Difference between revisions of "ISO/IEC 17025"
Shawndouglas (talk | contribs) m (→History: Clarified 2005 version) |
Shawndouglas (talk | contribs) |
||
| (3 intermediate revisions by the same user not shown) | |||
| Line 1: | Line 1: | ||
[[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. | [[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.]]'''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. | ||
'''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. | |||
==History== | ==History== | ||
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= | 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=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 |accessdate=16 April 2020}}</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 | 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 |archiveurl=https://web.archive.org/web/20170124140236/http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf |format=PDF |title=ISO/IEC 17025:1999 versus 2005 |author=Hoolihan, D.D. |publisher=Hoolihan EMC Consulting |archivedate=24 January 2017 |accessdate=16 April 2020}}</ref><ref name="Comp17025" /> | ||
ISO/IEC 17025: | At the end of November 2017, the ISO released an updated version, ISO/IEC 17025:2017. This update brought with it broader scope in sampling, testing, and calibration; a more consistent process approach; a stronger focus on information technologies; and the addition of risk-based thinking methods.<ref name="TranchardNewEd17">{{cite web |url=https://www.iso.org/news/ref2250.html |title=New Edition of ISO/IEC 17025 Just Published |author=Tranchard, S. |work=ISO News |publisher=International Organization for Standardization |date=01 December 2017 |accessdate=16 April 2020}}</ref> | ||
==The standard== | ==The standard== | ||
The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, | The ISO/IEC 17025:2017 standard itself comprises eight (formerly five) elements: scope, normative references, terms and definitions, general requirements, structural requirements, resource requirements, process requirements, and management system requirements. Two annexes are also included. The management and technical requirements sections of 2005 were further broken out into general, structural, resource, process, and management system requirements. The management system requirements section remains one of the more important ones, detailing the operation and effectiveness of the quality management system within the laboratory, with the process requirements being equally as vital. | ||
The standard is organized as follows<ref name="ISO17025Peak">{{cite web |url=https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed- | 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 |archiveurl=https://web.archive.org/web/20191005053732/http://www.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 |archivedate=05 October 2019 |accessdate=16 April 2020}}</ref><ref name="PJLA_ISO_19">{{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 |accessdate=16 April 2020}}</ref>: | ||
===Scope=== | ===Scope=== | ||
| Line 23: | Line 22: | ||
===Terms and definitions=== | ===Terms and definitions=== | ||
This | This section simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM. The 2017 version added nine new terms to be defined, including "impartiality," "complaint," and "validation."<ref name="ISO17025Peak" /><ref name="PJLA_ISO_19" /> | ||
=== | ===General requirements=== | ||
This section discusses the risks associated with creating biased results (impartiality) and risks associate with handling protected information (confidentiality) to the standard. The requirements are broken down into two subsections: | |||
'''4.1''' | '''4.1''' Impartiality | ||
'''4.2''' | '''4.2''' Confidentiality | ||
===Structural requirements=== | |||
This section addresses the organization as a legal entity, responsible for its processes and actions, including the protection of customer information. | |||
===Resource requirements=== | |||
This section addresses the provisioning of resources necessary to supporting organizational operations. The requirements are broken down into six subsections: | |||
''' | '''6.1''' General | ||
''' | '''6.2''' Personnel | ||
''' | '''6.3''' Facilities and environmental conditions | ||
'''4 | '''6.4''' Equipment | ||
''' | '''6.5''' Metrological traceability | ||
''' | '''6.6''' Externally provided products and services | ||
===Process requirements=== | |||
This section gets into the nuts and bolts of operations within the laboratory, running through best practices for various laboratory functions. The requirements are broken down into 11 subsections: | |||
''' | '''7.1''' Review of requests, tenders and contracts | ||
''' | '''7.2''' Selection, verification and validation of methods | ||
''' | '''7.3''' Sampling | ||
'''4 | '''7.4''' Handling of test or calibration items | ||
'''7.5''' Technical records | |||
''' | '''7.6''' Evaluation of measurement uncertainty | ||
''' | '''7.7''' Ensuring the validity of results | ||
''' | '''7.8''' Reporting of results | ||
''' | '''7.9''' Complaints | ||
''' | '''7.10''' Nonconforming work | ||
''' | '''7.11''' Control of data and information management | ||
'' | ===Management system requirements=== | ||
The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this section. It splits compliance into two options: A. complying with all of this section's subsections, or B. complying with ISO 9001:2015. The requirements are broken down into nine subsections: | |||
''' | '''8.1''' Options | ||
''' | '''8.2''' Management system documentation (Option A) | ||
'''5. | '''8.3''' Control of management system documents (Option A) | ||
'''8.4''' Control of records (Option A) | |||
'''8.5''' Actions to address risks and opportunities (Option A) | |||
'''8.6''' Improvement (Option A) | |||
'''8.7''' Corrective actions (Option A) | |||
'''8.8''' Internal audits (Option A) | |||
'''8.9''' Management reviews (Option A) | |||
===Annexes=== | ===Annexes=== | ||
Two annexes and a bibliography are included. ''Annex A: | Two annexes and a bibliography are included. ''Annex A: Metrological traceability'' provides further context on section 6.5 of the standard, including addressing international agreements. ''Annex B: Management system options'' elaborates on section 8, including rationale behind the various options. | ||
==Accreditation== | ==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 | 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 |title=ISO 17025: Practical Benefits of Implementing a Quality System |journal=Journal of AOAC International |author=Honsa, J.D.; McIntyre, D.A. |volume=86 |issue=5 |pages=1038–1044 |year=2003 |doi=10.1093/jaoac/86.5.1038}}</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. | 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== | ==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= | * {{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== | ||
* [ | * [https://www.iso.org/standard/39883.html ISO/IEC 17025:2017] | ||
* [https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed- | * [https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en ISO/IEC 17025:2017] on the ISO Online Browsing Platform | ||
==References== | ==References== | ||
{{Reflist|colwidth=30em}} | |||
<!---Place all category tags here--> | <!---Place all category tags here--> | ||
[[Category: | [[Category:Laboratory informatics standards]] | ||
Latest revision as of 20:52, 24 January 2023
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.
History
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."[1] 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—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.[2][1]
At the end of November 2017, the ISO released an updated version, ISO/IEC 17025:2017. This update brought with it broader scope in sampling, testing, and calibration; a more consistent process approach; a stronger focus on information technologies; and the addition of risk-based thinking methods.[3]
The standard
The ISO/IEC 17025:2017 standard itself comprises eight (formerly five) elements: scope, normative references, terms and definitions, general requirements, structural requirements, resource requirements, process requirements, and management system requirements. Two annexes are also included. The management and technical requirements sections of 2005 were further broken out into general, structural, resource, process, and management system requirements. The management system requirements section remains one of the more important ones, detailing the operation and effectiveness of the quality management system within the laboratory, with the process requirements being equally as vital.
The standard is organized as follows[4][5][6]:
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 section simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM. The 2017 version added nine new terms to be defined, including "impartiality," "complaint," and "validation."[4][6]
General requirements
This section discusses the risks associated with creating biased results (impartiality) and risks associate with handling protected information (confidentiality) to the standard. The requirements are broken down into two subsections:
4.1 Impartiality
4.2 Confidentiality
Structural requirements
This section addresses the organization as a legal entity, responsible for its processes and actions, including the protection of customer information.
Resource requirements
This section addresses the provisioning of resources necessary to supporting organizational operations. The requirements are broken down into six subsections:
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
Process requirements
This section gets into the nuts and bolts of operations within the laboratory, running through best practices for various laboratory functions. The requirements are broken down into 11 subsections:
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
Management system requirements
The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this section. It splits compliance into two options: A. complying with all of this section's subsections, or B. complying with ISO 9001:2015. The requirements are broken down into nine subsections:
8.1 Options
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Annexes
Two annexes and a bibliography are included. Annex A: Metrological traceability provides further context on section 6.5 of the standard, including addressing international agreements. Annex B: Management system options elaborates on section 8, including rationale behind the various options.
Accreditation
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.[7] 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]
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."[1] 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
- "Complying with ISO 17025" (PDF). United Nations Industrial Development Organization. October 2009. pp. 106. https://www.unido.org/sites/default/files/2010-08/Complying_with_ISO_17025_A_practical_guidebook_0.pdf.
- "ISO/IEC 17025:2017 Transition" (PDF). Perry Johnson Laboratory Accreditation, Inc. 26 February 2019. https://www.pjlabs.com/downloads/17025-Transition-Book.pdf.
External links
- ISO/IEC 17025:2017
- ISO/IEC 17025:2017 on the ISO Online Browsing Platform
References
- ↑ 1.0 1.1 1.2 1.3 "Complying with ISO 17025" (PDF). United Nations Industrial Development Organization. October 2009. pp. 106. https://www.unido.org/sites/default/files/2010-08/Complying_with_ISO_17025_A_practical_guidebook_0.pdf. Retrieved 16 April 2020.
- ↑ Hoolihan, D.D.. "ISO/IEC 17025:1999 versus 2005" (PDF). Hoolihan EMC Consulting. Archived from the original on 24 January 2017. https://web.archive.org/web/20170124140236/http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf. Retrieved 16 April 2020.
- ↑ Tranchard, S. (1 December 2017). "New Edition of ISO/IEC 17025 Just Published". ISO News. International Organization for Standardization. https://www.iso.org/news/ref2250.html. Retrieved 16 April 2020.
- ↑ 4.0 4.1 "ISO/IEC 17025:2017(en) - General requirements for the competence of testing and calibration laboratories". ISO Online Browsing Platform (OBP). International Organization for Standardization. 2017. https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en. Retrieved 19 March 2020.
- ↑ "ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories". Activation Laboratories Ltd. Archived from the original on 05 October 2019. https://web.archive.org/web/20191005053732/http://www.actlabs.com/page.aspx?menu=60&app=206&cat1=732&tp=2&lk=no. Retrieved 16 April 2020.
- ↑ 6.0 6.1 "ISO/IEC 17025:2017 Transition" (PDF). Perry Johnson Laboratory Accreditation, Inc. 26 February 2019. https://www.pjlabs.com/downloads/17025-Transition-Book.pdf. Retrieved 16 April 2020.
- ↑ Honsa, J.D.; McIntyre, D.A. (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.
