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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 IOS in 2000 {{Short description|General requirements for the competence of testing and calibration laboratories}}
{{Multiple issues|
. There are many commonalities with the ] 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.
{{External links|date=August 2020}}
{{More citations needed|date=January 2024}}
}}
{{Use Oxford spelling|date=January 2012}}


''']/] 17025''' '''General requirements for the competence of testing and calibration laboratories''' is the main standard used by testing and calibration laboratories. In most 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 ISO/IEC in 1999. There are many commonalities with the ] standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles.<ref>{{cite web |url=http://www.cala.ca/ISO-IEC_17025_Principals.pdf|title = Principles behind ISO/IEC 17025|publisher=Canadian Association for Laboratory Accreditation (CALA) |access-date=27 March 2018 |archive-url=https://web.archive.org/web/20190811075127/http://www.cala.ca/ISO-IEC_17025_Principals.pdf |archive-date=11 August 2019}}</ref> Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.<ref>{{cite journal |last=Honsa |first=Julie D. |author2=Deborah A. McIntyre |title=ISO 17025: Practical Benefits of Implementing a Quality System |journal=Journal of AOAC International |volume=86 |issue=5 |pages=1038–1044 |year=2003 |doi=10.1093/jaoac/86.5.1038 |pmid=14632407 |url=http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac/2003/00000086/00000005/art00023 |access-date=28 February 2012|doi-access=free }}</ref> Material in the standard also forms the basis for accreditation from an accreditation body.
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 <ref name=ciso17025>{{cite web
| last = ]
| first =
| authorlink =
| coauthors =
| title = Comparison of ISO 17025:2005 with 1999 version
| work =
| publisher =
| date =
| url = http://www.ukas.com/Library/downloads/News/News_2006/Lab%20assessment%20-%20a%20comparison%20of%20ISO%2017025%202005%20and%201999.pdf
| format =
| doi =
| accessdate = 27 February
| accessyear = 2008 }}</ref>.


There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. The 2005 release also aligned more closely with the 2000 version of ISO 9001 with regards to implementing continuous improvement.<ref>{{cite web |url=http://us.training.saiglobal.com/iso-iec-comparison-free-download |title=ISO/IEC 17025 Comparison - 1999 to 2005 |publisher=SAI Global Limited ABN |access-date=28 February 2012 |archive-url=https://web.archive.org/web/20110410155633/http://us.training.saiglobal.com/iso-iec-comparison-free-download |archive-date=2011-04-10 |url-status=dead }}</ref>
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 ] within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration equipment.


The 2005 version of the standard comprises four elements:
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results <ref name=pbiqs>{{cite journal
| last =Honsa
| first = Julie D.
| authorlink =
| coauthors = Deborah A. McIntyre
| title = ISO 17025: Practical Benefits of Implementing a Quality System
| journal = AOAC International
| volume = 86
| issue = 5
| pages = 1038–1044
| publisher =
| location =/dmirror/http/en.wikipedia.org/dmirror/http/en.wikipedia.org/dmirror/http/en.wikipedia.org/dmirror/http/en.wikipedia.org/w/
| date = 2003
| url = http://www.atypon-link.com/AOAC/doi/abs/10.5555/jaoi.2003.86.5.1038?journalCode=jaoi
| doi =
| id =
| accessdate = 26 February
| accessyear = 2008 }}</ref>. 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.


# Normative References
A prerequisite for a laboratory to become accredited is to have a documented ]. The usual contents of the quality manual follow the outline of the ] standard .
# Terms and Definitions
# Management Requirements - related to the operation and effectiveness of the ] within the laboratory
# Technical Requirements - factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.

The 2017 version comprises eight elements:

# Scope
# Normative References
# Terms and Definitions
# General Requirements - related to the organization of the laboratory
# Structural Requirements -related to the organization of the laboratory
# Resource Requirements - cites issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results
# Process Requirements - the heart of this version of the standard describes the activities to ensure that results are based on accepted science and aimed at technical validity.
# Management System Requirements -steps taken by the organization to give itself ] tools to support the work of its people in the production of technically valid results


==Predecessors== ==Predecessors==
Some national systems (e.g. ] 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 ]or may require the laboratory to justify using a particular method. Some national systems (e.g. ] M10 in the UK) were the forerunners of ISO/IEC 17025:1999 but could also be exceedingly prescriptive. ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but 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. In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. 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 ], rather than "certificated" (c.f. ISO 9000 series). In common with other accreditation standards of the ISO 17000 series (and unlike most ISO standards for management systems), assessment of the laboratory is normally carried out by the national organization responsible for ]. Laboratories are therefore "accredited" under ISO/IEC 17025, rather than "certified" or "registered" by a third party service as is the case with ISO 9000 quality standard.


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.
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.


==Accreditation Bodies== ==Accreditation bodies==
In order for accreditation bodies to recognize each other's accreditations, the ] (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, regions such as the ], the 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 African Development Community Cooperation in Accreditation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).
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 (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.


The first laboratory accreditation bodies to be established were ] (NATA) in Australia (1947) and ] in New Zealand (1973).<ref>{{Cite web|url=https://www.nata.com.au/nata/accreditation-publication/nata-field-and-program-accreditation-criteria/category/74-iso-iec-17025-laboratory-accreditation|title=NATA - NATA Field and Program Accreditation Criteria - ISO-IEC 17025 Laboratory Accreditation (Applicable to all ISO/IEC 17025 fields)|website=www.nata.com.au|language=en-gb|access-date=2017-04-28}}</ref><ref>{{Cite web|url=http://www.ianz.govt.nz/wp-content/uploads/2012/05/2001.pdf|title=Testing Laboratory Registration Council Of New Zealand|access-date=2017-04-28|archive-date=2019-08-11|archive-url=https://web.archive.org/web/20190811075133/http://www.ianz.govt.nz/wp-content/uploads/2012/05/2001.pdf|url-status=dead}}</ref> Most other bodies are based on the NATA/TELARC model include ] in the UK, ] in Finland and 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).


=== USA ===
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).
In the U.S. there are several, multidisciplinary 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. These ILAC MRA signatory accreditation bodies carry identical acceptance across the globe. It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies. ABs include:
* <ref>{{cite web |url=http://www.anab.org |title=About ANAB |publisher=American Association for Laboratory Accreditation |access-date=30 August 2022}}</ref>
* <ref>{{cite web |url=http://www.a2la.org/genweb/about.cfm |title=About A2LA |publisher=American Association for Laboratory Accreditation |access-date=28 February 2012}}</ref>
* <ref>{{cite web|url=http://www.pjlabs.com/|title=ISO/IEC 17025:2005 – Laboratory Accreditation Program- PJLA|access-date=29 May 2015}}</ref>
* ]
* <ref>{{cite web |url= http://www.iasonline.org |title= About IAS {{!}} The International Accreditation Service |access-date= 29 May 2015}}</ref>
* 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)<ref>{{cite web |url=http://www.ascld-lab.org/ |title=ASCLD-LAB home page |publisher=American Society of Crime Laboratory Directors-Laboratory Accreditation Board |access-date=12 July 2012}}</ref> which is now ANAB (see above).


=== Canada ===
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.
In Canada, there are two accreditation bodies:
* ]
* <ref>{{cite web|url=http://www.cala.ca|title=CALA|access-date=29 May 2015}}</ref>


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 ] (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.
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.

=== Other countries ===
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:

* (Australia)
* (France)
* (Germany)
* (India)
* (Indonesia)
* (Ireland)
* (Italy)
* {{Webarchive|url=https://web.archive.org/web/20210724181642/https://www.rva.nl/en/about-accreditation/disciplines/test-laboratories |date=2021-07-24 }} (The Netherlands)
* (New Zealand)
* (South Korea)
* (Vietnam)
* (Bosnia & Hercegovina)
* (Spain)
* (Belgium)


==See also== ==See also==

* ] * ]
*
* ]
*]
*]


== Notes == ==References==
{{Reflist}}
<references/>
* ISO/IEC 17025:2005


==External links== == External links ==
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Latest revision as of 18:34, 29 August 2024

General requirements for the competence of testing and calibration laboratories
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ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most 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 ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Material in the standard also forms the basis for accreditation from an accreditation body.

There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. The 2005 release also aligned more closely with the 2000 version of ISO 9001 with regards to implementing continuous improvement.

The 2005 version of the standard comprises four elements:

  1. Normative References
  2. Terms and Definitions
  3. Management Requirements - related to the operation and effectiveness of the quality management system within the laboratory
  4. Technical Requirements - factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.

The 2017 version comprises eight elements:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. General Requirements - related to the organization of the laboratory
  5. Structural Requirements -related to the organization of the laboratory
  6. Resource Requirements - cites issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results
  7. Process Requirements - the heart of this version of the standard describes the activities to ensure that results are based on accepted science and aimed at technical validity.
  8. Management System Requirements -steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results

Predecessors

Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO/IEC 17025:1999 but could also be exceedingly prescriptive. ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method.

In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. 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), 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" by a third party service as is the case with ISO 9000 quality standard.

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.

Accreditation bodies

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, regions such as the European Community, the 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 African Development Community Cooperation in Accreditation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

The first laboratory accreditation bodies to be established were National Association of Testing Authorities (NATA) in Australia (1947) and TeLaRC in New Zealand (1973). Most other bodies are based on the NATA/TELARC model include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few.

USA

In the U.S. there are several, multidisciplinary 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. These ILAC MRA signatory accreditation bodies carry identical acceptance across the globe. It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies. ABs include:

Canada

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.

Other countries

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:

See also

References

  1. "Principles behind ISO/IEC 17025" (PDF). Canadian Association for Laboratory Accreditation (CALA). Archived from the original (PDF) on 11 August 2019. Retrieved 27 March 2018.
  2. Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". Journal of AOAC International. 86 (5): 1038–1044. doi:10.1093/jaoac/86.5.1038. PMID 14632407. Retrieved 28 February 2012.
  3. "ISO/IEC 17025 Comparison - 1999 to 2005". SAI Global Limited ABN. Archived from the original on 2011-04-10. Retrieved 28 February 2012.
  4. "NATA - NATA Field and Program Accreditation Criteria - ISO-IEC 17025 Laboratory Accreditation (Applicable to all ISO/IEC 17025 fields)". www.nata.com.au. Retrieved 2017-04-28.
  5. "Testing Laboratory Registration Council Of New Zealand" (PDF). Archived from the original (PDF) on 2019-08-11. Retrieved 2017-04-28.
  6. "About ANAB". American Association for Laboratory Accreditation. Retrieved 30 August 2022.
  7. "About A2LA". American Association for Laboratory Accreditation. Retrieved 28 February 2012.
  8. "ISO/IEC 17025:2005 – Laboratory Accreditation Program- PJLA". Retrieved 29 May 2015.
  9. "About IAS | The International Accreditation Service". Retrieved 29 May 2015.
  10. "ASCLD-LAB home page". American Society of Crime Laboratory Directors-Laboratory Accreditation Board. Retrieved 12 July 2012.
  11. "CALA". Retrieved 29 May 2015.

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