ISO/IEC 17025
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 International Organization for Standardization in 2000 . 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 organizations 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.
The standard was first published in 2001 and 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 [1].
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 [2]. 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.
A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard [1].
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Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO/IEC 17025:1999 but could sometimes be exceedingly prescriptive. ISO/IEC 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/IEC 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/IEC 17025:1999 was withdrawn and replaced by ISO/IEC 17025:2005, though the differences between the two standards are small.
In the US there are multiple Accreditation Bodies, IAS, 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 (1947) 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.
- ^ United Kingdom Accreditation Service. "Comparison of ISO 17025:2005 with 1999 version". Retrieved on 27 February, 2008.
- ^ Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". AOAC International 86 (5): 1038–1044. http://www.atypon-link.com/AOAC/doi/abs/10.5555/jaoi.2003.86.5.1038?journalCode=jaoi. Retrieved on 26 February.
- ISO/IEC 17025:2005
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