QM Bench

ISO 9001 Internal Audit Checklist (Clauses 4–10) with Report

Rate each requirement, record evidence and findings, assign corrective actions and print the audit report. Audits are saved in your browser.How to use ↓
  1. 1Enter your data
  2. 2Read the verdict
  3. 3Download the PDF report
Saved in this browser

Rate each requirement. Minor or major opens fields for evidence, the finding and the corrective action. Click a selected rating again to clear it.

4 Context of the organisation

  • 4.1

    Internal and external issues relevant to the quality system are identified and reviewed.

  • 4.2

    Interested parties and their relevant requirements are known and kept up to date.

  • 4.3

    Scope of the quality management system is documented, including justified exclusions.

  • 4.4

    Processes, their sequence, interactions, inputs, outputs, owners and measures are defined.

5 Leadership

  • 5.1

    Top management takes part in the quality system and promotes process approach and risk-based thinking.

  • 5.2

    Quality policy is documented, communicated and understood (ask employees).

  • 5.3

    Roles, responsibilities and authorities are assigned and communicated.

6 Planning

  • 6.1

    Risks and opportunities are identified, actions are planned and their effectiveness evaluated.

  • 6.2

    Quality objectives are measurable, monitored and have plans with owners and dates.

  • 6.3

    Changes to the quality system are planned and controlled.

7 Support

  • 7.1.5

    Monitoring and measuring equipment is suitable, calibrated, identified and protected.

  • 7.1.6

    Organisational knowledge needed for the processes is kept and available.

  • 7.2

    Competence requirements are defined, training is given and its effectiveness evaluated.

  • 7.3

    Employees are aware of the policy, objectives and their contribution.

  • 7.5

    Documented information is controlled: approval, revision, availability, protection and retention.

8 Operation

  • 8.1

    Operational planning defines criteria, resources and records for products and services.

  • 8.2

    Customer requirements are reviewed before acceptance of orders and changes.

  • 8.3

    Design and development has planning, inputs, reviews, verification, validation and change control.

  • 8.4

    External providers are evaluated, selected and monitored, and requirements are communicated to them.

  • 8.5.1

    Production is done under controlled conditions: instructions, equipment, monitoring and qualified people.

  • 8.5.2

    Product identification and traceability are maintained where required.

  • 8.5.4

    Product is preserved during handling, storage, packaging and delivery.

  • 8.6

    Product release is done by authorised people after planned checks, with records.

  • 8.7

    Nonconforming outputs are identified, segregated and dispositioned, with records.

9 Performance evaluation

  • 9.1.2

    Customer satisfaction is monitored and the results are used.

  • 9.1.3

    Data is analysed to evaluate process performance, suppliers and the need for improvement.

  • 9.2

    Internal audit programme covers all processes, auditors are impartial and findings are followed up.

  • 9.3

    Management review is held with all required inputs and documented outputs.

10 Improvement

  • 10.2

    Nonconformities are corrected, causes are analysed and corrective actions are checked for effectiveness.

  • 10.3

    Continual improvement is planned and visible in results.

Photos (evidence)

How to use the checklist

  1. Plan: choose the processes and clauses for this audit from your audit programme. Remove questions that are out of scope with “Edit checklist”.
  2. Collect evidence: records, documents, interviews and observation. Note what you saw in the evidence field, for example “training records of 12 operators”.
  3. Rate: Conform, OFI, minor or major nonconformity, or N/A.
  4. Write the finding as requirement, evidence and gap, so the auditee can act on it.
  5. Agree actions with owners and dates and close them after checking effectiveness. Use an 8D report or A3 for the larger ones.

Writing a good nonconformity

A clear finding has three parts: the requirement (clause or internal procedure), the evidence (what was seen, with references) and the gap (why it does not meet the requirement). Avoid opinions and avoid naming people.

For automotive suppliers, use the IATF 16949 checklist in addition, and the VDA 6.3 process audit for the manufacturing process itself.

Frequently asked questions

›What is the difference between a minor and a major nonconformity?

A major nonconformity is the absence or total breakdown of a required process, or a situation that raises serious doubt that the system can deliver conforming product. A minor nonconformity is a single lapse or partial failure that does not put the system at risk. Many minors on the same requirement can add up to a major.

›What is an opportunity for improvement (OFI)?

An observation where the requirement is met, but the auditor sees a way to make the process more effective. It needs no corrective action, but it is worth recording.

›Is this checklist the text of ISO 9001?

No. The questions are our own short wording, organised by the clauses 4 to 10 of ISO 9001:2015. Use them as audit prompts together with the standard, which you need to buy from ISO or your national standards body.

›How is the conformity percentage calculated?

Conform and OFI count as 100 %, a minor nonconformity as 50 % and a major as 0 %, averaged over the rated questions. N/A is left out. The percentage is only a summary, the certification decision depends on the findings, not on a score.

›How often must internal audits be done?

ISO 9001 clause 9.2 asks for audits at planned intervals, based on the importance of the processes, changes and previous results. Most companies cover every process at least once a year.