ISO 17025
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ISO 17025, "General requirements for the competence of testing and calibration laboratories" is an ISO standard differs from "ISO 9000 in that it takes quality management systems a stage further by looking at the competence of the laboratory as well as the fitness for purpose of the quality management system.
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[edit] Predecessors
Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO 17025:1999 but could sometimes be exceedingly prescriptive. ISO 17025 allows laboratories to carry out procedures in their own ways, but an auditor may require the laboratory to justify using a particular method.
In common with other ISO quality standards, ISO 17025 requires continual improvement. Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.
Unlike most ISO standards for systems, third party auditing and appraisal of the laboratory is not usually carried out by a certification body, but by the national organisation responsible for accreditation. Laboratories are therefore "accredited" under ISO/IEC 17025, rather than "certificated" (c.f. ISO 9000 series).
The original standard, ISO 17025:1999 was withdrawn and replaced by ISO 17025:2005, though the differences between the two standards are small.
[edit] Accreditation Bodies
In the US there are multiple Accreditation Bodies, NVLAP, L.A.B., Perry Johnson Laboratories, ACLASS, A2LA, ILAA and others. In other countries there is usually at least one Accreditation Body. The first laboratory accreditation bodies to be established were NATA in Australia (1948) and TELARC in New Zealand (1973) most other bodies are based on the NATA/TELARC model and include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few.[citation needed]
In order for accreditation bodies to recognise each others' accreditation, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geopolitical regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).[citation needed] Within the United States of America, an organisation was started to mutually recognise the work of these bodies. It is the National Cooperation for Laboratory Accreditation (NACLA).[citation needed] Many people perceive these arrangement bodies to be oversight groups for accrediting bodies, but they are really there to help accreditation bodies mutually recognise each other in a systematic and formal way. They also help regulators by formally recognising the processes and competence of the accrediting body.[citation needed] They help build trust between accrediting bodies and for their biggest stakeholders - labs, the public and regulatory agencies. Within the USA, both A2LA and, as of April 2006, NVLAP, have decided to remove themselves from NACLA citing redundancy in accreditation as well as financial issues.[citation needed]
