Courtesy: ISO 17025
ISO/IEC 17025 is an International Organization for Standardization (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the ISO 9000 family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.
History
ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions following in 1982 and 1990. Guide 25 was created with the belief that “third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures.” In the mid- to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard and introduce tight compatibility with ISO 9001, which was also being revised, such that ISO 9001 would be treated as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to testing and calibration laboratories.
ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release—ISO/IEC 17025:2005—was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.
At the end of November 2017, the ISO released an updated version, ISO/IEC 17025:2017. This update brought with it broader scope in sampling, testing, and calibration; a more consistent process approach; a stronger focus on information technologies; and the addition of risk-based thinking methods.
The standard
The ISO/IEC 17025:2017 standard itself comprises eight (formerly five) elements: scope, normative references, terms and definitions, general requirements, structural requirements, resource requirements, process requirements, and management system requirements. Two annexes are also included. The management and technical requirements sections of 2005 were further broken out into general, structural, resource, process, and management system requirements. The management system requirements section remains one of the more important ones, detailing the operation and effectiveness of the quality management system within the laboratory, with the process requirements being equally as vital.