ISO 17025 is an international standard that specifies the requirements for the competence of testing and calibration laboratories. Developed collaboratively by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), the ISO/IEC 17025 standard was devised to help these facilities ensure that they operate efficiently and can produce valid and reliable results. Certification to ISO 17025 enables testing and calibration laboratories around the world to demonstrate that they maintain a high level of technical competence and have sufficiently developed their quality management systems (QMS). ISO 17025 is referenced by regulators and accreditation bodies to assess or confirm the competence, consistent operation, and impartiality of laboratories.
A laboratory of any size that performs testing and calibration can obtain ISO 17025 accreditation by preparing its quality management and technical operations to meet the standard’s guidelines, conducting internal audits and management reviews, and then applying to an accreditation body for a formal assessment. Upon successful assessment and resolution of any nonconformities, accreditation is granted.
The main benefits of ISO 17025 accreditation include enhanced credibility, reduced uncertainty in test results, access to more contracts for testing and calibration, and an improvement in operational efficiency. While there are no specific prerequisites for ISO 17025 accreditation, laboratories must be fully operational and capable of performing testing or calibration activities that fall within the scope of their accreditation.
If a laboratory fails to meet ISO 17025 standards during an audit, it may be given a specific time frame in which to correct any nonconformities. If the issues are not resolved satisfactorily, the laboratory may lose its accreditation until it can demonstrate compliance.
No, ISO 17025 applies to organizations of all types and sizes that perform tests and/or calibrations. These include first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
Yes, the updated version of ISO 17025 released in 2017 introduced several changes, including a greater emphasis on the responsibilities of senior management, risk-based thinking, the addition of information technology and cybersecurity in the context of calibration and testing, and adjustments to the structure to align with other ISO quality standards.