PAGEPAGE24目錄Scope范圍NormativereferencesanddefinitionsContextoftheorganizationUnderstandingtheorganizationanditsUnderstandingtheneedsandexpectationsofpartiesDeterminingthescopeofthequalitymanagementsystemQualitymanagementLeadership領(lǐng)導(dǎo)作用LeadershipandcommitmentQualitypolicyOrganizationalrolesresponsibilitiesandauthoritiesPlanning策劃ActionstoaddressrisksandopportunitiesQualityobjectivesandplanningachievethemPlanningofchangesSupport支持Resources資源Competence能力Awareness意識Communication溝通DocumentedinformationOperation運(yùn)行OperationalplanningandcontrolDeterminationofneedsandinteractionswithcustomersOperationalplanningprocessControlofexternalprovisionofgoodsandservicesDevelopmentofgoodsandservicesProductionofgoodsandprovisionofservicesReleaseofgoodsandservicesNonconforminggoodsandservicesPerformanceevaluationMonitoringmeasurementanalysisandevaluationInternalAuditManagementreview管理評審Continualimprovement持續(xù)改進(jìn)NonconformityandcorrectiveactionImprovementAAnnexAQualitymanagementprinciples(Informative)質(zhì)量管理原則文獻(xiàn)Scope范圍ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求：a）needstodemonstrateitsabilitytoconsistentlyprovidegoodsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,and需要證實其具有穩(wěn)定地提供滿足顧客要求和適用法律法規(guī)要求的產(chǎn)品和服務(wù)的能力；b）aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationoftheincludingcontinualofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirementsthisInternationalStandard,thetermproductonlyappliesto“產(chǎn)品”僅適用于：goodsandservicesintendedoraand所要求的商品和服務(wù)；anyintendedoutputresultingtheoperational注2：Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements法律法規(guī)要求可稱作為法定要求。Normativereferences規(guī)范性引用文件Thefollowingdocumentsindispensabletheapplicationofthisdocument.datedonlytheeditioncitedapplies.undatedtheeditionofthedocument(includinganyamendments（）ISO9000:2015,QualitymanagementFundamentalsandvocabularyGB/T19000-2015anddefinitions術(shù)語和定義Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply本標(biāo)準(zhǔn)采用GB/T19000中所確立的術(shù)語和定義。Contextoftheorganization組織的背景環(huán)境theorganizationanditscontext理解組織及其背景環(huán)境Theorganizationshalldetermineexternalandinternalissuesthatarerelevantitspurposeanditsstrategicdirectionandthataffectitsabilityachievetheintendedoutcome(s)ofitsqualitymanagementTheorganizationshallupdatesuchdeterminationswhenneeded需要時，組織應(yīng)更新這些信息。Whendeterminingexternalandinternaltheorganizationshallconsiderthosearisingchanges andtrendswhichcanhaveanimpactontheobjectivesoftheorganizationrelationshipswithandperceptionsandvaluesofrelevantpartiesgovernanceissuesstrategicprioritiesinternalpoliciesandcommitmentsandresourceavailabilityandprioritiesandtechnologicalchange更。注1：Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,competitive,cultural,social,economicandnaturalenvironment,whetherinternational,national,regionalorlocal.外部的環(huán)境，可以考慮法律、技術(shù)、競爭、文化、社會、經(jīng)濟(jì)和自然環(huán)境方面，不管是國際、國家、地區(qū)或本地。注2：Whenunderstandingtheinternalcontexttheorganizationcouldconsiderthosetoperceptionsvaluesandcultureoftheorganization.Understandingtheneedsandexpectationsofparties理解相關(guān)方的需求和期望Theorganizationshalldetermine組織應(yīng)確定：theinterestedpartiesthatarerelevanttothequalitymanagementandtherequirementsofthesepartiesTheorganizationshallupdatesuchdeterminationsinordertounderstandandanticipateneedsorexpectationsaffectingcustomerrequirementsandcustomersatisfaction組織應(yīng)更新以上確定的結(jié)果，以便于理解和滿足影響顧客要求和顧客滿意度的需求和期望。Theorganizationshallconsiderthefollowingrelevantinterestedparties組織應(yīng)考慮以下相關(guān)方：directcustomersendusers最終使用者suppliers,distributors,retailersorinthesupplychain商、零售商及其他regulators;andanyotherparties其他注：NoteAddressingcurrentandanticipatedfutureneedscanleadtotheidentificationofimprovementandinnovationopportunities應(yīng)對當(dāng)前的和預(yù)期的未來需求可導(dǎo)致改進(jìn)和變革機(jī)會的識別。Determiningthescopeofthequalitymanagement確定質(zhì)量管理體系的范圍Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope組織應(yīng)界定質(zhì)量管理體系的邊界和應(yīng)用，以確定其范圍。Whendeterminingthisscope,theorganizationshallconsider在確定質(zhì)量管理體系范圍時，組織應(yīng)考慮：theexternalandinternalissuesreferredto4.1,and4.1therequirementsreferredin4.24.2Thescopeshallbestatedintermsofgoodsandservices,themainprocessestodeliverthemandthesitesoftheorganizationincluded質(zhì)量管理體系的范圍應(yīng)描述為組織所包含的產(chǎn)品、服務(wù)、主要過程和地點。Whenstatingthescope,theorganizationshalldocumentandjustifydecisionnottoapplyarequirementofthisInternationalStandardandtoitthescopeofthequalitymanagementsuchshalltoclause7.1.4and8andshallaffecttheabilityorresponsibilitytoassureconformityofgoodsandservicesandcustomersatisfaction,norcananexclusionbejustifiedonthebasisofadecisiontoarrangeanexternalprovidertoperformafunctionorprocessoftheorganization.7.148注：Anprovidercanbeasupplierorasistersuchasaoralternatesitelocation)thatisoutsidethequalityThescopeshallbeavailableasdocumentedinformation質(zhì)量管理管理體系范圍應(yīng)形成文件。Qualitymanagement質(zhì)量管理體系General總則Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisInternationalStandard.組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系、過程及其相互作用，加以實施和保持，并持續(xù)改進(jìn)。Processapproach過程方法Theorganizationshallapplyaprocessapproachtoitsqualitymanagementsystem.Theorganizationshall:組織應(yīng)將過程方法應(yīng)用于質(zhì)量管理體系。組織應(yīng)：determinetheneededthequalitymanagementandtheirapplicationthroughoutthe;determinetheinputsandtheoutputsexpectedeachprocess;需的輸入和期望的輸出；determinethesequenceandinteractionoftheseprocesses;determinetheriskstoconformityofgoodsandservicesandcustomersatisfactionifunintendedoutputsdeliveredorprocessinteractionisineffective;determinecriteria,methods,measurements,andrelatedperformanceindicatorsneededtoensurethatboththeoperationandcontroloftheseeffectivedeterminetheandensuretheiravailabilityassignresponsibilitiesandauthoritiesimplementactionsnecessarytoachieveplannedanalyseandchange,ifneeded,theseensuringthattheycontinuetodelivertheintendedoutputs;andensurecontinualimprovementoftheseLeadership領(lǐng)導(dǎo)作用Leadershipandcommitment領(lǐng)導(dǎo)作用與承諾Leadershipandcommitmentwithrespecttothequalitymanagement針對質(zhì)量管理體系的領(lǐng)導(dǎo)作用與承諾managementshalldemonstrateleadershipandcommitmentwithrespectthequalitymanagementbyensuringthatqualitypoliciesandqualityobjectivesareforthequalitymanagementandarecompatiblewiththestrategicdirectionoftheorganization;ensuringthequalitypolicyisunderstoodandwithintheorganization;在組織內(nèi)得到理解和實施；ensuringtheintegrationofthequalitymanagementrequirementstheorganization’sbusinessprocesses;promotingawarenessoftheprocessapproach;ensuringthattheresourcesneededforthequalitymanagementareavailable;communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementrequirementsandtherequirementsofgoodsandservices;傳達(dá)有效ensuringthatthequalitymanagementachievesitsintendedoutcomesoutputs;engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem吸納、指導(dǎo)和支持員工參與對質(zhì)量管理體系的有效性作出貢獻(xiàn)；promotingcontinualimprovementand innovation;andsupportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.Leadershipandcommitmentwithrespecttotheneedsandexpectationsofcustomers針對顧客需求和期望的領(lǐng)導(dǎo)作用與承諾managementshalldemonstrateleadershipandcommitmentwithrespecttocustomerfocusbyensuringthattheriskswhichcanconformityofgoodsandservicesandcustomersatisfactionidentifiedandcustomerrequirementsdeterminedandmet;thefocusonconsistentlyprovidinggoodsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirementsismaintained;thefocusonenhancingcustomersatisfactionis注：Referenceto“business”inthisInternationalshouldbebroadlytothoseactivitiesthatarecoretothepurposesofthe“業(yè)務(wù)”Qualitypolicy質(zhì)量方針Topmanagementshallestablishaqualitypolicythat:最高管理者應(yīng)制定質(zhì)量方針，方針應(yīng)：isappropriatethepurposeoftheorganization;providesaframeworkforsettingqualityobjectives;includesacommitmenttosatisfyapplicablerequirementsandincludesacommitmenttocontinualimprovementofthequalitymanagementsystem.Thequalitypolicyshall:質(zhì)量方針應(yīng)：beavailableasdocumentedinformation;becommunicatedwithintheorganization;beavailableparties,asappropriate;andbereviewedcontinuingsuitability.QulityngeetPncilscnesdstebisorteqltypoic.Organizationalroles,responsibilitiesandauthorities組織的作用、職責(zé)和權(quán)限Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesareassignedandcommunicatedwithintheorganization.最高管理者應(yīng)確保組織內(nèi)相關(guān)的職責(zé)、權(quán)限得到規(guī)定和溝通。Topmanagementshallbeaccountablefortheeffectivenessofthequalitymanagementsystemandshallassigntheresponsibilityandauthorityfor:最高管理者應(yīng)對質(zhì)量管理體系的有效性負(fù)責(zé)，并規(guī)定職責(zé)和權(quán)限以便：ensuringthatthequalitymanagementconformstherequirementsofthisInternationalStandardand,ensuringthattheinteractanddeliveringtheirintendedoutputs;作用并產(chǎn)生期望的結(jié)果；reportingontheperformanceofthequalitymanagementtomanagementandanyneedimprovement,andensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.確保在整個組織內(nèi)提高滿足顧客要求的意識。Planning策劃ActionstoaddressrisksandopportunitiesWhenplanningforthequalitymanagementsystem,theorganizationshallconsidertheissuesreferredtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksandopportunitiesthatneedtobeaddressedto策劃質(zhì)量管理體系時，組織應(yīng)考慮4.1和4.2的要求，確定需應(yīng)對的風(fēng)險和機(jī)遇，以便：assurethequalitymanagementcanachieveitsintendedoutcome(s);assurethattheorganizationcanconsistentlyachieveconformityofgoodsandservicesandcustomersatisfaction;preventorreduce,undesiredeffects,andachievecontinualimprovement.Theorganizationshallplan:組織應(yīng)策劃：actionstoaddresstheserisksandopportunitiesandhowto如何integrateandimplementtheactionsitsqualitymanagementprocesses(see4.4),and4.4）evaluatetheeffectivenessoftheseactions.actionstorisksandopportunitiesshallbeproportionatetothepotentialeffectsonconformityofgoodsandservicesandcustomersatisfaction.ptinsodssiscnncldeorpleiskodne,isktitinorskcetce可選的Qualityobjectivesandplanningtoachievethem質(zhì)量目標(biāo)及其實施的策劃Theorganizationshallestablishqualityobjectivesatrelevantfunctions,levelsandprocesses.Thequalityobjectivesshall:組織應(yīng)在相關(guān)職能、層次、過程上建立質(zhì)量目標(biāo)。質(zhì)量目標(biāo)應(yīng)：beconsistentwiththequalitypolicy;berelevanttoconformityofgoodsandservicesandcustomersatisfaction;符合性和顧客滿意相關(guān)bemeasurable(ifpracticable);可測量可行時）takeaccountapplicablerequirements,bemonitored,becommunicatedandbeupdatedasappropriate.Theorganizationshallretaindocumentedinformationonthequalityobjectives.組織應(yīng)將質(zhì)量目標(biāo)形成文件。Whenplanninghowtoachieveitsqualityobjectives,theorganizationshalldetermine:在策劃目標(biāo)的實現(xiàn)時，組織應(yīng)確定：whatwillbedone;hatousilbequde見whowillberesponsible;責(zé)任人；whenitwillbecompleted,andhowtheresultswillbePlanningofchanges變更的策劃TheorganizationshalldeterminetheneedsandopportunitieschangetomaintainandimprovetheperformanceofthequalitymanagementTheorganizationshallundertakechangeinaplannedandsystematicidentifyingrisksandopportunitiesandreviewingthepotentialconsequencesofchange.peiiceuietsoncntolofchgseincuddincluse.8條規(guī)定。Support支持Resources資源General總則Theorganizationshalldetermineandprovidetheresourcesneededfortheestablishment,implementation,maintenanceandcontinualimprovementofthequalitymanagementsystem.組織應(yīng)確定、提供為建立、實施、保持和改進(jìn)質(zhì)量管理體系所需的資源。Theorganizationshallconsider組織應(yīng)考慮：whatexistinginternalcapabilitiesandlimitationsand限whichgoodsandservicestobesourcedInfrastructure基礎(chǔ)設(shè)施Theorganizationshalldetermine,provideandmaintaintheinfrastructurenecessaryforitsoperationsandtoassureconformityofgoodsandservicesandcustomersatisfaction.組織應(yīng)確定、提供和維護(hù)其運(yùn)行和確保產(chǎn)品、服務(wù)符合性和顧客滿意所需的基礎(chǔ)設(shè)施。注：Note Infrastructurecaninclude:基設(shè)施可括：buildingsandassociatedutilities;equipmentincludingandsoftware,and（）transportationcommunicationandinformationProcessenvironment過程環(huán)境Theorganizationshalldetermine,provideandmaintaintheprocessenvironmentnecessaryforitsoperationsandtoassureconformityofgoodsandservicesandcustomersatisfaction.組織應(yīng)確定、提供和維護(hù)其運(yùn)行和確保產(chǎn)品、服務(wù)符合性和顧客滿意所需的過程環(huán)境。注：Processcanincludephysical,social,psychologicalandsuchtemperature,recognitionschemesergonomicsandatmosphericcomposition).MonitoringandmeasuringdevicesTheorganizationshalldetermine,provideandmaintainthemonitoringandmeasuringdevicesneededtoverifyconformitytoproductrequirementsandshallensurethatthedevicesfitpurpose.Theorganizationshallappropriatedocumentedinformationasevidenceoffitnesspurposeofmonitoringandmeasuringdevices.注andmeasurementcanincludeequipmentandmethodssuchassurveys.（注2：Monitoringandcanbeverified,orboth,specifiedintervals,priortouse,measurementstandardstraceabletointernationalornationalstandards.對（或檢定。Knowledge知識Theorganizationshalldeterminetheknowledgenecessaryfortheoperationofthequalitymanagementsystemanditsprocessesandtoassureconformityofgoodsandservicesandcustomersatisfaction.Thisknowledgeshallbemaintained,protectedandmadeavailableasnecessary.組織應(yīng)確定質(zhì)量管理體系運(yùn)行、過程、確保產(chǎn)品和服務(wù)符合性及顧客滿意所需的知識。這些知識應(yīng)得到保持、保護(hù)、需要時便于獲取。Whereaddressingchangingneedsandtrendstheorganizationshallintoaccountitscurrentknowledgebaseanddeterminehowtooraccessthenecessaryadditionalknowledge.(Seealso6.3)6.3）Competence能力Theorganizationshall:組織應(yīng)：determinethenecessarycompetenceofperson(s)doingworkunderitscontrolthataffectsitsqualityperformance,andensurethatthesepersonsarecompetentonthebasisofappropriateeducation,training,orexperience;whereapplicable,actionsacquirethenecessarycompetence,andevaluatetheeffectivenessoftheactionsandretainappropriatedocumentedinformationasevidenceofcompetence注：Applicableactionsmayinclude,forexample:theprovisionoftrainingto,thementoringof,orthere-assignmentofcurrentlyemployedpersons;orthehiringorcontractingofcompetentpersons.適當(dāng)?shù)拇胧┛砂ǎ缣峁┡嘤?xùn)、輔導(dǎo)、重新分配任務(wù)、招聘勝任的人員等。Awareness意識Personsdoingworkundertheorganization’scontrolshallbeawareof在組織控制下工作的人員應(yīng)意識到：thequalitypolicy;relevantqualityobjectivestheircontributiontheeffectivenessofthequalitymanagementincludingthebenefitsofimprovedqualityperformance,andtheimplicationsofnotconformingwiththequalitymanagementrequirements.偏離質(zhì)量管理體系要求的后果Communication溝通Theorganizationshalldeterminetheforinternalandexternalcommunicationsrelevanttothequalitymanagementincluding:onwhatitwillcommunicate;whentocommunicate,andwithwhomcommunicate.Documentedinformation形成文件的信息General總則Theorganization’squalitymanagementsystemshallinclude組織的質(zhì)量管理體系應(yīng)包括：documentedinformationrequiredbythisInternationalStandard;documentedinformationdeterminedbytheorganizationasbeingnecessaryfortheeffectivenessofthequalitymanagementsystem;注：Theofdocumentedinformationforaqualitymanagementdifferfromoneorganizationtoanotherduetothesizeoforganizationanditstypeofactivitiesprocessesproductsgoodsandservices;thecomplexityofprocessesandtheirinteractionsandthecompetenceofpersonsCreatingandupdating編制和更新Whencreatingandupdatingdocumentedinformationtheorganizationshallensureappropriate在編制和更新文件時，組織應(yīng)確保適當(dāng)?shù)模篴）identificationanddescription(e.g.atitle,date,author,orreferencenumber);標(biāo)識和說明（例如：標(biāo)題、日期、作者、索引編號等）format(e.g.language,softwareversion,graphics)andmedia(e.g.,electronic);（例如：語言、軟件版本、圖示）和媒介（例如：紙質(zhì)、電子格式）reviewandapprovalforsuitabilityandadequacy.ControlofdocumentedInformation文件控制DocumentedinformationrequiredbythequalitymanagementsystemandbythisInternationalStandardshallbecontrolledtoensure:質(zhì)量管理體系和本標(biāo)準(zhǔn)所要求的形成文件的信息應(yīng)進(jìn)行控制，以確保：itisavailableandsuitableforuse,whereandwhenitisneeded,itisadequatelyprotected(e.g.fromlossofimproperuse,orlossofintegrity).文件得到充分保護(hù)，如防止泄密、誤用、缺損。Forthecontrolofdocumentedinformation,theorganizationshalladdressthefollowingactivities,asapplicable適用時，組織應(yīng)以下文件控制活動：distributionaccess,retrievalanduse,storageandpreservationincludingpreservationoflegibility;controlofchangese.gversioncontrol),and（retentionanddisposition.Documentedinformationofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemshallbeidentifiedasappropriate,andcontrolled組織所確定的策劃和運(yùn)行質(zhì)量管理體系所需的外來文件應(yīng)確保得到識別和控制。注：Accessimpliesadecisionregardingthepermissiontoviewthedocumentedinformationonly,orthepermissionandauthoritytoviewandchangethedocumentedinformation,etc.“訪問”指僅得到查閱文件的許可，或授權(quán)查閱和修改文件。Operation運(yùn)行Operationalplanningandcontrol運(yùn)行策劃和控制Theorganizationshallplan,implementandcontroltheprocessesneededtomeetrequirementsandtoimplementtheactionsdeterminedin6.1,by組織應(yīng)策劃、實施和控制滿足要求和標(biāo)準(zhǔn)6.1條確定的措施所需的過程，包括：establishingcriteriafortheprocessesimplementingcontroloftheprocessesaccordancewiththecriteria,and程控制；keepingdocumentedinformationthenecessarytohaveconfidencethattheprocesseshavebeencarriedoutasplanned.Theorganizationshallcontrolplannedchangesandreviewtheconsequencesofunintendedchangestakingactiontomitigateadverseeffectsasnecessary.Theorganizationshallensurethatoutsourcedprocessesaretheoperationofafunctionorprocessoftheorganizationbyexternalprovideriscontrolled(see8.4).（見注：Operationofafunctionorprocessoftheorganizationbyanexternalproviderisoftenreferredtoasoutsourcing..組織的某項職能或過程由外部供方實施通常稱作為外包。Determinationofneedsandinteractionswithcustomers市場需求的確定和顧客溝通General總則Theorganizationshallimplementaprocessinteractingwithtodeterminetheirrequirementsrelatingtogoodsandservices.注1：A“customer”meansanexistingorpotentialcustomer“顧客”指當(dāng)前的或潛在的顧客；注2：Thecaninteractwithotherpartiestodetermineadditionalforgoodsandservices(see4.2).組織可與其他相關(guān)方溝通以確定對產(chǎn)品和服務(wù)的附加要求（見Determinationofrequirementsthegoodsandservices與產(chǎn)品和服務(wù)有關(guān)要求的確定Theorganizationshalldetermineasapplicable適用時，組織應(yīng)確定：a)requirementsspecifiedbythecustomerincludingtherequirementsdeliveryandpost-deliveryactivities;thecustomerbutnecessaryspecifiedorintendeduse,known,c）statutoryandregulatoryrequirementsapplicabletothegoodsandservices,and適用于產(chǎn)品和服務(wù)的法律法規(guī)要求；d）anyadditionalrequirementsconsiderednecessarybytheorganization組織認(rèn)為必要的任何附加要求。注：Additionalrequirementscanincludethosearisingfromrelevantinterestedparties附加要求可包含由有關(guān)的相關(guān)方提出的要求。ReviewofrequirementstothegoodsandservicesTheorganizationshallreviewtherequirementstothegoodsandservices.Thisreviewshallbeconductedpriortotheorganization'scommitmenttosupplygoodsandservicestothecustomer(e.g.submissionoftenders,acceptanceofcontractsoracceptanceofchangestocontractsorandshallensurethat（a）goodsandservicesrequirementsaredefinedandagreed,產(chǎn)品和服務(wù)要求已得到規(guī)定并達(dá)成一致；b）contractororderrequirementsdifferingthosepreviouslyareand與c）theorganizationisabletomeetthedefinedrequirements組織有能力滿足規(guī)定的要求。Documentedinformationdescribingtheresultsofthereviewshallbemaintained.評審結(jié)果的信息應(yīng)形成文件。Wherethecustomerdoesnotprovidedocumentedstatementoftheirrequirements,thecustomerrequirementsshallbeconfirmedbytheorganizationbeforeacceptance.若顧客沒有提供形成文件的要求，組織在接受顧客要求前應(yīng)對顧客要求進(jìn)行確認(rèn)。Whererequirementsgoodsandserviceschanged,theorganizationshallensurethatrelevantdocumentedinformationisamendedandthatrelevantpersonnelmadeawareofthechangedrequirements注：InsomesituationsaisimpracticalforeachInsteadthereviewcancoverotherinformationavailabletotheCustomercommunication顧客溝通Theorganizationshalldetermineandimplementplannedarrangementsforcommunicatingwithcustomersinrelationto:組織應(yīng)對以下有關(guān)方面確定并實施與顧客溝通的安排：a)goodsandservicesinformation;產(chǎn)品和服務(wù)信息；contractsororderhandlingincludingamendments;c）customerfeedback,includingcustomercomplaints(see9.1);顧客反饋，包括顧客抱怨（見9.1）;d）thehandlingofcustomerproperty,ifapplicable,and適用時，對顧客財產(chǎn)的處理；e)thespecificrequirementsforcontingencyactions,whererelevant.相關(guān)時，應(yīng)急措施的特定要求。Operationalplanningprocess運(yùn)行策劃過程Inpreparingfortherealizationofgoodsandservices,theorganizationshallimplementaprocesstodeterminethefollowing,asappropriate為產(chǎn)品和服務(wù)實現(xiàn)作準(zhǔn)備，組織應(yīng)實施過程以確定以下內(nèi)容，適用時包括：a）requirementsforthegoodsandservicestakingintoconsiderationrelevantqualityobjectives;產(chǎn)品和服務(wù)的要求，并考慮相關(guān)的質(zhì)量目標(biāo)；b）actionstoidentifyandaddressrisksrelatedtoachievingconformityofgoodsandservicestorequirements;識別和應(yīng)對與實現(xiàn)產(chǎn)品和服務(wù)滿足要求所涉及的風(fēng)險相關(guān)的措施；thatwillbearisingtherequirementsthegoodsandservices針d）thecriteriafortheacceptanceofgoodsandservices產(chǎn)品和服務(wù)的接收準(zhǔn)則e）requiredverification,validation,monitoring,measurement,inspectionandtestactivitiesspecifictothegoodsandservices產(chǎn)品和服務(wù)所要求的驗證、確認(rèn)、監(jiān)視、檢驗和試驗活動；f）howtheperformancedatawillbeestablishedandcommunicated;and績效數(shù)據(jù)的形成和溝通；g）requirementsfortraceability,preservation,goodsandservicesdeliveryandpostdeliveryactivities可追溯性、產(chǎn)品防護(hù)、產(chǎn)品和服務(wù)交付及交付后活動的要求。Theoutputofthisplanningprocessshallbeinaformsuitablefortheorganization'soperations.策劃的輸出形式應(yīng)便于組織的運(yùn)作。注1：Documentedinformationspecifyingthethequalityincludingrealizationgoodsandservicesandthetoappliedtoaspecificgoodandservice,orcontractcanbetoasaqualityplan.）注2：Theorganizationcanalsoapplytherequirementsgivenin8.5tothedevelopmentofprocessesfortherealizationofgoodsandservices.組織也可將8.5的要求應(yīng)用于產(chǎn)品和服務(wù)實現(xiàn)過程的開發(fā)。Controlofexternalprovisionofgoodsandservices供應(yīng)的產(chǎn)品和服務(wù)的控制General總則Theorganizationshallensurethatexternallyprovidedgoodsandservicesconformtospecifiedrequirements組織應(yīng)確保外部提供的產(chǎn)品和服務(wù)滿足規(guī)定的要求。注：Wheretheorganizationhasarrangedforanexternalprovidertoperformafunctionorprocessoftheorganizationitisassumedthiswillresultintheprovisionofgoods,servicesorbothgoodsandservices.當(dāng)組織安排由外部供方實施其職能和過程時，這就意味由外部提供產(chǎn)品和（或）服務(wù)。Typeandofcontrolofexternalprovision外部供應(yīng)的控制類型和程度Thetypeandofcontrolappliedtotheexternalprovidersandthegoodsandservicesshallbedependentupontherisksidentifiedandthepotentialimpacts,thedegreetowhichthecontrolofanexternallyprovidedprocessissharedbetweentheorganizationandtheandthecapabilityofpotential controlsTheorganizationshallestablishandapplycriteriatheevaluation,selection,andevaluationofexternalprovidersbasedontheirabilitytoprovide,goodsandservicesinaccordancewiththeorganization'srequirements.Documentedinformationdescribingtheresultsofevaluationsshallbemaintained.評價結(jié)果的信Documentedinformationexternalproviders提供外部供方的文件信息Documentedinformationshallbeprovidedtotheexternalproviderdescribing,whereappropriate:適用時，提供給外部供方的形成文件信息應(yīng)闡述：thegoodsandservicestobeprovidedortheprocesstobeperformed,及實施的過程；therequirementsapprovalorreleaseofgoodsandservices,orequipment,therequirementscompetenceofpersonnel,includingnecessaryqualification,要求，包含必要的資格；thequalitymanagementsystemrequirements,thecontrolandmonitoringoftheexternalprovider’sperformancetobeappliedbytheorganization;anyverificationactivitiesthattheorganization,oritsintendstoperformattheexternalprovider’spremises,andtherequirementshandlingofexternalprovider’spropertyprovidedtotheorganization將產(chǎn)品從外部供方到組織現(xiàn)場的搬運(yùn)要求；Theorganizationshallensuretheadequacyofspecifiedrequirementspriortotheircommunicationtotheexternalprovider在與外部供方溝通前，組織應(yīng)確保所規(guī)定的要求是充分與適宜的。Theorganizationshallmonitortheperformanceofexternalproviders.Documentedinformationdescribingontheresultsofmonitoringshallbemaintained.組織應(yīng)對外部供方的業(yè)績進(jìn)行監(jiān)視。應(yīng)將監(jiān)視結(jié)果的信息形成文件。DevelopmentofgoodsandservicesDevelopmentprocesses開發(fā)過程Theorganizationshallplanandimplementthedevelopmentofgoodsandservicesconsistentwiththeprocessapproach.thedevelopmenttheorganizationshallaccountof:thenature,durationandcomplexityofthedevelopmentactivitiesstatutoryandregulatoryrequirementsspecifyingparticularprocessorcontrols,requirementsspecifiedbytheorganizationasessentialthespecifictypeofgoodsandservicesbeingdevelopedstandardsorcodesofpracticethattheorganizationhascommittedtoimplement,thedeterminedrisksandopportunitiesassociatedwiththedevelopmentactivitieswithrespecttotheofthegoodsandservicestobeandpotentialconsequencesof開發(fā)的產(chǎn)品和服務(wù)的特性，以及失敗的潛在后果thelevelofcontrolexpectedofthedevelopmentprocessbycustomersandotherparties,and3）thepotentialimpactontheorganization’sabilitytoconsistentlymeetcustomerrequirementsandenhancecustomersatisfaction.對組織穩(wěn)定的滿足顧客要求和增強(qiáng)顧客滿意的能力的潛在影響internalandexternalneedsforthedevelopmentofgoodsandservicestheneedclaritywithrespecttotheresponsibilitiesandauthoritiesoftheindividualsandpartiesinvolvedinthedevelopmentprocesstheneedthemanagementoftheinterfacesbetweenindividualsandpartiesinvolvedinthedevelopmentortheneedinvolvementofcustomergroupsandusergroupsinthedevelopmentprocessandtheirinterfacewithmanagementofthedevelopmentprocess,thenecessarydocumentedinformationontheapplicationofdevelopmenttheoutputsandtheirsuitability,andtheactivitiesneededtotransferdevelopmenttoproductionorserviceprovision將開發(fā)轉(zhuǎn)化為產(chǎn)品和服務(wù)提供所需的活動Developmentcontrols開發(fā)控制Thecontrolsappliedtothedevelopmentprocessshallensurethat對開發(fā)過程的控制應(yīng)確保：thetobebythedevelopmentactivitiesisclearlyinputsdefinedtoalevelsufficientthedevelopmentactivitiesbeinganddonotgiverisetoconflictorlackof不清楚；outputsinasuitablesubsequentuseproductionofgoodsandprovisionofservicesandmonitoringandmeasurement,problemsandissuesarisingduringthedevelopmentprocessorotherwisemanagedcommittingtofurtherdevelopmentorsettingprioritiesthatwork,在進(jìn)theplanneddevelopmenthavebeentheoutputsconsistentwiththeinputsandtheobjectiveofthedevelopmentactivityhasbeenmet,goodsproducedorservicesprovidedasaconsequenceofthedevelopmentundertakenfitpurpose,andappropriatechangecontrolandconf