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 International Organization for Standardization 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 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 12 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]

The contents of ISO/IEC 17025 - 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.[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.

Contents

[edit] Predecessors

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.

A notable predecessor was the european standard EN 45001, which was withdrawn after ISO 17025 was published.

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 and appraisal of the laboratory is normally carried out by the national organisation 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.

[edit] Accreditation Bodies

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).

In the US there are multiple Accreditation Bodies (ABs). The non-profit, non- government multidisciplinary ABs are A2LA American Association for Laboratory Accreditation, NVLAP (smaller but focused technical areas and some government involvement) and American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB)(crime labs). For-profit ABs are ANSI-ASQ National Accreditation Board/ACLASS, International Accreditation Service (IAS), Laboratory Accreditation Bureau (L-A-B) and Perry Johnson Laboratories (PJLA).

In Canada, there are two Accreditation bodies; The Standards Council of Canada and The Canadian Association for Laboratory Accreditation. 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. 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 India National Accreditation Board For Testing & Calibration Laboratories (NABL) under the Ministry of Department of Science & Technology, Government of India provides accreditation.

Within the United States of America, some industries and government recognize and acknowledge ILAC and its regional cooperations as acceptable; other national regulators and specifiers also acknowledge the National Cooperation for Laboratory Accreditation (NACLA).

[edit] See also

[edit] Notes

  1. ^ United Kingdom Accreditation Service. "Comparison of ISO 17025:2005 with 1999 version" (PDF). http://www.ukas.com/Library/downloads/News/News_2006/Lab%20assessment%20-%20a%20comparison%20of%20ISO%2017025%202005%20and%201999.pdf. Retrieved 27 February 2008. 
  2. ^ Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". AOAC International 86 (5): 1038–1044. doi:10.5555/jaoi.2003.86.5.1038. http://www.atypon-link.com/AOAC/doi/abs/10.5555/jaoi.2003.86.5.1038?journalCode=jaoi. Retrieved 26 February 2008. 

[edit] External links

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