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.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
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- ISO17025 质量 手册 英文 模板