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| LIMSwiki provides [[:Category:LIMS vendors by industry|a useful directory]] of LIMS vendors serving specific industries. If a vendor clearly indicates what industries they serve on their website, they are categorized under those industries. Otherwise, they are placed under the "General" category. However, "ISO/IEC 17025" isn't considered an industry for purposes of categorization; as we learned in Chapter 2, the testing, calibration, and sampling activities covered by ISO/IEC 17025 occur in a wide variety of industry contexts. As such, using such a directory will require you to examine vendors serving your industry and then investigate further how their LIMS touches all those requirements listed in the previous chapter.
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| For purposes of this guide, we simply list all known LIMS vendors as a base starting point. This may have little use to you, so you may also wish to consult the previously mentioned categorized directory for further granularity. The LIMS vendors and consultants listed below are directly pulled from LIMSwiki's maintained tabular listings of these types of entities. The professional section addresses trade organizations, conferences, and more. The last section further explores LIMSpec, which has been discussed in prior chapters.
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| ===4.1 LIMS vendors===
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| NOTE: This listing represents all known active LIMS vendors. For a categorized listing of LIMS vendors by industry, see the [[:Category:LIMS vendors by industry|listing of vendors by industry]].
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| {{All active LIMS vendors}}
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| ===4.2 Consultants===
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| {{LIMS, LIS, and laboratory}}
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| ===4.3 Other resources===
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| ====4.3.1 ISO/IEC 17025 accreditation bodies====
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| What follows is a set of examples of accreditation bodies handling ISO/IEC 17025 accreditation for laboratories around the world. For a more complete list of accreditation bodies, see the International Laboratory Accreditation Cooperation (ILAC) [https://ilac.org/signatory-search/ directory] of approved bodies.
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| *[https://www.accredia.it/en/accredited-services/ Accredia, the Italian Accreditation Body] (Italy)
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| *[https://a2la.org/ American Association for Laboratory Accreditation (A2LA)] (U.S.)
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| *[https://www.aihaaccreditedlabs.org/lab-accreditation-programs American Industrial Hygiene Association (AIHA)] (U.S.)
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| *[https://anab.ansi.org/laboratory-accreditation/iso-iec-17025 ANSI National Accreditation Board (ANAB)] (U.S.)
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| *[http://www.boa.gov.vn/ Bureau of Accreditation (BoA)] (Vietnam)
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| *[https://www.cala.ca/accreditation/fields-of-testing/ Canadian Association for Laboratory Accreditation (CALA)] (Canada)
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| *[https://www.cofrac.fr/en/ Comité français d'accréditation (Cofrac)] (France)
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| *[https://www.dakks.de/en/testing-and-calibration-laboratories.html Deutsche Akkreditierungsstelle (DAkkS)] (Germany)
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| *[https://www.rva.nl/en/disciplines/ Dutch Accreditation Council (RVA)] (Netherlands)
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| *[https://egac.gov.eg/en/accreditation/ Egyptian Accreditation Council (EGAC)] (Egypt)
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| *[http://www.bata.gov.ba/Default.aspx?langTag=en-US Institute for Accreditation of B&H (BATA)] (Bosnia and Herzegovina)
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| *[https://www.ianz.govt.nz/ International Accreditation New Zealand (IANZ)] (New Zealand)
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| *[https://www.iasonline.org/services/ International Accreditation Service (IAS)] (U.S.)
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| *[https://www.inab.ie/inab-services/ Irish National Accreditation Board (INAB)] (Ireland)
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| *[http://kan.or.id/index.php/programs/sni-iso-iec-17025 Komite Akreditasi Nasional (KAN)] (Indonesia)
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| *[https://www.knab.go.kr/ Korea Laboratory Accreditation Scheme (KOLAS)] (South Korea)
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| *[https://nabl-india.org/ National Accreditation Board for Testing and Calibration Laboratories (NABL)] (India)
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| *[https://nata.com.au/accreditation/laboratory-accreditation-iso-iec-17025/ National Association of Testing Authorities (NATA)] (Australia)
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| *[https://nrc.canada.ca/en/certifications-evaluations-standards/calibration-laboratory-assessment-service/about-calibration-laboratory-assessment-service National Research Council of Canada (NRC)] (Canada)
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| *[https://www.nist.gov/nvlap National Voluntary Laboratory Accreditation Program (NVLAP)] (U.S.)
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| *[https://www.pjlabs.com/accreditation-programs/isoiec-17025 Perry Johnson Laboratory Accreditation (PJLA)] (U.S.)
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| *[https://www.en.aenor.com/certificacion/analisis-y-ensayos-de-laboratorio Spanish Association for Standardization and Certification (AENOR)] (Spain)
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| *[https://www.scc.ca/en/accreditation/programs/laboratories Standards Council of Canada (SCC)] (Canada)
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| ====4.3.2 ISO/IEC 17025 reference and resource library====
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| '''Guides''':
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| * {{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf |title=Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report |format=PDF |author=Association of Public Health Laboratories |date=February 2018}}
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| * {{cite web |url=https://www.limswiki.org/index.php/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors |title=FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors |author=Douglas, S.E. |work=LIMSwiki.org |date=21 February 2022}}
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| * {{cite book |url=https://pasargadabzar.com/wp-content/uploads/2022/04/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf |format=PDF |title=Implementing ISO/IEC 17025:2017 |author=Mehta, B. |edition=2nd |publisher=ASQ Quality Press |year=2019 |isbn=9780873899802}}
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| * {{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}}
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| * {{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}}
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| * {{cite web |url=http://www.ipac.pt/docs/publicdocs/requisitos/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf |format=PDF |title=Guide for ISO/IEC 17025 Application |author=Portuguese Accreditation Institute |date=10 November 2019}}
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| * {{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}}
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| '''Journal articles''':
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| * {{Cite journal |last=Dror |first=Itiel E. |last2=Pierce |first2=Michal L. |date=2020-05 |title=ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work |url=https://onlinelibrary.wiley.com/doi/10.1111/1556-4029.14265 |journal=Journal of Forensic Sciences |language=en |volume=65 |issue=3 |pages=800–808 |doi=10.1111/1556-4029.14265 |issn=0022-1198}}
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| * {{Cite journal |last=Krismastuti |first=Fransiska Sri Herwahyu |last2=Habibie |first2=Muhammad Haekal |date=2022-12 |title=Complying with the resource requirements of ISO/IEC 17025:2017 in Indonesian calibration and testing laboratories: current challenges and future directions |url=https://link.springer.com/10.1007/s00769-022-01523-w |journal=Accreditation and Quality Assurance |language=en |volume=27 |issue=6 |pages=359–367 |doi=10.1007/s00769-022-01523-w |issn=0949-1775 |pmc=PMC9579603 |pmid=36275871}}
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| * {{Cite journal |last=Mandal |first=Goutam |last2=Ansari |first2=M. A. |last3=Aswal |first3=D. K. |date=2021-09 |title=Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016 |url=https://link.springer.com/10.1007/s12647-021-00490-w |journal=MAPAN |language=en |volume=36 |issue=3 |pages=657–668 |doi=10.1007/s12647-021-00490-w |issn=0970-3950 |pmc=PMC8308083}}
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| * {{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=https://www.limswiki.org/index.php/Journal:ISO/IEC_17025:_History_and_introduction_of_concepts |journal=Química Nova |doi=10.21577/0100-4042.20170726}}
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| * {{Cite journal |last=Monteiro Bastos da Silva |first=Juliana |last2=Chaker |first2=Jade |last3=Martail |first3=Audrey |last4=Costa Moreira |first4=Josino |last5=David |first5=Arthur |last6=Le Bot |first6=Barbara |date=2021-01-26 |title=Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO/IEC 17025: 2017 Quality Standard as a Guideline |url=https://www.mdpi.com/2039-4713/11/1/1 |journal=Journal of Xenobiotics |language=en |volume=11 |issue=1 |pages=1–15 |doi=10.3390/jox11010001 |issn=2039-4713 |pmc=PMC7838891 |pmid=33530331}}
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| * {{Citation |last=Neves |first=Rodrigo S. |last2=Da Silva |first2=Daniel P. |last3=Galhardo |first3=Carlos E.C. |last4=Ferreira |first4=Erlon H.M. |last5=Trommer |first5=Rafael M. |last6=Damasceno |first6=Jailton C. |date=2017-02-22 |editor-last=Kounis |editor-first=Leo D. |title=Key Aspects for Implementing ISO/IEC 17025 Quality Management Systems at Materials Science Laboratories |url=http://www.intechopen.com/books/quality-control-and-assurance-an-ancient-greek-term-re-mastered/key-aspects-for-implementing-iso-iec-17025-quality-management-systems-at-materials-science-laborator |work=Quality Control and Assurance - An Ancient Greek Term Re-Mastered |language=en |publisher=InTech |doi=10.5772/66100 |isbn=978-953-51-2921-9}}
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| * {{Cite journal |last=Okezue |first=Mercy A. |last2=Adeyeye |first2=Mojisola C. |last3=Byrn |first3=Steve J. |last4=Abiola |first4=Victor O. |last5=Clase |first5=Kari L. |date=2020-12 |title=Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study |url=https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-020-05934-8 |journal=BMC Health Services Research |language=en |volume=20 |issue=1 |pages=1065 |doi=10.1186/s12913-020-05934-8 |issn=1472-6963 |pmc=PMC7686690 |pmid=33228675}}
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| * {{cite journal |last=Pillai |first=Segaran |last2=Calvert |first2=Jennifer |last3=Fox |first3=Elizabeth |date=2022-11-03 |title=Practical considerations for laboratories: Implementing a holistic quality management system |url=https://www.frontiersin.org/articles/10.3389/fbioe.2022.1040103/full |journal=Frontiers in Bioengineering and Biotechnology |volume=10 |pages=1040103 |doi=10.3389/fbioe.2022.1040103 |issn=2296-4185 |pmc=PMC9670165 |pmid=36406233}}
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| '''Other useful documents''':
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| * [[LII:LIMSpec 2022 R2|LIMSpec 2022 R2]]
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| * [https://www.nist.gov/nist-quality-system NIST Quality System for Measurement Services]
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| ===4.4 LIMSpec===
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| [[File:LIMSpec.png|right]][[Book:LIMSpec 2022 R2|LIMSpec]] is an ever-evolving set of software user requirements specifications for [[laboratory informatics]] systems, especially the [[laboratory information management system]] (LIMS). The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' "wishlist" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as "nice to have" or "essential to system operation," or something in between.<ref name="AasemAnalysis10">{{cite journal |title=Analysis and optimization of software requirements prioritization techniques |author=Aasem, M.; Ramzan, M.; Jaffar, A. |journal=Proceedings from the 2010 International Conference on Information and Emerging Technologies |pages=1–6 |year=2010 |doi=10.1109/ICIET.2010.5625687}}</ref><ref name="Hirsch10Steps13">{{cite web |url=https://www.phase2technology.com/blog/successful-requirements-gathering |title=10 Steps To Successful Requirements Gathering |author=Hirsch, J. |publisher=Phase2 Technology, LLC |date=22 November 2013 |accessdate=20 January 2023}}</ref><ref name="BurrissSoftware07">{{cite web |url=http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |archiveurl=https://web.archive.org/web/20190724173601/http://sce2.umkc.edu/BIT/burrise/pl/requirements/ |title=Requirements Specification |work=CS451R, University of Missouri–Kansas City |author=Burris, E. |publisher=University of Missouri–Kansas City |date=2007 |archivedate=24 July 2019 |accessdate=20 January 2023}}</ref> This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems.
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| At its core, LIMSpec is rooted in [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."
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| LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources, including [[ISO/IEC 17025]]. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.
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| If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=20 January 2023}}</ref> Within this organized "plan or proposal" are requirements. A requirement typically comes in the form of a statement that begins with "the system/user/vendor shall/should ..." and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.
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| An example of a functional software requirement could be "the user shall be able to query either all of the initial set of databases or select a subset from it." This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state "the system's query tool shall conform to the ABC 123-2014 standard." The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<ref name="MemonSoftware10">{{cite web |url=https://www.cs.umd.edu/~atif/Teaching/Spring2010/Slides/3.pdf |format=PDF |title=Software Requirements: Descriptions and specifications of a system |author=Memon, A. |publisher=University of Maryland |date=Spring 2010 |accessdate=20 January 2023}}</ref>
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| Section 3.1.2 of Chapter 3 took those specific LIMSpec requirements linked to ISO/IEC 17025 and presented them as a means to demonstrate the critical functionality a LIMS should have in order for a [[laboratory]] to more easily comply with the standard. However, there's more to LIMSpec than just those requirements. The requirements span multiple areas of laboratory [[workflow]] and practice, from the core functions of a lab to its ancillary operations, specialty functions, technology and performance touch points, and data and security touch points. As of December 2022, LIMSpec is based off more than 130 regulations, standards, guidance documents, and more, proving to be a robust starting point for labs seeking to use a requirements specification to acquire a LIMS.
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| The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors.
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| ==References==
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| {{Reflist|colwidth=30em}}
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