| Ref | Question | Evidence | |-----|----------|----------| | 7.1 | Are adequate resources (people, infrastructure, environment, monitoring equipment) available? | Equipment list, facility conditions, hiring records | | 7.1.5 | Is monitoring and measuring equipment calibrated/traceable? | Calibration register, stickers, certificates | | 7.2 | Are personnel competent based on education, training, or experience? | Competence matrix, training records, interview | | 7.3 | Do employees have awareness of quality policy, objectives, and their contribution? | Random employee interviews | | 7.4 | Is internal and external communication regarding QMS effective? | Communication logs, meeting minutes, intranet | | 7.5 | Is documented information controlled (review, approval, version, access)? | Document control list, revision history, access restrictions | | 7.5.3 | Are records retained and protected from loss/damage? | Retention schedule, backup logs, filing system |
An ISO 9001 audit checklist typically consists of several sections, each corresponding to a clause of the standard. The checklist may include: audit 9001 checklist
| Section | Conforming? (Y/N/Partial) | Major Nonconformities | Minor Nonconformities | Observations / OFIs | |---------|----------------------------|-----------------------|-----------------------|----------------------| | 4 – Context | | | | | | 5 – Leadership | | | | | | 6 – Planning | | | | | | 7 – Support | | | | | | 8 – Operation | | | | | | 9 – Evaluation | | | | | | 10 – Improvement | | | | | | Ref | Question | Evidence | |-----|----------|----------|
Below are examples of high-impact questions derived from the standard. | Competence matrix, training records, interview | | 7
Do not audit clause by clause in isolation. Audit by process.