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ISO/IEC 17025ISO/IEC 17025General requirementsfor the competence of testingand calibration laboratories

ISO/IEC 17025, General requirementsfor the competence of testing andcalibration laboratories, is theinternational reference for testingand calibration laboratories wantingto demonstrate their capacity todeliver reliable results.

ISO/IEC 17025A new version of the standard was published by ISO andthe International Electrotechnical Commission (IEC) in2017 to update its content and better serve the laboratories that use it.ISO/IEC 17025 was developed by laboratory experts fromall over the world, along with 18 liaison organizations,such as the International Laboratory AccreditationCooperation (ILAC), and many associations representing laboratories.ISO/IEC 17025, Testing and calibration laboratories –1

What benefits will itbring to my businessor organization ?ISO/IEC 17025 enables laboratories to dem-onstrate that they operate competently andgenerate valid results, thereby promotingconfidence in their work both nationallyand around the world.It also helps facilitate cooperation betweenlaboratories and other bodies by generating wider acceptance of results betweencountries. Test reports and certificates canbe accepted from one country to anotherwithout the need for further testing, which,in turn, improves international trade.2 – ISO/IEC 17025, Testing and calibration laboratories

Who isISO/IEC 17025 for ?ISO/IEC 17025 is useful for any organiza-tion that performs testing, sampling orcalibration and wants reliable results.This includes all types of laboratories,whether they be owned and operated bygovernment, industry or, in fact, any otherorganization.The standard is also useful to universities,research centres, governments, regulators,inspection bodies, product certificationorganizations and other conformity assessment bodies with the need to do testing,sampling or calibration.Why was it revised ?The last version of ISO / IEC 17025 waspublished in 2005 and, since then,market conditions and technology havechanged. The new version covers technical changes, vocabulary and developments in IT techniques. It also takesinto consideration the latest version ofISO 9001.ISO/IEC 17025, Testing and calibration laboratories –3

What are thekey changes ?ISO/IEC 17025 takes into considerationthe new ways of working of laboratoriestoday. The most substantive changes areas follows : The scope has been revised to cover alllaboratory activities, including testing,calibration and the sampling associated with subsequent calibration andtesting.A new structure has been adopted toalign the standard with the other existing ISO/IEC conformity assessmentstandards such as the ISO/IEC 17000series on conformity assessment.The process approach now matchesthat of newer standards such asISO 9001 (quality management),ISO 15189 (quality of medical laboratories) and the ISO/IEC 17000 series(standards for conformity assessmentactivities), putting the emphasis onthe results of a process instead of thedetailed description of its tasks andsteps.4 – ISO/IEC 17025, Testing and calibration laboratories The standard has a stronger focus oninformation technologies. In recognition of the fact that hard-copy manuals,records and reports are slowly beingphased out in favour of electronic versions, it incorporates the use of computer systems, electronic records andthe production of electronic results andreports.A new section has been added introducing the concept of risk-basedthinking and describes the commonalities with the new version ofISO 9001:2015, Quality managementsystems – Requirements.

The terminology has been updated.Examples include changes to the International Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common termsand definitions for all standards dedicated to conformity assessment.Find out moreLearn more about ISO/IEC 17025 and theISO Committee for conformity assessment (CASCO), the technical committee that developed the standard, atwww.iso.org/casco.Moreinformation ISO Websitewww.iso.orgISOfocus magazinewww.iso.org/isofocusISO videoswww.iso.org/youtubeFollow us on Twitterwww.iso.org/twitterJoin us on Facebookwww.iso.org/facebookJoin us on GooglePluswww.iso.org/gplusISO/IEC 17025, Testing and calibration laboratories –5

About ISOISO (International Organization for Standardization)is an independent, non-governmental organizationwith a membership of 162* national standards bodies. Through its members, ISO brings together expertsto share knowledge and develop voluntary, consensus-based, market-relevant International Standardsthat support innovation and provide solutions toglobal challenges.ISO has published more than 21 500* InternationalStandards and related documents, covering almostevery industry, from technology to food safety, toagriculture and healthcare. For more information,please visit www.iso.org.*October 2017International Organizationfor StandardizationISO Central SecretariatCh. de Blandonnet 8Case Postale 401CH – 1214 Vernier, GenevaSwitzerlandiso.org ISO, 2017All rights reservedISBN 978-92-67-10780-6