ISO17025培训教材(共113页)

检测和校准实验室能力的通用要求修订：ISO/IEC17025讲师介绍学员自我介绍姓名职务参加本次课程的目的期望Day–1Agenda第1天日程表IntroductiontoISO/IEC17025:2005标准介绍质量管理八大原则介绍Managementrequirement管理要求Day–2Agenda第2天日程表Processapproach-LaboratoryAudit过程方法－实验室审核Technicalrequirement技术要求Day–3Agenda第3天日程表Technicalrequirement技术要求IntroductiontoUncertaintyofMeasurement测量不确定度介绍Exam考试练习1请列举你认为一个好的校准或检测实验室应具备哪些条件或特色，以符合客戶的要求并使客户满意。(使用时间：10分钟)请各组讨论后，派一名代表上台发表。(各组使用时间:3分钟以內)ISO/IEC17025标准介绍1.制定ISO/IEC17025目标2.新版17025与17025:99版的区别3.ISO/IEC17025适用的专业领域4.ISO/IEC标准与ISO9000的关系ISO/IEC/17025:2005标准介绍ISO/IEC17025的制定目标证明其按管理体系运行、具有技术能力并能提供正确的技术结果所必须满足的所有要求主要适用实验室，也必须可用作认可准则必须代替EN45001，达成国际上的统一必须明确与ISO9000的关系作为国际标准出版扩大范围，纳入抽样、新方法制定和专业判断内容将管理要求和技术要求分离，利于使用更具灵活性更关注电子手段的应用避免制定过多应用或解释性文件ISO/IEC17025新旧版的显著区别增加了适用性条款强调了管理更关注顾客规定了质量方针声明的最基本内容扩大了合同评审内容新增加了纠正措施章节(接上页)新增加了预防措施章节新增加了持续改进章节（2005版本）增加了管理评审过程中应包括的内容增加了新方法制定要求，规定了有效性（确认）的准则强化了对测量不确定度要求区分开校准和检测实验室的量值溯源性结果报告增加了很多内容ISO/IEC17025新旧版的显著区别ISO/IEC17025适用的专业领域Biological(生物)Mechanical(机械性)Acoustical&Vibration(声学与振动)Non-destructive(非破坏性)Chemical(化学)Environmental(环境)ConstructionMaterials(结构材料)Electrical(电学)Thermal(热)Calibration(校正)ISO/IEC标准与ISO9000的关系ISO/IEC17025:2005包含了ISO9001中与实验室管理体系所覆盖的检测和校准服务有关的所有要求实验室质量管理体系符合ISO9001的要求，并不证明实验室具有出具技术上有效数据和结果的能力实验室质量管理体系符合本准则，也不意味其运作符合ISO9001的所有要求。Scope范围NormativeReferences参考标准TermsandDefinitions名词与定义ManagementRequirements管理要求TechnicalRequirements技术要求ISO/IEC17025规范的架构范围制定执行测试与校正的一般能力要求，包括取样涵盖了使用标准、非标准实验室自行开发之方法所执行的测试与校正适用于所有的实验室，而与实验室的人数和所执行的测试与校正的范围无关本准则中的注是对正文的说明、举例和指导。它们既不包含要求，也不构成本准则的主体部分本准则是CNAS对检测和校准实验室能力进行认可的依据，也可用于实验室建立管理体系，以及为实验室的客户、法定管理机构对实验室的能力进行确认或承认提供指南不涵盖实验室作业的相关法规与安全要求ISO/IEC17025标准介绍质量管理八大原则顾客导向(CustomerFocus)领导作用(Leadership)全员参与(InvolvementofPeople)系统性管理(SystemApproachtoManagement)流程导向(ProcessApproach)持续改善(ContinualImprovement)基于事实的决策(FactualApproachtoDecisionMaking)互利(双赢)的供应链关系(MutuallyBeneficialSupplierRelationship)安全与健康（1.5）任何国家的认可活动，都是以符合该国的安全与健康相关法律/法规为前提的实验室的活动，也应以遵守ManagementRequirements管理要求4.1Organization组织组织4.2QualitySystem质量体系4.3DocumentControl文控4.4ReviewofRequests,TendersandContracts合同评审4.5SubcontractingofTestsandCalibrations检测和校准的分包4.6PurchasingServicesandSupplies服务和供应品的采购4.7ServicetotheClient服务客户4.8Complaints抱怨4.9ControlofNonconformingTestingand/orCalibrationWork不合格检测和校准的控制4.10Improvement改进4.11CorrectiveAction纠正措施4.12PreventiveAction预防措施4.13ControlofRecords纪录控制4.14InternalAudits内审4.15ManagementReviews管理评审4.1Organization(I)组织ILegallyresponsible法律实体MeetStandard,Customer,Regulatory&AccreditationBodiesRequirements满足标准客户法规和认可机构的要求Coverworkcarriedoutinpermanent,offsite,mobileortemporaryfacilities覆盖固定外部移动或临时场所Otheractivities/responsibilitiesinfluencinglabworkshallbedefinedinordertoidentifypotentialconflictsofinterest明确责任以鉴别潜在的利益冲突Otherfunctions(e.g.Sales,ProductionorFinanceetc.)其他职能Independenceofthirdpartylaboratories三方实验室的独立性4.1Organization(II)组织IIThelaboratoryshall实验室应a)Havemanagerialandtechnicalpersonnelwithauthorityandresourcestocarryouttheirduties拥有所需权力和资源的管理人员和技术人员b)Ensuremanagementandpersonnelarefreefromanyunduepressure(commercialorfinancialetc.)识别偏离c)Havepoliciesandproceduresforprotectionofclient’sconfidentialinformationandproprietaryrights方针和程序确保机密信息和所有权的保护d)Havepoliciesandprocedurestoprotectcompetence,impartialityandjudgmentoroperationalintegrity方针和程序避免有损能力公正判断能力诚实性4.1Organization(III)组织IIIe)Definetheorganizationstructure,itsplaceinparentorganizationandrelationshipsbetweenlaboratoryandsupportservices确定组织机构和母体与支持服务的关系f)Specifytheresponsibilities,authoritiesandinterrelationshipsofallpersonnel规定责任权限和相互关系g)Provideadequatesupervisionoftestingandcalibrationstaff对测试和校准人员实施适当监督h)Havetechnicalmanagementresponsibleforthetechnicaloperations技术管理者i)AppointaQualityManager(howevernamed)whocandirectaccesstothehighestlevelofmanagement质量经理j)Appointdeputiesforkeymanagerialpersonnel代理人关键人员（4.1.4）关键人员的范围一般至少含：首席执行官（CEO）技术主管、授权签字人质量主管4.2QualitySystem(I)质量体系IEstablish,Implement,andMaintainaqualitysystemappropriatetothescopeofitsactivities建立、实施和维持与其活动范围相适应的质量体系Documentitspolicies,system,proceduresandinstructions文件化政策、制度、、程序和指导．等等PoliciesandobjectivesshallbedefinedintheQualityManual在质量手册中规定质量方针和目标QualityPolicystatementauthorizedbyChiefExecutive,includeatleastthefollowing:主要管理者发布批准质量方针:Commitmenttogoodpracticeandclientservice承诺为客户服务的良好职业操守Standardofservice实验室服务标准的声明Objectivesofthequalitysystem确定目标Familiarity,UnderstandingandImplementationbyallpersonnel为全员认知CommitmenttocompliancewithISO17025承诺符合ISO17025质量方针与质量目标举例(仅供参考)实验室质量方针以优良的测试品质提供客戶最佳的滿意服务实验室质量目标每月客诉件数不超过2件延误报告交期不超过1天报告出错率小于5%客户满意度高于80分2005年取得ISO/IEC17025的证书订定目标的原则-SMART特定性(Specific)可衡量(Measurable)可达成性v.s.有挑战性(Attainable)相关性(Relevant)时限性(Timeframe)上司的支持与承诺，以及员工的认同是达成目标的关键因素！！实验室的工作范围专业领域和学科校准领域检测领域实验室的质量体系应覆盖其工作范围4.2QualitySystem(II)质量体系IIQualityManual质量手册Policiesandobjectivesshallbedefined定义方针目标Outlinethestructureofthedocumentationusedinthequalitysystem概述质量体系文件结构Includeormakereferencetothesupporting&technicalprocedures引用程序文件DutiesofTechnicalandQualityManagersshallbedefined规定技术质量经理的职责4.3DocumentControl(I)文件控制IGeneral总则Establishandmaintainprocedurestocontrolinternal/externaldocuments建立程序控制外部文件,内部文件Externaldocumentsmayberegulations,standards,test/calibrationmethods,drawings,software,specificationsandinstructionmanualsetc.外部文件可能包括法规标准测试校准方法图纸软件规范和指导书等DocumentApprovalandIssue文件的批准和发布Alldocumentsshallbereviewedandapprovedpriortoissue发布前的审查和批准Masterlistorequivalentcontrolprocedureshallbeestablishedtoidentifythecurrentrevisionanddistributionstatus建立清单Authorizeddocumentsshallbeavailableatpointofuse适当的授权版本Documentsshallbeperiodicallyreviewedandrevisedasnecessary定期审查文件Invalid/obsoletedocumentsshallberemovedfromallpointsofusepromptly,orassureagainstunintendeduse撤除作废文件文件的价值文件可以沟通意图、统一行动，有助于：实现产品质量和质量改进；提供适宜的培训；确保重复性和可追溯性；提供客观的证据；评价体系的有效性。文件的制定应是一项增值的活动4.3DocumentControl(II)文件控制IIRetainedobsoletedocuments(forlegalorknowledgepreservationpurpose)shallbesuitablymarked标记保留作废文件Documentsshallbeuniqueidentified(dateofissue/revision,pagenumbering,totalnumberofpagesandissuingauthority)唯一标识DocumentChanges文件更改Changesshallbereviewedandapprovedbyauthorizedpersonnel审批Changes(alteredornewtext)shallbeidentified标注更改Proceduresandauthoritiesforhandwrittenamendmentsshallbedefined手改的程序和权限Handwrittenamendmentsshallbeclearlymarked,initialedanddated手改应清楚标记签名和注明日期Procedureforchangestoelectronicdocumentsshallbeestablished电子版文件更改的程序4.4ReviewofRequests,TendersandContracts要求、标书和合同的评审IProceduresforcontractreviewshallensurethat:建立和维持评审客户要求，标书和合同的程序Requirementsaredefined,documentedandunderstood要求被适当地规定，形成文件，被理解Capabilityandresourcestomeettherequirements能力和资源Appropriatetestand/orcalibrationmethodisselectedandcapable选择适当的检测和校准方法Differencesbetweentenderandcontractshallberesolved工作开始前，已解决差异Subcontractedworkshallbereviewed审查所有被分包的工作4.4ReviewofRequests,TendersandContracts要求、标书和合同的评审IIRecordsofreview,includingsignificantchangesanddiscussionswithclient,shallbemaintained保持评审包括重大变化的记录Clientshallbeinformedofanydeviationfromthecontract对合同的任何偏离均应通知客户Changestocontractshallbereviewedandcommunicatedtoallaffectedpersonnel变更情况应评审并通知所有受影响的人员4.5SubcontractingofTestsandCalibrations检测和校准的分包Subcontractingofwork:工作的分包Unforeseenreasons(e.g.workload,needforfurtherexpertiseortemporaryincapacity)不可预见原因Continuingbasis(e.g.throughpermanentsubcontracting,agencyorfranchisingarrangements)长期连续情况下shallbeplacedwithacompetentsubcontractor应分包给合格的分包方Advisetheclientinwritingandgainapprovalwhenappropriate获得客户的批准Laboratoryisresponsibletotheclientforthesubcontractor’swork,exceptclientorregulatoryauthorityspecifies实验室就其分包方的工作对客户负责Maintainaregisterofallsubcontractors保存所有分包方的注册资料4.6PurchasingServicesandSupplies服务和供应品的采购IPolicyandproceduresfor拥有的政策和程序Selectionofservicesandsupplies选择和购买的服务和供应品Purchase,receptionandstorageofreagentandconsumablematerials采购接受储存试剂和易耗品Purchasingdocumentsshallbereviewedandapprovedfortechnicalcontentpriortorelease采购文件在发出之前,其技术内容应经过审查和批准Inspectionorverificationofpurchasedservicesormaterials:检查验证购买的服务和供应品Priortouse使用前Compliancewithspecifiedrequirements符合要求Recordsshallbemaintained保持记录4.6PurchasingServicesandSupplies服务和供应品的采购IIEvaluationofsuppliersforcriticalconsumablesandservices:评价重要供应品和服务的供应商Recordsofevaluationshallbemaintained保存这些评价的记录AVL(ApprovedVendorsList)shallbemaintained获批准的供应商名单4.7ServicetotheClient服务顾客Affordclientscooperationto与客户或其代表合作Clarifyclient’srequest明确客户的要求Monitorlaboratory’sperformance监视其工作有关的操作Ensureconfidentialitytootherclients保密Cooperationmayinclude:合作可包括Reasonableaccesstorelevantareasforwitness见证Preparation,packaging,anddispatchoftestand/orcalibrationitems制备包装分发样品Communicationprocess沟通Clientsurveys(positiveandnegativefeedbackfromclients)客户调查4.7ServicetotheClient服务顾客应理解并明确客户要求合理准许客户到现场监督开展定期的客户调查是简便有效的方法...OFFERASMILE. 4.8Complaints报怨Policyandprocedureforcompliantresolution有政策和程序处理来自客户的抱怨Recordsshallbemaintained:保持记录Complaints抱怨Investigations调查Correctiveactionstaken纠正措施4.9ControlofNonconformingTestingand/orCalibrationWork(I)不符合检测和校准工作的控制IPolicyandproceduresfordeviationsshallensurethat有政策和程序确保:Responsibilitiesandauthoritiesforthemanagementofnonconformingworkaredesignated确定对不符合工作进行管理的责任和权力,确定所采取的措施Evaluationofthesignificanceofthenonconformingworkismade评价不符合工作的严重性Remedialactions(containment)aretakenimmediately立即采取纠正措施Clientisnotifiedandworkisrecalledwherenecessary必要时,通知客户并取消工作Responsibilityforauthorizingtheresumptionofworkisdefined确定批准恢复工作的职责4.9ControlofNonconformingTestingand/orCalibrationWork(II)不符合检测和校准工作的控制IIExamples:例如Customercomplaints,Internal/Externalaudits,Managementreview顾客投诉内/外审管理评审Test/Calibration/MaintenanceresultsandQualityControl(e.g.IQC)测试/校准/维护结果和质量控制Staffobservationsorsupervision/Documentationchecks人员监督管理/文件检查Correctiveactionproceduresgivenin4.11shallbepromptlyfollowedwherethenonconformingworkcouldrecur不合格工作重复发生应立即运行4.11规定的纠正措施4.10Improvement改进Thelaboratoryshallcontinuallyimprovetheeffectivenessofitsmanagementsystemthroughtheuseof:qualitypolicyQualityobjectivesAuditresultsAnalysisofdataCorrectiveandpreventiveactionsManagementreview實驗室應運用品質政策、品質目標、稽核結果、數據、矯正及預防措施及管理審查，持續改進其管理系統的有效性。4.11CorrectiveAction(I)纠正措施IEstablishpolicyandprocedureanddesignateappropriateauthoritiesforimplementingcorrectiveaction制定实施纠正措施的政策和程序Determinetherootcausesoftheproblem确定问题的根本原因Selectionandimplementationofcorrectiveactions纠正措施的选择和执行Identifypotentialcorrectiveactions识别潜在的纠正措施Appropriatetothemagnitudeandtheriskoftheproblem力度应与问题的严重性和危险性相适应Documentandimplementanychangesresultingfromcorrectiveactions文件化并执行任何需要的变更4.11CorrectiveAction纠正措施IIMonitortheresultstoensurethatthecorrectiveactionstakenhavebeeneffective监控结果确保措施有效AdditionalauditsshallbedoneASAPatappropriateareasinaccordancewith4.13wherenonconformance'snotcomplywithlaboratory’spoliciesandprocedures,orISO17025如果发现导致与实验室方针和程序不符合,应尽快实施附加审核Note：问题严重或对业务有风险时采用，否则不强制要求进行。4.12PreventiveAction预防措施Develop,implementandmonitoractionplanswhenpreventiveactionisrequired需要时制定监控措施计划Topreventfromrecurrence防止再发生Totakeadvantageoftheopportunitiesforimprovement有利于持续改进Pro-activevs.Reactive(preventivevs.correctiveaction)事先对事后Proceduretoensurethatthepreventiveactionsareeffective确保预防措施有效Preventiveactionmightinvolveanalysisofdata,includingtrendandriskanalysisandproficiency-testingresults涉及数据分析,包括趋势（SPC）和风险水平和水平测试结果的分析纠正(Corrective)V.S.预防(Preventive)纠正解決已存在的问题被动的(Reactive)避免问题再发生通常为单一事件通常属于局部性的通常需要纠正对策消除问题的真因(治本)预防解決潜在的问题主动的(Proactive)让问题不会发生资料分析/趋势分析通常为全面性的仅趋势不好时才需要采取对策消除潜在问题的真因趋势图与預防措施月份123456789101112每月客诉件数510目标值：客诉件数每月小于10件采取预防措施趋势变差趋势变好预防措施有效纠正与预防措施的步骤(8D)D1:成立问题处理小组D2:问题描述D3:采取临时的围堵措施D4:真因分析D5:采取永久的纠正措施D6:执行并确认纠正措施D7:防止再发生(预防措施)D8:肯定团队和个人表现4.13ControlofRecords(I)记录的控制IProceduresforidentification,collection,indexing,access,filing,storage,maintenanceanddisposalofqualityandtechnicalrecords应建立并维持识别、收集、索引、存取、存档、存放、维护和清理质量记录和技术记录的程序Qualityrecordsincludeinternalaudit&managementreviewreportsandrecordsofcorrective&preventiveactions质量记录包括内审管理评审和纠正措施Allrecordsshallbelegible,stored,retainedandreadilyretrievableinasuitableenvironment所有记录应清晰明了，便于存放和保存Retentiontimesshallbeestablished规定保存时间Allrecordsshallbeheldsecureandinconfidence所有记录应保证安全保密Documentedprocedurestoprotectandback-uprecordsstoredelectronicallyandtopreventunauthorizedaccess有程序来保护和备份以电子形式存储的记录，防止未经授权的侵入4.13ControlofRecords(II)记录控制IIRetainrecordsoforiginalobservationsandderiveddataforadefinedperiod对原始数据导出数据保持一定时间Sufficientforrepetition充分可接受Identityofresponsiblepersonnel标识责任人Observations,dataandcalculationsshallberecorded观察值,数据和计算值应记录Mistakesinrecordsshallbecrossedout,noterased,andthecorrectvalueenteredalongsideandsignedbythepersonmakingthecorrection出错记录不应擦掉应划去错值在旁标上正确值并签上姓名Equivalentmeasuresshallbetakenforelectronicdatatoavoidlossorchangeoforiginaldata同样的措施对待电子数据4.14InternalAudit内审质量审核确定质量活动及其相关结果是否符合计划安排，以及这些安排是否有效贯彻并适合于达到目标的有系统的、独立的审查。（ISO8402）4.14InternalAudit内审Conductinternalauditsperiodicallywithaplannedschedule根据预定的日程表和程序定期进行Addressallelementsofthequalitysystem应涉及质量体系的全部要素ControlledbyQualityManager质量主管控制Bytrainedandqualifiedpersonnel由经过培训和有资格的人员来执行Taketimelycorrectiveactionforanydeviations应及时采取纠正措施Notifyclientinwritingifdoubtraised通知客户Areaaudited,auditfindingsandcorrectiveactionstakenshallberecorded审核活动的领域、审核发现和纠正措施应予以记录Implementationandeffectivenessofthecorrectiveactionshallbeverifiedandrecorded验证纠正措施有效性ThecycleforIQAshouldnormallybecompletedinoneyear内审通常在一年内完成LabAudit–ProcessApproach实验室审过程方法审核WhatisaProcessandProcessapproach?什么是过程和过程方法?IdentificationofBusinessProcesses识别业务流程COP(CustomerorientedProcesses)–ProductRealizationProcesses顾客导向过程—产品实现过程SOP(SupportOrientedProcesses)支持导向过程MOP(ManagementOrientedProcesses)管理导向过程IdentificationofBusinessProcesses识别业务流程Exercise–ProcessIdentification练习2—过程识别COP:抽样过程，合同评审过程，测试过程SOP：设施管理过程，校准过程，采购过程，QA过程，HR过程，文件和记录管理过程，验证过程MOP：管理评审，内审过程典型实验室业务流程识别1.如何编制一个审核计划2.不符合项的写法介绍LabAudit–ProcessApproach实验室审过程方法审核4.15ManagementReview管理评审Conductmanagementreviewperiodicallyandconsider:根据预定的日程表和程序定期进行,考虑:Suitabilityofpolicesandprocedures程序适宜性Managementreports管理报告Outcomeofrecentinternalaudits内审Correctiveandpreventiveactions纠正预防措施Externalassessments外审Resultsofinter-laboratorycomparisonsorproficiencytests实验室间比对Workloadandtypeofwork工作量和类型的变化Clientfeedback/complaints客户反馈QCchecks,resourcesandstafftraining质量控制、资源与人员培训Findingsfrommanagementreviewandactionsarisefromthemshallberecordedandcarriedouttimely评审结果记录并及时实施Atypicalperiodforconductingamanagementreviewisonceayear一年一次TechnicalRequirements技术要求5.1General总则5.2Personnel人员5.3AccommodationandEnvironmentalConditions设施和环境条件5.4TestandCalibrationMethodsandMethodValidation检测和校准方法及方法的确认5.5Equipment设备5.6MeasurementTraceability测量溯源性5.7Sampling抽样5.8HandlingofTestandCalibrationItems检测和校准物品的处置5.9AssuringtheQualityofTestandCalibrationResults检测和校准结果质量的保证5.10ReportingtheResults结果报告5.1General总则Factorsdeterminethecorrectnessandreliabilityoftestsand/orcalibrations:正确性可靠性影响因素Hunanfactors人员Accommodationandenvironmentalconditions设施和环境Testandcalibrationmethodsandmethodvalidation测试和校准方法及方法验证Equipment设备Measurementtraceability测量溯源性Sampling抽样Handlingoftestandcalibrationitems检测和校准物品的处置Thesefactorsallcontributetototaluncertaintyofmeasurementandshouldbetakenintoaccountbythelaboratory造成测量总不确定度应加以考虑5.2Personnel(I)人员IEnsurecompetenceofallpersonnelwho能力Operatespecificequipment操作设备Performtestsorcalibrations完成测试校准Evaluateresults评估结果Signtestreportsandcalibrationcertificates签署测试报告校准证书Providesupervisionofunqualifiedstaff监督未有资格人员Qualifypersonnelonthebasisofappropriateeducation,training,experience,personnelcertification(e.g.non-destructivetesting)and/ordemonstratedskills,asrequired教育，培训，技能Formulategoalswithrespecttoeducation,trainingandskills素质目标Identifytrainingneedsandprovidetrainingofpersonnel培训需求5.2Personnel(II)人员IIUseemployedorcontractedpersonnel签约人员和额外技术人员的使用Maintaincurrentjobdescriptions岗位说明书Maintainfollowingrecordsforalltechnicalpersonnel:记录Relevantauthorizations授权Competence能力Educationalandprofessionalqualifications教育和职业资格Training培训Skills技能Experience经验Theserecordsshallincludethedateonwhichauthorizationand/orcompetenceisconfirmed记录应便于查询包括授权或能力确认日期5.2Personnel(II)人员II练习3开发一份计量人员的岗位要求描述.5.3AccommodationandEnvironmentalConditions(I)设施和环境条件ISuitablefacilities(e.g.energysources,lightingetc.)andenvironmentalconditionstoperformcorrecttestsand/orcalibrations适宜的设施(如能源、照明)和环境条件应有利于测试和或校准的正确进行。Technicalrequirementsforaccommodationandenvironmentalconditionsthatcanaffecttheresultsoftestsandcalibrationsshallbedocumented对可能影响测试和校准结果的设施和环境条件的技术要求应加以文件化。Monitor,controlandrecordrelevantenvironmentalconditions监测控制并记录环境条件Examplesmaybepaidattentionto,asappropriatetothetechnicalactivitiesconcerned:Biologicalsterility,dust,EMI,humidity,electricalsupply,temperature,andsound&vibrationlevels对有关技术活动涉及的因素，如生物无菌、灰尘、电磁干扰、辐射、湿度、电源、温度、声音和振动水平5.3AccommodationandEnvironmentalConditions(II)设施和环境条件IITestsandcalibrationsshallbestoppedwhentheenvironmentalconditionsjeopardizetheresultsofthetestsand/orcalibrations当环境条件危及测试校准结果时，停止测试和校准Effectiveseparationofincompatibleactivities有效隔离临近区域。Accesstoanduseofareasaffectingqualityshallbecontrolled对进入和使用影响质量的区域应加以控制。Measuresshallbetakentoensuregoodhousekeeping采取措施进行内务管理。5.3AccommodationandEnvironmentalConditions(II)设施和环境条件II练习4开发一份电子和电气检测领域实验室设施和环境条件检查表5.4TestandCalibrationMethodsandMethodValidation(I)检测和校准方法及方法的确认IUseappropriatemethodsandproceduresforalltestsand/orcalibrationswithinlaboratory’sscope,including在实验室范围内使用合适的方法和程序包括Sampling抽样Handling处置Transport运输Storage贮存Preparation制备EstimationofMeasurementUncertainty测量不确定度估计StatisticalTechniques统计技术Useup-to-dateoperatinginstructions,standards,manualsandreferencedataandmakereadilyavailabletopersonnel使用现行有效的操作指导书标准手册和参考数据并便于人员得到5.4TestandCalibrationMethodsandMethodValidation(II)检测和校准方法及方法的确认IIDeviationfrommethodsshallbedocumented,technicallyjustified,authorizedandacceptedbytheclient偏离需文件化经过技术验证授权并客户接收International,regionalornationalstandardsorrecognizedspecificationsthatcontainsufficientandconciseinformationdonotneedtobesupplementedorrewrittenasinternalprocedures国际、区域或国家发布的方法直接使用SelectionofMethods(includingsampling)选择方法Meetcustomer’sneeds满足顾客要求PublishedinInternational,Regional,NationalStandardsorScientificjournals,or,shallbepreferable最好采用国际、区域或国家发布的方法Publishedbyreputabletechnicalorganization知名技术组织发布Specifiedbythemanufactureroftheequipment设备厂商指定Usethelatestvalidedition使用当前最新版本Laboratory-developedmethodsshallbevalidatedandconfirmedpriortouse,andtheclientshallbeinformedastothemethodchosen实验室开发方法应使用前经过验证并通知顾客5.4TestandCalibrationMethodsandMethodValidation(III)检测和校准方法及方法的确认III内部或非标准方法的确认制订方法很难，建议尽量采用国际通用方法。非标准方法需经适当的和确认（ISO9001第4.4条和ISO/IEC17025第5.4.5条）5.4TestandCalibrationMethodsandMethodValidation(III)检测和校准方法及方法的确认IIIRe-confirmationshallbedoneifmethodchanged如标准方法有变应重新确认Clientshallbeinformedwhenthemethodproposedisinappropriateoroutofdate如顾客通知的方法已过时应通知顾客Laboratory-developedMethods实验室制定的方法Introductionoflaboratory-developedmethodsshallbeaplannedactivity有计划Plansshallbeupdatedasdevelopmentevolves适时修正Assignqualifiedpersonnelwithadequateresources有资格的人员进行Ensureeffectivecommunicationamongallpersonnelinvolved有效交流Non-standardMethods非标方法Gainagreementwithclient客户同意Includeaclearspecificationoftheclient’srequirementsandpurposeofthetestand/orcalibration清楚说明顾客要求和测试校准目的的规范Validatethemethodappropriatelypriortouse使用前验证5.4TestandCalibrationMethodsandMethodValidation(IV)检测和校准方法及方法的确认IVProceduresshouldbedevelopedpriortoperformfornewtestand/orcalibrationmethods,andcontainatleast:制定程序Identification识别Scope范围Descriptionofitemtobetestedorcalibrated样品类型描述Parametersorquantitiesandrangestobedetermined参数量值范围Apparatusandequipment,includingtechnicalperformancerequirements器具设备包括技术操作要求referencestandardsandmaterialsrequired所需参考标准和标准物质Environmentalconditionsrequiredandanystabilizationperiodneeded环境条件Descriptionoftheprocedure程序描述Criteriaand/orrequirementsforapproval/rejection判断准则Datatoberecordedandmethodofanalysisandpresentation数据及表示方法Theuncertaintyortheprocedureforestimatinguncertainty测量不确定度或评价程序5.4TestandCalibrationMethodsandMethodValidation(V)检测和校准方法及方法的确认VValidationofMethods方法验证Validationistheconfirmationbyexaminationandtheprovisionofobjectiveevidencethattheparticularrequirementsforaspecificintendedusearefulfilled验证就是通过检查并提供客观证据确认某一具体预期用途的特定要求得到满足Methodsneededtobevalidated:需要验证的方法Recordtheresultsobtained,theprocedureusedandastatementastowhetherthemethodisfitfortheintendeduse记录验证结果,程序以及方法