ISO17025内部审核检查表英文版Word格式文档下载.docx
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Generalrequirements
4.1
Impartiality
4.1.1
Laboratoryactivitiesshallbeundertakenimpartialityandstructuredandmanagedsoastosafeguardimpartiality
4.1.2
Thelaboratorymanagementshallbecommittedtoimpartiality
4.1.3
Thelaboratoryshallberesponsiblefortheimpartialityofitslaboratoryactivitiesandshallnotallowcommercial,financialorotherpressurestocompromiseimpartiality.
4.1.4
Thelaboratoryshallidentifyriskstoitsimpartialityonanon-goingbasis.Thisshallincludethoserisksthatarisefromitsactivities,orfromitsrelationships,orfromtherelationshipsofitspersonnel.However,suchrelationshipsdonotnecessarilypresentalaboratorywitharisktoimpartiality.
4.1.5
Ifarisktoimpartialityisidentified,thelaboratoryshallbeabletodemonstratehowiteliminatesorminimizessuchrisk.
4.2
Confidentiality
4.2.1
Thelaboratoryshallberesponsible,throughlegallyenforceablecommitments,forthemanagementofallinformationobtainedorcreatedduringtheperformanceoflaboratoryactivities.Thelaboratoryshallinformthecustomerinadvance,oftheinformationitintendstoplaceinthepublicdomain.Exceptforinformationthatthecustomermakespubliclyavailable,orwhenagreedbetweenthelaboratoryandthecustomer（e.g.forthepurposeofrespondingtocomplaints）,allotherinformationisconsideredproprietaryinformationandshallberegardedasconfidential.
4.2.2
Whenthelaboratoryisrequiredbylaworauthorizedbycontractualarrangementstoreleaseconfidentialinformation,thecustomerorindividualconcernedshall,unlessprohibitedbylaw,benotifiedoftheinformationprovided.
4.2.3
Informationaboutthecustomerobtainedfromsourcesotherthanthecustomer（e.g.complainant,regulators）shallbeconfidentialbetweenthecustomerandthelaboratory.Theprovider（source）ofthisinformationshallbeconfidentialtothelaboratoryandshallnotbesharedwiththecustomer,unlessagreedbythesource.
4.2.4
Personnel,includinganycommitteemembers,contractors,personnelofexternalbodies,orindividualsactingonthelaboratory'
sbehalf,shallkeepconfidentialallinformationobtainedorcreatedduringtheperformanceoflaboratoryactivities,exceptasrequiredbylaw.
5
Structuralrequirements
5.1
Thelaboratoryshallbealegalentity,oradefinedpartofalegalentity,thatislegallyresponsibleforitslaboratoryactivities.
5.2
Thelaboratoryshallidentifymanagementthathasoverallresponsibilityforthelaboratory.
5.3
Thelaboratoryshalldefineanddocumenttherangeoflaboratoryactivitiesforwhichitconformswiththisdocument.Thelaboratoryshallonlyclaimconformitywiththisdocumentforthisrangeoflaboratoryactivities,whichexcludesexternallyprovidedlaboratoryactivitiesonanongoingbasis.
5.4
Laboratoryactivitiesshallbecarriedoutinsuchawayastomeettherequirementsofthisdocument,thelaboratory’scustomers,regulatoryauthoritiesandorganizationsprovidingrecognition.Thisshallincludelaboratoryactivitiesperformedinallitspermanentfacilities,atsitesawayfromitspermanentfacilities,inassociatedtemporaryormobilefacilitiesoratacustomer'
sfacility.
5.5
Thelaboratoryshall:
a）definetheorganizationandmanagementstructureofthelaboratory,itsplaceinanyparentorganization,andtherelationshipsbetweenmanagement,technicaloperationsandsupportservices;
b）specifytheresponsibility,authorityandinterrelationshipofallpersonnelwhomanage,performorverifyworkaffectingtheresultsoflaboratoryactivities;
c）documentitsprocedurestotheextentnecessarytoensuretheconsistentapplicationofitslaboratoryactivitiesandthevalidityoftheresults.
5.6
Thelaboratoryshallhavepersonnelwho,irrespectiveofotherresponsibilities,havetheauthorityandresourcesneededtocarryouttheirduties,including:
a）implementation,maintenanceandimprovementofthemanagementsystem;
b）identificationofdeviationsfromthemanagementsystemorfromtheproceduresforperforminglaboratoryactivities;
c）initiationofactionstopreventorminimizesuchdeviations;
d）reportingtolaboratorymanagementontheperformanceofthemanagementsystemandanyneedforimprovement;
e）ensuringtheeffectivenessoflaboratoryactivities.
5.7
Laboratorymanagementshallensurethat:
a）communicationtakesplaceregardingtheeffectivenessofthemanagementsystemandtheimportanceofmeetingcustomers'
andotherrequirements;
b）theintegrityofthemanagementsystemismaintainedwhenchangestothemanagementsystemareplannedandimplemented.
6
Resourcerequirements
6.1
General
Thelaboratoryshallhaveavailablethepersonnel,facilities,equipment,systemsandsupportservicesnecessarytomanageandperformitslaboratoryactivities.
6.2
Personnel
6.2.1
Allpersonnelofthelaboratory,eitherinternalorexternal,thatcouldinfluencethelaboratoryactivitiesshallactimpartially,becompetentandworkinaccordancewiththelaboratory'
smanagementsystem.
6.2.2
Thelaboratoryshalldocumentthecompetencerequirementsforeachfunctioninfluencingtheresultsoflaboratoryactivities,includingrequirementsforeducation,qualification,training,technicalknowledge,skillsandexperience.
6.2.3
Thelaboratoryshallensurethatthepersonnelhavethecompetencetoperformlaboratoryactivitiesforwhichtheyareresponsibleandtoevaluatethesignificanceofdeviations.
6.2.4
Themanagementofthelaboratoryshallcommunicatetopersonneltheirduties,responsibilitiesandauthorities.
6.2.5
Thelaboratoryshallhaveprocedure（s）andretainrecordsfor:
a）determiningthecompetencerequirements;
b）selectionofpersonnel;
c）trainingofpersonnel;
d）supervisionofpersonnel;
e）authorizationofpersonnel;
f）monitoringcompetenceofpersonnel.
6.2.6
Thelaboratoryshallauthorizepersonneltoperformspecificlaboratoryactivities,includingbutnotlimitedto,thefollowing:
a）development,modification,verificationandvalidationofmethods;
b）analysisofresults,includingstatementsofconformityoropinionsandinterpretations;
c）report,reviewandauthorizationofresults.
6.3
Facilitiesandenvironmentalconditions
6.3.1
Thefacilitiesandenvironmentalconditionsshallbesuitableforthelaboratoryactivitiesandshallnotadverselyaffectthevalidityofresults.
6.3.2
Therequirementsforfacilitiesandenvironmentalconditionsnecessaryfortheperformanceofthelaboratoryactivitiesshallbedocumented.
6.3.3
Thelaboratoryshallmonitor,controlandrecordenvironmentalconditionsinaccordancewithrelevantspecifications,methodsorproceduresorwheretheyinfluencethevalidityoftheresults.
6.3.4
Measurestocontrolfacilitiesshallbeimplemented,monitoredandperiodicallyreviewedandshallinclude,butnotbelimitedto:
a）accesstoanduseofareasaffectinglaboratoryactivities;
b）preventionofcontamination,interferenceoradverseinfluencesonlaboratoryactivities;
c）effectiveseparationbetweenareaswithincompatiblelaboratoryactivities.
6.3.5
Whenthelaboratoryperformslaboratoryactivitiesatsitesorfacilitiesoutsideitspermanentcontrol,itshallensurethattherequirementsrelatedtofacilitiesandenvironmentalconditionsofthisdocumentaremet.
6.4
Equipment
6.4.1
Thelaboratoryshallhaveaccesstoequipment（including,butnotlimitedto,measuringinstruments,software,measurementstandards,referencematerials,referencedata,reagents,consumablesorauxiliaryapparatus）thatisrequiredforthecorrectperformanceoflaboratoryactivitiesandthatcaninfluencetheresults.
6.4.2
Whenthelaboratoryusesequipmentoutsideitspermanentcontrol,itshallensurethattherequirementsforequipmentofthisdocumentaremet.
6.4.3
Thelaboratoryshallhaveaprocedureforhandling,transport,storage,useandplannedmaintenanceofequipmentinordertoensureproperfunctioningandtopreventcontaminationordeterioration.
6.4.4
Thelaboratoryshallverifythatequipmentconformstospecifiedrequirementsbeforebeingplacedorreturnedintoservice.
6.4.5
Theequipmentusedformeasurementshallbecapableofachievingthemeasurementaccuracyand/ormeasurementuncertaintyrequiredtoprovideavalidresult.
6.4.6
Measuringequipmentshallbecalibratedwhen:
-themeasurementaccuracyormeasurementuncertaintyaffectsthevalidityofthereportedresults,and/or
-calibrationoftheequipmentisrequiredtoestablishthemetrologicaltraceabilityofthereportedresults.
6.4.7
Thelaboratoryshallestablishacalibrationprogramme,whichshallbereviewedandadjustedasnecessaryinordertomaintainconfidenceinthestatusofcalibration.
6.4.8
Allequipmentrequiringcalibrationorwhichhasadefinedperiodofvalidityshallbelabelled,codedorotherwiseidentifiedtoallowtheuseroftheequipmenttoreadilyidentifythestatusofcalibrationorperiodofvalidity.
6.4.9
Equipmentthathasbeensubjectedtooverloadingormishandling,give
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