ISO/TS16949:2002標(biāo)準(zhǔn)講解ISO/TS16949STANDARDINTERPRETATIONISO/TS16949:2002標(biāo)準(zhǔn)講解ISO/TS1QualitysystemdocumentationprogressionQualitysystemdocumentationpKeyWords

關(guān)鍵詞語Shall–mandatoryrequirements應(yīng)–強(qiáng)制性要求Should–recommendation應(yīng)該–建議Note–guidanceforunderstanding注–指南以便明白Suchas–forguidance例如–指導(dǎo)性Documentedprocedure–musthavedocumentedsystemprocedure文件化程序–必須有文件化的體系程序KeyWords

關(guān)鍵詞語Shall–mandato

ProcessAnactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.ProcessApproachTheapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoasthe“processapproach”.過程通過使用資源和管理,將輸入轉(zhuǎn)化為輸出的活動(dòng)可視為過程。過程方法組織內(nèi)諸過程的系統(tǒng)的應(yīng)用，連同這些過程的識(shí)別和相互作用及其管理，可稱之為“過程方法”。

Process過程

質(zhì)量管理體系的持續(xù)改進(jìn)管理職責(zé)測量，分析，改進(jìn)產(chǎn)品實(shí)現(xiàn)資源管理客戶滿意客戶要求產(chǎn)品增值的過程信息傳遞的途徑質(zhì)量管理體系的持續(xù)改進(jìn)管理職責(zé)測量，分析，改進(jìn)產(chǎn)品實(shí)現(xiàn)資源質(zhì)量管理體系8大原則

以客戶為關(guān)注焦點(diǎn)CustomerFocus領(lǐng)導(dǎo)作用Leadership全員參與InvolvementofPeople過程方法ProcessApproach系統(tǒng)化管理SystemApproachtoManagement持續(xù)改進(jìn)ContinualImprovement

基于事實(shí)的決策方法FactualapproachtoDecisionMaking與供方互利的關(guān)系MutuallyBeneficialSupplierRelationships質(zhì)量管理體系8大原則以客戶為關(guān)注焦點(diǎn)Custo4Qualitymanagementsystem

質(zhì)量管理體系4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisinternationalStandards.Theorganizationshall:a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,4Qualitymanagementsystem

4質(zhì)量管理體系4.1總要求組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系,形成文件,加以實(shí)施和保持,并持續(xù)改進(jìn)其有效性.組織應(yīng):a)識(shí)別質(zhì)量管理體系所需的過程及其在組織中的應(yīng)用(見1.2),b)確定這些過程的順序和相互作用,c)確定為確保這些過程的有效運(yùn)行和控制所需的準(zhǔn)則和方法,4.1Generalrequirements4

4Qualitymanagementsystem

4質(zhì)量管理體系4.1Generalrequirementsd)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measureandanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisinternationalStandard.4.1總要求d)確?？梢垣@得必要的資源和信息,以支持這些過程的運(yùn)行和對這些過程的監(jiān)視,e)監(jiān)視,測量和分析這些過程f)實(shí)施必要的措施,以實(shí)現(xiàn)對這些過程策劃的結(jié)果和對這些過程的持續(xù)改進(jìn).組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過程.4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshall

ensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.Note:Processneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.針對組織所選擇的任何影響產(chǎn)品符合要求的外包過程,組織應(yīng)確保對其實(shí)施控制.對此類外包過程的控制應(yīng)在質(zhì)量管理體系中加以識(shí)別.注:上述質(zhì)量管理體系所需的過程應(yīng)當(dāng)包括與管理活動(dòng),資源提供,產(chǎn)品實(shí)現(xiàn)和測量有關(guān)的過程.4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系4.1.1Generalrequirements-SupplementalEnsuringcontroloveroutsourcedprocessesshallnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomersrequirements.NOTESeealso7.4.1and4.1.1總則-補(bǔ)充確?？刂仆獍^程不應(yīng)免除組織對符合所有客戶要求的職責(zé)。注：見7.4.1和4Qualitymanagementsy4Qualitymanagementsystem

4質(zhì)量管理體系4.2Documentationrequirements4.2.1General

Thequalitymanagementsystemdocumentationshallinclude:a)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresrequiredbythisinternationalStandard,d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,ande)recordsrequiredbythisInternationalStandard(see4.2.4)4.2Documentationrequirements4.2.1總則質(zhì)量管理體系文件應(yīng)包括:a)形成文件的質(zhì)量方針和質(zhì)量目標(biāo)b)質(zhì)量手冊c)本標(biāo)準(zhǔn)所要求的形成文件的程序d)組織為確保其過程的有效策劃,運(yùn)行和控制所需的文件e)本標(biāo)準(zhǔn)所要求的記錄(見4.2.4)4Qualitymanagementsys

4Qualitymanagementsystem

4質(zhì)量管理體系NOTE1:Wheretheterm<documentedprocedure>appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2:Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto:a)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnelNOTE3:Thedocumentationcanbeinanyformortypeofmedium.注1:本標(biāo)準(zhǔn)出現(xiàn)“形成文件的程序”之處,即要求建立該程序,形成文件,并加以實(shí)施和保持.注2:不同組織的質(zhì)量管理體系文件的多少于詳略程度取決于:a)組織的規(guī)模和活動(dòng)的類型,b)過程及其相互作用的復(fù)雜程度,c)人員的能力.注3:文件可采用任何形式或類型的媒體.4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系4.2.2Qualitymanual

Theorganizationshallestablishandmaintainaqualitymanualthatincludes:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2).b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.4.2.2質(zhì)量手冊組織應(yīng)編制和保持質(zhì)量手冊,質(zhì)量手冊包括:a)質(zhì)量管理體系的范圍,包括任何刪減的細(xì)節(jié)與合理性(見1.2)b)為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟胏)質(zhì)量管理體系過程之間的相互作用的表述.4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系4.2.3Controlofdocuments

Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Qualityrecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshall

beestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandre-approvedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,4.2.3文件控制質(zhì)量管理體系所要求的文件應(yīng)予以控制.記錄是一種特殊類型的文件,應(yīng)按照4.2.4的要求進(jìn)行控制.應(yīng)編制形成文件的程序,以規(guī)定以下方面所需的控制:a)文件發(fā)布前得到批準(zhǔn),以確保文件是充分與適宜的,b)必要時(shí)對文件進(jìn)行評審與更新,并再次批準(zhǔn),c)確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別,4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse.e)toensurethatdocumentsremainlegibleandreadilyidentifiable.f)toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocument,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.d)確保在使用處可獲得適用文件的有關(guān)版本e)確保文件保持清晰,易于識(shí)別,f)確保外來文件得到識(shí)別,并控制其分發(fā),g)防止作廢文件的非預(yù)期使用,若因任何原因而保留作廢文件時(shí),對這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí).4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系EngineeringspecificationsTheorganizationshallhaveaprocesstoassurethetimelyreview,distributionandimplementationofallcustomerengineeringstandards/specificationsandchangesbasedoncustomerrequiredschedule.Timelyreviewshouldbeassoonaspossible,andshallnotexceedtwoworkingweeks.Theorganizationshallmaintainarecordofthedateonwhicheachchangeisimplementedinproduction.Implementationshallincludeupdatesdocuments.工程規(guī)范組織應(yīng)有一過程以確保對所有客戶的工程標(biāo)準(zhǔn)/規(guī)范和更改和在客戶要求的時(shí)間表的基礎(chǔ)上進(jìn)行及時(shí)的評審，發(fā)放和實(shí)施。進(jìn)行及時(shí)的評審應(yīng)該盡早，并且不應(yīng)超過2個(gè)工作周。組織應(yīng)保持在生產(chǎn)中的每一個(gè)更改實(shí)施日期的記錄。實(shí)施應(yīng)包括更新文件。4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系

NOTE:Achangeinthesestandards/specificationsrequiresanupdatedrecordofcustomerproductionpartapprovalwhenthesespecificationsarereferencedonthedesignrecordoriftheyaffectdocumentsofproductionpartapprovalprocess,suchascontrolplan,FMEAs,etc.注：當(dāng)這些規(guī)范指向設(shè)計(jì)記錄或他們影響到生產(chǎn)零件審批過程，諸如控制計(jì)劃，F(xiàn)MEA等時(shí)，這些標(biāo)準(zhǔn)/規(guī)范中的每一個(gè)更改都要求客戶生產(chǎn)零件審批的更新記錄。4Qualitymanagementsy

4Qualitymanagementsystem

4質(zhì)量管理體系4.2.4ControlofrecordsRecordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.4.2.4記錄控制應(yīng)建立并保持記錄,以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù).記錄應(yīng)保持清晰,易于識(shí)別和檢索.應(yīng)編制形成文件的程序,以規(guī)定記錄的標(biāo)識(shí),貯存,保護(hù),檢索,保存期限和處置所需的控制.4Qualitymanagementsy

4Qualitymanagementsystem4質(zhì)量管理體系NOTE1:“Disposition”aboveincludesdisposal.NOTE2:“Records”alsoincludecustomer-specifiedrecords.Recordsretention

Thecontrolofrecordsshallsatisfyregulatoryandcustomerrequirement.注1：上述的“處置”包括處理。注2：“記錄”也包括客戶指定的記錄。記錄的保持記錄控制應(yīng)滿足法規(guī)和客戶要求。4Qualitymanagementsy5Managementresponsibility

管理層職責(zé)5Managementresponsibility

5Managementresponsibility

5管理層職責(zé)5.1Managementcommitment

Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby:a)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,b)establishingthequalitypolicy,c)ensuringthatqualityobjectivesareestablished,d)conductingmanagementreviews,ande)ensuringtheavailabilityofresources.5.1管理承諾最高管理者應(yīng)通過以下活動(dòng),對其建立,實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù):a)向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性,b)制定質(zhì)量方針,c)確保質(zhì)量目標(biāo)的制定,d)進(jìn)行管理評審,e)確保資源的獲得,5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.1.1ProcessefficiencyTopmanagementshallreviewtheproductrealizationprocessesandthesupportprocessestoassuretheireffectivenessandefficiency.5.1.1過程有效性最高管理層應(yīng)評審產(chǎn)品的實(shí)現(xiàn)過程和支持過程以確保它們的有效性和效率。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.2CustomerfocusTopmanagementshallensurethatcustomerrequirementsaredeterminedandfulfilledwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).5.2以顧客為關(guān)注焦點(diǎn)最高管理者應(yīng)以增強(qiáng)顧客滿意為目的,確保顧客的要求得到確定并予以滿足(見7.2.1和8.2.1).5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.3Qualitypolicy

Topmanagementshallensurethatthequalitypolicy.a)isappropriatetothepurposeoftheorganization,b)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,c)providesaframeworkforestablishingandreviewingqualityobjectives,d)iscommunicatedandunderstoodwithintheorganization,ande)isreviewedforcontinuingsuitability.5.3質(zhì)量方針最高管理者應(yīng)確保質(zhì)量方針:a)與組織的宗旨相適應(yīng),b)包括對滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾,c)提供制定和評審質(zhì)量目標(biāo)的框架,d)在組織內(nèi)得到溝通和理解e)在持續(xù)適宜性方面得到評審.5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.4Planning5.4.1QualityobjectivesTopmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct(see7.1)areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.5.4策劃5.4.1質(zhì)量目標(biāo)最高管理者應(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo),質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容(見7.1).質(zhì)量目標(biāo)應(yīng)是可測量的,并與質(zhì)量方針保持一致.5Managementresponsib

5Managementresponsibility

5管理層職責(zé)Qualityobjectives-supplementalTopmanagementshall

definequalityobjectivesandmeasurementsthat

shallbeincludedinthebusinessplanandusedtodeploythequalitypolicy.NOTE:Qualityobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod.質(zhì)量目標(biāo)-補(bǔ)充最高管理層應(yīng)確定質(zhì)量目標(biāo)和度量指標(biāo)，應(yīng)包含于業(yè)務(wù)計(jì)劃和用來展開質(zhì)量方針。注：質(zhì)量目標(biāo)中應(yīng)該注明客戶的期望，并在所定期限內(nèi)可以達(dá)到。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.4.2QualitymanagementsystemplanningTopmanagementshallensurethat:a)theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,andb)theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.5.4.2質(zhì)量管理體系策劃最高管理者應(yīng)確保:a)對質(zhì)量管理體系進(jìn)行策劃,以滿足質(zhì)量目標(biāo)以及4.1的要求,b)在對質(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí),保持質(zhì)量管理體系的完整性.5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.5Responsibility,authorityandcommunication5.5.1ResponsibilityandauthorityTopmanagementshallensurethattheresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization.5.5職責(zé),權(quán)限與溝通5.5.1職責(zé)和權(quán)限最高管理者應(yīng)確保組織內(nèi)的職責(zé),權(quán)限得到規(guī)定和溝通.5Managementresponsib

5Managementresponsibility

5管理層職責(zé)ResponsibilityforQualityManagerswithresponsibilityandauthorityforcorrectiveactionshall

bepromptlyinformedofproductsorprocesseswhichdonotconformtorequirements.Personnelresponsibleforproductquality

shall

havetheauthoritytostopproductiontocorrectqualityproblems.Productionoperationsacrossallshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityfor，ensuringproductquality.質(zhì)量職責(zé)對糾正措施賦有職責(zé)和權(quán)限的管理者應(yīng)被及時(shí)通知不符合要求的產(chǎn)品或過程。賦有產(chǎn)品質(zhì)量職責(zé)的人員應(yīng)有權(quán)限停止生產(chǎn)以糾正質(zhì)量問題。所有班次的生產(chǎn)運(yùn)作應(yīng)有人員看管，或委派相關(guān)職責(zé)人員以確保產(chǎn)品質(zhì)量。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.5.2Managementrepresentative

Topmanagementshall

appointamemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes:a)ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,b)reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,andc)ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.NOTE:Theresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.5.5.2管理者代表最高管理者應(yīng)指定一名管理者,無論該成員在其它方面的職責(zé)如何,應(yīng)具有以下方面的職責(zé)和權(quán)限:a)確保質(zhì)量管理體系所需的過程得到建立,實(shí)施和保持,b)向最高管理者報(bào)告質(zhì)量管理體系的業(yè)績和任何改進(jìn)的需求,c)確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí).注:管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò).5Managementresponsib

5Managementresponsibility

5管理層職責(zé)CustomerrepresentativeTopmanagementshall

designatepersonnelwithresponsibilityandauthoritytoensurethecustomerrequirementsareaddressed.Thisincludesselectionofspecialcharacteristics,settingqualityobjectivesandrelatedtraining,correctiveandpreventiveactions,productdesignanddevelopment.

客戶代表最高管理層應(yīng)指派人員擁有職責(zé)和權(quán)限以確保滿足客戶要求。包括選擇特殊特性、建立質(zhì)量目標(biāo)和相關(guān)的培訓(xùn)、糾正和預(yù)防措施、產(chǎn)品設(shè)計(jì)和開發(fā)。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.5.3Internalcommunication

Topmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplacesregardingtheeffectivenessofthequalitymanagementsystem.5.5.3內(nèi)部溝通最高管理者應(yīng)確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程,并確保對質(zhì)量管理體系的有效性進(jìn)行溝通.5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.6Managementreview5.6.1General

Topmanagementshallreviewtheorganization'squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitability,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives.Recordsfrommanagementreviewsshallbemaintained(see4.2.4)5.6管理評審5.6.1總則最高管理者應(yīng)按策劃的時(shí)間間隔評審質(zhì)量管理體系,以確保其持續(xù)的適宜性,充分性和有效性.評審應(yīng)包括評價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要,包括質(zhì)量方針和質(zhì)量目標(biāo)..應(yīng)保持管理評審的記錄(見4.2.4).5Managementresponsib

5Managementresponsibility

5管理層職責(zé)QualitymanagementsystemperformanceThesereviewsshallincludeallrequirementsofthequalitymanagementsystemanditsperformancetrendsasanessentialpartofthecontinualimprovementprocess.Partofthemanagementreviewshallbethemonitoringofqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality(see8.4.1and8.5.1)質(zhì)量管理體系績效這些評審應(yīng)包括質(zhì)量管理體系的所有要求，并且將它的績效趨勢作為持續(xù)改進(jìn)過程的實(shí)質(zhì)部分。管理評審的其中部分應(yīng)是質(zhì)量目標(biāo)的監(jiān)控，定期報(bào)告和評價(jià)不良質(zhì)量成本。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)Theseresults

shallberecordedtoprovide,asaminimum,evidenceoftheachievementof:-thequalityobjectivesspecifiedinthebusinessplan,and-customersatisfactionwithproductsupplied.這些結(jié)果應(yīng)被記錄，至少可提供作為證據(jù)達(dá)到：-業(yè)務(wù)計(jì)劃中規(guī)定的質(zhì)量目標(biāo)，和-客戶對產(chǎn)品提供的滿意度。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.6.2Reviewinput

Theinputtomanagementreviewshallincludeinformationon:a)resultsofaudits,b)customerfeedback,c)processperformanceandproductconformity,d)statusofpreventiveandcorrectiveactions,e)follow-upactionsfrompreviousmanagementreviews,f)plannedchangesthatcouldaffectthequalitymanagementsystem,andg)recommendationsforimprovement.5.6.2評審輸入管理評審的輸入應(yīng)包括以下方面的信息:a)審核結(jié)果b)顧客反饋c)過程的業(yè)績和產(chǎn)品的符合性d)預(yù)防和糾正措施的狀況e)以往管理評審的跟蹤措施f)可能影響質(zhì)量管理體系的變更g)改進(jìn)的建議5Managementresponsib

5Managementresponsibility

5管理層職責(zé)Reviewinput-SupplementalInputtomanagementreviewshall

includeananalysisofactualandpotentialfield-failuresandtheirimpactonquality,safety,ortheenvironment.

評審輸入-補(bǔ)充管理評審的輸入應(yīng)包括對實(shí)際和潛在使用失效的分析以及它們對質(zhì)量，安全或環(huán)境的影響。5Managementresponsib

5Managementresponsibility

5管理層職責(zé)5.6.3ReviewoutputTheoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto:a)improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses,b)improvementofproductrelatedtocustomerrequirements,andc)resourceneeds.5.6.3評審輸出管理評審的輸出應(yīng)包括與以下方面有關(guān)的任何決定和措施:a)質(zhì)量管理體系及其過程有效性的改進(jìn)b)與顧客要求有關(guān)的產(chǎn)品的改進(jìn)c)資源需求.5Managementresponsib6Resourcemanagement

資源管理6Resourcemanagement

6Resourcemanagement

6資源管理6.1ProvisionofresourcesTheorganizationshalldetermineandprovidetheresourcesneeded:a)toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,andb)toenhancecustomersatisfactionbymeetingcustomerrequirements.6.1資源提供組織應(yīng)確定并提供以下方面所需的資源:a)實(shí)施,保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性,b)通過滿足顧客要求,增強(qiáng)顧客滿意.6Resourcemanagem

6Resourcemanagement

6資源管理6.2Humanresources6.2.1General

Personnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience.6.2人力資源6.2.1總則基于適當(dāng)?shù)慕逃?培訓(xùn),技能和經(jīng)驗(yàn),從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的.6Resourcemanagem

6Resourcemanagement

6資源管理6.2.2Competence,awarenessandtraining

Theorganizationshall:a)determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality,b)providetrainingortakeotheractionstosatisfytheseneeds,c)evaluatetheeffectivenessoftheactionstaken,d)ensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,ande)maintainappropriaterecordsofeducation,training,skillsandexperience.6.2.2能力,意識(shí)和培訓(xùn)組織應(yīng):a)確定從事影響產(chǎn)品質(zhì)量工作的人員所必要的能力,b)提供培訓(xùn)或采取其它措施以滿足這些需求,c)評價(jià)所采取措施的有效性,d)確保員工認(rèn)識(shí)到所從事活動(dòng)的相關(guān)性和重要性,以及如何為實(shí)現(xiàn)質(zhì)量目標(biāo)作出貢獻(xiàn),e)保持教育,培訓(xùn),技能和經(jīng)驗(yàn)的適當(dāng)記錄.6Resourcemanagem

6Resourcemanagement

6資源管理ProductdesignskillsTheorganizationshallensurethatpersonnelwithproductdesignresponsibilityarecompetenttoachievedesignrequirementsandareskilledinapplicabletoolsandtechniques.Applicabletoolsandtechniquesshallbeidentifiedbytheorganization.產(chǎn)品設(shè)計(jì)技術(shù)組織應(yīng)確保負(fù)責(zé)產(chǎn)品設(shè)計(jì)的人員有能力完成設(shè)計(jì)要求并熟練使用適用的工具和技巧。適用的工具和技巧應(yīng)被組織識(shí)別。6Resourcemanagem

6Resourcemanagemnet

6資源管理TrainingTheorganizationshallestablishandmaintaindocumentedproceduresforidentifyingtrainingneedsandachievingcompetenceofallpersonnelperformingactivitiesaffectingproductquality.Personnelperformingspecificassignedtasksshallbequalified，asrequiredwithparticularattentiontothesatisfactionofcustomerrequirements.培訓(xùn)組織應(yīng)建立和保持文件化程序以識(shí)別培訓(xùn)需求和影響產(chǎn)品質(zhì)量的所有員工具備能力。執(zhí)行特殊任務(wù)的員工應(yīng)具備資格，特殊關(guān)注按照滿足客戶要求。6Resourcemanagemn

6Resourcemanagemnet

6資源管理TrainingNOTE1Thisappliestoallemployeesaffectingqualityatalllevelsoftheorganization.NOTE2Anexampleofthecustomerspecificrequirementsistheapplicationofdigitizedmathematicallybaseddata.培訓(xùn)注1適用于組織各個(gè)階層的對質(zhì)量有影響的所有員工。注2客戶特殊要求的一個(gè)例子是數(shù)字?jǐn)?shù)據(jù)的應(yīng)用。6Resourcemanagemn

6Resourcemanagemnet

6資源管理在職培訓(xùn)組織應(yīng)向員工，包括合同或中介人員提供關(guān)于影響產(chǎn)品質(zhì)量的新的或修改過的作業(yè)的在職培訓(xùn)。對質(zhì)量有影響的員工，應(yīng)被通知關(guān)于不符合質(zhì)量要求對客戶的后果。Trainingonthejob

Theorganizationshallprovideonthejobtrainingforpersonnelinanynewormodifiedjobaffectingproductqualityincludingcontractoragencypersonnel.Personnelwhoseworkcanaffectqualityshallbeinformedabouttheconsequencestothecustomerofnon-conformitytoqualityrequirements.6Resourcemanagemn

6Resourcemanagemnet

6資源管理員工的積極性和推動(dòng)組織應(yīng)具備一過程以激勵(lì)員工達(dá)成質(zhì)量目標(biāo)，做到持續(xù)改進(jìn)，并創(chuàng)造一個(gè)促進(jìn)革新的環(huán)境。這個(gè)過程應(yīng)包括整個(gè)組織對質(zhì)量和技術(shù)意識(shí)的提升。EmployeemotivationandempowermentTheorganizationshallhaveaprocesstomotivateemployeestoachievequalityobjectives,tomakecontinualimprovements,andtocreateanenvironmenttopromoteinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.6Resourcemanagemn

6Resourcemanagemnet

6資源管理員工的積極性和推動(dòng)組織應(yīng)具備一測量過程以保證其人員了解他們活動(dòng)的恰當(dāng)性和重要性及他們?nèi)绾斡兄谶_(dá)到質(zhì)量目標(biāo)(見6.2.2d)。EmployeemotivationandempowermentTheorganization

shall

haveaprocesstomeasuretheextenttowhichitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives(see6.2.2d).6Resourcemanagemn

6Resourcemanagement

6資源管理6.3Infrastructure

Theorganizationshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicablea)buildings,workspaceandassociatedutilities,b)processequipment,(bothhardwareandsoftware),andc)supportingservices(suchastransportorcommunication).6.3基礎(chǔ)設(shè)施組織應(yīng)確定,提供并維護(hù)為達(dá)到產(chǎn)品符合要求所需的基礎(chǔ)設(shè)施.適用時(shí),基礎(chǔ)設(shè)施包括:a)建筑物,工作場所和相關(guān)的設(shè)施b)過程設(shè)備(硬件和軟件)c)支持性服務(wù)(如運(yùn)輸或通訊).6Resourcemanagem

6Resourcemanagemnet

6資源管理6.3.1工廠，設(shè)施和設(shè)備策劃組織應(yīng)采用多方論證方式(見)以開發(fā)工廠，設(shè)施和設(shè)備的計(jì)劃。工廠的布局應(yīng)優(yōu)化材料的運(yùn)輸，搬運(yùn)及增值使用空間，并應(yīng)方便材料的同步流動(dòng)。應(yīng)開發(fā)和實(shí)施方法來評估和監(jiān)控現(xiàn)有運(yùn)作的有效性。6.3.1Plant,facilityandequipmentplanningTheorganizationshalluseamultidisciplinaryapproach(see)fordevelopingplant,facilityandequipmentplans.Plantlayoutsshalloptimizematerialtravel,handlingandvalue-addeduseoffloorspace,andshallfacilitatesynchronousmaterialflow.Methodsshallbedevelopedandimplementedtoevaluateandmonitortheeffectivenessofexistingoperations.6Resourcemanagemn

6Resourcemanagemnet

6資源管理6.3.1工廠，設(shè)施和設(shè)備策劃注這些要求應(yīng)該關(guān)注于精益生產(chǎn)原則及與質(zhì)量管理體系有效性的連系。6.3.1Plant,facilityandequipmentplanningNOTETheserequirementsshouldfocusonleanmanufacturingprinciplesandthelinktotheeffectivenessofthequalitymanagementsystem.6Resourcemanagemn

6Resourcemanagemnet

6資源管理6.3.2ContingencyplansTheorganizationshallpreparecontingencyplanstosatisfythecustomerrequirementsintheeventofanemergencysuchasutilityinterruptions,labourshortages,keyequipmentfailure,andfieldreturns.

6.3.2應(yīng)急計(jì)劃組織應(yīng)準(zhǔn)備應(yīng)急計(jì)劃以在緊急情況下，諸如供應(yīng)中斷，勞動(dòng)力短缺，關(guān)鍵設(shè)備故障和市場退回時(shí)，滿足客戶要求。6Resourcemanagemn

6Resourcemanagement

6資源管理6.4WorkenvironmentTheorganizationshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements.6.4工作環(huán)境組織應(yīng)確定并管理為達(dá)到產(chǎn)品符合要求所需的工作環(huán)境.6Resourcemanagem

6Resourcemanagement

6資源管理6.4.1Personnelsafety

toachieveproductqualityProductsafetyandmeanstominimizepotentialriskstoemployeesshallbeaddressedbytheorganization,especiallyindesignanddevelopmentprocessandinthemanufacturingprocessactivities.6.4.1人員安全以達(dá)到產(chǎn)品質(zhì)量產(chǎn)品安全性和降低對員工的潛在風(fēng)險(xiǎn)的方法應(yīng)由組織提出，尤其是設(shè)計(jì)和開發(fā)過程及生產(chǎn)過程活動(dòng)。6Resourcemanageme

6Resourcemanagemnet

6資源管理6.4.2Cleanlinessofpremises

Theorganizationshallmaintainitspremisesinastateoforder，cleanlinessandrepairconsistentwiththeproductandmanufacturingprocessneeds.6.4.2廠區(qū)的清潔組織應(yīng)保持廠區(qū)與產(chǎn)品一致的有序、清潔，并按產(chǎn)品和制造過程需求進(jìn)行適當(dāng)?shù)木S護(hù)。

6Resourcemanagemne7ProductRealization

產(chǎn)品實(shí)現(xiàn)7ProductRealization

7productrealization

7產(chǎn)品實(shí)現(xiàn)7.1Planningofproductrealization

Theorganizationshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherpro