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ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence. 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 1999 and on 12 May 2005 the alignment work of the ISO/CASCO committee responsible for it was completed with the issuance of the reviewed 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.
The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are 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 includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
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. 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.
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 (assessor) may require the laboratory to justify using a particular method.
A notable predecessor was the European standard EN 45001, which was withdrawn after ISO/IEC 17025 was published and adopted as EN ISO/IEC 17025.
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.
In common with other accreditation standards of the ISO 17000 series (and unlike most ISO standards for management systems), third party auditing (assessment) of the laboratory is normally carried out by the national organization responsible for accreditation. Laboratories are therefore accredited under ISO/IEC 17025, rather than certified or registered (c.f. ISO 9000 series).
In short, accreditation differs from certification by adding the concept of a third party (Accreditation Body (AB)) attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system, specific to a Scope of Accreditation.
In order for accreditation bodies to recognize each other's accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO/CASCO 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).
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 the U.S. there is a variety of accreditation bodies that serve the laboratory community. These bodies accredit testing and calibration labs, reference material producers, PT providers, product certifiers, inspection bodies, forensic institutions and others to a multitude of standards and programs. The two primary multidisciplinary, non-profit, non-government ABs in the US are ANSI-ASQ National Accreditation Board (ACLASS, ANAB, FQS) and the A2LA. A comprehensive list of ABs include:
- The ANSI-ASQ National Accreditation Board and their associated brands ACLASS, FQS, and ANAB
- The American Association for Laboratory Accreditation (A2LA)
- Laboratory Accreditation Bureau
- Perry Johnson Laboratory Accreditation (PJLA)
- American Industrial Hygiene Association
- International Accreditation Service
- National Voluntary Laboratory Accreditation Program (NVLAP) - technically part of the US government and only accredits a few narrow disciplines
- American Society of Crime Laboratory Directors-Laboratory Accreditation Board (ASCLD-LAB)
In Canada, there are two accreditation bodies:
The accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada (SCC) Program for the Accreditation of Laboratories-Canada (PALCAN), and the National Research Council of Canada (NRC) Calibration Laboratory Assessment Service (CLAS). The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System. In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for management systems, product certification, laboratory, inspection, personnel and others.
In New Zealand (Aotearoa), the accreditation body is:
In Vietnam, the accreditation body is:
In India, the accreditation body is:
- "ISO/IEC 17025 Comparison - 1999 to 2005". SAI Global Limited ABN. Retrieved 28 February 2012.
- Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". Journal of AOAC International 86 (5): 1038–1044. Retrieved 28 February 2012.
- "ACLASS Overview - Who We Are". ANSI-ASQ National Accreditation Board. Retrieved 28 February 2012.
- "About A2LA". American Association for Laboratory Accreditation. Retrieved 28 February 2012.
- "ASCLD-LAB home page". American Society of Crime Laboratory Directors-Laboratory Accreditation Board. Retrieved 12 July 2012.