In short: ISO/IEC 17025:2017 is the updated standard for the competence of testing and calibration laboratories. It adds risk-based thinking, a stronger process focus, new rules on decision rules and statements of conformity, and flexible management system options.
What is ISO/IEC 17025?
ISO/IEC 17025 specifies general requirements for the competence, impartiality and consistent operation of laboratories. Accreditation bodies use it to accredit testing and calibration laboratories.
What changed in the 2017 edition?
- New structure aligned with other conformity assessment standards
- Risk-based thinking replacing preventive action
- Greater focus on process requirements and results
- Requirements for decision rules when stating conformity
- Options A and B for the laboratory management system, including use of ISO 9001
- Updated requirements for information technology and electronic records
How long do laboratories have to transition?
A three-year transition period applies for accredited laboratories to move to the 2017 edition.
Key takeaways
- ISO/IEC 17025:2017 modernizes laboratory competence requirements.
- Impartiality, risk and decision rules are key new themes.
- Laboratories can use an ISO 9001-based management system (Option B).
Frequently asked questions
Is ISO/IEC 17025 a certification or accreditation?
Laboratories are accredited to ISO/IEC 17025 by accreditation bodies, not certified.
What is a decision rule?
A rule describing how measurement uncertainty is accounted for when stating conformity with a specification.
Does the lab need ISO 9001?
No, but Option B allows a lab with an ISO 9001 system to meet the management requirements through it.