An internal audit is your best tool for ensuring your laboratory's quality management system is working as intended. This comprehensive checklist, broken down by clause, will help you assess every aspect of your ISO/IEC 17025:2017 system and prepare you for your external audit.

Clause 4: General Requirements

  • 4.1 Impartiality: Is there a documented commitment to impartiality? Are risks to impartiality identified and managed on an ongoing basis?
  • 4.2 Confidentiality: Are there legally enforceable commitments to maintain confidentiality of all information obtained during laboratory activities?

Clause 5: Structural Requirements

  • 5.1 Legal Entity: Is the laboratory, or the organization of which it is a part, a legal entity?
  • 5.2 Laboratory Management: Has management been identified with overall responsibility for the laboratory?
  • 5.3 Range of Activities: Is the range of laboratory activities defined and documented?
  • 5.4 QMS: Does the laboratory have a quality management system that is appropriate to the scope of its activities?

Clause 6: Resource Requirements

  • 6.2 Personnel: Are all personnel, both internal and external, competent and working in accordance with the laboratory's management system? Are job descriptions and training records maintained?
  • 6.3 Facilities and Environmental Conditions: Are the facilities and environmental conditions suitable for the laboratory activities and do they not adversely affect the validity of results?
  • 6.4 Equipment: Is all equipment required for the correct performance of laboratory activities available? Is it calibrated and maintained?
  • 6.5 Metrological Traceability: Are measurement results traceable to the International System of Units (SI)?

Clause 7: Process Requirements

  • 7.1 Review of Requests, Tenders and Contracts: Is there a procedure for the review of requests, tenders and contracts?
  • 7.2 Selection, Verification and Validation of Methods: Are methods and procedures appropriate for the laboratory activities? Are they validated?
  • 7.4 Handling of Test or Calibration Items: Is there a procedure for the transportation, receipt, handling, protection, storage, retention, and/or disposal of test or calibration items?
  • 7.7 Ensuring the Validity of Results: Is there a procedure for monitoring the validity of results? (e.g., use of reference materials, participation in proficiency testing).
  • 7.8 Reporting of Results: Are results reviewed and authorized prior to release? Do reports include all the information required by the standard?

Clause 8: Management System Requirements

  • 8.2 Management System Documentation: Has the laboratory established, documented, and maintained policies and objectives for the fulfillment of the purposes of this document?
  • 8.5 Actions to Address Risks and Opportunities: Has the laboratory planned actions to address risks and opportunities?
  • 8.7 Corrective Actions: Is there a procedure for implementing corrective actions when nonconforming work is identified?
  • 8.8 Internal Audits: Does the laboratory conduct internal audits at planned intervals?
  • 8.9 Management Reviews: Does top management review the laboratory's management system at planned intervals?