質(zhì)量管理體系翻譯s 2016

TheQualityManagement質(zhì)量管理體系組人設(shè)流程管采購與TheQualityManagement質(zhì)量管理體系組人設(shè)流程管采購與庫存信息管理EventMgnt件的管理評(píng)文檔記設(shè)施和安全持續(xù)改聚焦于客戶2WhatisanWhatisan評(píng)審是什么？SomeoneisWhatisbeing做了HowdoesthiscomplywithwrittenpoliciesandComparisonofactualresultsto實(shí)際結(jié)果與預(yù)期的對(duì)Whyassess?Whymeasure?為什么要評(píng)審為什么要Whyassess?Whymeasure?為什么要評(píng)審為什么要測(cè)量Howdoyouknowifyouaremeetingyour如何知道你是否達(dá)到了目標(biāo)？HowdoyouknowifyouareyourcustomerneedsandHowdoyoucomparewith如何與其它實(shí)驗(yàn)室進(jìn)行比較？Howdoyouknowifachangeisan如何知道你是否進(jìn)步了？外部評(píng)審groupor外部評(píng)審groupor外部團(tuán)體或機(jī)構(gòu)評(píng)審內(nèi)部評(píng)Quality優(yōu)質(zhì)實(shí)驗(yàn)室TypesofAssessments評(píng)審TypesofAssessments評(píng)審的Internal內(nèi)部評(píng)審Qualityindicators質(zhì)量指標(biāo)（及測(cè)量值BloodutilizationExternal外部評(píng)審Accreditationorlicensureassessment,mandatoryandtestingwhenPTisnot內(nèi)部評(píng)外部?jī)?nèi)部評(píng)外部評(píng)審Assessing/Auditing/Assessing/Auditing/評(píng)審/審核/監(jiān)GatherComparefindingswithdocumentedqualitymanagementIdentifygapsinsystemordeparturefromproceduresReportUseaudit8assignsfortheassessment指派評(píng)assignsfortheassessment指派評(píng)審項(xiàng)目的職責(zé)評(píng)審結(jié)果–Quality質(zhì)量管理者 corrective 實(shí)驗(yàn)室主任開發(fā)計(jì)劃表select&train開發(fā)計(jì)劃表select&train選擇&培訓(xùn)內(nèi)部評(píng)審員管理糾正coordinatetheauditprocesses協(xié)調(diào)審核流程評(píng)審結(jié)果向員工reportto向管理部門報(bào)告QualityManagerResponsibility質(zhì)量管理establishandmaintainanqualityassessment建立和維護(hù)質(zhì)量評(píng)審系統(tǒng)Preparationü組üGatherandrecords收集信息和Preparationü組üGatherandrecords收集信息和記錄üSchedulewithstaff與員工制時(shí)間ü計(jì)AuditsShouldLeadtoAuditsShouldLeadto審核后應(yīng)該予以行動(dòng)Audit-審核-監(jiān)行識(shí)別改進(jìn)的機(jī)會(huì)QSEASSESSMENTS質(zhì)QSEASSESSMENTS質(zhì)量系統(tǒng)要素：評(píng)內(nèi)部評(píng)審InternalAuditsand內(nèi)部審InternalAuditsand內(nèi)部審核和監(jiān)測(cè)靈LookatyourownprocessesCostsless減小成§requiredbyISOstandardISO標(biāo)準(zhǔn)中的要求§conductedonaregularbasisANDwhenproblemsidentifiedInternalISOInternalISO內(nèi)部審核：ISO標(biāo)準(zhǔn)要求§musthaveanaudit§mustdocument§auditorsindependentofactivitywhenpossible§resultsdocumentedreportedtomanagementfor§promptfollow-up§必須具有審核項(xiàng)§必須記錄審核程§評(píng)審員盡可能獨(dú)立于實(shí)驗(yàn)§記錄結(jié)果并向管理層報(bào)告§促使后續(xù)行AssesstheentireQMSandpathof評(píng)審?fù)暾馁|(zhì)量管理體系及AssesstheentireQMSandpathof評(píng)審?fù)暾馁|(zhì)量管理體系及其工作流學(xué)實(shí)驗(yàn)室工作流程檢驗(yàn)????????檢驗(yàn)檢驗(yàn)????標(biāo)本檢??樣發(fā)管評(píng) 質(zhì)量體系要 持續(xù)改文檔&記 信息管 不符合事管人 采購&庫 設(shè) 流程管組 聚焦于客 設(shè)施和安AssessAssesstheentireQMSandpathof評(píng)審整個(gè)工作流的質(zhì)量管理體系以及路徑評(píng)審類系統(tǒng)評(píng)審類系統(tǒng)評(píng)流程評(píng)審產(chǎn)品/服務(wù)評(píng)評(píng)審方法回評(píng)審方法回前定義:系統(tǒng)評(píng)審Determineswhetherthemultipleprocessesinasystemmeet確定系統(tǒng)的多個(gè)流程是否符合要 Looksatprocess,products,servicesandsupporting Objectiveevidencedemonstratingthatelementsofthesystemare:客觀證據(jù)顯示系統(tǒng)的要素是 Developed,documented,and建立、存檔和實(shí)施 Incompliancewith符合要求 適合的 有效的?定義：流程評(píng)審Determineswhethertheinputs,actions,andoutputsofasingleprocessoccurasProcessauditscantraceaselectedprocessforwardorbackwardDefinitions:Focused定義：重點(diǎn)評(píng)審?ExaminationofaproductorDefinitions:Focused定義：重點(diǎn)評(píng)審?Examinationofaproductorservicetoevaluatewhetheritconformstorequirements檢查“產(chǎn)品”以評(píng)估它是否符合要?續(xù)任一情Reviewof回PTrecordsforQCexceptions室cttio前Patient病人調(diào)樣本標(biāo)優(yōu)秀實(shí)驗(yàn)室Quality微生物實(shí)驗(yàn)室Internal內(nèi)部審核Donotauditown優(yōu)秀實(shí)驗(yàn)室Quality微生物實(shí)驗(yàn)室Internal內(nèi)部審核Donotauditown尿檢實(shí)驗(yàn)室內(nèi)另一間實(shí)驗(yàn)室的顧問病毒學(xué)實(shí)驗(yàn)室Int.todetail注意細(xì)todetail注意細(xì)有效經(jīng)過培for評(píng)審員的重要技技術(shù)/質(zhì)量管善于溝QualityQuality質(zhì)量指標(biāo)質(zhì)量指標(biāo)是一個(gè)度量標(biāo)準(zhǔn)(measuredprocess（測(cè)量了流程信息DeterminequalityofHighlightpotentialqualityIdentifyareasthatneedfurtherstudyandTrackchangesoverMetricsQuality質(zhì)量指Quality質(zhì)量控–––?MetricsQuality質(zhì)量指Quality質(zhì)量控–––????ProcessInstrument––––––Operator?ReactiontimeFluorescenceColonyCountUsingtheUsingtheRight使用正確的度量標(biāo)準(zhǔn)Brown,MarkGraham–KeepingScoreDONotWasteTimeDONotWasteTimeand不要浪費(fèi)時(shí)間和精力Establishingindicatorsthatyou……定期測(cè)解釋改MeasureOutofyourToomany不能控制變量太多Whatto計(jì)劃：去測(cè)量什么？以病人為Whatto計(jì)劃：去測(cè)量什么？以病人為中心的CustomerPathof管理質(zhì)量體系A(chǔ)SSESSMENTS評(píng)ASSESSMENTS評(píng)EXTERNAL外部評(píng)審ExternalAuditors外部ExternalAuditors外部認(rèn)可機(jī)構(gòu)實(shí)驗(yàn)室資助項(xiàng)Preparingforanexternal外部評(píng)審Preparingforanexternal外部評(píng)審的準(zhǔn)TobeüSchedulewith要想成功：ü計(jì)劃ü組üGatherinformation,documents,ü收集必要的息、文檔錄and“Auditsare“AuditsarefactfindingnotfaultExternalExternal外部評(píng)審：室間質(zhì)評(píng)ExternalQualityAssessmentExternalQualityAssessmentAsystemforobjectivelycheckingthelaboratory’sperformanceusinganexternalagencyorfacility一個(gè)用外部機(jī)構(gòu)或者設(shè)施去客觀檢查實(shí)驗(yàn)室性能的系統(tǒng)P室間質(zhì)評(píng)組織/提供分寄送檢驗(yàn)室間質(zhì)評(píng)能力報(bào)告P室間質(zhì)評(píng)組織/提供分寄送檢驗(yàn)室間質(zhì)評(píng)能力報(bào)告PTsamples定期發(fā)送室間質(zhì)評(píng)樣本評(píng)PTISO樣樣LaboratoryAnalyzesameISO樣樣LaboratoryAnalyzesamemannerwithsamepersonnel由同一位員工以同的操作分FinalPT間質(zhì)改betweenlabsLaboratory 評(píng) 評(píng)TAKING采取行FindingsandPlanof發(fā)現(xiàn)和行動(dòng)FindingsandPlanof發(fā)現(xiàn)和行動(dòng)計(jì)劃實(shí)驗(yàn)室理解報(bào)告中的建總結(jié)報(bào)RecordresultsandWriteIdentify識(shí)別差Developtimeline制定時(shí)間線；指派責(zé)Plancorrective計(jì)劃糾正措即時(shí)的和糾正的措施TheseactionsarethestepstakentoimproveaprocessortocorrectaWhoisQuality由誰質(zhì)量管理者Documents文?InternalauditDocuments文?Internalaudit內(nèi)部審核項(xiàng)selecting,establishingandmonitoringQIhostingexternalassessmentsEQA室間質(zhì)評(píng)項(xiàng)???monitoringmonitoringisthekeyelementtosuccessintheQualitySystemquality監(jiān)控&評(píng)quality監(jiān)控&評(píng)估客質(zhì)量控質(zhì)量提高計(jì)劃持續(xù)的質(zhì)量提升Action糾正行為計(jì)劃 “Itisn’t“Itisn’twhatyoufind…it’swhatyoudoaboutwhatyouPhilip?Assessmentisimportant?Assessmentisimportantinmoni