ISO/IEC 17025:2017 Internal Audit Checklist

Purpose

This checklist is designed to assist internal auditors in assessing a laboratory’s compliance with ISO/IEC 17025:2017. It covers all clauses from 4 to 8.

How to Use

1. Preparation: Review the laboratory’s documents (Quality Manual, procedures) before the audit.
2. Audit: Use the checklist to guide your questions and observations.
3. Evidence: Record objective evidence for each question (e.g., “Observed record X,” “Interviewed staff Y”).
4. Finding: Mark each item as Compliant (C), Non-Compliant (NC), or Opportunity for Improvement (OFI).

Checklist Sections

4. General Requirements

• 4.1 Impartiality: Are risks to impartiality identified and managed? Is the laboratory structured to safeguard impartiality?
• 4.2 Confidentiality: Are there legally enforceable commitments to keep information confidential?

5. Structural Requirements

• 5.1 Legal Entity: Is the laboratory a legal entity or part of one?
• 5.2 Management: Has the laboratory identified management with overall responsibility?
• 5.3 Scope: Is the range of laboratory activities defined and documented?
• 5.5 Organization: Is the organizational structure, authority, and interrelationships documented?

6. Resource Requirements

• 6.2 Personnel: Are all personnel competent? are there records of authorization, competence, and monitoring?
• 6.3 Facilities: Are environmental conditions suitable and monitored?
• 6.4 Equipment: Is equipment verified/calibrated? Are records maintained? Is there a calibration program?
• 6.5 Metrological Traceability: Is measurement results traceable to the SI?
• 6.6 Externally Provided Products/Services: Are suppliers evaluated and monitored?

7. Process Requirements

• 7.1 Review of Requests: Are requirements adequately defined, documented, and understood? Can the lab meet them?
• 7.2 Methods: are appropriate methods selected and verified/validated?
• 7.3 Sampling: Is there a sampling plan and method (if applicable)?
• 7.4 Handling of Test Items: Are items protected from deterioration? Is there a tracking system?
• 7.5 Technical Records: Do records contain sufficient information to facilitate an identification of factors affecting the measurement result?
• 7.6 Measurement Uncertainty: Is MU evaluated for all calibrations and testing (where applicable)?
• 7.7 Validity of Results: is there a procedure for monitoring the validity of results (QC)?
• 7.8 Reporting: Do reports contain all required information?
• 7.9 Complaints: Is there a documented process for handling complaints?
• 7.10 Nonconforming Work: Is there a procedure implemented when work does not conform?

8. Management System Requirements

• 8.2 Documentation: are policies and objectives established?
• 8.3 Control of Documents: Are documents approved, reviewed, and controlled?
• 8.4 Control of Records: Are records legible and retrievable?
• 8.5 Risks and Opportunities: Are risks and opportunities considered and acted upon?
• 8.6 Improvement: Does the lab seek feedback and identify improvements?
• 8.7 Corrective Actions: Are causes of nonconformities eliminated?
• 8.8 Internal Audits: Are audits conducted at planned intervals?
• 8.9 Management Reviews: Does management review the system at planned intervals?