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
5.1.1
Top management demonstrates leadership and commitment to the QMS.
Interview top management; review quality policy sign-off and meeting attendance.
☐
5.1.1
Top management ensures quality policy and objectives are established and compatible with strategic direction.
Confirm policy is reviewed and signed by top management.
☐
5.1.1
Top management promotes a customer focus culture throughout the organization.
Check communications, training records, and customer satisfaction initiatives.
☐
5.1.2
Customer and statutory/regulatory requirements are determined and met.
Review contract review procedures and legal compliance logs.
☐
5.1.2
Risks that can affect product/service conformity are determined and addressed.
Confirm risk assessments include customer-facing risks.
☐
5.2.1
A quality policy is established, appropriate, and includes a commitment to continual improvement.
Review quality policy document for required elements.
☐
5.2.2
The quality policy is available, communicated, and understood within the organization.
Verify display locations, intranet access, and staff awareness via interviews.
☐
5.3
Roles, responsibilities, and authorities are assigned and communicated.
Review org charts, job descriptions, and responsibility matrices.
☐
Clause 6: Planning
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
6.1.1
Risks and opportunities that could affect QMS conformity are identified.
Review risk register; confirm methodology is documented.
☐
6.1.2
Actions to address risks and opportunities are planned, implemented, and evaluated.
Check action plans for risk treatment; verify effectiveness reviews.
☐
6.2.1
Quality objectives are established at relevant functions, levels, and processes.
Confirm objectives are SMART and aligned with the quality policy.
☐
6.2.2
Plans to achieve quality objectives are defined (what, who, when, how).
Review objective tracking sheets or scorecards.
☐
6.3
Changes to the QMS are planned and carried out in a controlled manner.
Check change management procedure and recent change records.
☐
Clause 7: Support
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
7.1.1
Resources needed for the QMS are determined and provided.
Review resource planning records and budget allocations.
☐
7.1.2
Competent personnel are provided for effective QMS operation.
Verify staffing levels meet process requirements.
☐
7.1.3
Infrastructure required for operation is determined and maintained.
Review maintenance schedules, equipment lists, and calibration records.
☐
7.1.4
Work environment (human and physical factors) is managed.
Check workplace assessments, ergonomic studies, and environmental monitoring.
☐
7.1.5.1
Monitoring and measuring resources are suitable, maintained, and fit for purpose.
Review calibration records; confirm traceability to national standards.
☐
7.1.5.2
Measurement traceability is maintained; calibration status is known.
Confirm equipment labels, calibration certificates, and recall systems.
☐
7.1.6
Organizational knowledge is determined, maintained, and made available.
Review knowledge management systems, lessons learned, technical libraries.
☐
7.2
Personnel competence is determined, ensured, and documented.
Review competency matrices, training records, and qualifications.
☐
7.3
Personnel are aware of the quality policy, objectives, and their contribution to the QMS.
Interview staff; review onboarding and awareness training records.
☐
7.4
Internal and external communications relevant to the QMS are determined and managed.
Review communication plans and records (meetings, emails, notices).
☐
7.5.1
Documented information required by the QMS and the standard is available.
Review document list against ISO 9001 requirements.
☐
7.5.2
Documented information is adequately created and updated (format, review, approval).
Verify document control procedure; check approval signatures and version control.
☐
7.5.3
Documented information is controlled (availability, protection, distribution, retention).
Check document control system; verify access controls and retention schedules.
☐
Clause 8: Operation
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
8.1
Operational processes are planned, implemented, and controlled.
Review operational procedures; confirm criteria and controls are in place.
☐
8.2.1
Customer communication processes are established.
Review customer communication procedures and records.
☐
8.2.2
Requirements for products and services are determined before acceptance.
Review tender/quotation processes and statutory requirement checklists.
☐
8.2.3
Requirements are reviewed before commitment to supply.
Check contract review records; confirm differences are resolved.
☐
8.2.4
Changes to requirements for products and services are communicated and documented.
Verify change order processes and updated records.
☐
8.3.1
A process for design and development of products/services is established (if applicable).
Review design & development procedure; confirm applicability.
☐
8.3.2
Design and development planning includes stages, reviews, verification, and validation.
Check project plans and design review records.
☐
8.3.3
Design and development inputs are determined and documented.
Review input requirement records, functional requirements, safety standards.
☐
8.3.4
Controls for design and development (reviews, verification, validation) are implemented.
Review design review meeting minutes and approval records.
☐
8.3.5
Design and development outputs meet input requirements.
Check sign-off records, drawings, and specifications.
☐
8.3.6
Design and development changes are identified, reviewed, and controlled.
Verify design change control records and approval logs.
☐
8.4.1
Externally provided processes, products, and services conform to requirements.
Review supplier approval process and approved supplier list.
☐
8.4.2
Controls applied to external providers are defined and communicated.
Review purchase orders, specifications, and supplier quality agreements.
☐
8.4.3
Adequate information is communicated to external providers.
Check purchase orders for completeness of technical requirements.
☐
8.5.1
Production/service provision is carried out under controlled conditions.
Review work instructions, process controls, and monitoring records.
☐
8.5.2
Outputs are identified and traceability is maintained where required.
Check labeling, tagging, batch records, and traceability systems.
☐
8.5.3
Property belonging to customers or external providers is identified, verified, and safeguarded.
Review records of customer-supplied materials or tooling.
☐
8.5.4
Outputs are preserved to maintain conformity during internal processing and delivery.
Check packaging, storage, and handling procedures.
☐
8.5.5
Post-delivery activities are addressed (warranty, maintenance, recycling).
Review post-delivery service records and warranty procedures.
☐
8.5.6
Changes to production/service provision are reviewed and controlled.
Verify change control records and re-validation activities.
☐
8.6
Release of products/services occurs only when planned arrangements are verified.
Check inspection records, test reports, and approval signatures.
☐
8.7
Nonconforming outputs are identified and controlled to prevent unintended use.
Review NCR system; verify disposition records and customer notification.
☐
Clause 9: Performance Evaluation
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
9.1.1
Monitoring, measurement, analysis, and evaluation processes are determined.
Review QMS performance monitoring plan and KPI dashboard.
☐
9.1.2
Customer satisfaction is monitored and actions are taken based on results.
Review customer survey results, complaints, and satisfaction trends.
☐
9.1.3
Data and information from monitoring and measurement are analyzed and evaluated.
Check statistical reports, trend analysis, and management review inputs.
☐
9.2.1
Internal audits are conducted at planned intervals.
Review audit schedule; confirm all areas/processes are covered annually.
☐
9.2.2
Internal audit program is planned considering importance, changes, and previous results.
Check audit program; verify auditor competence and independence.
☐
9.3.1
Management reviews are conducted at planned intervals.
Review management review meeting minutes and frequency.
☐
9.3.2
Management review inputs include all required topics (audit results, performance data, etc.).
Cross-check minutes against clause 9.3.2 input list.
☐
9.3.3
Management review outputs include decisions on improvement and resource needs.
Verify action items are assigned, tracked, and closed.
☐
Clause 10: Improvement
Ref.
Audit Requirement
Guidance / Evidence to Seek
Rating
Auditor Notes / Findings
10.1
Opportunities for improvement are determined and implemented.
Review improvement register, suggestion systems, and innovation records.
☐
10.2.1
Nonconformities are identified, reacted to, and corrective actions are taken.
Review NCR/CAR log; confirm root cause analysis methodology.
☐
10.2.2
Corrective actions are appropriate to the effects of the nonconformities found.
Verify actions address root cause, not just symptoms.
☐
10.2.2
Effectiveness of corrective actions is reviewed and documented.
Check follow-up reviews and closure criteria in CAR records.
☐
10.3
Continual improvement of the QMS suitability, adequacy, and effectiveness is pursued.
Review trend data, benchmarking, and strategic improvement plans.
☐
Audit Summary & Sign-off
Audit Summary
Total Items Audited
Conforming (✓)
Nonconformities
OFIs
Overall Audit Conclusion:
Lead Auditor Signature
Date
Management Rep. Signature
Date