ISO17025质量手册英文版模板.docx

ISO17025质量手册英文版模板.docx

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ISO17025质量手册英文版模板

XYZLaboratory

ISO/IEC17025QUALITYMANUAL

Revision:

01

Date:

MM/DD/YY

UNCONTROLLEDCOPY

CONTROLLEDCOPY

Serial#_________

IssuedTo:

___________________________Date:

___________

SAMPLE

Note:

Thissamplemanualonlycontainspartialtext,therefore,thenumberingisnotconsecutive

TableofContents

APPROVALS4

REVISIONANDAPPROVALRECORD5

1.0General6

1.1Applicability7

2.0References8

3.0TermsandDefinitions9

4.0GeneralRequirements10

4.1Impartiality10

4.2Confidentiality11

5.0StructuralRequirements12

5.1AdministrativeandGeneralRequirements12

5.2OrganizationandManagement13

XYZLaboratoryOrganizationalChart15

6.0ResourceRequirements20

6.1General20

6.2Personnel20

6.3FacilitiesandEnvironmentalConditions23

6.4Equipment25

6.5MetrologicalTraceability29

6.6ExternallyProvidedProductsandServices31

7.0ProcessRequirements33

7.1ReviewofRequests,Tenders,andContracts33

7.2Selection,Verification,andValidationofMethods36

7.3Sampling40

7.4HandlingofTestand/orCalibrationItems41

7.5TechnicalRecords42

7.6EvaluationofMeasurementUncertainty42

7.7EnsuringtheValidityofResults44

7.8ReportingofResults46

7.9Complaints52

7.10NonconformingWork53

7.11ControlofDataandInformationManagement54

8.0ManagementSYSTEMRequirements56

8.1Options56

8.1.1General56

8.2ManagementSystemDocumentation57

8.3ControlofManagementSystemDocuments63

8.4ControlofRecords64

8.5ActionstoAddressRisksandOpportunities65

8.6Improvement66

8.7CorrectiveAction67

8.8InternalAudits68

8.9ManagementReviews70

APPROVALS

APPROVEDBY:

____________________________________________________

（Name）,PresidentDate

____________________________________________________

（Name）,QualityManagerDate

____________________________________________________

（Name）,TechnicalManagerDate

____________________________________________________

（Name）,PurchasingManagerDate

5.0StructuralRequirements

5.1AdministrativeandGeneralRequirements

5.1.1XYZLaboratoryholdslegalresponsibilityforitsoperation.

5.1.2Calibration/testingactivitiesareperformedinsuchawayastomeettherequirementsoftheISO/IEC17025standard,aswellassatisfyingtheneedsofthecustomer,regulatoryauthorities,ororganizationsprovidingrecognition.

5.1.3Themanagementsystemcoversworkcarriedoutinthelaboratory’spermanentfacilities,atsitesawayfromitspermanentfacilities,andinassociatedtemporaryormobilefacilitiesorcustomers’facilities.

5.1.4XYZLaboratory’scalibration/testcapabilitiesaredocumented.See“ScopeofServices”and“ScopeofAccreditation”in1.0General.

6.0ResourceRequirements

6.1General

XYZLaboratoryhasthenecessarypersonnel,accommodationandenvironmentalconditions,measuring/testequipment,informationsystem（s）andsupportservicestoperformitslaboratoryactivities.

6.2Personnel

6.2.1XYZLaboratorymanagementensuresthecompetencyofallwhooperatespecificequipment,whoperformtestsand/orcalibrations,evaluateresults,andsigntestreportsand/orcalibrationcertificates.Staffundergoingtrainingisadequatelyandappropriatelysupervised.Personnelperformingspecifictaskswithinthemanagementsystemthatmaydirectlyorindirectlyaffecttheconformanceoftheproducttoqualityrequirementsarequalifiedonthebasisofappropriateeducation,qualification,training,technicalknowledge,experience,and/ordemonstratedskills,asrequired.Allpersonnelunderstandthesignificanceof,andrespondto,deviationsfoundwithregardtothelaboratoryactivities.

6.2.2XYZLaboratoryusespersonnelwhoarepermanentlyemployedby,orundercontractto,thelaboratory.TheTechnicalManagerensuresthatcontractual,additionaltechnicalemployeesandkeysupportpersonnelareadequatelysupervisedandworkinaccordancewiththelaboratory’smanagementsystem.

6.2.3TheQualityManagermaintainscurrentjobdescriptionsformanagerial,technical,andkeysupportpersonnelinvolvedintests/calibrationsandlaboratoryoperations.Thisincludesduties,responsibilitiesandauthorities.

6.2.4XYZLaboratoryhasadocumentedprocessfor,selecting,training;supervising;authorizing;andongoingmonitoringofpersonnelcompetencyinvolvedinlaboratoryactivities.Fordetails,refertotheTrainingProcedure.

7.0ProcessRequirements

7.1ReviewofRequests,Tenders,andContracts

7.1.1TheContractReviewProcedureoutlinestheprocessesforreviewofrequests,tenders,orcontracts.Thisprocedureensuresthat:

a）therequirements,includingthemethodstobeused,areadequatelydefined,documented,andunderstood;

b）thelaboratoryhasthecapabilityandresourcestomeettherequirements,andwhereexternalprovidersarenecessary,therequirementsofclause6.6.2aresatisfied;

c）theappropriatetestand/orcalibrationmethodisselectedandcapableofmeetingthecustomer’srequirements

XYZlaboratoryinformsthecustomerwhenthemethodrequestedbythecustomerisdeterminedtobeinappropriateorobsolete.

7.1.2Anydifferencesbetweentherequestortenderandthecontractareresolvedbeforeanyworkcommences.Eachcontractmustbeacceptabletoboththelaboratoryandthecustomer.Deviationsrequestedbythecustomermustnotjeopardizetheintegrityofthelaboratoryortheresults.

7.1.3Therequest,tender,andcontractreviewisconductedinapracticalandefficientmanner,andtheeffectoffinancial,legal,andtimescheduleaspectsaretakenintoaccount.

7.1.4XYZLaboratoryensuresthatlaboratoryactivitieswhichareexternallyprovidedmeetthecustomer’srequirementsandwhereapplicable,therelevantrequirementsoftheISO/IEC17025standard.

7.1.5Recordsofreviews,includinganysignificantchanges,aremaintained.Thisincludespertinentdiscussionswithacustomerrelatingtothecustomer'srequirementsortheresultsofthework.

7.2Selection,Verification,andValidationofMethods

7.2.1XYZLaboratoryusesappropriatemethodsandproceduresforalltestsand/orcalibrationswithinitsscopeincludingsampling,handling,transport,storage,andpreparationofitemstobetestedand/orcalibrated,andwhereappropriate,anestimationofthemeasurementuncertaintyaswellasstatisticaltechniquesforanalysisoftestand/orcalibrationdata.

TheXYZLaboratorymaintainsinstructionsontheuseandoperationofallrelevantequipment,andonthehandlingandpreparationofitemsfortestingand/orcalibration,orbothwheretheabsenceofsuchinstructionscouldjeopardizetheresultsoftestsand/orcalibrations.Allinstructions,standards,manuals,andreferencedatarelevanttotheworkofthelaboratoryaremaintainedcurrentandaremadereadilyavailabletopersonnel.Deviationfromtestandcalibrationmethodsoccuronlyifthedeviationisdocumented,technicallyjustified,authorized,andacceptedbythecustomer.

7.2.2Methodsfortestand/orcalibration,includingmethodsforsampling,areselectedandusedtomeettheneedsofthecustomerandareappropriateforthetestsand/orcalibrationsundertaken.Methodspublishedasinternational,regional,ornationalstandardsareusedwheneverpossible.Thelatestvalideditionofastandardisusedunlessitisnotappropriateorpossibletodoso.Whennecessary,thestandardsaresupplementedwithadditionaldetailstoensureconsistentapplication.

7.2.3ValidationofMethods

7.2.3.1Validationofmethodsconfirmsthatparticularrequirementsforaspecificintendedusearefulfilled.

7.2.3.2Allstandardandnon-standardtestmethodsandprocedures,andstandardmethodsusedoutsidetheirintendedscope（modifiedstandardsmethods）,includingthosedevelopedbythelaboratoryarevalidatedtoensurethatsuchmethodsandproceduresarefitfortheintendeduseandarerelevanttotherequirementsofISO/IEC17025,aswellas,thecustomer.Validationisasextensiveasisnecessarytomeettheneedsofthegivenapplicationorfieldofapplication.

Ifchangesaremadetovalidatednon-standardmethods,theinfluenceofsuchchangesisdocumentedand,ifappropriate,anewvalidationiscarriedout.

Theresultsofsuchvalidationarerecordedtogetherwiththeprocedureutilizedandanyotherrelevantinformation.Therecordstateswhetherthemethodorprocedureisfitfortheintendeduse.

7.6EvaluationofMeasurementUncertainty

7.6.1TheEstimationofUncertaintyofMeasurementProcedureisappliedtoallinhousecalibrations（includingthelaboratory’sownequipment）.Theuncertaintyofmeasurementisavailableonthecertificateofanalysisorcalibrationcertificatefromasubcontractor.

7.6.2TheEstimationofUncertaintyofMeasurementProcedureisappliedtoestimatinguncertaintyofallsamplingactivitiesandmeasurementintests,exceptwhenthetestmethodsmayprecluderigorouscalculations.Incertaincasesitisnotpossibletoundertakemetrologicallyandstatisticallyvalidestimationsofuncertaintyofmeasurement.Inthesecasesthelaboratoryattemptstoidentifyallthecomponentsofuncertaintyandmakethebestpossibleestimation,andensurethattheformofreportingdoesnotgiveanexaggeratedimpressionofaccuracy.Reasonableestimationisbasedonknowledgeoftheperformanceofthemethodandonthemeasurementscope,andmakesuseofpreviousexperience,qualitycontrolandvalidationdata.

7.10NonconformingWork

7.10.1XYZLaboratoryhasestablishedandmaintainsaControlofNonconformingProduct/WorkProcedurethatisimplementedwhenanyaspectofitstestingand/orcalibrationwork,ortheresultsofthiswork,donotconformtoitsownprocedures