ISO/IEC17025:1999 is the international standard, for accrediting calibration and testing laboratories. ISO/IEC Guide 25 'General Requirements for the Competence of Calibration and Testing Laboratories' was published in 1990 as the internationally agreed set of quality system requirements applicable to laboratories who perform calibration and/or testing services. It was superseded in early 2000 by ISO/IEC 17025 which will form the basis for laboratory accreditation in the future. Based upon ISO 9001, but written for the particular needs of laboratory management, ISO/IEC 17025 addresses the proficiency of the organization to perform the testing and calibration activities. ISO/IEC 17025 provides a framework for the special needs of organizations that want to control their laboratory processes and are seeking to achieve an independent, external accreditation.
When a laboratory seeks to prove conformity with ISO/IEC 17025, it must satisfy all of the following requirements:
- to operate a Quality Management System.
- to have technical competence.
- to have the competence to produce technically reliable results.
Of the above requirements, item 1 is covered by the Quality Management System Standard, ISO 9001:2008. ISO 9001:2008 does not, however, cover items 2 and 3, which relate to technical competence. Therefore, it is internationally accepted practice for laboratories to obtain accreditation against ISO/IEC 17025. This is because ISO 9001 certification only covers QMS for a laboratory but does not prove its technical competence. ISO/IEC 17025 is, in fact, a conformity assessment standard, a check on the competence of a laboratory to undertake certain tests and issue reliable test reports.
ISO/IEC 17025 does however, contain all the QMS elements of ISO 9001/9002:1994. Therefore, if a laboratory is accredited against ISO/IEC 17025 this means that it is operated in accordance with ISO 9001/9002 and that it is competent to conduct tests in certain fields and issue test reports.
The requirements of ISO/IEC 17025 address the following two areas:
- “Management requirements” – requirements for sound management .
- “Technical requirement” – requirements for technical competence appropriate for the types of testing and calibration that the laboratory conducts.
The ISO/IEC 17025 standard is applicable for both free standing laboratories, as well as laboratories which are part of a larger organization. While many quality system elements of ISO/IEC 17025 mirror those of the international quality management systems standard, ISO 9001, ISO/IEC 17025 has additional technical competency requirements, which are unique for testing, and calibration, laboratories. The technical requirements go beyond QMS accreditation and relate specifically to the qualifications needed, which respect to personnel, equipment, facilities, and laboratory methods.
The standard can be applied to any permanent or mobile laboratory that performs calibration and/or testing for its own or an external organization. The majority of accreditations have been granted to commercial and governmental calibration or test facilities.