ISO17025内部审核检查表英文版.docx

ISO17025内部审核检查表英文版.docx

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ISO17025内部审核检查表英文版

AdequacyAuditChecklistbasedonMSISO/IEC17025:

2017

LaboratoryName:

……………………………………………………………………..

Note:

*Laboratorytospecifytheclausenumberfromtherelevantdocuments.Wheredocuments/proceduresarenotapplicable,thelaboratoryarerequiredtoprovideinformationontheimplementation.

Clause

Requirement

ComparableLaboratoryDocumentsClauses/InfoontheImplementation*

Remarks

4

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