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Guide25toISO/IEC17025: ABriefHistoryandIntroduction DanielD.Hoolihan Hoolihan EMC Consulting HoolihanEMCConsulting April2010

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • Gu Guide25andISO/IEC17025areinternational de 5 a d SO/ C 0 5 a e te at o a documentsthatspecifyrequirementsthattesting laboratoriesshouldmeettobehighquality l b laboratories • ThedocumentscamefromtheInternational St d d Standardsarenaandmanycountriescontributed d ti t ib t d tothematerialinthepublications • Productacceptancearoundtheworldisbasedon Product acceptance around the world is based on testresultsfromaccreditedlaboratories – LaboratoriesareaccreditedtoISO/IEC17025 Laboratories are accredited to ISO/IEC 17025

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • The Theaveragepersonexpectstobuyproducts average person expects to buy products thatworkthewaytheyareadvertised • Thelabaccreditationprocessinconcertwith The lab accreditation process in concert with manufacturerswhotestproductsto standards permits the average consumer to standards,permitstheaverageconsumerto beconfidentintheproductstheybuy • So,everyonebenefitsfromahighquality S b fi f hi h li laboratoryaccreditationsystem

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • ISOGuide25:1978 ISO Guide 25: 1978 – FirstEdition First Edition • ISO/IECGuide25:1982 SecondEdition • ISO/IECGuide25:1990– SO/ C G id 2 990 ThirdEdition hi d di i • TheEuropeanversionofGuide25was p EuropeanStandardEN45001:1989– “GeneralCriteriafortheOperationofTesting Laboratories.”

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 •

HistoryofISO/IEC17025– GeneralRequirementsfortheCompetenceof Testing and Calibration Laboratories TestingandCalibrationLaboratories

•

ISO/IEC17025andISO/IECGuide25werepreparedbytheInternational g ( ) y StandardsOrganization(ISO)CommitteeonConformityAssessmentwhich isrepresentedbytheacronym CASCO. – IECistheInternationalElectrotechnical Commission.

•

ISO/IEC 17025 1999 FirstEdition– ISO/IEC17025:1999– Fi t Editi releasedinDecemberof1999 l di D b f 1999

•

ISO/IEC17025:2005– SecondEdition–

– TheFirstEditionofISO/IEC17025cancelledandreplacedISO/IECGuide 25:1990.

– releasedinMayof2005 – thisisthelatestEdition

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • In Inthe1990s,therelevantdocumentforlab the 1990s the relevant document for lab accreditationwasISO/IECGuide25,"General Requirements for the Competence of Testing RequirementsfortheCompetenceofTesting andCalibrationLaboratories.” • Reflectingtheincreasingworldwide Reflecting the increasing worldwide importanceofthissubject,Guide25was revised as ISO/IEC 17025 with the same title revisedasISO/IEC17025withthesametitle.

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • Ingeneral,therequirementsinthe17025 ge e a , t e equ e e ts t e 0 5 standard aremoremandatoryinnaturethanthe recommendationsofGuide 25 • Theorganizationofthe17025standardhas changedtoreflectthisdifference. • Thatis,themainbodyofthestandardisdivided intothreeparts: – initialrequirements, i iti l i t – managementrequirements,and – technicalrequirements. technical requirements

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • TheISO/IEC170252005Standardisasuccessortothe / 1999versionofthesamenumberedstandard. • The1999versionwasafollowontotheearlierGuide 25 d 25document. t • Unfortunately,oneyearafterthe1999versionof 17025 was released; the ISO 9000 series of standards 17025wasreleased;theISO9000seriesofstandards changed! • So,itthentooktheinternationalstandards organization(anditsworkinggroupon17025)almost6 yearstobringouttherevised17025in2005.

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • NOTE NOTE– thestandardiswritteninageneral the standard is written in a general fashionforalltypesoflaboratories(chemical, biological environmental etc ) but this biological,environmental,etc.)butthis presentationapproachesthesubjectfroman EMC Lab perspective EMCLabperspective.

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • The The1999versionwasabigimprovementover 1999 version was a big improvement over theGuide25documentbecauseitdividedthe labrequirementsintoManagementCriteria andTechnicalCriteria. • TheManagementportionofthestandardwas verysimilartoISO9000. • TheTechnicalportionaddressedthetechnical detailsofbothtesting andcalibration laboratories.

Management Requirements ManagementRequirements – 4.1 – 4.2 – 4.3

• 4.3.1 431 • 4.3.2 • 4.3.3

Organization ManagementSystem DocumentControl General DocumentApprovalandIssue DocumentChanges

–4 4.4 4 R i ReviewofRequests,Tenders, fR t T d andContracts – 4.5 SubcontractingofTestsand Calibrations lib i – 4.6 PurchasingServicesand Supplies pp

Management Requirements ManagementRequirements – 4.7 ServicetotheCustomer – 4.8 Complaints – 4.9 ControlofNonconforming Testing and/or Calibration Work Testingand/orCalibrationWork – 4.10 Improvement(onlynewClausein2005edition) – 4.11 CorrectiveAction • 4.11.1 General • 4.11.2 CauseAnalysis • 4.11.3 SelectionandImplementationof p CorrectiveActions • 4.11.4 MonitoringofCorrectiveActions • 4.11.5 AdditionalAudits

Management Requirements ManagementRequirements – 4.12 – 4.13

PreventiveAction Preventive Action ControlofRecords

• 4.13.1 • 4.13.2

– 4.14 – 4.15

General TechnicalRecords

InternalAudits ManagementReviews

Technical Requirements TechnicalRequirements – 5.1 General – 5.2 Personnel – 5.3 Accommodationand Environmental Environmental Conditions – 5.4 TestandCalibrationMethodsand MethodValidation • • • • • • •

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7

General SelectionofMethods LaboratoryDevelopedMethods NonStandardMethods ValidationofMethods EstimationofUncertaintyofMeasurement ControlofData

Technical Requirements TechnicalRequirements • 5.5 – 5.6 • 5.6.1 • 5.6.2 562 • 5.6.3

Equipment q p MeasurementTraceability General S ifi R SpecificRequirements i ReferenceStandardsandReference Materials

– 5.7 Sampling – 5.8 HandlingofTestandCalibration Items – 5.9AssuringtheQualityofTestandCalibration Results

Technical Requirements TechnicalRequirements – 5.10 • • • • • • • • •

ReportingtheResults p g

5.10.1General 5.10.2TestReportsandCalibrationCertificates 5 10 3 Test Reports 5.10.3TestReports 5.10.4CalibrationCertificates 5.10.5OpinionsandInterpretations 5.10.6TestingandCalibrationResultsObtainedfromSubcontractors 5.10.7ElectronicTransmissionofResults 5.10.8FormatofReportsandCertificates p 5.10.9AmendmentstoTestReportsandCalibrationCertificates

Guide 25 to ISO/IEC 17025 Guide25toISO/IEC17025 • ISO/IEC17025(anInternationalStandard)wasabig / ( ) g improvementoverISO/IECGuide25 • SplittingtheManagementRequirementsandthe T h i lR TechnicalRequirementswasamajorstep i t j t • ISO/IEC17025iswidelyacceptedaroundtheworld – The ThenexteditionofISO/IEC17025isbeingdiscussed next edition of ISO/IEC 17025 is being discussed becauseithasbeenfiveyearssincethereleaseofEdition 2

• FFutureimprovements– t i t splittingthestandardintotwo litti th t d d i t t – onefortestinglabsandoneforcalibrationlabs