ISO/IEC 17025
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ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the ISO in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organisations that produce testing and calibration results. Since its initial release, a second release was made in 2005 after it was agreed that it needed to have its quality system words more closely aligned with the 2000 version of ISO 9001.
On 12th May 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.
There are two main sections in ISO/IEC 17025 - Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration equipment.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an Accreditation Body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
In the US there are multiple Accreditation Bodies, NVLAP, L.A.B., Perry Johnson Laboratories, ACLASS, A2LA, 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.
In order for accreditation bodies to recognise each others' accreditations, 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, geo-political 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).
Within the United States of America, a nation that has over 160 accreditation bodies of all different types, an organisation was started to mutually recognise the work of these bodies. It is the National Cooperation for Laboratory Accreditation (NACLA).
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. 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.
[edit] References
- ISO/IEC 17025:2005
