ISO17025-培訓(xùn)教材培訓(xùn)教材

檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求修訂：ISO/IEC170251講師介紹2學(xué)員自我介紹姓名職務(wù)參加本次課程的目的期望3Day–1Agenda第1天日程表

IntroductiontoISO/IEC17025:2005標(biāo)準(zhǔn)介紹質(zhì)量管理八大原則介紹Managementrequirement管理要求4Day–2Agenda第2天日程表

Processapproach-LaboratoryAudit過(guò)程方法－實(shí)驗(yàn)室審核Technicalrequirement技術(shù)要求

5Day–3Agenda第3天日程表

Technicalrequirement技術(shù)要求IntroductiontoUncertaintyofMeasurement測(cè)量不確定度介紹Exam考試6練習(xí)1請(qǐng)列舉你認(rèn)為一個(gè)好的校準(zhǔn)或檢測(cè)實(shí)驗(yàn)室應(yīng)具備哪些條件或特色，以符合客戶的要求并使客戶滿意。

(使用時(shí)間：10分鐘)請(qǐng)各組討論后，派一名代表上臺(tái)發(fā)表。

(各組使用時(shí)間:3分鐘以內(nèi))ISO/IEC17025標(biāo)準(zhǔn)介紹71.制定ISO/IEC17025目標(biāo)

2.新版17025與17025:99版的區(qū)別

3.ISO/IEC17025適用的專業(yè)領(lǐng)域

4.ISO/IEC標(biāo)準(zhǔn)與ISO9000的關(guān)系

ISO/IEC/17025:2005標(biāo)準(zhǔn)介紹8ISO/IEC17025的制定目標(biāo)證明其按管理體系運(yùn)行、具有技術(shù)能力并能提供正確的技術(shù)結(jié)果所必須滿足的所有要求主要適用實(shí)驗(yàn)室，也必須可用作認(rèn)可準(zhǔn)則必須代替EN45001，達(dá)成國(guó)際上的統(tǒng)一必須明確與ISO9000的關(guān)系作為國(guó)際標(biāo)準(zhǔn)出版擴(kuò)大范圍，納入抽樣、新方法制定和專業(yè)判斷內(nèi)容將管理要求和技術(shù)要求分離，利于使用更具靈活性更關(guān)注電子手段的應(yīng)用避免制定過(guò)多應(yīng)用或解釋性文件

9ISO/IEC17025新舊版的顯著區(qū)別增加了適用性條款強(qiáng)調(diào)了管理更關(guān)注顧客規(guī)定了質(zhì)量方針聲明的最基本內(nèi)容擴(kuò)大了合同評(píng)審內(nèi)容新增加了糾正措施章節(jié)10(接上頁(yè))新增加了預(yù)防措施章節(jié)新增加了持續(xù)改進(jìn)章節(jié)（2005版本）增加了管理評(píng)審過(guò)程中應(yīng)包括的內(nèi)容增加了新方法制定要求，規(guī)定了有效性（確認(rèn)）的準(zhǔn)則強(qiáng)化了對(duì)測(cè)量不確定度要求區(qū)分開(kāi)校準(zhǔn)和檢測(cè)實(shí)驗(yàn)室的量值溯源性結(jié)果報(bào)告增加了很多內(nèi)容ISO/IEC17025新舊版的顯著區(qū)別11ISO/IEC17025適用的專業(yè)領(lǐng)域Biological(生物)Mechanical(機(jī)械性)Acoustical&Vibration(聲學(xué)與振動(dòng))Non-destructive(非破壞性)Chemical(化學(xué))Environmental(環(huán)境)ConstructionMaterials(結(jié)構(gòu)材料)Electrical(電學(xué))Thermal(熱)Calibration(校正)12ISO/IEC標(biāo)準(zhǔn)與ISO9000的關(guān)系

ISO/IEC17025:2005包含了ISO9001中與實(shí)驗(yàn)室管理體系所覆蓋的檢測(cè)和校準(zhǔn)服務(wù)有關(guān)的所有要求實(shí)驗(yàn)室質(zhì)量管理體系符合ISO9001的要求，并不證明實(shí)驗(yàn)室具有出具技術(shù)上有效數(shù)據(jù)和結(jié)果的能力實(shí)驗(yàn)室質(zhì)量管理體系符合本準(zhǔn)則，也不意味其運(yùn)作符合ISO9001的所有要求。13Scope范圍NormativeReferences參考標(biāo)準(zhǔn)TermsandDefinitions名詞與定義ManagementRequirements管理要求TechnicalRequirements技術(shù)要求ISO/IEC17025規(guī)范的架構(gòu)14范圍制定執(zhí)行測(cè)試與校正的一般能力要求，包括取樣涵蓋了使用標(biāo)準(zhǔn)、非標(biāo)準(zhǔn)實(shí)驗(yàn)室自行開(kāi)發(fā)之方法所執(zhí)行的測(cè)試與校正適用于所有的實(shí)驗(yàn)室，而與實(shí)驗(yàn)室的人數(shù)和所執(zhí)行的測(cè)試與校正的范圍無(wú)關(guān)本準(zhǔn)則中的注是對(duì)正文的說(shuō)明、舉例和指導(dǎo)。它們既不包含要求，也不構(gòu)成本準(zhǔn)則的主體部分本準(zhǔn)則是CNAS對(duì)檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力進(jìn)行認(rèn)可的依據(jù)，也可用于實(shí)驗(yàn)室建立管理體系，以及為實(shí)驗(yàn)室的客戶、法定管理機(jī)構(gòu)對(duì)實(shí)驗(yàn)室的能力進(jìn)行確認(rèn)或承認(rèn)提供指南不涵蓋實(shí)驗(yàn)室作業(yè)的相關(guān)法規(guī)與安全要求ISO/IEC17025標(biāo)準(zhǔn)介紹15質(zhì)量管理八大原則顧客導(dǎo)向(CustomerFocus)領(lǐng)導(dǎo)作用

(Leadership)全員參與

(InvolvementofPeople)系統(tǒng)性管理

(SystemApproachtoManagement)流程導(dǎo)向

(ProcessApproach)持續(xù)改善(ContinualImprovement)基于事實(shí)的決策

(FactualApproachtoDecisionMaking)互利(雙贏)的供應(yīng)鏈關(guān)系

(MutuallyBeneficialSupplierRelationship)16安全與健康（1.5）任何國(guó)家的認(rèn)可活動(dòng)，都是以符合該國(guó)的安全與健康相關(guān)法律/法規(guī)為前提的實(shí)驗(yàn)室的活動(dòng)，也應(yīng)以遵守17ManagementRequirements管理要求4.1Organization組織組織4.2QualitySystem質(zhì)量體系4.3DocumentControl文控4.4ReviewofRequests,TendersandContracts合同評(píng)審4.5SubcontractingofTestsandCalibrations檢測(cè)和校準(zhǔn)的分包4.6PurchasingServicesandSupplies服務(wù)和供應(yīng)品的采購(gòu)4.7ServicetotheClient服務(wù)客戶4.8Complaints抱怨4.9ControlofNonconformingTestingand/orCalibrationWork不合格檢測(cè)和校準(zhǔn)的控制4.10Improvement改進(jìn)4.11CorrectiveAction糾正措施4.12PreventiveAction預(yù)防措施4.13ControlofRecords紀(jì)錄控制4.14InternalAudits內(nèi)審4.15ManagementReviews管理評(píng)審184.1Organization(I)組織ILegallyresponsible法律實(shí)體MeetStandard,Customer,Regulatory&AccreditationBodiesRequirements滿足標(biāo)準(zhǔn)客戶法規(guī)和認(rèn)可機(jī)構(gòu)的要求Coverworkcarriedoutinpermanent,offsite,mobileortemporaryfacilities覆蓋固定外部移動(dòng)或臨時(shí)場(chǎng)所Otheractivities/responsibilitiesinfluencinglabworkshallbedefinedinordertoidentifypotentialconflictsofinterest

明確責(zé)任以鑒別潛在的利益沖突Otherfunctions(e.g.Sales,ProductionorFinanceetc.)其他職能Independenceofthirdpartylaboratories三方實(shí)驗(yàn)室的獨(dú)立性194.1Organization(II)組織IIThelaboratoryshall實(shí)驗(yàn)室應(yīng)a)Havemanagerialandtechnicalpersonnelwithauthorityandresourcestocarryouttheirduties擁有所需權(quán)力和資源的管理人員和技術(shù)人員b)Ensuremanagementandpersonnelarefreefromanyunduepressure(commercialorfinancialetc.)識(shí)別偏離c)Havepoliciesandproceduresforprotectionofclient’sconfidentialinformationandproprietaryrights方針和程序確保機(jī)密信息和所有權(quán)的保護(hù)d)Havepoliciesandprocedurestoprotectcompetence,impartialityandjudgmentoroperationalintegrity方針和程序避免有損能力公正判斷能力誠(chéng)實(shí)性204.1Organization(III)組織IIIe)Definetheorganizationstructure,itsplaceinparentorganizationandrelationshipsbetweenlaboratoryandsupportservices確定組織機(jī)構(gòu)和母體與支持服務(wù)的關(guān)系f)Specifytheresponsibilities,authoritiesandinterrelationshipsofallpersonnel規(guī)定責(zé)任權(quán)限和相互關(guān)系g)Provideadequatesupervisionoftestingandcalibrationstaff對(duì)測(cè)試和校準(zhǔn)人員實(shí)施適當(dāng)監(jiān)督h)Havetechnicalmanagementresponsibleforthetechnicaloperations技術(shù)管理者i)AppointaQualityManager(howevernamed)whocandirectaccesstothehighestlevelofmanagement質(zhì)量經(jīng)理j)Appointdeputiesforkeymanagerialpersonnel代理人21關(guān)鍵人員（4.1.4）關(guān)鍵人員的范圍一般至少含：首席執(zhí)行官（CEO）技術(shù)主管、授權(quán)簽字人質(zhì)量主管224.2QualitySystem(I)質(zhì)量體系IEstablish,Implement,andMaintainaqualitysystemappropriatetothescopeofitsactivities建立、實(shí)施和維持與其活動(dòng)范圍相適應(yīng)的質(zhì)量體系Documentitspolicies,system,proceduresandinstructions文件化政策、制度、計(jì)劃、程序和指導(dǎo)書(shū)．等等

PoliciesandobjectivesshallbedefinedintheQualityManual在質(zhì)量手冊(cè)中規(guī)定質(zhì)量方針和目標(biāo)QualityPolicystatementauthorizedbyChiefExecutive,includeatleastthefollowing:主要管理者發(fā)布批準(zhǔn)質(zhì)量方針:Commitmenttogoodpracticeandclientservice承諾為客戶服務(wù)的良好職業(yè)操守Standardofservice實(shí)驗(yàn)室服務(wù)標(biāo)準(zhǔn)的聲明Objectivesofthequalitysystem確定目標(biāo)Familiarity,UnderstandingandImplementationbyallpersonnel為全員認(rèn)知CommitmenttocompliancewithISO17025承諾符合ISO1702523質(zhì)量方針與質(zhì)量目標(biāo)舉例(僅供參考)實(shí)驗(yàn)室質(zhì)量方針以優(yōu)良的測(cè)試品質(zhì)提供客戶最佳的滿意服務(wù)實(shí)驗(yàn)室質(zhì)量目標(biāo)每月客訴件數(shù)不超過(guò)2件延誤報(bào)告交期不超過(guò)1天報(bào)告出錯(cuò)率小于5%客戶滿意度高于80分2005年取得ISO/IEC17025的證書(shū)24訂定目標(biāo)的原則-SMART特定性

(Specific)可衡量

(Measurable)可達(dá)成性v.s.

有挑戰(zhàn)性

(Attainable)相關(guān)性

(Relevant)時(shí)限性

(Timeframe)上司的支持與承諾，以及員工的認(rèn)同是達(dá)成目標(biāo)的關(guān)鍵因素??！25實(shí)驗(yàn)室的工作范圍專業(yè)領(lǐng)域和學(xué)科

校準(zhǔn)領(lǐng)域檢測(cè)領(lǐng)域

實(shí)驗(yàn)室的質(zhì)量體系應(yīng)覆蓋其工作范圍264.2QualitySystem(II)質(zhì)量體系IIQualityManual質(zhì)量手冊(cè)Policiesandobjectivesshallbedefined定義方針目標(biāo)Outlinethestructureofthedocumentationusedinthequalitysystem概述質(zhì)量體系文件結(jié)構(gòu)Includeormakereferencetothesupporting&technicalprocedures引用程序文件Dutiesof

TechnicalandQualityManagersshallbedefined規(guī)定技術(shù)質(zhì)量經(jīng)理的職責(zé)274.3DocumentControl(I)文件控制IGeneral總則Establishandmaintainprocedurestocontrolinternal/externaldocuments建立程序控制外部文件,內(nèi)部文件Externaldocumentsmayberegulations,standards,test/calibrationmethods,drawings,software,specificationsandinstructionmanualsetc.外部文件可能包括法規(guī)標(biāo)準(zhǔn)測(cè)試校準(zhǔn)方法圖紙軟件規(guī)范和指導(dǎo)書(shū)等DocumentApprovalandIssue文件的批準(zhǔn)和發(fā)布Alldocumentsshallbereviewedandapprovedpriortoissue發(fā)布前的審查和批準(zhǔn)Masterlistorequivalentcontrolprocedureshallbeestablishedtoidentifythecurrentrevisionanddistributionstatus建立清單Authorizeddocumentsshallbeavailableatpointofuse適當(dāng)?shù)氖跈?quán)版本Documentsshallbeperiodicallyreviewedandrevisedasnecessary定期審查文件Invalid/obsoletedocumentsshallberemovedfromallpointsofusepromptly,orassureagainstunintendeduse撤除作廢文件28文件的價(jià)值文件可以溝通意圖、統(tǒng)一行動(dòng)，有助于：實(shí)現(xiàn)產(chǎn)品質(zhì)量和質(zhì)量改進(jìn)；提供適宜的培訓(xùn)；確保重復(fù)性和可追溯性；提供客觀的證據(jù)；評(píng)價(jià)體系的有效性。

文件的制定應(yīng)是一項(xiàng)增值的活動(dòng)294.3DocumentControl(II)文件控制IIRetainedobsoletedocuments(forlegalorknowledgepreservationpurpose)shallbesuitablymarked標(biāo)記保留作廢文件Documentsshallbeuniqueidentified(dateofissue/revision,pagenumbering,totalnumberofpagesandissuingauthority)唯一標(biāo)識(shí)DocumentChanges文件更改Changesshallbereviewedandapprovedbyauthorizedpersonnel審批Changes(alteredornewtext)shallbeidentified標(biāo)注更改Proceduresandauthoritiesforhandwrittenamendmentsshallbedefined手改的程序和權(quán)限Handwrittenamendmentsshallbeclearlymarked,initialedanddated手改應(yīng)清楚標(biāo)記簽名和注明日期Procedureforchangestoelectronicdocumentsshallbeestablished電子版文件更改的程序304.4

ReviewofRequests,Tendersand

Contracts要求、標(biāo)書(shū)和合同的評(píng)審IProceduresforcontractreviewshallensurethat:建立和維持評(píng)審客戶要求，標(biāo)書(shū)和合同的程序Requirementsaredefined,documentedandunderstood要求被適當(dāng)?shù)匾?guī)定，形成文件，被理解Capabilityandresourcestomeettherequirements能力和資源Appropriatetestand/orcalibrationmethodisselectedandcapable選擇適當(dāng)?shù)臋z測(cè)和校準(zhǔn)方法Differencesbetweentenderandcontractshallberesolved工作開(kāi)始前，已解決差異Subcontractedworkshallbereviewed審查所有被分包的工作314.4

ReviewofRequests,Tendersand

Contracts要求、標(biāo)書(shū)和合同的評(píng)審IIRecordsofreview,includingsignificantchangesanddiscussionswithclient,shallbemaintained保持評(píng)審記錄包括重大變化的記錄Clientshallbeinformedofanydeviationfromthecontract對(duì)合同的任何偏離均應(yīng)通知客戶Changestocontractshallbereviewedandcommunicatedtoallaffectedpersonnel變更情況應(yīng)評(píng)審并通知所有受影響的人員324.5SubcontractingofTestsand

Calibrations檢測(cè)和校準(zhǔn)的分包Subcontractingofwork:工作的分包Unforeseenreasons(e.g.workload,needforfurtherexpertiseortemporaryincapacity)不可預(yù)見(jiàn)原因Continuingbasis(e.g.throughpermanentsubcontracting,agencyorfranchisingarrangements)長(zhǎng)期連續(xù)情況下shallbeplacedwithacompetentsubcontractor應(yīng)分包給合格的分包方Advisetheclientinwritingandgainapprovalwhenappropriate獲得客戶的批準(zhǔn)Laboratoryisresponsibletotheclientforthesubcontractor’swork,exceptclientorregulatoryauthorityspecifies實(shí)驗(yàn)室就其分包方的工作對(duì)客戶負(fù)責(zé)Maintainaregisterofallsubcontractors保存所有分包方的注冊(cè)資料334.6PurchasingServicesandSupplies服務(wù)和供應(yīng)品的采購(gòu)IPolicyandproceduresfor擁有的政策和程序Selectionofservicesandsupplies選擇和購(gòu)買的服務(wù)和供應(yīng)品Purchase,receptionandstorageofreagentandconsumablematerials采購(gòu)接受儲(chǔ)存試劑和易耗品Purchasingdocumentsshallbereviewedandapprovedfortechnicalcontentpriortorelease采購(gòu)文件在發(fā)出之前,其技術(shù)內(nèi)容應(yīng)經(jīng)過(guò)審查和批準(zhǔn)Inspectionorverificationofpurchasedservicesormaterials:檢查驗(yàn)證購(gòu)買的服務(wù)和供應(yīng)品Priortouse使用前Compliancewithspecifiedrequirements符合要求Recordsshallbemaintained保持記錄344.6PurchasingServicesandSupplies服務(wù)和供應(yīng)品的采購(gòu)IIEvaluationofsuppliersforcriticalconsumablesandservices:評(píng)價(jià)重要供應(yīng)品和服務(wù)的供應(yīng)商Recordsofevaluationshallbemaintained保存這些評(píng)價(jià)的記錄AVL(ApprovedVendorsList)shallbemaintained獲批準(zhǔn)的供應(yīng)商名單354.7ServicetotheClient服務(wù)顧客Affordclientscooperationto與客戶或其代表合作Clarifyclient’srequest明確客戶的要求Monitorlaboratory’sperformance監(jiān)視其工作有關(guān)的操作Ensureconfidentialitytootherclients保密Cooperationmayinclude:合作可包括Reasonableaccesstorelevantareasforwitness見(jiàn)證Preparation,packaging,anddispatchoftestand/orcalibrationitems制備包裝分發(fā)樣品Communicationprocess溝通Clientsurveys(positiveandnegativefeedbackfromclients)客戶調(diào)查364.7ServicetotheClient服務(wù)顧客應(yīng)理解并明確客戶要求合理準(zhǔn)許客戶

到現(xiàn)場(chǎng)監(jiān)督開(kāi)展定期的客戶調(diào)查是簡(jiǎn)便有效的方法...OFFERASMILE.

374.8Complaints報(bào)怨Policyandprocedureforcompliantresolution有政策和程序處理來(lái)自客戶的抱怨Recordsshallbemaintained:保持記錄Complaints抱怨Investigations調(diào)查Correctiveactionstaken糾正措施384.9ControlofNonconformingTesting

and/orCalibrationWork(I)不符合檢測(cè)和校準(zhǔn)工作的控制IPolicyandproceduresfordeviationsshallensurethat有政策和程序確保:Responsibilitiesandauthoritiesforthemanagementofnonconformingworkaredesignated確定對(duì)不符合工作進(jìn)行管理的責(zé)任和權(quán)力,確定所采取的措施Evaluationofthesignificanceofthenonconformingworkismade評(píng)價(jià)不符合工作的嚴(yán)重性Remedialactions(containment)aretakenimmediately立即采取糾正措施Clientisnotifiedandworkisrecalledwherenecessary必要時(shí),通知客戶并取消工作Responsibilityforauthorizingtheresumption

ofworkisdefined確定批準(zhǔn)恢復(fù)工作的職責(zé)394.9ControlofNonconformingTestingand/orCalibrationWork(II)

不符合檢測(cè)和校準(zhǔn)工作的控制IIExamples:

例如Customercomplaints,Internal/Externalaudits,Managementreview顧客投訴內(nèi)/外審管理評(píng)審Test/Calibration/MaintenanceresultsandQualityControl(e.g.IQC)測(cè)試/校準(zhǔn)/維護(hù)結(jié)果和質(zhì)量控制Staffobservationsorsupervision/Documentationchecks人員監(jiān)督管理/文件檢查Correctiveactionproceduresgivenin4.11shallbepromptlyfollowedwherethenonconformingworkcouldrecur不合格工作重復(fù)發(fā)生應(yīng)立即運(yùn)行4.11規(guī)定的糾正措施404.10Improvement改進(jìn)Thelaboratoryshallcontinuallyimprovetheeffectivenessofitsmanagementsystemthroughtheuseof:qualitypolicyQualityobjectivesAuditresultsAnalysisofdataCorrectiveandpreventiveactionsManagementreview

實(shí)驗(yàn)室應(yīng)運(yùn)用品質(zhì)政策、品質(zhì)目標(biāo)、稽核結(jié)果、數(shù)據(jù)分析、矯正及預(yù)防措施及管理審查，持續(xù)改進(jìn)其管理系統(tǒng)的有效性。

414.11CorrectiveAction(I)糾正措施IEstablishpolicyandprocedureanddesignateappropriateauthoritiesforimplementingcorrectiveaction制定實(shí)施糾正措施的政策和程序Determinetherootcausesoftheproblem確定問(wèn)題的根本原因Selectionandimplementationofcorrectiveactions糾正措施的選擇和執(zhí)行Identifypotentialcorrectiveactions識(shí)別潛在的糾正措施Appropriatetothemagnitudeandtheriskoftheproblem力度應(yīng)與問(wèn)題的嚴(yán)重性和危險(xiǎn)性相適應(yīng)Documentandimplementanychangesresultingfromcorrectiveactions文件化并執(zhí)行任何需要的變更424.11CorrectiveAction糾正措施IIMonitortheresultstoensurethatthecorrectiveactionstakenhavebeeneffective監(jiān)控結(jié)果確保措施有效AdditionalauditsshallbedoneASAPatappropriateareasinaccordancewith4.13wherenonconformance'snotcomplywithlaboratory’spoliciesandprocedures,orISO17025如果發(fā)現(xiàn)導(dǎo)致與實(shí)驗(yàn)室方針和程序不符合,應(yīng)盡快實(shí)施附加審核Note：?jiǎn)栴}嚴(yán)重或?qū)I(yè)務(wù)有風(fēng)險(xiǎn)時(shí)采用，否則不強(qiáng)制要求進(jìn)行。434.12PreventiveAction預(yù)防措施Develop,implementandmonitoractionplanswhenpreventiveactionisrequired需要時(shí)制定監(jiān)控措施計(jì)劃Topreventfromrecurrence防止再發(fā)生Totakeadvantageoftheopportunitiesforimprovement有利于持續(xù)改進(jìn)Pro-activevs.Reactive(preventivevs.correctiveaction)事先對(duì)事后Proceduretoensurethatthepreventiveactionsareeffective確保預(yù)防措施有效Preventiveactionmightinvolveanalysisofdata,includingtrendandriskanalysisandproficiency-testingresults涉及數(shù)據(jù)分析,包括趨勢(shì)（SPC）和風(fēng)險(xiǎn)水平和水平測(cè)試結(jié)果的分析44糾正(Corrective)V.S.預(yù)防(Preventive)

糾正解決已存在的問(wèn)題被動(dòng)的(Reactive)避免問(wèn)題再發(fā)生通常為單一事件通常屬于局部性的通常需要糾正對(duì)策消除問(wèn)題的真因(治本)

預(yù)防解決潛在的問(wèn)題主動(dòng)的(Proactive)讓問(wèn)題不會(huì)發(fā)生資料分析/趨勢(shì)分析通常為全面性的僅趨勢(shì)不好時(shí)才需要采取對(duì)策消除潛在問(wèn)題的真因45趨勢(shì)圖與預(yù)防措施月份

123456789101112每月客訴件數(shù)510目標(biāo)值：客訴件數(shù)每月小于10件采取預(yù)防措施趨勢(shì)變差趨勢(shì)變好預(yù)防措施有效46糾正與預(yù)防措施的步驟

(8D)D1:成立問(wèn)題處理小組D2:問(wèn)題描述D3:采取臨時(shí)的圍堵措施D4:真因分析D5:采取永久的糾正措施D6:執(zhí)行并確認(rèn)糾正措施D7:防止再發(fā)生(預(yù)防措施)D8:肯定團(tuán)隊(duì)和個(gè)人表現(xiàn)474.13ControlofRecords(I)記錄的控制IProceduresforidentification,collection,indexing,access,filing,storage,maintenanceanddisposalofqualityandtechnicalrecords應(yīng)建立并維持識(shí)別、收集、索引、存取、存檔、存放、維護(hù)和清理質(zhì)量記錄和技術(shù)記錄的程序Qualityrecordsincludeinternalaudit&managementreviewreportsandrecordsofcorrective&preventiveactions質(zhì)量記錄包括內(nèi)審管理評(píng)審和糾正措施Allrecordsshallbelegible,stored,retainedandreadilyretrievableinasuitableenvironment所有記錄應(yīng)清晰明了，便于存放和保存Retentiontimesshallbeestablished規(guī)定保存時(shí)間Allrecordsshallbeheldsecureandinconfidence所有記錄應(yīng)保證安全保密Documentedprocedurestoprotectandback-uprecordsstoredelectronicallyandtopreventunauthorizedaccess有程序來(lái)保護(hù)和備份以電子形式存儲(chǔ)的記錄，防止未經(jīng)授權(quán)的侵入484.13ControlofRecords(II)記錄控制IIRetainrecordsoforiginalobservationsandderiveddataforadefinedperiod對(duì)原始數(shù)據(jù)導(dǎo)出數(shù)據(jù)保持一定時(shí)間Sufficientforrepetition充分可接受Identityofresponsiblepersonnel標(biāo)識(shí)責(zé)任人Observations,dataandcalculationsshallberecorded觀察值,數(shù)據(jù)和計(jì)算值應(yīng)記錄Mistakesinrecordsshallbecrossedout,noterased,andthecorrectvalueenteredalongsideandsignedbythepersonmakingthecorrection出錯(cuò)記錄不應(yīng)擦掉應(yīng)劃去錯(cuò)值在旁標(biāo)上正確值并簽上姓名Equivalentmeasuresshallbetakenforelectronicdatatoavoidlossorchangeoforiginaldata同樣的措施對(duì)待電子數(shù)據(jù)494.14InternalAudit內(nèi)審質(zhì)量審核確定質(zhì)量活動(dòng)及其相關(guān)結(jié)果是否符合計(jì)劃安排，以及這些安排是否有效貫徹并適合于達(dá)到目標(biāo)的有系統(tǒng)的、獨(dú)立的審查。（ISO8402）504.14InternalAudit內(nèi)審Conductinternalauditsperiodicallywithaplannedschedule根據(jù)預(yù)定的日程表和程序定期進(jìn)行Addressallelementsofthequalitysystem應(yīng)涉及質(zhì)量體系的全部要素ControlledbyQualityManager質(zhì)量主管控制Bytrainedandqualifiedpersonnel由經(jīng)過(guò)培訓(xùn)和有資格的人員來(lái)執(zhí)行Taketimelycorrectiveactionforanydeviations應(yīng)及時(shí)采取糾正措施Notifyclientinwritingifdoubtraised通知客戶Areaaudited,auditfindingsandcorrectiveactionstakenshallberecorded審核活動(dòng)的領(lǐng)域、審核發(fā)現(xiàn)和糾正措施應(yīng)予以記錄Implementationandeffectivenessofthecorrectiveactionshallbeverifiedandrecorded驗(yàn)證糾正措施有效性ThecycleforIQAshouldnormallybecompletedinoneyear內(nèi)審?fù)ǔＴ谝荒陜?nèi)完成51LabAudit–ProcessApproach實(shí)驗(yàn)室審過(guò)程方法審核WhatisaProcessandProcessapproach?什么是過(guò)程和過(guò)程方法?52IdentificationofBusinessProcesses識(shí)別業(yè)務(wù)流程COP(CustomerorientedProcesses)–ProductRealizationProcesses顧客導(dǎo)向過(guò)程—產(chǎn)品實(shí)現(xiàn)過(guò)程SOP(SupportOrientedProcesses)支持導(dǎo)向過(guò)程MOP(ManagementOrientedProcesses)管理導(dǎo)向過(guò)程53IdentificationofBusinessProcesses識(shí)別業(yè)務(wù)流程Exercise–ProcessIdentification

練習(xí)2—過(guò)程識(shí)別54COP:抽樣過(guò)程，合同評(píng)審過(guò)程，測(cè)試過(guò)程SOP：設(shè)施管理過(guò)程，校準(zhǔn)過(guò)程，采購(gòu)過(guò)程，QA過(guò)程，HR過(guò)程，文件和記錄管理過(guò)程，驗(yàn)證過(guò)程MOP：管理評(píng)審，內(nèi)審過(guò)程典型實(shí)驗(yàn)室業(yè)務(wù)流程識(shí)別551.如何編制一個(gè)審核計(jì)劃2.不符合項(xiàng)的寫(xiě)法介紹LabAudit–ProcessApproach實(shí)驗(yàn)室審過(guò)程方法審核564.15ManagementReview管理評(píng)審Conductmanagementreviewperiodicallyandconsider:根據(jù)預(yù)定的日程表和程序定期進(jìn)行,考慮:Suitabilityofpolicesandprocedures程序適宜性Managementreports管理報(bào)告Outcomeofrecentinternalaudits內(nèi)審Correctiveandpreventiveactions糾正預(yù)防措施Externalassessments外審Resultsofinter-laboratorycomparisonsorproficiencytests實(shí)驗(yàn)室間比對(duì)Workloadandtypeofwork工作量和類型的變化Clientfeedback/complaints客戶反饋QCchecks,resourcesandstafftraining質(zhì)量控制、資源與人員培訓(xùn)Findingsfrommanagementreviewandactionsarisefromthemshallberecordedandcarriedouttimely評(píng)審結(jié)果記錄并及時(shí)實(shí)施Atypicalperiodforconductingamanagementreviewisonceayear一年一次57TechnicalRequirements

技術(shù)要求5.1

General總則5.2Personnel人員5.3AccommodationandEnvironmentalConditions設(shè)施和環(huán)境條件5.4TestandCalibrationMethodsandMethodValidation檢測(cè)和校準(zhǔn)方法及方法的確認(rèn)5.5Equipment設(shè)備5.6MeasurementTraceability測(cè)量溯源性5.7Sampling

抽樣5.8HandlingofTestandCalibrationItems檢測(cè)和校準(zhǔn)物品的處置5.9AssuringtheQualityofTestandCalibrationResults檢測(cè)和校準(zhǔn)結(jié)果質(zhì)量的保證5.10ReportingtheResults結(jié)果報(bào)告585.1General總則Factorsdeterminethecorrectnessandreliabilityoftestsand/orcalibrations:正確性可靠性影響因素Hunanfactors人員Accommodationandenvironmentalconditions設(shè)施和環(huán)境Testandcalibrationmethodsandmethodvalidation測(cè)試和校準(zhǔn)方法及方法驗(yàn)證Equipment設(shè)備Measurementtraceability測(cè)量溯源性Sampling抽樣Handlingoftestandcalibrationitems檢測(cè)和校準(zhǔn)物品的處置Thesefactorsallcontributetototaluncertaintyofmeasurementandshouldbetakenintoaccountbythelaboratory造成測(cè)量總不確定度應(yīng)加以考慮595.2Personnel(I)人員IEnsurecompetenceofallpersonnelwho能力Operatespecificequipment操作設(shè)備Performtestsorcalibrations完成測(cè)試校準(zhǔn)Evaluateresults評(píng)估結(jié)果Signtestreportsandcalibrationcertificates簽署測(cè)試報(bào)告校準(zhǔn)證書(shū)Providesupervisionofunqualifiedstaff監(jiān)督未有資格人員Qualifypersonnelonthebasisofappropriateeducation,training,experience,personnelcertification(e.g.non-destructivetesting)and/ordemonstratedskills,asrequired教育，培訓(xùn)，技能Formulategoalswithrespecttoeducation,trainingandskills素質(zhì)目標(biāo)Identifytrainingneedsandprovidetrainingofpersonnel培訓(xùn)需求605.2Personnel(II)人員IIUseemployedorcontractedpersonnel簽約人員和額外技術(shù)人員的使用Maintaincurrentjobdescriptions崗位說(shuō)明書(shū)Maintainfollowingrecordsforalltechnicalpersonnel:記錄Relevantauthorizations授權(quán)Competence能力Educationalandprofessionalqualifications教育和職業(yè)資格Training培訓(xùn)Skills技能Experience經(jīng)驗(yàn)Theserecordsshallincludethedateonwhichauthorizationand/orcompetenceisconfirmed記錄應(yīng)便于查詢包括授權(quán)或能力確認(rèn)日期615.2Personnel(II)人員II練習(xí)3開(kāi)發(fā)一份計(jì)量人員的崗位要求描述.625.3AccommodationandEnvironmental

Conditions(I)設(shè)施和環(huán)境條件ISuitablefacilities(e.g.energysources,lightingetc.)andenvironmentalconditionstoperformcorrecttestsand/orcalibrations適宜的設(shè)施(如能源、照明)和環(huán)境條件應(yīng)有利于測(cè)試和或校準(zhǔn)的正確進(jìn)行。Technicalrequirementsforaccommodationandenvironmentalconditionsthatcanaffecttheresultsoftestsandcalibrationsshallbedocumented對(duì)可能影響測(cè)試和校準(zhǔn)結(jié)果的設(shè)施和環(huán)境條件的技術(shù)要求應(yīng)加以文件化。Monitor,controlandrecordrelevantenvironmentalconditions監(jiān)測(cè)控制并記錄環(huán)境條件Examplesmaybepaidattentionto,asappropriatetothetechnicalactivitiesconcerned:Biologicalsterility,dust,EMI,humidity,electricalsupply,temperature,andsound&vibrationlevels對(duì)有關(guān)技術(shù)活動(dòng)涉及的因素，如生物無(wú)菌、灰塵、電磁干擾、輻射、濕度、電源、溫度、聲音和振動(dòng)水平635.3AccommodationandEnvironmental

Conditions(II)設(shè)施和環(huán)境條件IITestsandcalibrationsshallbestoppedwhentheenvironmentalconditionsjeopardizetheresultsofthetestsand/orcalibrations當(dāng)環(huán)境條件危及測(cè)試校準(zhǔn)結(jié)果時(shí)，停止測(cè)試和校準(zhǔn)Effectiveseparationofincompatibleactivities有效隔離臨近區(qū)域。Accesstoanduseofareasaffectingqualityshallbecontrolled對(duì)進(jìn)入和使用影響質(zhì)量的區(qū)域應(yīng)加以控制。Measuresshallbetakentoensuregoodhousekeeping采取措施進(jìn)行內(nèi)務(wù)管理。645.3AccommodationandEnvironmental

Conditions(II)設(shè)施和環(huán)境條件II練習(xí)4開(kāi)發(fā)一份電子和電氣檢測(cè)領(lǐng)域?qū)嶒?yàn)室設(shè)施和環(huán)境條件檢查表655.4

TestandCalibrationMethodsand

MethodValidation(I)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)IUseappropriatemethodsandproceduresforalltestsand/orcalibrationswithinlaboratory’sscope,including在實(shí)驗(yàn)室范圍內(nèi)使用合適的方法和程序包括Sampling抽樣Handling處置Transport運(yùn)輸Storage貯存Preparation制備EstimationofMeasurementUncertainty測(cè)量不確定度估計(jì)StatisticalTechniques統(tǒng)計(jì)技術(shù)Useup-to-dateoperatinginstructions,standards,manualsandreferencedataandmakereadilyavailabletopersonnel使用現(xiàn)行有效的操作指導(dǎo)書(shū)標(biāo)準(zhǔn)手冊(cè)和參考數(shù)據(jù)并便于人員得到665.4

TestandCalibrationMethodsand

MethodValidation(II)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)IIDeviationfrommethodsshallbedocumented,technicallyjustified,authorizedandacceptedbytheclient偏離需文件化經(jīng)過(guò)技術(shù)驗(yàn)證授權(quán)并客戶接收International,regionalornationalstandardsorrecognizedspecificationsthatcontainsufficientandconciseinformationdonotneedtobesupplementedorrewrittenasinternalprocedures國(guó)際、區(qū)域或國(guó)家發(fā)布的方法直接使用SelectionofMethods(includingsampling)選擇方法Meetcustomer’sneeds滿足顧客要求PublishedinInternational,Regional,NationalStandardsorScientificjournals,or,shallbepreferable最好采用國(guó)際、區(qū)域或國(guó)家發(fā)布的方法Publishedbyreputabletechnicalorganization知名技術(shù)組織發(fā)布Specifiedbythemanufactureroftheequipment設(shè)備廠商指定Usethelatestvalidedition使用當(dāng)前最新版本Laboratory-developedmethodsshallbevalidatedandconfirmedpriortouse,andtheclientshallbeinformedastothemethodchosen實(shí)驗(yàn)室開(kāi)發(fā)方法應(yīng)使用前經(jīng)過(guò)驗(yàn)證并通知顧客675.4

TestandCalibrationMethodsand

MethodValidation(III)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)III內(nèi)部或非標(biāo)準(zhǔn)方法的確認(rèn)

制訂方法很難，建議盡量采用國(guó)際通用方法。

非標(biāo)準(zhǔn)方法需經(jīng)適當(dāng)?shù)脑O(shè)計(jì)和確認(rèn)（ISO9001第4.4條和ISO/IEC17025第5.4.5條）685.4

TestandCalibrationMethodsand

MethodValidation(III)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)IIIRe-confirmationshallbedoneifmethodchanged如標(biāo)準(zhǔn)方法有變應(yīng)重新確認(rèn)Clientshallbeinformedwhenthemethodproposedisinappropriateoroutofdate如顧客通知的方法已過(guò)時(shí)應(yīng)通知顧客Laboratory-developedMethods實(shí)驗(yàn)室制定的方法Introductionoflaboratory-developedmethodsshallbeaplannedactivity有計(jì)劃Plansshallbeupdatedasdevelopmentevolves適時(shí)修正Assignqualifiedpersonnelwithadequateresources有資格的人員進(jìn)行Ensureeffectivecommunicationamongallpersonnelinvolved有效交流Non-standardMethods非標(biāo)方法Gainagreementwithclient客戶同意Includeaclearspecificationoftheclient’srequirementsandpurposeofthetestand/orcalibration清楚說(shuō)明顧客要求和測(cè)試校準(zhǔn)目的的規(guī)范Validatethemethodappropriatelypriortouse使用前驗(yàn)證695.4

TestandCalibrationMethodsand

MethodValidation(IV)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)IVProceduresshouldbedevelopedpriortoperformfornew

testand/orcalibrationmethods,andcontainatleast:制定程序Identification識(shí)別Scope范圍Descriptionofitemtobetestedorcalibrated樣品類型描述Parametersorquantitiesandrangestobedetermined參數(shù)量值范圍Apparatusandequipment,includingtechnicalperformancerequirements器具設(shè)備包括技術(shù)操作要求referencestandardsandmaterialsrequired所需參考標(biāo)準(zhǔn)和標(biāo)準(zhǔn)物質(zhì)Environmentalconditionsrequiredandanystabilizationperiodneeded環(huán)境條件Descriptionoftheprocedure程序描述Criteriaand/orrequirementsforapproval/rejection判斷準(zhǔn)則Datatoberecordedandmethodofanalysisandpresentation數(shù)據(jù)及表示方法Theuncertaintyortheprocedureforestimatinguncertainty測(cè)量不確定度或評(píng)價(jià)程序705.4

TestandCalibrationMethodsand

MethodValidation(V)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)VValidationofMethods方法驗(yàn)證Validationistheconfirmationbyexaminationandtheprovisionofobjectiveevidencethattheparticularrequirementsforaspecificintendedusearefulfilled驗(yàn)證就是通過(guò)檢查并提供客觀證據(jù)確認(rèn)某一具體預(yù)期用途的特定要求得到滿足Methodsneededtobevalidated:需要驗(yàn)證的方法Recordtheresultsobtained,theprocedureusedandastatementastowhetherthemethodisfitfortheintendeduse記錄驗(yàn)證結(jié)果,程序以及方法是否適于預(yù)期用途的聲明715.4

TestandCalibrationMethodsand

MethodValidation(VI)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)VIValidationmaybeperformedby(oneoforcombinationof):確認(rèn)方法包括一項(xiàng)或多項(xiàng)組合Calibrationusingreferencestandardsorreferencematerials使用標(biāo)準(zhǔn)的校準(zhǔn)Comparisonofresultsachievedwithothermethods與其它方法對(duì)比Interlaboratorycomparison實(shí)驗(yàn)室間對(duì)比Systematicassessmentofthefactorsinfluencingtheresult影響結(jié)果因素的系統(tǒng)評(píng)價(jià)Assessmentoftheuncertaintyoftheresultsbasedonscientificunderstandingofthetheoreticalprinciplesofthemethodandpracticalexperience建立在科學(xué)理論和實(shí)踐經(jīng)驗(yàn)上的不確定度評(píng)價(jià)Therangeandaccuracyofthevaluesobtainablefromvalidatedmethodsshallberelevanttotheclients’needs(e.g.uncertaintyoftheresults,detectionlimit,linearity,repeatabilityand/orreproducibilityetc.)由經(jīng)驗(yàn)證方法獲得的數(shù)據(jù)其范圍和準(zhǔn)確性應(yīng)適于顧客要求(不確定度,線性,重復(fù)再現(xiàn)性等)725.4

TestandCalibrationMethodsand

MethodValidation(VI)檢測(cè)和校準(zhǔn)方法

及方法的確認(rèn)VI評(píng)審客戶的意愿和需求；判斷與標(biāo)準(zhǔn)方法間的偏差；偏差應(yīng)有科學(xué)的基礎(chǔ)/邏輯；考慮基體效應(yīng)和干擾因素；線形相關(guān)范圍、精確度和重復(fù)性；關(guān)鍵或嚴(yán)格的方法步驟的確定；實(shí)驗(yàn)室間比對(duì)結(jié)果和標(biāo)準(zhǔn)方法結(jié)果的比較；內(nèi)部質(zhì)量控制。735.4.6

EstimationofUncertaintyof

Measurement測(cè)量不確定度估計(jì)Acalibrationlaboratory,oratestinglaboratoryperformingitsowncalibrations,shallhaveandapplyaproceduretoestimatetheuncertaintyofmeasurement校準(zhǔn)或測(cè)試實(shí)驗(yàn)室應(yīng)建立程序估計(jì)不確定度Atestinglaboratoryshallidentifyallthecomponentsofuncertaintyandmakeareasonableestimationincasethatthenatureofthetestmethodprecludesrigorouscalculationofuncertaintyofmeasurement當(dāng)無(wú)法對(duì)不確定度從統(tǒng)計(jì)學(xué)角度嚴(yán)格計(jì)算時(shí)應(yīng)識(shí)別不確定度所有分量并作出合理的評(píng)估Factorsdeterminethedegreeofrigorneededinanestimationofuncertaintyofmeasurement:不確定度評(píng)估的精確程度取決于Therequirementsofthetestmethod測(cè)試方法要求Therequirementsoftheclient客戶要求Theexistenceofnarrowlimitsonwhichdecisionsonconformancetoaspecificationarebased確定符合某規(guī)范依據(jù)的限量范圍745.4.6

EstimationofUncertaintyof

Measurement(II)測(cè)量不確定度估計(jì)IIUncertaintyistherangeofvaluesthattruevaluecanbebasedonthereportedvalue不確定度指真值可能存在的范圍UncertaintyisexpressedasanestimateofStandardDeviation表述為標(biāo)準(zhǔn)差的估計(jì)All

uncertaintycomponents(factors)thatcaninfluenceameasuredvalueshallbetakenintoaccountusingappropriatemethodsofanalysiswhenestimatingtheuncertaintyofmeasurement采用適當(dāng)分析方法考慮所有測(cè)量不確定度分量Sourcescontributingtotheuncertaintyinclude:不確定度來(lái)源于Referencestandardsandreferencematerialsused標(biāo)準(zhǔn)物質(zhì)MethodsandEquipmentused方法和設(shè)備Environmentalconditions環(huán)境條件Propertiesandconditionoftheitembeingtestedorcalibrated樣品的性質(zhì)Operator操縱者755.4.6

EstimationofUncertaintyof

Measurement(III)測(cè)量不確定度估計(jì)IIITypeAUncertaintyA類不確定度StatisticallyderivedestimateofStandardDeviationIdeallythemethodshouldidentifysourcesofv