《ISO9001质量管理体系》ISO9001标准中英文版

ISO9001：2015Qualitymanagementsystems—Requirements质量管理体系-要求Introduction引言0.1General总则Theadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.ThepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedonthisInternationalStandardare:a)theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;b)facilitatingopportunitiestoenhancecustomersatisfaction;c)addressingrisksandopportunitiesassociatedwithitscontextandobjectives;d)theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.ItisnottheintentofthisInternationalStandardtoimplytheneedfor:—uniformityinthestructureofdifferentqualitymanagementsystems;—alignmentofdocumentationtotheclausestructureofthisInternationalStandard;—theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardareplementarytorequirementsforproductsandservices.ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlan-Do-Check-Act(PDCA)cycleandrisk-basedthinking.Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.ThePDCAcycleenablesanorganizationtoensurethatitsprocessesareadequatelyresourcedandmanaged,andthatopportunitiesforimprovementaredeterminedandactedon.Risk-basedthinkingenablesanorganizationtodeterminethefactorsthatcouldcauseitsprocessesanditsqualitymanagementsystemtodeviatefromtheplannedresults,toputinplacepreventivecontrolstominimizenegativeeffectsandtomakemaximumuseofopportunitiesastheyarise(seeClauseA.4).Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsposesachallengefororganizationsinanincreasinglydynamicandplexenvironment.Toachievethisobjective,theorganizationmightfinditnecessarytoadoptvariousformsofimprovementinadditiontocorrectionandcontinualimprovement,suchasbreakthroughchange,innovationandre-organization.InthisInternationalStandard,thefollowingverbalformsareused:—“shall”indicatesarequirement;—“should”indicatesaremendation;—“may”indicatesapermission;—“can”indicatesapossibilityoracapability.Informationmarkedas“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.采用质量管理体系应该是组织的一项战略性决策，可以帮助组织改进其整体绩效，并为可持续发展 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 提供良好的基础。对于根据本 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 实施质量管理体系的组织来说，潜在的收益是：a)稳定提供满足顾客要求和法律法规要求的产品和服务的能力；b)获取增强顾客满意的机会；c)应对与组织环境和目标相关的风险；d)证实符合质量管理体系特定要求的能力。本标准可用于内部和外部。以下方面不是本标准的目的：-统一不同质量管理体系的结构；-统一本标准条款结构的文件；-在组织中使用本标准的特定术语。本标准所规定的质量管理体系要求是对产品要求的补充。本标准采用过程 方法 快递客服问题件处理详细方法山木方法pdf计算方法pdf华与华方法下载八字理论方法下载 ，该方法结合了策划-实施-检查-改进（PDCA）循环和基于风险的思维。过程方法使组织能够策划组织的过程及其相互作用。PDCA循环使组织能够确保其过程得到充分的资源和管理，并确定和实施改进机会。基于风险的思维能够使组织确定可能导致其过程和质量管理体系偏离所策划的结果的因素，采取预防性控制，以最小化负面影响并在机会出现时将机会利用最大化（见A.4条款）。在日益变化和复杂的环境中，持续满足要求和应对未来的需求和期望是组织面临的挑战。要实现这个目标，组织可能发现除了纠正和持续改进以外，变革、创新和重组也是必要的。本标准中采用了以下动词形式：“shall”表示要求；“should”表示建议；“may”表示允许；“can”表示可能性或能力标注为“注”的信息是理解或说明相关要求的指南。0.2Qualitymanagementprinciples质量管理原则ThisInternationalStandardisbasedonthequalitymanagementprinciplesdescribedinISO9000.Thedescriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantfortheorganization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesoftypicalactionstoimprovetheorganization’sperformancewhenapplyingtheprinciple.Thequalitymanagementprinciplesare:—customerfocus;—leadership;—engagementofpeople;—processapproach;—improvement;—evidence-baseddecisionmaking;—relationshipmanagement.本标准基于ISO9000中阐述的质量管理原则，该阐述包括每项原则的说明、对组织的重要性、与该原则相关的益处的示例，以及应用该原则时改进组织绩效所采取的典型措施的示例。质量管理原则是：-以顾客为关注焦点；-领导力；-全员参与；-过程方法；-改进；-循证决策；-关系管理。0.3Processapproach过程方法0.3.1General总则ThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirements.Specificrequirementsconsideredessentialtotheadoptionofaprocessapproachareincludedin4.4.Understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganization’seffectivenessandefficiencyinachievingitsintendedresults.Thisapproachenablestheorganizationtocontroltheinterrelationshipsandinterdependenciesamongtheprocessesofthesystem,sothattheoverallperformanceoftheorganizationcanbeenhanced.Theprocessapproachinvolvesthesystematicdefinitionandmanagementofprocesses,andtheirinteractions,soastoachievetheintendedresultsinaccordancewiththequalitypolicyandstrategicdirectionoftheorganization.ManagementoftheprocessesandthesystemasawholecanbeachievedusingthePDCAcycle(see0.3.2)withanoverallfocusonrisk-basedthinking(see0.3.3)aimedattakingadvantageofopportunitiesandpreventingundesirableresults.Theapplicationoftheprocessapproachinaqualitymanagementsystemenables:a)understandingandconsistencyinmeetingrequirements;b)theconsiderationofprocessesintermsofaddedvalue;c)theachievementofeffectiveprocessperformance;d)improvementofprocessesbasedonevaluationofdataandinformation.Figure1givesaschematicrepresentationofanyprocessandshowstheinteractionofitselements.Themonitoringandmeasuringcheckpoints,whicharenecessaryforcontrol,arespecifictoeachprocessandwillvarydependingontherelatedrisks本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。采用过程方法须考虑的特定要求包含在4.4中。将相互关联的过程作为体系进行理解和管理，会有助于组织实现其预期结果的有效性和效率。该方法能够是组织控制体系的过程间的相互关系和相互依存，以使组织的整体绩效得到提高。过程方法运用系统的定义和管理过程及其相互作用，以期实现与组织的质量方针和战略方向一致的预期结果。将PDCA循环全面用于旨在利用机会优势和预防不期望的结果的基于风险的思维（见0.3.3），能够实现对过程和整个体系进行管理。在质量管理体系中应用过程方法能够：a)对满足要求的理解和一致性；b)从增值的角度考虑过程；c)实现有效的过程绩效；d)在评价数据和信息的基础上改进过程。图1给出了过程示意图并展示了过程要素的相互作用。将必要控制的监视和测量检查具体到每个过程并将根据相关风险而改变。图1：单一过程要素图0.3.2Plan-Do-Check-Actcycle策划-实施-检查-改进循环ThePDCAcyclecanbeappliedtoallprocessesandtothequalitymanagementsystemasawhole.Figure2illustrateshowClauses4to10canbegroupedinrelationtothePDCAcycle.PDCA循环能够应用于所有过程和整个质量管理体系。图2展示了第4章到第10章分别与PDCA的关联。NOTENumbersinbracketsrefertotheclausesinthisInternationalStandard.图中数字表示本国际标准中的章节。图2：本标准中的PDCA循环模式ThePDCAcyclecanbebrieflydescribedasfollows:—Plan:establishtheobjectivesofthesystemanditsprocesses,andtheresourcesneededtodeliverresultsinaccordancewithcustomers’requirementsandtheorganization’spolicies;andidentifyandaddressrisksandopportunitys;—Do:implementwhatwasplanned;—Check:monitorand(whereapplicable)measureprocessesandtheresultingproductsandservicesagainstpolicies,objectivesandrequirementsandplannedactivities,andreporttheresults;—Act:takeactionstoimproveperformance,asnecessary.PDCA模式可以简要描述如下：Plan–策划：根据顾客要求和组织方针，为提供结果建立体系目标及其过程，以及所需的资源，识别并提出风险及机会；Do–实施：实施所策划的（安排）；Check–检查：根据方针、目标和要求及策划的活动，对过程、产品和服务进行监视和测量（适用时），并报告结果；Act–处置：必要时，采取措施，以改进过程绩效。0.3.3Risk-basedthinking基于风险的思维Risk-basedthinking(seeClauseA.4)isessentialforachievinganeffectivequalitymanagementsystem.Theconceptofrisk-basedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandardincluding,forexample,carryingoutpreventiveactiontoeliminatepotentialnonconformities,analyzinganynonconformitiesthatdooccur,andtakingactiontopreventrecurrencethatisappropriatefortheeffectsofthenonconformity.ToconformtotherequirementsofthisInternationalStandard,anorganizationneedstoplanandimplementactionstoaddressrisksandopportunities.Addressingbothrisksandopportunitiesestablishesabasisforincreasingtheeffectivenessofthequalitymanagementsystem,achievingimprovedresultsandpreventingnegativeeffects.Opportunitiescanariseasaresultofasituationfavorabletoachievinganintendedresult,forexample,asetofcircumstancesthatallowtheorganizationtoattractcustomers,developnewproductsandservices,reducewasteorimproveproductivity.Actionstoaddressopportunitiescanalsoincludeconsiderationofassociatedrisks.Riskistheeffectofuncertaintyandanysuchuncertaintycanhavepositiveornegativeeffects.Apositivedeviationarisingfromariskcanprovideanopportunity,butnotallpositiveeffectsofriskresultinopportunities.为实现有效的质量管理体系，基于风险的思维（见A.4条款）是必要的。基于风险的思维的概念在本标准的以往版本中一直是没有言明的，包括如实施预防措施以消除潜在不合格、 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 发生的不合格并采取与不合格的影响相适应的措施防止其再发生。为符合本标准的要求，组织需要策划和实施应对风险和机会的措施。应对风险和机会是为提高质量管理体系有效性、实现改进的结果并防止负面影响建立基础。机会可以形成有益于实现预期结果的状况的结果，例如，让组织吸引顾客、开发新产品和服务、减少浪费或改进生产效率的一系列情况。应对机会的措施还可以包括对相关风险的考虑。风险是不确定的影响，这种不确定可能是正面或负面的影响。来自风险的正面偏离可以提供机会，但不是风险的所有正面影响都能产生机会。0.4Relationshipwithothermanagementsystemstandards与其他管理体系标准的关系ThisInternationalStandardappliestheframeworkdevelopedbyISOtoimprovealignmentamongitsInternationalStandardsformanagementsystems(seeClauseA.1).ThisInternationalStandardenablesanorganizationtousetheprocessapproach,coupledwiththePDCAcycleandrisk-basedthinking,toalignorintegrateitsqualitymanagementsystemwiththerequirementsofothermanagementsystemstandards.ThisInternationalStandardrelatestoISO9000andISO9004asfollows:—ISO9000Qualitymanagementsystems—FundamentalsandvocabularyprovidesessentialbackgroundfortheproperunderstandingandimplementationofthisInternationalStandard;—ISO9004Managingforthesustainedsuccessofanorganization—AqualitymanagementapproachprovidesguidancefororganizationsthatchoosetoprogressbeyondtherequirementsofthisInternationalStandard.AnnexBprovidesdetailsofotherInternationalStandardsonqualitymanagementandqualitymanagementsystemsthathavebeendevelopedbyISO/TC176.ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseforenvironmentalmanagement,occupationalhealthandsafetymanagement,orfinancialmanagement.Sector-specificqualitymanagementsystemstandardsbasedontherequirementsofthisInternationalStandardhavebeendevelopedforanumberofsectors.Someofthesestandardsspecifyadditionalqualitymanagementsystemrequirements,whileothersarelimitedtoprovidingguidancetotheapplicationofthisInternationalStandardwithintheparticularsector.AmatrixshowingthecorrelationbetweentheclausesofthiseditionofthisInternationalStandardandthepreviousedition(ISO9001:2008)canbefoundontheISO/TC176/SC2openaccesswebsiteat:HYPERLINK"".本标准采用了ISO为改进其管理体系国际标准间的一致性而开发的框架（见A.1条款）。本标准能够是使组织应用过程方法，再加上PDCA循环和基于风险的思维，使其质量管理体系与与其他管理体系标准的要求保持一致或整合。本标准与ISO9000和ISO9004相关联：ISO9000质量管理体系基础和术语为本标准的正确理解和实施提供了必要的背景ISO9004组织持续成功的管理一种质量管理方法为选择超越本标准要求的发展的组织提供了指南附录B提供了ISOTC/176开发的与质量管理和质量管理体系有关的其他标准的信息。本标准不包括针对其他管理体系的特定要求，如环境管理、职业健康安全管理或财务管理。已开发了一部分基于本标准要求的特定行业的质量管理体系标准，这些标准中的某些标准规定了附加的质量管理体系要求，而其他标准限于为本标准在特定行业内的应用提供指南。在ISO/TC176/SC2公开获取网站可以找到本标准和ISO9001:2008标准条款的对照矩阵表。Qualitymanagementsystems—Requirements质量管理体系要求1Scope范围ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhenanorganization:a)needstodemonstrateitsabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements.AlltherequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoanyorganization,regardlessofitstypeorsize,ortheproductsandservicesitprovides.NOTE1InthisInternationalStandard,theterms“product”or“service”onlyapplytoproductsandservicesintendedfor,orrequiredby,acustomer.NOTE2Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.本标准为有下列需求的组织规定了质量管理体系要求：a)需要证实其有能力稳定地提供满足顾客要求和适用的法律法规要求的产品或服务；b)通过体系的有效应用，包括体系改进过程的有效应用，以及保证符合顾客要求和适用的法律法规要求，旨在增强顾客满意。本标准的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品和服务的组织。注1：本标准中，术语“产品”或“服务”仅适用于预期提供给顾客或顾客所要求的产品和服务。注2：法律法规要求可称作法定要求。2Normativereferences 规范 编程规范下载gsp规范下载钢格栅规范下载警徽规范下载建设厅规范下载 性引用文件Thefollowingdocuments,inwholeorinpart,arenormativelyreferencedinthisdocumentandareindispensableforitsapplication.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO9000:2015,Qualitymanagementsystems—Fundamentalsandvocabulary下列文件中的全部和部分内容在本标准中引用并在应用中不可或缺。凡是注日期的引用文件，仅该版本适用于本标准。凡未标注日期的引用文件，引用文件的最新版（包括修订）适用于本标准。ISO9000:2015质量管理体系基础和术语3Termsanddefinitions术语和定义Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000:2015apply.本标准采用ISO9000:2015中的术语和定义。4Contextoftheorganization组织的环境4.1Understandingtheorganizationanditscontext理解组织及其环境Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsqualitymanagementsystem.Theorganizationshallmonitorandreviewinformationabouttheseexternalandinternalissues.NOTE1Issuescanincludepositiveandnegativefactorsorconditionsforconsideration.NOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,petitive,market,cultural,socialandeconomicenvironments,whetherinternational,national,regionalorlocal.NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,knowledgeandperformanceoftheorganization.组织应确定与其宗旨和战略方向有关且影响质量管理体系实现其预期结果的能力的内部和外部环境。组织应监视和评审有关内部和外部环境的信息。注1：环境可能是正面或负面的因素或要考虑的状况；注2：可以通过考虑源于国际、国家、地区或本地的法律法规、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部环境的了解。注3：可以通过考虑与价值、文化、知识和组织绩效相关的情况，促进对内部环境的了解。4.2Understandingtheneedsandexpectationsofinterestedparties理解相关方的需求和期望Duetotheireffectorpotentialeffectontheorganization’sabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,theorganizationshalldetermine:a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem;b)therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanagementsystem.Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartiesandtheirrelevantrequirements.由于对组织持续提供满足顾客和适用的法律法规要求的产品和服务的能力的影响或潜在影响，组织应确定：a)与质量管理体系有关的相关方；b)与质量管理体系有关的相关方的要求。组织应监视和评审有关相关方及其有关要求的信息。4.3Determiningthescopeofthequalitymanagementsystem确定质量管理体系的范围Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope.Whendeterminingthisscope,theorganizationshallconsider:a)theexternalandinternalissuesreferredtoin4.1;b)therequirementsofrelevantinterestedpartiesreferredtoin4.2;c)theproductsandservicesoftheorganization.TheorganizationshallapplyalltherequirementsofthisInternationalStandardiftheyareapplicablewithinthedeterminedscopeofitsqualitymanagementsystem.Thescopeoftheorganization’squalitymanagementsystemshallbeavailableandbemaintainedasdocumentedinformation.Thescopeshallstatethetypesofproductsandservicescovered,andprovidejustificationforanyrequirementofthisInternationalStandardthattheorganizationdeterminesisnotapplicabletothescopeofitsqualitymanagementsystem.ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonotaffecttheorganization’sabilityorresponsibilitytoensuretheconformityofitsproductsandservicesandtheenhancementofcustomersatisfaction.组织应确定质量管理体系的边界和适用性来建立其范围。在确定质量管理体系范围时，组织应考虑：a)在4.1中涉及的外部和内部情况；b)在4.2中涉及的有关相关方要求；c)组织的产品与服务。如本标准的要求在确定的范围内适用，组织应应用本标准的所有要求。组织的质量管理体系范围应可获取并保持形成文件的信息。范围应说明质量管理体系所覆盖的产品和服务，并对组织确定不适用于管理体系范围的本标准的要求说明正当理由。当被确定为不适用的要求不影响组织确保产品和服务的符合性以及增强顾客满意的能力或责任时，才能声称符合本标准的要求。4.4Qualitymanagementsystemanditsprocesses质量管理体系及其过程4.4.1Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization,andshall:a)determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses;b)determinethesequenceandinteractionoftheseprocesses;c)determineandapplythecriteriaandmethods(includingmonitoring,measurementsandrelatedperformanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;d)determinetheresourcesneededfortheseprocessesandensuretheiravailability;e)assigntheresponsibilitiesandauthoritiesfortheseprocesses;f)addresstherisksandopportunitiesasdeterminedinaccordancewiththerequirementsof6.1;g)evaluatetheseprocessesandimplementanychangesneededtoensurethattheseprocessesachievetheirintendedresults;h)improvetheprocessesandthequalitymanagementsystem.4.4.1组织应按本标准的要求建立、实施、保持和持续改进质量管理体系，包括质量管理体系所需的过程及其相互作用。组织应确定质量管理体系所需的过程及其在整个组织中的应用，组织应：a)确定这些过程所需的输入和期望的输出；b)确定这些过程的顺序和相互作用；c)确定和应用所需的准则和方法（包括监视、测量和相关的绩效指标），以确保这些过程的有效运行和控制；d)确定这些过程所需的资源并确保其可用性；e)规定这些过程的职责和权限；f)应对按照6.1的要求确定的风险和机会；g)评价这些过程并实施所需的变更，以确保这些过程实现预期的结果；h)改进过程和质量管理体系。4.4.2Totheextentnecessary,theorganizationshall:a)maintaindocumentedinformationtosupporttheoperationofitsprocesses;b)retaindocumentedinformationtohaveconfidencethattheprocessesarebeingcarriedoutasplanned.4.4.2组织应保持必要程度的：a)保持形成文件的信息，为过程运行提供支持；b)保留形成文件的信息，以证实过程是按策划执行的。5Leadership领导力5.1Leadershipandmitment领导力和承诺5.1.1General总则Topmanagementshalldemonstrateleadershipandmitmentwithrespecttothequalitymanagementsystemby:a)takingaccountabilityfortheeffectivenessofthequalitymanagementsystem;b)ensuringthatthequalitypolicyandqualityobjectivesareestablishedforthequalitymanagementsystemandarepatiblewiththecontextandstrategicdirectionoftheorganization;c)ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheorganization’sbusinessprocesses;d)promotingtheuseoftheprocessapproachandrisk-basedthinking;e)ensuringthattheresourcesneededforthequalitymanagementsystemareavailable;f)municatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementsystemrequirements;g)ensuringthatthequalitymanagementsystemachievesitsintendedresults;h)engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem;i)promotingimprovement;j)supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.NOTEReferenceto“business”inthisInternationalStandardcanbeinterpretedbroadlytomeanthoseactivitiesthatarecoretothepurposesoftheorganization’sexistence,whethertheorganizationispublic,private,forprofitornotforprofit.最高管理者应通过以下方面证实其领导力和对质量管理体系承诺：a)对质量管理体系的有效性承担责任；b)确保质量方针和质量目标得到建立，并与组织的战略方向和组织环境保持一致；c)确保将质量管理体系要求融入组织的业务过程；d)促进过程方法和基于风险的思维的应用；e)确保获得质量管理体系所需的资源；f)传达有效的质量管理以及满足质量管理体系要求的重要性；g)确保质量管理体系实现其预期的结果；h)鼓励、指导和支持员工为质量管理体系的有效性做出贡献；i)增强改进；j)支持其他相关管理者在其负责的区域证实其领导力。注：本标准中的“业务”从广义上解释为对于组织的存在而言具有核心价值的活动，组织可以是公有的、私有的、盈利或非盈利的。5.1.2Customerfocus以顾客为关注焦点Topmanagementshalldemonstrateleadershipandmitmentwithrespecttocustomerfocusbyensuringthat:a)customerandapplicablestatutoryandregulatoryrequirementsaredetermined,understoodandconsistentlymet;b)therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilitytoenhancecustomersatisfactionaredeterminedandaddressed;c)thefocusonenhancingcustomersatisfactionismaintained.最高管理者应通过以下方面，证实其对以顾客为关注焦点的领导力和承诺：a)确定、理解和持续满足顾客要求和适用的法律法规要求；b)确定和应对影响产品和服务符合性以及增强顾客满意能力的风险与机会；c)维护以增强顾客满意为关注焦点。5.2Policy方针5.2.1Establishingthequalitypolicy建立质量方针Topmanagementshallestablish,implementandmaintainaqualitypolicythat:a)isappropriatetothepurposeandcontextoftheorganizationandsupportsitsstrategicdirection;b)providesaframeworkforsettingqualityobjectives;c)includesamitmenttosatisfyapplicablerequirements;d)includesamitmenttocontinualimprovementofthequalitymanagementsystem.最高管理者应建立、实施和保持质量方针，方针应：a)与组织的宗旨和环境相适应，并支持其战略方向；b)提供制定质量目标的框架c)包括对满足适用要求的承诺；d)包括对持续改进质量管理体系的承诺。5.2.2municatingthequalitypolicy沟通质量方针Thequalitypolicyshall:a)beavailableandbemaintainedasdocumentedinformation;b)bemunicated,understoodandappliedwithintheorganization;c)beavailabletorelevantinterestedparties,asappropriate.质量方针应：a)为可获得的保持为形成文件的信息；b)在组织内得到沟通、理解和应用c)适当时，可为相关方所获取。5.3Organizationalroles,responsibilitiesandauthorities组织的角色、职责和权限Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesareassigned,municatedandunderstoodwithintheorganization.Topmanagementshallassigntheresponsibilityandauthorityfor:a)ensuringthatthequalitymanagementsystemconformstotherequirementsofthisInternationalStandard;b)ensuringthattheprocessesaredeliveringtheirintendedoutputs;c)reportingontheperformanceofthequalitymanagementsystemandonopportunitiesforimprovement(see10.1),inparticulartotopmanagement;d)ensuringthepromotionofcustomerfocusthroughouttheorganization;e)ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.最高管理者应确保相关角色的职责和权限在整个组织得到分派、沟通和理解。最高管理者应规定职责和权限以：a)确保质量管理体系符合本标准的要求；b)确保过程实现其预期的输出；c)向最高管理者报告质量管理体系绩效和改进机会；d)确保在整个组织提高以顾客为关注焦点的意识；e)对质量管理体系的变更进行策划和实施时，维护质量管理体系的完整性。6Planning策划6.1Actionstoaddressrisksandopportunities应对风险和机会的措施6.1.1Whenplanningfort