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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| [[File:Qualsystem1.png|right|250px]]
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| '''Title''': ''What is the importance of ISO/IEC 17025 to society?''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': TBD
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| ==Introduction==
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| ==History of ISO/IEC 17025==
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| [[ISO/IEC 17025]]'s origins go back to the mid-1970s, when a conference on cross-border acceptance of test data led to the International Laboratory Accreditation Cooperation (ILAC) beginning work on what would eventually become ISO Guide 25 ''Guidelines for assessing the technical competence of testing laboratories'', after turning the work over to the [[International Organization for Standardization]] (ISO). The intent of developing the guide, published in 1978, was to gain international cooperation towards improving the world's laboratory services by promoting a scheme for accredited laboratory test results, such that the results could be more readily accepted across national borders.<ref name="SquirrelConform08">{{cite journal |last=Squirrell |first=A. |date=2008-09 |title=Conformity assessment: providing confidence in testing and calibration |url=http://link.springer.com/10.1007/s00769-008-0418-2 |journal=Accreditation and Quality Assurance |language=en |volume=13 |issue=9 |pages=543–546 |doi=10.1007/s00769-008-0418-2 |issn=0949-1775}}</ref><ref name="MiguelISO21">{{Cite journal |last=Miguel |first=Anna |last2=Moreira |first2=Renata |last3=Oliveira |first3=André |date=2021 |title=ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS |url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf |journal=Química Nova |doi=10.21577/0100-4042.20170726}}</ref><ref name="VehringTested20">{{cite web |url=https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf |format=PDF |title=Tested & Accepted: Implementing ISO/IEC 17025:2017 |author=Vehring, S. |publisher=United Nations Industrial Development Organization |date=June 2020 |accessdate=18 December 2022}}</ref> That first guide didn't address the activities of calibration labs, however, and it would require further revisions, as the general guidelines towards proving a lab's technical competence were also inadequate.<ref name="MiguelISO21" /> For the next version, released in 1982 as ISO/IEC Guide 25: ''General requirements for the technical competence of testing laboratories'', the [[International Electrotechnical Commission]] (IEC) became involved. That version saw upgrades in proving technical competence, as well as the addition of the requirement for a quality system, though it too didn't address calibration labs.<ref name="MiguelISO21" /> The next version, released in 1990 as ISO/IEC Guide 25 ''General requirements for the competence of calibration and testing laboratories'', finally addressed calibration labs and, with the help of the Council Committee on Conformity Assessment (CASCO), lent "support for national systems, thus easing bilateral agreements" associated with laboratory testing.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" /> It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the [[ISO 9000]] standard. Four years later, CASCO pushed to turn ISO/IEC Guide 25 into a full standard, and by 1999, ISO/IEC 17025:1999 ''General requirements for the competence of testing and calibration laboratories'' was born, which also met the requirements of ISO 90001.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" />
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| Since then, the standard has seen two additional revisions, one in 2005 and another in 2017.<ref name="SquirrelConform08" /><ref name="MiguelISO21" /><ref name="VehringTested20" /> With the ISO 9001 standard in revision at the same time as ISO/IEC 17025:1999, the standard's take on ISO 9001 when published was antiquated, requiring the 2005 update.<ref name="MiguelISO21" /> The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from it 2005 predecessor, with the 2005 division between technical management and quality management being replaced by "a more unified focus on a laboratory's general responsibility management."<ref name="MiguelISO21" /> (For more on the differences between the 2005 and 2017 version, see the National Association of Testing Authorities' (NATA's) [https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf gap analysis document] comparing the two.<ref name="NATAGeneral18">{{cite web |url=https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf |format=PDF |title=General Accreditation Guidance: ISO/IEC 17025:2017 Gap analysis |author=National Association of Testing Authorities |date=April 2018 |accessdate=21 Decemeber 2022}}</ref>) As of December 2022, ISO/IEC 17025:2017 remains the latest version of the standard, putting a focus on labs developing a more efficient management system (i.e., a [[quality management system]] or QMS).
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| ==ISO/IEC 17025 vs. ISO 9001: Supporting quality management in the lab==
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| Given the history of ISO/IEC 17025, the uninformed individual may wonder what the difference is between that and the ISO 9000 series of standards. While it is true that ISO 9001 is mentioned in the context of complying with ISO/IEC 17025, there are several differences, though the critical concept of quality management is found in both. Let's first talk about what ISO 9001 and the 9000 series are geared to do and how they address quality management.
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| The ISO 9000 family of standards addresses the fundamentals of QMSs for an organization<ref name="TsimAnAdapt02">{{cite journal |title=An adaptation to ISO 9001:2000 for certified organisations |journal=Managerial Auditing Journal |author=Tsim, Y.; Yeung, V.; Leung, E. |volume=17 |issue=5 |pages=245–50 |year=2002 |doi=10.1108/02686900210429669}}</ref>, including the eight management principles on which the family of standards is based.<ref name="TsimAnAdapt02" /><ref name="BeattieImplem10">{{cite journal |title=Implementing ISO 9000: A study of its benefits among Australian organizations |journal=Total Quality Management |author=Beattie, K.R. |volume=10 |issue=1 |pages=95–106 |year=2010 |doi=10.1080/0954412998090}}</ref> ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.<ref>{{cite web |url=https://www.iso.org/standard/62085.html |title=ISO 9001:2015 Quality management systems — Requirements |publisher=International Organization for Standardization |date=September 2015 |accessdate=22 December 2022}}</ref> In turn, third-party certification bodies provide independent confirmation that organizations meet the requirements of the standard.
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| Quality management is defined by [[ISO 9000]] as a set of "coordinated activities to direct and control an organization with regard to quality.” By extension, those coordinated activities require sufficient "organizational structure, resources, processes and procedures" in order to implement quality management throughout the enterprise, otherwise known as a quality system.<ref name="WHOLQMS11">{{Cite web |last=World Health Organization |date=2011 |title=Laboratory Quality Management System: Handbook |url=http://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1 |format=PDF |publisher=World Health Organization |isbn=9789241548274}}</ref>
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| Note that the discussion so far has focused on how the standard addresses the "organization" seeking to improve quality. That's because ISO 9001 is directed at all kinds of organizations operating in any type of industry and sector, whereas ISO/IEC 17025 specifically targets testing, calibration, and sampling laboratories. There are other differences from ISO/IEC 17025 as well, the most significant being that ISO 9001 deals strictly with deploying a QMS in the organization, whereas ISO/IEC 17025 expands into a toolbox of requirements for ensuring not only quality but also the "competence, impartiality, and consistent operation of laboratories."<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=22 December 2022}}</ref>
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| Finally, accrediting to either of the two standards is also a different process, which highlights the inherent differences between the two standards. As laboratory consultancy Perry Johnson Consulting notes, the difference between the ISO/IEC 17025 and ISO 9001:2015 standards can be found in comparing the accreditation process: "ISO/IEC 17025:2017 accreditation is recognition of a laboratory’s competence to produce technically valid results, while ISO 9001:2015 registration of a laboratory is limited to QMS conformance."<ref name="PJC17025_22">{{cite web |url=https://www.pjcinc.com/Downloads/ISOIEC17025_exov.pdf |format=PDF |title=ISO/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview |author=Perry Johnson Consulting, Inc |date=January 2022 |accessdate=18 December 2022}}</ref> They add that ISO/IEC 17025:2017's "technical competency requirements go beyond QMS registration and relate specifically to the qualifications needed with regard to personnel, equipment, facilities, and laboratory methods."<ref name="PJC17025_22" />
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| From this, we may conclude that—at least for the laboratory—ISO/IEC 17025 is the quality management standard to comply with, end of story. However, the utility of ISO 9001 to the laboratory should not be completely dismissed. For those struggling with implementing the management system portion of ISO/IEC 17025, additional inspiration and guidance may be found in ISO 9001. For example, ISO 9001:2015 provides additional scope in establishing a QMS, particularly through identifying problematic issues and important stakeholders. It also expands discussion about the importance of leadership establishing quality policy and the organization developing quality objectives, as well as the greater need for identifying organizational knowledge and fully implementing monitoring and measurement mechanisms.<ref name="HammarISO19">{{cite web |url=https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/ |title=ISO 17025 vs. ISO 9001 – Main differences and similarities |author=Hammar, M. |work=Advisera Blog |publisher=Advisera |date=11 July 2019 |accessdate=22 December 2022}}</ref> From this, the laboratory may gain additional benefits by supplementing their ISO/IEC 17025:2017 compliance with some aspects of ISO 9001:2015, further enabling a more risk-based approach to managing quality in the lab.<ref name="HammarISO19" /> (For more about how the laboratory benefits from ISO/IEC 17025:2017, see [[LIMS FAQ:How does ISO/IEC 17025 impact laboratories?|How does ISO/IEC 17025 impact laboratories?]].)
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| ==How supporting laboratory quality management improves society==
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| The discussion so far has been useful in giving background about standards bodies giving organizations—including laboratories—a framework for improving operational quality, but how does this all relate to the primary question about ISO/IEC 17025 benefiting society? From here, it's useful to examine the importance of the laboratory itself to society. In the guide ''[[LII:The Laboratories of Our Lives: Labs, Labs Everywhere!|The Laboratories of Our Lives: Labs, Labs Everywhere!]]'', the first chapter emphasizes the ubiquity of the laboratory in the fabric of society, despite the lab being largely invisible to the average individual<ref name="DouglasLabs22">{{cite web |url=https://www.limswiki.org/index.php/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!/Laboratories:_A_historical_perspective |title=1. Laboratories: A historical perspective |work=The Laboratories of Our Lives: Labs, Labs Everywhere! |author=Douglas, S.E. |publisher=LIMSwiki |date=July 2022 |accessdate=22 December 2022}}</ref>:
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| <blockquote>Laboratories play an integral role in modern life, ubiquitous and often unseen by the average person. They improve quality of life, act as hotbeds of discovery, and help us make sense of our universe, particularly in the capable hands of the tens of thousands of professionals who work in them. But the laboratory as we know it today is actually a relatively new concept. It wasn't always as sectionally organized, well-staffed, and well-equipped. To gain a better sense of how common the laboratory is to our lives, we must first briefly look at the past history of laboratory research and how it developed from a philosophical and more selfish endeavor to one more focused on analysis and the benefits to society.</blockquote>
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| Labs can be a hotbed of economic activity, as found with the United States' Argonne National Laboratory in Illinois, which claimed in 2020 to employ more than 3,400 people and have approximately $168 million total economic impact for the state.<ref name="ArgonneOurImpact">{{cite web |url=https://www.anl.gov/argonne-impacts/illinois |title=Argonne Impacts State by State: Illinois |work=Argonne National Laboratory |publisher=UChicago Argonne, LLC |accessdate=28 June 2022}}</ref> Labs can also be a significant source of innovation to society, with the old Bell Telephone Laboratories at its peak employing some 1,200 PhDs and being responsible for the creation of vital technologies such as solid state components, wireless telephony technology, the C programming language, and the Unix operating system (thanks to Bell researchers like Ken Thompson and Dennis Ritchie).<ref name="GertnerTheIdea13">{{cite book |url=https://books.google.com/books?id=OkECDAAAQBAJ |title=The Idea Factory: Bell Labs and the Great Age of American Innovation |author=Gertner, J. |publisher=Penguin |year=2013 |pages=422 |isbn=9780143122791}}</ref> In fact, laboratories are often at the heart of a company's R&D efforts towards bringing people new products. Vehicle<ref name="VolvoMaterials">{{cite web |url=http://www.volvogroup.com/en-en/about-us/r-d-and-innovations/materials-technology.html |archiveurl=https://web.archive.org/web/20170629222307/http://www.volvogroup.com/en-en/about-us/r-d-and-innovations/materials-technology.html |title=Materials Technology |work=Volvo Group |publisher=AB Volvo |archivedate=29 June 2017 |accessdate=22 December 2022}}</ref> and makeup<ref name="LOrealUSAResearch">{{cite web |url=http://www.lorealusa.com/group/discover-l%27or%C3%A9al-usa/l%E2%80%99or%C3%A9al-usa-research-and-innovation |archiveurl=https://web.archive.org/web/20181021232022/http://www.lorealusa.com/group/discover-l'or%C3%A9al-usa/l%E2%80%99or%C3%A9al-usa-research-and-innovation |title=L’Oréal USA Research And Innovation |publisher=L’Oréal Group |archivedate=21 October 2018 |accessdate=22 December 2022}}</ref> users alike are affected by manufacturing laboratories that research, design, test, and [[quality control]] their products. Clinical labs help keep current and future generations healthy, and [[Forensic science#The forensic laboratory|forensic labs]] help bring justice to the wronged. Of course, [[Reference laboratory|calibration laboratories]] are vital to ensuring the precise measurement and production values of any equipment those other laboratories strongly depend on.
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| However, labs can and do fail (completely, or at their tasks)<ref name="AhujaWhy19">{{cite web |url=https://hbr.org/2019/07/why-innovation-labs-fail-and-how-to-ensure-yours-doesnt |title=Why Innovation Labs Fail, and How to Ensure Yours Doesn’t |author=Ahuja, S.B. |work=Harvard Business Review |date=22 July 2019 |accessdate=22 December 2022}}</ref><ref>{{Cite journal |last=Keppel |first=Martin H |last2=Cadamuro |first2=Janne |last3=Haschke-Becher |first3=Elisabeth |last4=Oberkofler |first4=Hannes |last5=Felder |first5=Thomas K |last6=Lippi |first6=Giuseppe |last7=Mrazek |first7=Cornelia |date=2020-06-15 |title=Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions |url=https://www.biochemia-medica.com/en/journal/30/2/10.11613/BM.2020.020502 |journal=Biochemia medica |volume=30 |issue=2 |pages=215–233 |doi=10.11613/BM.2020.020502 |pmc=PMC7271754 |pmid=32550813}}</ref><ref name="ParvinMonit15">{{cite web |url=https://www.qcnet.com/resources/qc-articles/learning-from-laboratory-failures |title=Monitoring test system failures and QC performance can help identify opportunities for improvement |author=Parvin, C.A.; Yundt-Pacheco, J.; Quintenz, A. |work=QCNet |date=2015 |accessdate=22 December 2022}}</ref>, like any other business
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| "Quality management is as applicable for the [[Clinical laboratory|medical laboratory]] as it is for manufacturing and industry," states the [[World Health Organization]] (WHO) in its 2011 ''Laboratory Quality Management System: Handbook''.<ref name="WHOLQMS11" /> While the medical laboratory is better covered by [[ISO 15189]], the WHO's statement highlights that all laboratories can benefit from implementing quality management principles.
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| ==Conclusion==
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| ==References==
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| {{Reflist|colwidth=30em}}
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| <!---Place all category tags here-->
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| [[Category:LIMS FAQ articles (added in 2022)]]
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| [[Category:LIMS FAQ articles (all)]]
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| [[Category:LIMS FAQ articles on ISO/IEC 17025]]
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