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ASBStandard017,FirstEdition2017
StandardPracticesforMeasurementTraceabilityinForensicToxicology
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ASBStd017,1stEd.‐2017
StandardPracticesforMeasurementTraceabilityinForensicToxicology
ApprovedbytheAcademyStandardsBoardforusebytheAAFSStandardsBoard,LLC.Xxxx2017
AcademyStandardsBoard4200WisconsinAvenue,NW
Suite106‐310Washington,DC20016‐2143
Thisdocumentmaybedownloadedforfreeat:http://asb.aafs.org/
Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,including
photocopying,orpostingontheinternetoronanintranet,withoutpriorwrittenpermissionfromtheAcademyStandardsBoard,4200WisconsinAvenue,NW,Suite106‐310,Washington,
DC20016‐2143,asb.aafs.org.
Copyright©AcademyStandardsBoard2017
ISOInternationalClassificationKeywords:MeasurementTraceability,Calibration,ForensicToxicologyThis standard was developed to provide guidance on minimum requirements forestablishingmeasurement traceability inForensicToxicology laboratories.Theneed forreliability, uniformity, consistency, and comparability is the fundamental reason forestablishing traceability of a measurement. Measurement traceability inherently bringswithitconfidenceandreliability.
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ForewordThis Standard Practices forMeasurement Traceability in Forensic Toxicologywas developed toprovideminimumrequirements forestablishingmeasurement traceability in forensic toxicologylaboratories.Thefundamentalreasonforestablishingtraceabilityofameasurementistoensureconfidenceandreliabilityinforensictoxicologicaltestresults.ThisstandardwasdevelopedbytheToxicology Subcommittee of theOrganizational Scientific Area Committee. Itwas prepared andfinalized as a standard by the Toxicology Consensus Body of the ASB. All hyperlinks and webaddressesshowninthedocumentarecurrentasofthepublicationdateofthisstandard.
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AcknowledgementsBaseDraftDevelopedbytheOrganizationofScientificAreaCommittees(OSAC)ToxicologySubcommittee:
Editor: DustinTateYeatman,M.S.F‐ABFT,F‐ABC;PalmBeachCountySheriff’sOfficeCrimeLaboratory;WestPalmBeach,Florida
WorkingGroup: Amanda Black, B.S.; Washington State Patrol Toxicology LaboratoryDivision;Seattle,WashingtonSabra Botch‐Jones, M.S. M.A. D‐ABFT‐FT; Boston University School ofMedicine,BiomedicalForensicSciences;Boston,MassachusettsAlbertElian,M.S.;MassachusettsStatePoliceCrimeLaboratory;Maynard,MassachusettsLaurel Farrell, B.A.; American Society of Crime Laboratory DirectorsLaboratoryAccreditationBoard;Longmont,ColoradoPhilip Kemp, Ph.D., F‐ABFT; Civil Aerospace Medical Institute (FAA);OklahomaCity,OklahomaSuePearring,M.S.; LosAngelesCountyDepartment ofMedicalExaminer‐Coroner;LosAngeles,CaliforniaNicholas Tiscione, M.S., D‐ABFT‐FT; Palm Beach County Sheriff’s OfficeCrimeLaboratory;WestPalmBeach,Florida
FinalStandardPreparedandFinalizedbytheASBToxicologyConsensusBody:
Members: WendyAdams,Ph.D.,F‐ABFT;NMSLabs;WillowGrove,PennsylvaniaSabra Botch‐Jones, M.S. M.A. D‐ABFT‐FT; Boston University School ofMedicine,BiomedicalForensicSciences;Boston,MassachusettsRandalClouette,M.S.F.S.,D‐ABFT‐FD;QuestDiagnostics,Inc;Lenexa,KansasFionaCouper,Ph.D.,WashingtonStatePatrol;Seattle,WashingtonKennethFerslew,Ph.D.,F‐ABFT;EastTennesseeStateUniversity; JohnsonCity,TennesseeDean Fritch, Ph.D., F‐ABFT; OraSure Technologies, Inc; Bethlehem,PennsylvaniaShannonGeorge,B.S.;IllinoisStatePolice;Springfield,IllinoisMichele Glinn, Ph.D., F‐ABFT; Essential Testing LLC/Avertest; Collinsville,Illinois
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James Hutchison, Jr., M.S., D‐ABFT‐FT; Montana Forensic ToxicologyServices,LLC;Lolo,MontanaMatthew Juhascik, Ph.D., F‐ABFT; Montgomery County Coroner’s Office;Dayton,OhioPhilip Kemp, Ph.D., F‐ABFT; Civil Aerospace Medical Institute (FAA);OklahomaCity,OklahomaMelissaKennedy,M.S.,D‐ABFT‐FA;ANSI‐ASQNationalAccreditationBoard;Garner,NorthCarolinaMarc LeBeau, Ph.D., F‐ABFT; Federal Bureau of Investigation; Quantico,VirginiaAdamNegrusz,Ph.D.,F‐ABFT;UnitedStatesDrugTestingLaboratories,Inc.;DesPlaines,IllinoisDouglasRohde,M.S.;LakeCountyCrimeLaboratory;Painesville,OhioRobert Sears, M.S., F‐ABFT; South Carolina Law Enforcement Division;Columbia,SouthCarolinaMichaelStypa,M.S.,D‐ABFT‐FT;LasVegasMetropolitanPoliceDepartment;LasVegas,NevadaTedVosk,J.D.;Kirkland,WashingtonFrankWallace,B.A.;AmeritoxLLC;HighPoint,NorthCarolinaDarcie Wallace‐Duckworth, Ph.D.; Aegis Sciences Corporation; Nashville,TennesseeJeffWalterscheid,Ph.D.,F‐ABFT;ArmedForcesMedicalExaminerSystem;DoverAFB,DelawareRuthWinecker,Ph.D.,F‐ABFT;OfficeoftheChiefMedicalExaminer;Raleigh,NorthCarolinaDustinTateYeatman,M.S.F‐ABFT,F‐ABC;PalmBeachCountySheriff’sOfficeCrimeLaboratory;WestPalmBeach,Florida
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TableofContents1. Scope.....................................................................................................................................................................2 2. NormativeReferences...................................................................................................................................2 3. TermsandDefinitions...................................................................................................................................3 4. GeneralMeasurementTraceability.........................................................................................................4 5. TraceabilityRequirementsforToxicology...........................................................................................7 6. Equipment..........................................................................................................................................................7 7 Conformance.....................................................................................................................................................9 AnnexA(informative).........................................................................................................................................10 AnnexB(informative).........................................................................................................................................11
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StandardPracticesforMeasurementTraceabilityinForensicToxicology
1. Scope
This standard defines the minimum requirements for establishing measurement traceability inforensic toxicology laboratories. The fundamental reason for establishing traceability of ameasurementistoensureconfidenceandreliabilityinforensictoxicologicaltestresults.2. NormativeReferencesThefollowingreferencesaredocumentsthatareindispensablefortheapplicationofthestandard.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.International Bureau ofWeights andMeasures (BIPM)‐International Committee forWeights andMeasures(CIPM)MutualRecognitionArrangement1International Bureau of Weights and Measures (BIPM) Key Comparison Database (KCDB),AppendixC2International Laboratory Accreditation Cooperation (ILAC), ILAC P10:01/2013 ILAC Policy onTraceabilityofMeasurementResults3
InternationalLaboratoryAccreditationCooperation(ILAC)MutualRecognitionArrangement3InternationalOrganizationforStandardization(ISO),ISO/IEC17025:2005Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories(Geneva,Switzerland:ISO,2005)4InternationalOrganizationforStandardization(ISO),ISOGuide34:2009Generalrequirementsforthecompetenceofreferencematerialproducers(Geneva,Switzerland:ISO,2009)4InternationalOrganizationforStandardization(ISO),ISO17034:2016Generalrequirementsforthecompetenceofreferencematerialproducers(Geneva,Switzerland:ISO,2016)4JointCommitteeforGuidesinMetrology(JCGM),Internationalvocabularyofmetrology–Basicandgeneralconceptsandassociatedterms(VIM),3rded.(Sèvres,France:InternationalBureauofWeightsandMeasures[BIPM]‐JCGM200,2012)(2008withminorcorrections)5
1MoreinformationabouttheBIPMisavailableat:http://www.bipm.org/en/cipm‐mra/2BIPMkeycomparisondatabaseavailableat:http://kcdb.bipm.org/appendixC/3ILACdocumentavailablefordownloadathttp://ilac.org4ISOdocumentsavailableforpurchaseathttp://www.iso.org/iso/home/store/catalogue_ics.htmorfromotherauthorizeddistributors5VIMavailablefordownloadathttp://www.bipm.org/en/publications/guides/vim.html
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3. TermsandDefinitionsForpurposesofthisdocument,thefollowingdefinitionsandacronymsapply.3.1 accreditationThirdpartyevaluationofaforensicscienceserviceproviderbasedonaparticularstandard(s),otherrelevantdocumentsandattestationofcompetencetocarryoutspecifictasks.3.2 accuracyCloseness of agreement between a measured quantity value and a true quantity value of ameasurement.3.3 calibrationOperation that,under specified conditions, establishesa relationbetween thequantityvalueandcorrespondingindications.3.4 calibratorMeasurementstandardusedincalibration.3.5 CertifiedReferenceMaterialCRMReferencematerial characterized by a metrologically valid procedure for one or more specifiedproperties, accompanied by a certificate that provides the value of the specified property, itsassociateduncertainty,andastatementofmetrologicaltraceability.3.6 controlMaterialofknowncompositionthatisanalyzedalongwithunknownsamples(s)inordertoevaluatetheperformanceofananalyticalprocedure.3.7 decisionpointAdministrativelydefinedcutofforconcentrationthatisatorabovethemethod’slimitofdetectionorlimitofquantitationandisusedtodiscriminatebetweenanegativeandpositivetestresult.3.8 LimitofDetectionLODAnestimateofthelowestconcentrationofananalyteinasamplethatcanbereliablydifferentiatedfromblankmatrixandmeetsidentificationcriteriafortheanalyticalmethod.
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3.9 LimitofQuantitationLOQAnestimateofthelowestconcentrationofananalyteinasamplethatcanbereliablymeasuredwithacceptablebiasandprecision.3.10 referencematerialMaterial, sufficientlyhomogeneous and stablewith reference to specifiedproperties,whichhavebeen established to be fit for its intended use in a measurement or in examination of nominalproperties.4. GeneralMeasurementTraceability4.1 Background4.1.1 Somemeasurementprocessesrequireonlyasinglestep,whereasothersmayrequiremorethanonestep.
Measurement(VIM2.1):processofexperimentallyobtainingoneormorequantityvaluesthatcanreasonablybeattributedtoaquantity.
Importantly,“process”isthefirstwordinthedefinitionofmeasurement.Measurementrelatestothewholeprocessofobtainingaquantityvalue.Relatedterms:
Quantity(VIM1.1):propertyofaphenomenon,body,orsubstance,wherethepropertyhasamagnitudethatcanbeexpressedasanumberandareference.QuantityValue(VIM1.19):numberandreferencetogetherexpressingmagnitudeofaquantity.
QuantityValueexample(Toxicology):Bloodalcoholcontent:0.158gramsofethanolper100mLofblood.
Note:VIMreferstoJointCommitteeforGuidesinMetrology(JCGM),Internationalvocabularyofmetrology–Basicandgeneralconceptsandassociatedterms
4.1.2 Measurements occur in different ways in testing and calibration processes. Themeasurement(s)maybe:a. thereportedtestorcalibrationresult;b. aquantitativedecisionpoint(cutoff)thatresultsinaqualitativetestreport;orc. madeduringthetestingorcalibrationprocessbutnotreportedtothecustomer.In all of these scenarios, the measurement(s) may be used as the basis for a conclusion, aninterpretation,oranopinion.
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4.1.3 The National Institute of Standards and Technology (NIST) expands on the definition ofmeasurement traceability stating that measurement traceability can be characterized by thefollowingessentialelements.6a. UnbrokenChainofComparisons–Adocumentedsystemofcomparisonswitheachstephaving
theessentialelementsofmetrologicaltraceabilitygoingbacktoastatedreferenceacceptabletotheparties,usuallyanationalorinternationalstandard.
b. DocumentedMeasurement Uncertainty – The measurement uncertainty for each step in thetraceabilitychainmustbecalculatedaccordingtodefinedmethodsandmustbestatedsothatanoveralluncertaintyforthewholechainmaybecalculated.
c. DocumentedMeasurementProcedure–Eachstepinthechainmustbeperformedaccordingtodocumentedandgenerallyacceptedproceduresandtheresultsmustbedocumented.
d. TechnicalCompetence–Thelaboratoriesorbodiesperformingoneormorestepsinthechainmustmaintainandsupplyevidenceof technicalcompetence(e.g.,bymaintainingappropriatetrainingrecords,participatingininter‐laboratorycomparisons,andbydemonstratingthattheyareaccreditedbyarecognizedaccreditationbody).
e. RealizationofSIUnits–Thechainofcomparisonsmust,wherepossible,endattherealizationoftheInternationalSystemofUnits(SI).
f. DocumentedCalibrationIntervals–Calibrationsmustberepeatedatestablishedandappropriateintervalstopreservemetrologicaltraceability;and
g. MeasurementAssurance–Apropermeasurementassuranceprogram[howevernamed]mustbeestablished to ensure the validity of themeasurement process and to ensure the calibrationstatusofequipment,referencestandardsandreferencematerials.
4.2 RequirementsforMeasurementTraceability4.2.1 General
Forensicscienceserviceprovidersestablishtraceabilityofameasurementprocessbymakingoneormore measurements using equipment that has been calibrated with established metrologicaltraceabilityand/orthroughtheuseofcertifiedreferencematerialsinthetestorcalibrationmethod.For equipment and certified reference materials used to establish and maintain measurementtraceability, proper handling and storage procedures which meet or exceed manufacturer’srecommendationsmustbefollowed.4.2.2 CalibrationServiceProvider
Iftraceabilityofameasurementwillbeestablished,eithertotallyorpartially,throughthecalibrationof equipment used to make the measurement, then this calibration shall be performed by anappropriatelyaccreditedcalibrationservicesupplierthat,ifavailable,iseither:
6See“SampleProcedureforMethodValidation”athttps://www.nist.gov/document/sapmethodvalidation2016‐12‐21doc.
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a. aNationalMetrologyInstitute(NMI)thatisasignatorytotheBIPM‐CIPMMutualRecognitionArrangement, with the calibration to be performed listed in Appendix C of the BIPM KeyComparisonDatabase(KCDB);or
b. aservicesupplieraccreditedtoISO/IEC17025:2005byanaccreditingbodythatisasignatorytotheInternationalLaboratoryAccreditationCooperation(ILAC)MutualRecognitionArrangement,withthecalibrationtobeperformedlistedinascopeofaccreditation.
If an appropriately accredited calibration service supplier is not available that meets the aboverequirement,thentheforensicscienceserviceprovidershallperformanevaluationtoensuretheexternal service supplier meets the competence, measurement traceability and measurementcapabilityequivalenttoanISO/IEC17025:2005accreditedsupplierorreferencedintheILACPolicyontheTraceabilityofMeasurementResults.Theforensicscienceserviceprovidershallkeepobjectiveevidenceofthisevaluation.Theforensicserviceprovidershallperformare‐evaluationofservicesatleasteverytwoyears.4.2.3 CalibrationProgram
Theforensicscienceserviceprovidershallidentifyallequipmentinacalibrationprogram,howevernamed,thatrequirescalibrationtoestablishmeasurementtraceability,eithertotallyorpartially.Thedocumentationshall:a. establishtheintervalforcalibration;b. delineateifintermediatechecksofthecalibrationstatusarerequiredbetweencalibrationsand
ifso,thescheduleandprocedureforthoseintermediatechecks;andc. require calibration of new equipment of this type (e.g., balance, pipette) prior to use of the
equipmentintesting,calibrationorinspectionwork.4.2.4 CertifiedReferenceMaterials
If traceabilityofameasurementwillbeestablished,either totallyorpartially, the laboratorywillestablishitthroughtheuseofoneormorecertifiedreferencematerial(s)(CRM).Ifavailable,thatCRMshallbeobtainedbythelaboratoryfromasupplierthatiseither:a. aNationalMetrologyInstitute(NMI)thatisasignatorytotheBIPM‐CIPMMutualRecognition
Arrangementwith the CRM to be purchased included in the BIPM key comparison database(KCDB);or
b. an accredited Reference Material Producer that is accredited to ISO Guide 34:2009 orISO17034:2016byanaccreditingbodythatisasignatorytoamutualormultilateralrecognitionarrangement in an ILAC recognized regional accreditation cooperation or the ILAC MutualRecognitionArrangement,withascopeofaccreditationcoveringtheCRM.
IfaCRMisnotavailabletothelaboratoryfromasupplierthatmeetstheaboverequirement,thentheforensicscienceserviceprovidershallperformanevaluationoftheCRMsupplierforcompetence,measurement traceability, and measurement capability equivalent to an ISO/IEC 17025:2005accreditedsupplierorreferencedintheILACPolicyontheTraceabilityofMeasurementResults.The
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forensicscienceserviceprovidershallkeepobjectiveevidenceofthisevaluation.Theforensicserviceprovidershallperformare‐evaluationofservicesatleasteverytwoyears.4.2.5 ModificationstoReferenceMaterials
Ifareferencematerial,whethercertifiedornot,isusedtoprepareastockorworkingsolution,thentheequipmentusedshallbecalibratedasdelineatedinSection6.5. TraceabilityRequirementsforToxicology5.1 The scope of forensic toxicology methods is typically categorized as screening methods,qualitativeconfirmation/identificationmethods,orquantitativemethods.Measurementtraceabilityshall be established by the forensic toxicology laboratory through the use of one or moremetrologicallypreparedcalibrators.CalibratorsmaybeundilutedCRM(s)orcalibratorspreparedusingappropriatelycalibratedequipmentandCRMsorreferencematerial(s)(RM)showntobefitfor purpose. Additionally, a laboratory may choose to use controls that are prepared in ametrologicallyvalidway.5.2 Thefollowing(5.2.1and5.2.2)measurementtraceabilityrequirementsshallbe followedbyforensictoxicologylaboratoriesfortheiranalyticalmethods.5.2.1 Measurement traceability shall be established during method validation and/or duringroutineanalysisofcasesfor:a. immunoassay‐basedscreeningprocedures;b. non‐chromatographicand/ormassspectrometricscreeningprocedures(e.g.,colortest,etc.).5.2.2 Measurementtraceabilityshallbeestablishedduringroutineanalysisofcasesfor:a. allscreeningproceduresutilizingchromatographicand/ormassspectrometrictechniques;b. qualitativeconfirmation/identificationmethods;c. quantitativemethods.6. Equipment6.1 GeneralEquipmentcommonlyusedinforensictoxicologylaboratories,listedbelow,shallbecalibratedbyappropriatelyaccreditedcalibrationservicesuppliersthatmeetthoserequirementsinSection3.2.1.Documentationoftheaccreditedcalibratedservicesuppliersshallbemaintainedbythelaboratory.Equipmentshallbecalibratedpriortouse,andthelaboratoryshallhaveaprocedurethatincludesthe frequencyofcalibrationandacceptability/tolerancespecifications.Calibrationdocumentationshall include the date the calibration is performed, the calibration status and the date the nextcalibrationisdue.Thelaboratoryshallevaluatewhetherintermediatechecksofthecalibrationstatusarenecessarybased on the frequency of use, work volume, occurrence of unexpected shutdown, equipmentmaintenance,andotherfactors.Ifintermediatechecksareperformed,thepolicyandprocedureshall
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includethefrequencyandspecificationsforintermediatechecksandthesewillbecarriedoutusingcalibrated equipment (e.g.mass reference standards, equipment used tomonitor environmentalconditions).6.2 AnalyticalBalancesAnalyticalbalancesshallbecalibratedatleastannuallybyanappropriatelyaccreditedcalibrationservicesupplier.6.3 ReferenceStandardsMass reference standards shall be calibratedat leastonceevery threeyearsby an appropriatelyaccreditedcalibrationservicesupplier.Anyadjustmentsofmassreferencestandardsshallonlybeconductedbyanexternalcalibrationservicesupplier,andthereferencestandardsshallbecalibratedbeforeandafteranyadjustment.Massreferencestandardsusedtoverifytheaccuracyofequipmentshallbededicatedforthispurpose,unlessthelaboratoryhasdemonstratedthattheirintegrityasreferencestandardsaremaintained.6.4 VolumetricGlasswareVolumetricglasswareusedforthepreparationofcalibratorsthatrequiremeasurementtraceabilityshallbecalibratedbyanexternalcalibrationservicesupplierpriortouse.Volumetricglasswareusedin thepreparationofcalibratorsshallbededicated for thispurpose,andshallbemaintainedandstoredastoprotectitsintegrity.Afterinitialcalibration,scheduledcalibrationisnotrequiredunlessthecalibrationstatusoftheglasswareisinquestion,duetodeterioration,mishandlingorimproperstorage.6.5 Pipettes,Diluters,andSyringesAllpipettes,pipettediluters,automaticdiluters,andsyringesusedforthepreparationofcalibratorsolutionsthatrequiremeasurementtraceabilityorinsamplepreparation(e.g.extractionstepsthatmayaffectoverallmeasurementuncertainty)shallbecalibratedatleastannuallybyanappropriatelyaccreditedexternalcalibrationservicesupplier.Autosamplersyringesusedforsampleintroductiontoanalyticalinstrumentation(gaschromatograph,liquidchromatograph,immunoassays,orother)donotrequirecalibration.6.6 OtherEquipmentCentrifuges, rotators, shakers,waterbaths,evaporators,heatingblocks, thermometers,andothergenerallaboratoryequipmentthatdoesnotsignificantlyaffecttheaccuracyandvalidityofthetestresult,donotrequirecalibrationtoestablishmeasurementtraceability.Alaboratorymaychoosetouse calibration or verification as a maintenance procedure to ensure proper functioning of theequipment.6.7 BreathAlcoholCalibrationEquipment6.7.1 BreathAlcoholMeasuringInstruments
Thermometers,multi‐metersandbarometers,asapplicable,shallbecalibratedatleastannuallybyanappropriatelyaccreditedexternal,calibrationservicesupplier.
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6.7.2 BreathAlcoholReferenceMaterials
Sections6.2to6.6applytoequipmentusedinpreparationofbreathalcoholreferencematerialsusedinabreathalcoholcalibrationmethod.7 Conformance
Documentation to verify conformance with the above requirements shall be maintained by thelaboratoryforaminimumoffiveyearsandwillbemadeavailabletoauditorsuponrequest.
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AnnexA(informative)
FoundationalPrinciples
Measurement traceability, formally referred to as metrological traceability, is defined in theInternationalVocabularyofMetrology(VIM):7
Metrologicaltraceability(VIM2.41):propertyofameasurementresultwherebytheresultcanberelatedtoareferencethroughadocumentedunbrokenchainofcalibrations,eachcontributingtothemeasurementuncertainty.
Customers of forensic science service providers require tests and calibrations performed to bereliable, accurate, and comparable. Customers need to know that if the test or calibration wasperformedonadifferentdaybythesameforensicscienceserviceprovider,orbyanotheraccreditedforensicscienceserviceprovider,thetestorcalibrationresultwouldbesimilarandcomparable.
7JointCommitteeforGuidesinMetrology(JCGM),Internationalvocabularyofmetrology–Basicandgeneralconceptsandassociatedterms(VIM),3rded.(Sèvres,France:InternationalBureauofWeightsandMeasures[BIPM]‐JCGM 200, 2012) (2008 with minor corrections). Available for download athttp://www.bipm.org/en/publications/guides/vim.html.
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AnnexB(informative)
Bibliography
1] ASCLD/LABGuidanceonMeasurementTraceability–MeasurementAssurancewww.ascld‐lab.org/
2] ASCLD/LABPolicyonMeasurementTraceabilitywww.ascld‐lab.org/3] ASTM International E542‐01 Standard Practice for Calibration of Laboratory Volumetric
Apparatusavailableatwww.astm.org4] Eurachem Terminology in Analytical Measurement – Introduction to VIM 3 available at
https://www.eurachem.org/index.php/publications/guides/terminology‐in‐analytical‐measurement
5] TheNationalInstituteofStandardsandTechnology(NIST)definitionof“internalmeasurementassuranceprogram”availableatwww.nist.gov/traceability/index.cfm
6] The National Institute of Standards and Technology (NIST) Sample Procedure for MethodValidationavailableathttps://www.nist.gov/document/sapmethodvalidation2016‐12‐21doc
7] Internal Organization for Standardization (ISO). ISO/IEC 9000:2005 Quality ManagementSystems—Fundamentals and Vocabulary (Geneva, Switzerland: ISO, 2000) ISO documentsavailableforpurchaseathttp://www.iso.org/iso/home/store/catalogue_ics.htmorfromotherauthorizeddistributors
8] InternalOrganizationforStandardization(ISO).ISO/IEC17000:2004ConformityAssessment—VocabularyandGeneralPrinciples(Geneva,Switzerland:ISO,2014)ISOdocumentsavailableforpurchaseathttp://www.iso.org/iso/home/store/catalogue_ics.htmor fromotherauthorizeddistributors