ISO 9001:2015 Internal Audit Checklist

ISO 9001:2015 Internal Audit Checklist

Use this comprehensive checklist to audit your QMS against ISO 9001:2015 requirements.

How to Use This Checklist

✅ C = Conformity (requirement met)
❌ NC = Nonconformity (requirement not met - major or minor)
🔍 OBS = Observation (opportunity for improvement)
➖ N/A = Not Applicable

Clause 4: Context of the Organization

4.1 Understanding the Organization and its Context

• Internal issues identified and documented?
• External issues identified and documented?
• Analysis reviewed and updated regularly?
• Issues relevant to QMS purpose and strategic direction?

Evidence to request: Context analysis document, SWOT/PESTLE

4.2 Understanding Needs and Expectations of Interested Parties

• Relevant interested parties identified?
• Their requirements determined?
• This information monitored and reviewed?

Evidence to request: Interested party register, stakeholder analysis

4.3 Determining the Scope of the QMS

• QMS scope determined and maintained as documented information?
• Consider external/internal issues (4.1)?
• Consider interested party requirements (4.2)?
• Scope states products and services?
• Available to interested parties?
• Any applicable requirements excluded justified?

Evidence to request: QMS Scope document

4.4 QMS and Its Processes

• Processes and interactions determined?
• For each process:
  • Required inputs and expected outputs determined?
  • Sequence and interaction with other processes?
  • Criteria and methods for operation and control?
  • Resources determined and ensured available?
  • Responsibilities and authorities assigned?
  • Risks and opportunities addressed?
  • monitoring and measurement methods determined?
  • Improvement opportunities determined?

Evidence to request: Process map, process descriptions, turtle diagrams

Clause 5: Leadership

5.1.1 General Leadership and Commitment

• Top management demonstrates leadership by:
  • Taking accountability for QMS effectiveness?
  • Ensuring quality policy and objectives established?
  • Ensuring integration into business processes?
  • Promoting process approach and risk-based thinking?
  • Ensuring resources available?
  • Communicating importance of effective QMS?
  • Ensuring QMS achieves intended results?
  • Engaging, directing, and supporting people?
  • Promoting improvement?
  • Supporting other management roles?

Evidence: Interview top management, management review minutes

5.1.2 Customer Focus

• Customer requirements determined and met?
• Applicable statutory/regulatory requirements determined and met?
• Risks and opportunities affecting conformity addressed?
• Focus on enhancing customer satisfaction?

Evidence: Contract review records, customer communications

5.2 Quality Policy

• Quality policy established?
• Appropriate to purpose and context?
• Framework for quality objectives?
• Includes commitment to satisfy requirements?
• Includes commitment to continual improvement?
• Available as documented information?
• Communicated within organization?
• Available to interested parties as appropriate?

Evidence: Quality policy document, communication records

5.3 Organizational Roles, Responsibilities and Authorities

• Responsibilities and authorities assigned and communicated?
• Specific responsibilities for:
  • Ensuring conformity to ISO 9001?
  • Ensuring processes deliver intended outputs?
  • Reporting on QMS performance?
  • Promoting customer focus?
  • Ensuring QMS integrity during changes?

Evidence: Organization chart, job descriptions, responsibility matrix

Clause 6: Planning

6.1 Actions to Address Risks and Opportunities

• Risks and opportunities determined?
• Actions planned to address risks/opportunities?
• How to integrate actions into QMS processes?
• How to evaluate effectiveness of actions?

Evidence: Risk register, risk assessments, FMEA

6.2 Quality Objectives and Planning

• Quality objectives established at relevant functions/levels?

• Objectives:

  • Consistent with quality policy?
  • Measurable?
  • Take into account applicable requirements?
  • Relevant to conformity and customer satisfaction?
  • Monitored?
  • Communicated?
  • Updated as appropriate?
  • Maintained as documented information?

• Planning for objectives includes:

  • What will be done?
  • Resources required?
  • Who is responsible?
  • When completed?
  • How results evaluated?

Evidence: Quality objectives document, progress tracking

6.3 Planning of Changes

• When changes needed, carried out in planned manner?
• Consider purpose and consequences of changes?
• Consider integrity of QMS?
• Consider resource availability?
• Consider allocation/reallocation of responsibilities?

Evidence: Change requests, change logs

Clause 7: Support

7.1.1 Resources - General

• Resources determined and provided for:
  • Establishment of QMS?
  • Implementation of QMS?
  • Maintenance of QMS?
  • Continual improvement of QMS?

Evidence: Budget allocation, resource planning

7.1.2 People

• Necessary persons for effective QMS determined and provided?

Evidence: Staff count, hiring plans

7.1.3 Infrastructure

• Infrastructure determined and provided?
• Buildings and associated utilities?
• Equipment (hardware and software)?
• Transportation resources?
• Information and communication technology?

Evidence: Facilities, equipment list

7.1.4 Environment for Process Operation

• Suitable environment determined and provided?
• Social factors considered (non-discriminatory, calm)?
• Psychological factors (stress-reducing)?
• Physical factors (temperature, humidity, light, hygiene)?

Evidence: Workplace assessment

7.1.5 Monitoring and Measuring Resources

• Resources suitable for monitoring/measurement determined and provided?
• Resources suitable for ensuring valid results?
• Resources maintained?
• Retained documented information as evidence of fitness?
• If measurement traceability required:
  • Calibrated or verified at specified intervals?
  • Identified to determine status?
  • Safeguarded from adjustments?
  • Protected from damage/deterioration?

Evidence: Calibration certificates, calibration schedule, equipment list

7.2 Competence

• Necessary competence determined?
• Personnel are competent based on education, training, experience?
• Actions taken to acquire competence if needed?
• Effectiveness of actions evaluated?
• Documented information retained as evidence?

Evidence: Training matrix, training records, competence evaluations

7.3 Awareness

• Personnel aware of:
  • Quality policy?
  • Relevant quality objectives?
  • Their contribution to QMS effectiveness?
  • Implications of not conforming to QMS requirements?

Evidence: Employee interviews, awareness surveys

7.4 Communication

• Internal and external communications determined?
• Determined:
  • What to communicate?
  • When to communicate?
  • With whom to communicate?
  • How to communicate?
  • Who communicates?

Evidence: Communication plan, meeting minutes

7.5 Documented Information

7.5.1 General

• QMS includes documented information required by ISO 9001?
• Includes documented information determined necessary?

7.5.2 Creating and Updating

• When creating/updating, appropriate:
  • Identification and description?
  • Format and media?
  • Review and approval for suitability and adequacy?

7.5.3 Control of Documented Information

• Documents controlled to ensure:
  • Available and suitable where needed?
  • Adequately protected?
• Distribution, access, retrieval, use addressed?
• Storage and preservation addressed?
• Control of changes addressed?
• Retention and disposition addressed?
• External documents identified and controlled?
• Obsolete documents prevented from unintended use?

Evidence: Document register, document control procedure

Clause 8: Operation

8.1 Operational Planning and Control

• Processes needed for products/services planned, implemented, controlled?
• Requirements for products/services determined?
• Criteria for processes and product/service acceptance?
• Resources determined?
• Process control implemented?
• Documented information retained for confidence in processes and products/services?

Evidence: Production plans, work instructions

8.2 Requirements for Products and Services

8.2.1 Customer Communication

• Communication with customers includes:
  • Information on products/services?
  • Inquiries, contracts, orders, changes?
  • Customer feedback, complaints?
  • Handling/controlling customer property?
  • Contingency actions when relevant?

Evidence: Customer communications, complaint logs

8.2.2 Determining Requirements

• Requirements for products/services determined:
  • Customer-specified including delivery and post-delivery?
  • Not stated but necessary?
  • Statutory and regulatory?
  • Additional requirements determined by organization?

Evidence: Specifications, contracts

8.2.3 Review of Requirements

• Review conducted before committing to supply?
• Review ensures:
  • Product/service requirements defined?
  • Contract/order requirements differing from previous resolved?
  • Organization has ability to meet requirements?
• Documented information retained on review results?
• New requirements confirmed when changed?

Evidence: Contract review records, order review

(Checklist continues with clauses 8.3-10.3)…

Download Complete: Full ISO 9001:2015 Audit Checklist (Excel)

Related: How to Conduct Internal Audits