ISO/IEC 17025 - Revision history

Shawndouglas: /* References */

2023-01-24T20:52:33Z

References

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	==Further reading==		==Further reading==

	* {{cite web \|url=https://www.unido.org/sites/default/files/2010-08/Complying_with_ISO_17025_A_practical_guidebook_0.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106}}		* {{cite web \|url=https://www.unido.org/sites/default/files/2010-08/Complying_with_ISO_17025_A_practical_guidebook_0.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106}}

	* {{cite web \|url=https://www.pjlabs.com/downloads/17025-Transition-Book.pdf \|format=PDF \|title=ISO/IEC 17025:2017 Transition \|publisher=Perry Johnson Laboratory Accreditation, Inc \|date=26 February 2019}}		* {{cite web \|url=https://www.pjlabs.com/downloads/17025-Transition-Book.pdf \|format=PDF \|title=ISO/IEC 17025:2017 Transition \|publisher=Perry Johnson Laboratory Accreditation, Inc \|date=26 February 2019}}

	==External links==		==External links==

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	==References==		==References==
	~~<references />~~		{{Reflist\|colwidth=30em}}

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Shawndouglas: Updated citations and content for 2020.

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Updated citations and content for 2020.

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Shawndouglas: Updated a citation

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	The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. Two annexes are also included. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.		The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. Two annexes are also included. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.

	The standard is organized as follows<ref name="ISO17025Peak">{{cite web \|url=https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en \|title=ISO/IEC 17025:~~2005~~(en) - General requirements for the competence of testing and calibration laboratories \|work=ISO Online Browsing Platform (OBP) \|publisher=International Organization for Standardization \|date=~~2005~~ \|accessdate=~~20 February 2015~~}}</ref><ref name="ACT">{{cite web \|url=http://actlabs.com/page.aspx?menu=60&app=206&cat1=732&tp=2&lk=no \|title=ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories \|publisher=Activation Laboratories Ltd \|accessdate=20 February 2015}}</ref>:		The standard is organized as follows<ref name="ISO17025Peak">{{cite web \|url=https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en \|title=ISO/IEC 17025:2017(en) - General requirements for the competence of testing and calibration laboratories \|work=ISO Online Browsing Platform (OBP) \|publisher=International Organization for Standardization \|date=2017 \|accessdate=19 March 2020}}</ref><ref name="ACT">{{cite web \|url=http://actlabs.com/page.aspx?menu=60&app=206&cat1=732&tp=2&lk=no \|title=ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories \|publisher=Activation Laboratories Ltd \|accessdate=20 February 2015}}</ref>:

	===Scope===		===Scope===

Shawndouglas: /* History */ Clarified 2005 version

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History: Clarified 2005 version

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	ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures."<ref name="Comp17025">{{cite web \|url=http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106 \|accessdate=20 February 2015}}</ref> In the mid- to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard and introduce tight compatibility with [[ISO 9001]], which was also being revised, such that ISO 9001 would be treated as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to testing and calibration laboratories.		ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures."<ref name="Comp17025">{{cite web \|url=http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106 \|accessdate=20 February 2015}}</ref> In the mid- to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard and introduce tight compatibility with [[ISO 9001]], which was also being revised, such that ISO 9001 would be treated as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to testing and calibration laboratories.

	ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<ref name="Difs">{{cite web \|url=http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf \|format=PDF \|title=ISO/IEC 17025:1999 versus 2005 \|author=Hoolihan, Daniel D \|publisher=Hoolihan EMC Consulting \|accessdate=20 February 2015}}</ref><ref name="Comp17025" />		ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release — ISO/IEC 17025:2005 — was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<ref name="Difs">{{cite web \|url=http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf \|format=PDF \|title=ISO/IEC 17025:1999 versus 2005 \|author=Hoolihan, Daniel D \|publisher=Hoolihan EMC Consulting \|accessdate=20 February 2015}}</ref><ref name="Comp17025" />

	ISO/IEC 17025:1999 became defunct in May 2007.		ISO/IEC 17025:1999 became defunct in May 2007.

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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]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.		[[File:US Navy 100714-N-3852A-118 Hull Systems Technician monitors nitrogen tank.jpg\|thumb\|400px\|Even military testing and calibration labs like the Navy Standards Laboratory (WPP) opt to get ISO/IEC 17025 certified.<ref name="NAVY">{{cite web \|url=http://l-a-b.com/company/navy-standards-laboratory-wpp-naval-surface-warfare-center-corona-division/ \|title=Navy Standards Laboratory (WPP), Naval Surface Warfare Center, Corona Division \|publisher=Lab Accreditation Bureau \|accessdate=20 February 2015}}</ref>]]
			'''ISO/IEC 17025''' is an [[International Organization for Standardization]] (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the [[ISO 9000]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.

	Since its initial release, a second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<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 \|accessdate~~=~~28 February 2012}}</ref>~~		==History==

	~~The~~ ISO/IEC 17025 ~~standard itself comprises five elements: scope~~, ~~normative references~~, ~~terms~~ and ~~definitions~~, ~~management requirements~~, and ~~technical requirements~~. In ~~particular~~ the ~~management and technical requirements are the most important sections~~, ~~with~~ the ~~management requirement section detailing~~ the ~~operation~~ and ~~effectiveness of the quality management system within the laboratory~~ and the ~~technical requirements section detailing the factors which determine the correctness and reliability~~ of ~~the tests~~ and ~~calibrations performed in laboratory~~.		ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures."<ref name="Comp17025">{{cite web \|url=http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106 \|accessdate=20 February 2015}}</ref> In the mid- to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard and introduce tight compatibility with [[ISO 9001]], which was also being revised, such that ISO 9001 would be treated as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to testing and calibration laboratories.

	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. \|coauthors=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 \|url=http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac/2003/00000086/00000005/art00023 \|accessdate=28 February 2012}}</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. 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.		ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<ref name="Difs">{{cite web \|url=http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf \|format=PDF \|title=ISO/IEC 17025:1999 versus 2005 \|author=Hoolihan, Daniel D \|publisher=Hoolihan EMC Consulting \|accessdate=20 February 2015}}</ref><ref name="Comp17025" />

			ISO/IEC 17025:1999 became defunct in May 2007.

			==The standard==

			The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. Two annexes are also included. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.

			The standard is organized as follows<ref name="ISO17025Peak">{{cite web \|url=https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en \|title=ISO/IEC 17025:2005(en) - General requirements for the competence of testing and calibration laboratories \|work=ISO Online Browsing Platform (OBP) \|publisher=International Organization for Standardization \|date=2005 \|accessdate=20 February 2015}}</ref><ref name="ACT">{{cite web \|url=http://actlabs.com/page.aspx?menu=60&app=206&cat1=732&tp=2&lk=no \|title=ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories \|publisher=Activation Laboratories Ltd \|accessdate=20 February 2015}}</ref>:

			===Scope===
			The scope of the standard is described over six points. It states what type of testing and calibration is covered; who it's applicable to; the purpose for the standard; what's not covered; and how it relates to ISO 9001.

			===Normative references===
			This section states both ISO/IEC 17000 and the International Vocabulary of Metrology (VIM) are vital to applying the standard.

			===Terms and definitions===
			This sections simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM.

			===Management requirements===
			The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this section. The requirements are broken down into 15 subsections:

			'''4.1''' Organization

			'''4.2''' Management system

			'''4.3''' Document control

			'''4.4''' Review of requests, tenders and contracts

			'''4.5''' Subcontracting of tests and calibrations

			'''4.6''' Purchasing services and supplies

			'''4.7''' Service to the customer

			'''4.8''' Complaints

			'''4.9''' Control of nonconforming testing and/or calibration work

			'''4.10''' Improvement

			'''4.11''' Corrective action

			'''4.12''' Preventive action

			'''4.13''' Control of records

			'''4.14''' Internal audits

			'''4.15''' Management reviews

			===Technical requirements===
			The requirements for staff competence, methodologies, equipment testing and calibration, and test methods are outlined in this section. The requirements are broken down into 10 subsections:

			'''5.1''' General

			'''5.2''' Personnel

			'''5.3''' Accommodation and environmental conditions

			'''5.4''' Test and calibration methods and method validation

			'''5.5''' Equipment

			'''5.6''' Measurement traceability

			'''5.7''' Sampling

			'''5.8''' Handling of test and calibration items

			'''5.9''' Assuring the quality of the test and calibration results

			'''5.10''' Reporting the results

			===Annexes===
			Two annexes and a bibliography are included. ''Annex A: Nominal cross-references to ISO 9001:2000'' provides links between this standard and ISO 9001, important as this standard includes requirements not covered in ISO 9001. ''Annex B: Guidelines for establishing applications for specific fields'' gives accreditation seekers explanations of specific requirements to better complete their applications.

			==Accreditation==

			Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.<ref name="Honsa">{{cite journal \|last=Honsa \|first=Julie D. \|coauthors=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 \|url=http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac/2003/00000086/00000005/art00023 \|accessdate=28 February 2012}}</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. 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.<ref name="Comp17025" />

			National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories can use either a domestic organization or some other internationally recognized body in cases where the domestic organization "has either no international recognition or where it lacks recognition in parts of the world relevant to the laboratory’s operations."<ref name="Comp17025" /> Laboratories typically select a range of common and frequently used methodologies that could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.

			==Further reading==

			* {{cite web \|url=http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf \|format=PDF \|title=Complying with ISO 17025 \|publisher=United Nations Industrial Development Organization \|date=October 2009 \|pages=106}}

			==External links==

			* [http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883 ISO 17025:2005]
			* [https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en ISO 17025:2005] on the ISO Online Browsing Platform

	==References==		==References==

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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]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.		'''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]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.

	Since its initial release, a second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<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 \|accessdate=28 February 2012}}</ref>		Since its initial release, a second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.<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 \|accessdate=28 February 2012}}</ref>

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	==References==		==References==
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