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质量管理体系一Quality ManagementSystems-Requirements forAviation,航空，航天和防务组织的要求Space,and Defenseorganization范围
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1.Scope本标准包括IS090012015质量管理体系要求,This standardincludes ISO9001:2015quality management system并规定了额外的航空,航天和防务的行业要求,定requirements andspecifies additionalaviation,space anddefense义和注释industry requirements,definitions andnotes.要强调的是本标准所规定的质量管理体系要求是It isemphasized that the requirementsspecified inthis standardare对顾客和适用法律法规要求的补充（不是取代）complementary notalternative to customer and applicable statutoryand regulatory requirements.If thereis aconflict between the requirements of thisstandard and如果本标准要求和适用法律法规之间有任何冲applicable statutoryor regulatory requirements,the lattershall take突,以后者优先.precedence.This International Standard specifiesrequirements for a quality本国际标准为有下列需求的组织规定了质量management systemwhen anorganization:管理体系要求a needs to demonstrateits ability to consistentlyprovide products and）需要证实其有能力稳定地提供满足顾客和适aservices that meet customer and applicable statutory and regulatory用的法律法规要求的产品；requirements,and）通过对体系的有效应用，包括体系持续改进b aimsto enhance customer satisfactionthrough the effective b的过程，以及保证符合顾客与适用的法律法application of the system,including processes for improvement of the规要求，旨在增强顾客满意system and the assuranceof conformity to customer and applicablestatutory and regulatory requirements.本国际标准的所有要求是通用的，旨在适用于All the requirements of this International Standard aregeneric and are各种类型的、不同规模或者提供的不同产品和intended to be applicable to anyorganization,regardless of its typeor服务的组织size,or the products and services itprovides.NOTE1In this International Standard,the terms“product or“service”only注1在本国际标准中，术语“产品”或“服务”仅适apply to products and services intendedfor,or required by,a customer.用于预期提供给顾客或顾客所要求的产品的服务NOTE2Statutory and regulatory requirements can beexpressed aslegal注2法律法规要求可称作法定要求requirements.下列文件中的全部或部分内容在本标准中并在引用中不可或缺凡是注日期的引用文件，仅规范性引用文件
22.Normative references该版本适用本标准凡未标注日期的引用文件，The followingdocuments,in wholeor inpart,are normatively其最新版本适用于本标准（包括任何修改）referenced inthis documentandareindispensable for its application.For datedreferences,only theedition citedapplies.For undatedreferences,the latestedition of the referenceddocument including any质量管理体系-基础与术语amendments applies.ISO9000:2015,ISO9001:2015质量管理体系-要求ISO9000:2015,Quality management systems—Fundamentals and
3.Terms and definitions术语与定义
3.vocabularyISO9001:2015Quality management system-RequirementFor the purposes of this document,the termsanddefinitionsgiven in本国际标准采用中的术语与定义1509000:2015ISO9000:2015apply.
3.1counterfeit parts
3.1假冒零件c physicale.g.temperature,heat,humidity,light,airflow,hygiene,c）物理因素（如温度、热量、湿度、照明、空noise.气流通、卫生、噪音等）These factorscan differsubstantially dependingon the products and由于所提供的产品和服务不同，这些因素可能services provided.存在显著差异监视和测量资源
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1.5Monitoring and measuring resources
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5.1General总则The organization shall determineand provide the resources needed to当利用监视或测量活动验证产品和服务是否符ensure validand reliableresults whenmonitoring ormeasuring is used合要求时，组织应确定并提供确保结果有效和to verifythe conformity of products and services to requirements.可靠所需的资源The organization shall ensure that the resources provided:组织应确保所提供的资源a aresuitable for the specifictype of monitoring and measurement）适合特定类型的监视和测量活动;aactivities beingundertaken;）得到适当的维护，以确保持续适用其用途bb aremaintained to ensure theircontinuing fitness for theirpurpose.The organization shall retain appropriate documented information as组织应保留作为监视和测量资源适合其用途evidence offitnessforpurpose of the monitoring and measurement的证据的形成文件的信息resources.测量溯源
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5.2Measurement traceability
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5.2When measurementtraceability is a requirement,or isconsidered by当要求溯源时，或组织认为测量溯源是信任测the organization to bean essentialpart ofproviding confidencein the量结果有效的前提时，则测量设备应validity ofmeasurement results,measuring equipmentshall be:）对照能溯源到国际或国家标准的测量标准，aa calibratedor verified,or both,at specifiedintervals,or prior to use,按照规定的时间间隔或在使用前进行校准against measurementstandards traceableto internationalornational measurementstandards;when nosuch standardsexist,和（或）检定当不存在上述标准时,应保the basis used forcalibration or verification shall be retained as留作为校准或检定依据的形成文件的信息；documented information;）予以识别，以确定其校准状态；bb identifiedin order to determine their status;c safeguardedfrom adjustments,damage ordeterioration that）予以保护，防止可能使校准状态和随后的cwould invalidate the calibrationstatus andsubsequent测量结果失效的调整、损坏或劣化measurement results.组织应建立、实施并保持一个需要校准或检定时The organization shall establish,implement and maintain a process对监视和测量设备进行召回的过程for therecall of monitoring and measuring equipmentrequiringcalibration orverification.组织必须保持一份监视和测量设备的清卓清单应包括设备型号、唯一性标识、位置、校准和检The organization shall maintain a register of the monitoring and定方法、检查频率和接收准贝measuring equipmentThe registershall include the equipmenttype,unique identification,location,and thecalibration orverification注:监视和测量设备包括但不限于:试验硬件、试method,frequency,and acceptance criteria.验软件、自动试验设备（）和用于生成检验数ATE据的绘图仪,也包括用于提供产品符合证据的个人NOTE Monitoring and measuringequipment can include,but are notlimited to:test hardware,test software,automated testequipment拥有的和顾客提供的设备ATE andplotters used to produceverification data.It also includespersonally ownedand customersupplied equipmentused to provideevidence ofproduct and service conformity.Calibration orverification ofmonitoring andmeasuring equipmentshall be carried out undersuitable environmentalconditions see
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4.监视和测量设备的校准或检定应在适宜环境条件下实施当发现测量设备不适合其预期用途时丁组织应确定以往测量结果的有效性是否受到不利影响，必要时采取适当的措施The organization shall determineif thevalidity ofpreviousmeasurement resultshas beenadversely affected when measuringequipmentis foundto beunfit for its intended purpose,and shall take组织的知识appropriate actionas necessary.组织应确定运行过程所需的知识，以获得合格
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1.6Organizational knowledge产品和服务The organization shall determine the knowledgenecessary for theoperation of its processes and to achieve conformity of products and这些知识应予以保持，并在需要范围内可得到services.This knowledgeshall be maintained and be madeavailable to theextent necessary.When addressingchanging needs and trends,the organization shallconsider itscurrent knowledge and determine how to acquire oraccessany necessaryadditional knowledge and requiredupdates.NOTE1Organizational knowledgeis knowledgespecific to the organization;itis gainedby experience.It isinformation thatisused and sharedto achieve theorganizations objectives.NOTE2Organizational knowledgecan bebased on:a internalsources e.g.intellectual property;knowledge gainedfromexperience;lessons learnedfrom failuresand successfulprojects;capturing andsharing undocumentedknowledgeandexperience;theresults of improvements inprocesses,products and services;b external sources e.g.standards;academia;conferences;gatheringknowledge fromcustomers or external providers.为应对不断变化的需求和发展趋势，组织应考虑现有的知识，确定能力
7.2如何获得更多必需的知识，并进行更新注组织的知识是从经验中获得的特定知识,是实现组织目标所使1组织应用的共享信息）确定其控制范围内的人员所需具备的能力，a这些人员从事的工作影响质量管理体系绩注组织的知识可以基于2效和有效性；）内部来源（例如知识产权、从经历获得的知识、从失败和成功项a）基于适当的教育、培训或经验，确保这些人b目得到的经验教训；得到和分享未形成文件的知识和经验，过员具备所需的能力；程、产品和服务的改进结果）；）外部来源（例如标准、学术交流、专业会议，从顾客或外部供方b）适用时，采取措施获得所需的能力，并评价c收集的知识）措施的有效性；）保留适当的形成文件的信息，作为人员能力d
7.2Competence的证据The organizationshall:注:考虑定期评审人员所需具备的能力a determinethe necessarycompetence of persons doing workunder itscontrol thataffects the performance and effectiveness of注适当的措施可包括对在职人员进行培训、辅the quality management system;导或重新分配任务，或者招聘具备能力的人员b ensure that thesepersons arecompetent on the basisof等appropriate education,training,or experience;意识
7.3c whereapplicable,take actions toacquirethe necessarycompetence,and evaluate the effectiveness of the actions taken;d retain appropriate documented information as evidence ofcompetence.NOTE Considerationshould begiven for the periodic review of thenecessary competency.NOTE Applicableactions can include,for example,the provision of trainingto,the mentoringof,or there-assignment ofcurrently employedpersons;or thehiringor contractingof competent persons.
7.3AwarenessThe organizationshall ensure that personsdoingworkunder the组织应确保其控制范围内的相关工作人员知organizations control are aware of:晓）质量方针；a the quality policy;ab relevantquality objectives;）相关的质量目标；bc their contribution to the effectiveness of the quality management）他们对质量管理体系有效性的贡献，包括改csystem,including the benefits ofimproved performance;进质量绩效的益处；d theimplications ofnot conformingwith the quality management）偏离质量管理体系要求的后果；system requirements;de relevantquality management system documented information e）相关的质量管理体系文件的信息以及其更改;and changesthereto;f）他们对产品或服务符合性的贡献;f their contribution to product orservice conformity;g）他们对产品安全的贡献;g theircontribution to product safety;h）道德行为的重要性h the importance of ethical behavior.
7.4Communication沟通
7.4The organizationshall determinethe internal and external组织应确定与质量管理相关的内部和外部沟communications relevant to the quality management system,including:通的需求，包括a on what it will communicate;）沟通什么;ab whento communicate;）沟通时机;bc withwhom to communicate;d how tocommunicate;）与谁沟通;c）如何沟通;de whocommunicates.）由谁负责e注:交流应包括与质量管理体系有关的内部和外部NOTE Communicationshould includeinternal andexternal feedbackrelevant to the quality management system.反馈
7.5Documented information形成文件的信息
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5.1General总则
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5.1The organizations quality management system shall include组织的质量管理体系应包括a documented information requiredby this International Standard;）本标准要求形成文件的信息;ab documented information determinedby the organization as）组织确定的为确保质量管理体系有效性所bbeing necessary for the effectiveness of the quality需的形成文件的信息management system.NOTE Theextent of documented informationfor a quality management注对于不同组织，质量管理体系形成文件的信system candiffer from one organizationto anotherdue to:息的多少与详略程度可以不同，取决于一-组织的规模、以及活动、过程、产品和服务的the sizeof organization and itstype of activities,processes,products andservices;类型；—the complexity of processesand theirinteractions;-过程的复杂程度及其相互作用;—the competenceof persons.-人员的能力
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5.2Creating and updating
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5.2创建与更新When creatingandupdatingdocumented information the organization在创建与更新形成文件的信息时，组织应确保shall ensureappropriate:适当的a identification and descriptione.g.a title,date,author,or reference）标识和说明（如标题、日期、作者、索引anumber;编号等）；）格式（如语言、软件版本、图示）和媒介bb formate.g.language,software version,graphics andmedia e.g.（如纸质、电子格式）；paper,electronic;）评审和批准，以确保适宜性和充分性cc review and approvalfor suitability and adequacy.注:批准意味着针对不同类型文件的信息应按组NOTE Approvalimplies authorizedpersons andapproval methodsare织确定的要求识别相应授权人员和批准方法identified for the relevanttypes ofdocumented information,asdetermined by the organization.形成文件的信息的控制
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5.3Control ofdocumented Information组织应控制质量管理体系和本标准所要
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3.1Documented informationrequiredby the quality management求的形成文件的信息，以确保system and by this International Standardshall be controlled to ensure:a it is available and suitablefor use,where andwhen itis needed;）无论何时何处需耍这些信息，均可获得并适a用；b itis adequatelyprotected e.g.from lossof confidentiality,improperuse,or lossof integrity.）予以妥善保护（如防止泄密、不当使用或不b完整）
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3.2For the control ofdocumented information,the organization为控制形成文件的信息，适用时，组织应关注shall address the followingactivities,as applicable:下列活动a distribution,access,retrieval and use;a）分发、访问、检索和使用;b storageand preservation,including preservationof legibility;）存储和保护，包括保持可读性;bc control of changese.g.version control;）变更的控制（比如版本控制）；cd retentionand disposition;）保留和处置de prevention of theunintended use of obsoletedocumentedinformation byremoval orby application of suitablee）当出于任何目的需要保留过时文件时,需要通identification orcontrols ifkept for any purpose.过移除或运用适当地标识,防止非预期的使用无效的文件的信息Documented information of externalorigin determinedby theorganizationto benecessary for the planning and operation of the对确定策划和运行质量管理体系所需的来自外quality management system shall be identified as appropriate,and be部的原始的形成文件的信息，组织应进行适当controlled.识别和控制Documented informationretainedas evidence of conformity shall beprotected fromunintended alterations.应对所保存的作为符合性证据的形成文件的信息予以保护，防止非预期的更改When documented information ismanaged electronically,dataprotection processes shall be defined eg,protection from当文件的信息是电子化管理时,数据保护过程应确loss,unauthorized changes,unintended alteration,corruption,physical damage.定（如防止丢失,非授权更改,无意识的修订,损坏,物理性破坏）NOTE Accesscan implya decisionregarding thepermission toview thedocumented information only,orthepermission and authority toviewand注形成文件的信息的“访问”可能意味着仅允change the documented information.许查阅、或者意味着允许查阅并授权修改8Operation运行
88.1Operational planning and control运行策划和控制
8.1The organizationshall plan,implement and control the processes see
4.4needed to meet the requirements for the provision of products and组织应通过采取下列措施，策划、实施和控制满services,and toimplement the actions determinedin Clause6,by:足产品和服务要求所需的过程（见）并实施
4.4,第章所确定的措施6a determining the requirements for the products and services;NOTE Determinationof requirements for the products and services cana）确定产品和服务的要求；include considerationof:注:确定产品和服务的要求应考虑下述方面:-personal and product safety;-producibility andinspectability;-人员和产品的安全;-reliability,availability andmaintainability;-可生产性和可检验性;-suitability of parts andmaterials usedin the product;-可靠性、可用性和可维护性;-selection and development ofembedded software;-使用在产品中的零件和材料的适宜性;-product obsolescence;-嵌入式软件的选择和开发;-prevention,detection,and removal of foreign objects;-产品的报废;-handling,packaging andpreservation;-预防,探测和移除外来物;-recycling or final disposalof the product at the endof itslife.-处置,包装和防护;b establishingcriteria for:-产品在寿命结束时的回收和最终处理1the processes;2the acceptanceof products and services;）过程；1NOTE Accordingto the nature of the product and dependingon the）产品和服务的接收；2specified requirements,statistical techniquescan be used to support:注:根据产品特性并取决于规定要求,统计技术可-design verificationeg,reliability,maintainability,product safety;用于支持:-process control;一设计验证（如:可靠性、可维修性、产品安全）;•selection and verification ofkey characteristics;•process capabilitymeasurements;一过程控制:•statistical process control;•design ofexperiment;•关键特性的选择和验证;•过程能力测量;-verification;•统计过程控制;-failure mode,effect and criticality analysis.•实验设计;c determining the resourcesneeded to achieve conformityto the一验证，和product and service requirementsand to meet on-time一失效模式、影响和危害性分析delivery of products and services;c）确定符合产品和服务要求以及游定产品和服务的准时交付所需的资源;d implementing control of the processesin accordance with thecriteria;）按照准则实施过程控制；de determiningand keepingdocumented information to the extentnecessary:）在需要的范围和程度上，确定并保持和保留e1to haveconfidence that the processeshave beencarried out as形成文件的信息planned;）证实过程已经按策划进行；12to demonstratethe conformity of products and services to their）证明产品和服务符合要求2requirements;f determining the processesand controlsneeded tomanage f）确定管理关键项目所需的过程和控制,包括当关critical items,including production process controlswhen key键特性已经识别时的生产过程控制;characteristics have been identified;g）受影响的组织职能代表参与运行策划和控制;g engagingrepresentatives of affected organizationfunctions foroperationalplanningand control;h）确定支持产品和服务的使用和维护所需的过程h determining the processand resourcesto supportthe use and和资源;maintenance of the products and services;i）确定产品和服务能从外部供方处获取;i determiningthe products and services to be obtained fromexternal providers;j）建立起控制要求，防止交付给顾客不合格的产j establishingthe controlsneeded to prevent thedelivery of品和服务nonconforming products and services to the customer.注:一种取得运行策划和控制的方法是通过使用整NOTE Onemethod toachieve operationplanningand control can be合各阶段过程through usingintegrated phasedprocesses.适用时,根据组织,顾客要求,产品和服务情况,组织应以一种结构化和受控的方式去策划和管理产As appropriate to the organization,customer requirements,and品和服务的提供,包括在有资源和时间约束情况products and services,the organizationshall plan and manage下,预定事件按策划次序执行,并在可接受的风险product andservice provisionin astructured and controlled manner内满足要求including scheduledevents performedina planned sequenceto meetrequirementsat acceptablerisk,with resourceand schedule注:这些活动通常称为项目策划,项目管理或计划constraints.管理NOTE This activity isgenerally referred to asproject planning,projectmanagement,or programmanagement策划的输出应适合组织的运行需要The output of thisplanning shall be suitablefor the organizationsoperations.NOTE Asan outputof thisplanning,documented information注:作为策划的输出,对具体产品,项目或合同用形specifying the processes of the quality management system and theresourcesto beapplied toa specificproduct,project orcontract can成文件的信息规定质量管理系统和资源的过程,称be referred to as a qualityplan.为质量计划The organizationshall controlplanned changesand review the组织应控制策划的更改，评审非预期变更的结consequences ofunintended changes,taking actionto mitigateadverse果，必要时，采取措施消除不利影响effects,as necessary.The organizationshall ensure that outsourcedprocesses arecontrolled组织应确保外包过程得到控制（见）
8.4see
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4.组织应建立、实施和保持一个策划和控制临时性The organizationshall establish,implement andmaintain a process to或永久性工作转移的过程,以保证持续地符合工作plan andcontrol thetemporary orpermanent transferof work,to的要求这个过程应保证工作转移时的影响和风ensure thecontinuing conformity of thework to requirements.The险是在管理process shall ensurethatwork transferimpacts and risks aremanaged.注:对于控制工作转移从组织到外部供方,或从一NOTE For thecontrol of work transfer from the organizationto an个外部供方转移到另一个外部供方,见
8.4对于external provider,or froman external provider to another external从组织的一处设施转移到另一处,或从外部供方转provider,see
8.
4.Forthecontrol ofworktransferfromone移到组织,见
8.
5.organization facilityto another,or froman external provider to theorganization,see
858.
1.1Operation risk management
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1.1运行风险管理The organizationshall plan,implement andcontrol aprocess for组织应建立、实施和控制运行风险的过程管理,managing operationrisks to the achievementof applicable以实现适用的要求,适当时包括针对组织,产品和requirements,which includesas appropriate to the organization and服务的要求如下:the products and services:a）风险管理的职责分配;a assignment of responsibilitiesfor riskmanagement;b）风险评估准则的确定（如:可能性、后果,风b definitionof riskassessment criteriae.g.,likelihood,险接受程度）;consequences,risk acceptance;c）在运行过程中对风险的识别、评估和交流;c identification,assessment and communication of risksthroughout operations;d identification,implementation and management of actions tod）对于超过确定的风险接受准则时，减轻风险的mitigate risksthat exceed the definedrisk acceptance criteria;措施的识别、实施和管理;e acceptanceofrisksremaining afterimplementation ofmitigatinge）减轻风险措施实施后，风险保持在可接受水平actions.上NOTE1While clause
6.1addresses the risks and opportunities whenplanningfor the quality management system of the organization,the注1条款
6.1阐明了在策划组织质量管理体系scope of this clause
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1.1is limitedto the risks associated to the时的风险和机遇，条款
8.
1.1的范围局限在和产operation of products and services clause
8.品和服务运行有关的风险上NOTE2Within aviation,space anddefense,risk isgenerally注2在航空,航天和防务领域,风险通常依据发expressed interms of the likelihoodof occurrenceand theseverity of生的可能性和后果的严重度进行表述the consequences.
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1.2技术状态管理
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1.2Configuration managementThe organizationshall plan,implement andcontrol aprocess for组织应建立、实施和控制适用于组织,产品和服务configuration managementas appropriate to the organization and的技术状态管理过程,目的是保证在产品生命周product and services in order to ensure the identification andcontrol期内物理和功能属性的识别和控制过程应包括:of physicaland functionalattributes throughoutthe product lifecycle.This process shall:a）与产品标识和追溯要求的控制,包括识别的更a controlproduct identityand traceability torequirements,includingthe implementation of identifiedchanges;改执行情况;b ensurethat thedocumented informatione.g.,requirements,b）保证文件的信息（如与要求,设计,验证,确认design,verification,validation and acceptance documentationis和接收有关的文件）是和实际产品和服务的属性consistent with the actualattributes of the products and services.相一致;
8.
1.3Product safety
8.
1.3产品安全The organizationshall plan,implement andcontrol the processes实适用于组织和产品时,组织应策戈h施和控制needed to assure product safety duringthe entireproductlifecycle,在产品整个寿命周期内保证产as appropriateto the organization and the品安全所需的过程product注:这些过程例如包括有:NOTE Examples of these processes include:-assessment ofhazards andmanagement of associated riskssee
8.
1.1;-评估危害和相关风险管理见；
8.
1.1-management ofsafety critical items;-安全关键项目的管理;-analysis andreporting ofoccurred eventsaffecting safety;-分析和报告已发生的影响安全事件;•communication of these eventsand training of persons.-交流安全事件并培训人员
8.
1.4Prevention of counterfeit product
8.
1.4预防假冒件The organizationshall plan,implement andcontrolaprocess,appropriateto the product,for thepreventionofcounterfeit or适用于组织和产品时,组织必须策划，实施和控制suspect counterfeit product useand their inclusion inproducts预防使用到假冒件或者怀疑的假冒件,和包含在delivered to the customer.产品中交付给客户的过程NOTE Counterfeitproduct preventionprocesses shouldconsider:-trainingofappropriate personsin theawareness andprevention注:假冒件预防过程应当考虑:ofcounterfeit product;-对相关人员进行假冒件的意识和预防培训；■applicationofa partsobsolescence monitoringprogram;-control for acquiring externally provided productform original一零件报废监控程序的应用;manufacturers,authorized distributors,or otherapproved sources.-控制从原始厂家,授权分销商,或者其他批准来-requirements for assuring traceabilityofpartsand componentsto源获得外部提供的产品；their originalauthorized manufacturers;-要求保证追溯零部件到它们的原始授权厂家;-verification andtest methodologiesto detectcounterfeitproduct;-验证和测试方法来发现假冒件;-monitoring ofcounterfeitproductreporting from externalsources;-监控外部对假冒件的报告;-quarantine andreporting ofsuspect ordetected counterfeitproduct-隔离和报告怀疑的或者发现的假冒件
8.2Requirements for products and services产品和服务的要求
8.
28.
2.1Customer communication顾客沟通
8.
2.1Communication withcustomers shall include:与顾客沟通的内容应包括a providinginformation relating to products and services;提供有关产品和服务的信息;b handlingenquiries,contracts or orders,including changes;a处埋问询、合同或订单，包括变更；c obtainingcustomer feedbackrelating to products and services,bincluding customer complaints;获得有关产品和服务的顾客反馈，包括顾d handlingor controllingcustomer property;C客抱怨；e establishingspecific requirements for contingencyactions,dwhen处置和控制顾客财产；relevant.关系重大时，制定有关应急措施的特定要e
8.
2.2Determining the requirements related to products and求services与产品和服务的要求的确定When determiningthe requirements for the products and services to beoffered to customers,the organizationshall ensurethat:在确定向顾客提供的产品和服务要求时，组织a the requirements for the products and services are defined,应确保including:）产品和服务的要求得到规定，包括a1any applicable statutory and regulatoryrequirements;2those considerednecessary by the organization;）适用的法律法规要求；1b the organization canmeet theclaims for the products and services）组织认为的必要要求；2it offers;）对其所提供产品和服务的要求，能够满足组bc special requirements of the products and servicesare织声称的要求determined;d operationrisks e.g”new technology,abilityandcapacity to）产品和服务的特殊要求得到确定;Cprovide,short deliverytime framehave beenidentified.）运行风险（如新的技术,提供的能力和产能,d短的交付期）已经识别
8.
2.3Review of requirements relatedtoproducts and services
8.
2.
3.1The organizationshall ensurethat ithas the ability tomeet the与产品和服务的要求的评审
8.
2.3requirements for products and services to be offeredto customers.Theorganization shall conduct areview beforecommitting tosupply组织应确保其有能力满足向顾客提供的
8.
2.
3.1products and servicesto the customer,to include:产品和服务的要求在承诺向顾客提供产品和服务之前，组织应对以下各项要求进行评审a requirementsspecified by the customer,including therequirements for delivery and post-delivery activities;）顾客规定的要求，包括对交付及交付后活动ab requirementsnot statedby the customer,but necessaryfor the的要求；specified or intended use,when known;）顾客虽然没有明示，但规定的用途或已知bc requirementsspecified by the organization;的预期用途所必需的要求;d statutory and regulatoryrequirements applicableto the productsand services;）组织规定的要求；ce contractor orderrequirements differing from those previouslyexpressed.）适用产品和服务的法律法规要求；eThis review shall becoordinated withapplicable functionsof the）与先前表述存在差异的合同或订单的要organization.f求；If uponreviewthe organization determinesthat somecustomerrequirements cannot be metor canonly partiallybe met,the评审应和组织的相关职能进行协调organizationshallnegotiate amutually acceptablerequirement withthe customer.如果依据组织的评审确定顾客的要求不能满足或者部分不能满足,组织应与顾客商讨一致相互可接The organizationshall ensurethat contractororderrequirements受的要求differingfromthosepreviouslydefined areresolved.The customerrequirements shall be confirmedby the organization若与先前合同或订单的要求存在差异，组织应确before acceptance,when the customer does not providea documented保有关事项已得到解决statement of their requirements.若顾客没有提供形成文件的要求，组织在接受顾NOTE Insome situations,such asinternet sales,a formalreview is客要求前应对顾客要求进行确认impractical for each order.Instead,the reviewcan coverrelevant productinformation,such ascatalogues oradvertising material.
8.
2.
3.2The organizationshall retain documented information,asapplicable:a on the results of the review;b onany newrequirements for theproducts and services.824Changes torequirements forproducts and servicesThe organizationshall ensurethat relevantdocumented informationisamended,and that relevant persons are madeaware of the changedrequirements,when therequirementsforproducts and services arechanged.注在某些情况下，如网上销售，对每一个订单
8.3Design and development of products and services进行正式的评审可能是不实际的，作为替代方法，对有关的产品信息，如产品目录进行评审适用时，组织应保留下列形成文件的信
8.
2.
3.2息）评审结果；a）针对产品和服务的新要求b产品和服务要求的更改若产品和服务的要求发生变更，组织应确保相关形成文件的信息得到修改，并确保相关人员知道已更改的要求产品和服务的设计和开发
8.
38.
3.1General总则The organizationshall establish,implement andmaintain a design
8.
3.1and development process thatis appropriateto ensure the组织应建立、实施和保持设计和开发过程，以确subsequent provisionof products and services.保后续的产品和服务的提供
1.
3.2Design and development planning设计和开发策划
8.
3.2In determiningthe stagesand controls for design and development,the在确定设计和开发的各个阶段及其控制时，组organizationshall consider:织应考虑a thenature,duration andcomplexityof the design and developmentactivities;）设计和开发活动的性质、持续时间和复杂a程度；b the required processstages,including applicabledesign and）所要求的过程阶段，包括适用的设计和开发development reviews;b评审；c therequired design and developmentverification and validationactivities;所要求的设计和开发验证和确认活动;cd the responsibilities and authorities involved in the design and）设计和开发过程涉及的职责与权限;ddevelopment process;）产品和服务的设计和开发所需的内部和外etheinternalandexternal resourceneeds for the design and edevelopmentof products andservices;部资源；fthe need to control interfacesbetween personsinvolvedin the）设计和开发过程参与人员之间接口的控制fdesign and developmentprocess;需求；gthe need forinvolvement of customers and users in the design anddevelopment process;g）顾客和使用者参与设计和开发过程中的需求；h therequirementsfor subsequent provisionof products andservices;）后续产品和服务提供的要求；hi thelevel ofcontrol expectedfor the designand developmentprocess bycustomers andother relevant interested parties;i）顾客和其他相关方期望的设计和开发过程的控制水平；j thedocumented informationneeded to demonstrate that designand developmentrequirements have been met.）证实已经满足设计和开发要求所需的形j通过未授权的复制,模仿,替代或者改装零件的方An unauthorizedcopy,imitation,substitute,or modifiedpart e.g.,material,part,component whichis knowinglymisrepresented as a式（如材料,零件或组件）,故意误导这是一个原specified genuinepart ofan originalor authorizedmanufacturer.始或者授权厂家指定的真品注:假冒零件可能包括但不限于假的标识或标Note:example ofa counterfeitpart can include,but arenot limitedto,签,等级,序列号,日期代码,文件,或者性能特性the falseidentification ofmarking orlabeling,grade,serial number,datecode,documentation,or performance characteristics.
3.2关键项目
3.2critical items对产品和服务的提供和使用有重要影响的项目（如功能,零件，软件，特性，过程）,包括安全,Those itemseg,functions,parts,software,characteristics,processeshaving significant effect on the provisionanduse of theproducts and性能,形成,安装,功能,可生产性,使用寿命等,需services;including safety,performance,form,fit,function,producibility,要特定的措施以保证能充分地管理关键项目举service life,etc.;that requirespecific actions to ensure they are例如安全关键项目,破裂关键项目,任务关键项adequately managed.Examplesof critical itemsinclude safetycritical目，关键特性等items,fracture critical items,mission critical items,key characteristics,etc.
3.4关键特性
3.3key characteristic是一种属性或特征,其变化将对产品安装,形成,An attributeor featurewhose variationhas asignificanteffect on功能,性能，使用寿命或可制造性产生重大影响,product fit,form,function,performance,service lifeor producibility,that因而需要采取特殊措施对其变化进行控制requires specific actions for the purpose of controllingvariation.
3.4productsafety
3.4产品安全在没有导致人员伤害或财产损失的风险到不可接The statein whicha productis ableto performto itsdesigned or受情况下,产品能履行其设计或者期待的用途intended purposewithout causingunacceptable risk of harmto personsordamage toproperty.
3.5special requirements
3.5特殊要求Those requirementsidentified by thecustomer,or determinedby the由顾客识别或组织自己确定的要求,这些要求的organization,which havehigh risksto beingachieved,thus requiring实现具有高风险性,因而要求它们包含在风险管theirinclusionintheriskmanagementprocess.Factors usedinthe理过程中确定特殊要求的因素,包括产品或过程determination of specialrequirements include product or process的复杂性,过去的经验,以及产品或过程的成熟complexity,past experienceand product or processmaturity.Examples度.特殊要求的例子包括顾客强制的行业极限能of specialrequirementsincludeperformance requirementsimposed by力,或者是组织自身确定的技术或过程的极限能thecustomerthat areatthe limit of the industryscapability,or力requirements determinedby the organizationto be atthelimitof itstechnicalor processcapabilities.注:特殊要求（
3.5）和关键项目（
3.2）以及关键特性是相互关联的特殊要求是在确定和评审NOTE Special requirements
3.5andcritical items
3.2,along withkey与产品有关的要求时识别的（见
8.
2.2和
8.
2.3）characteristics,are interrelated.Special requirementsare identified特殊要求可能要求识别关键项目设计输出（见when determiningand reviewingrequirements relatedto theproductsee822and
8.
2.
3.Specialrequirements can requirethe identification
8.
3.5）可能包括识别要求采取特殊措施保证其得ofcriticalitems.Design outputsee
8.
3.5can includeidentification of到充分管理的关键项目一些关键项目由于需要criticalitemsthat requirespecific actions to ensurethey are adequately对其变化进行控制,会被进一步分为关键特性managed.Some criticalitems will be furtherclassified askeycharacteristics becausetheir variationneeds to be controlled.组织环境4Context of the organization4理解组织及其环境
4.
14.1Understanding the organization and its contextWhen appropriate,the organizationshall dividethe designanddevelopment effortinto distinctactivities and,foreachactivity,definethe tasks,necessary resources,responsibilities,design content,andinputs andoutputs.成文件的信息在适用时,组织应将设计和开发工作分解为清楚的活动,并对每项活动,设计和开发策划应考虑供应,验证,测试和维修产确定任务、必需的资源、职责、设计内容、输入和输出品和服务的能力（见
8.la的输出）Design and development planningshall consider the abilityto provide,verify,test andmaintain theproduct andservice referenceoutputof
8.设计和开发输入1a.
8.
3.
38.
3.3Design and development inputs组织应针对具体类型产品和服务，确定设计和开发的基本要求组织应考虑The organizationshall determinetherequirementsessential for thespecific typesof products andservicesto bedesigned anddeveloped.The organizationshall consider:）功能和性能的要求；aa functionaland performancerequirements see
8.1a;）来源于以前类似设计和开发活动的信息；bb informationderived fromprevious similardesignand development）法律法规要求；activities;Cc statutoryand regulatoryrequirements;）组织承诺实施的标准或行业规范；dd standardsor codesof practicethat the organization hascommitted）由产品和服务性质所决定的，失效的潜在后eto implement;果e potential consequences offailure dueto thenature of theproductsand services;f）适用时,性能衰退的潜在后果（如材料,过程,部件,设备和产品）f when applicable,the potentialconsequences ofobsolescence eg,materials,processes,components,equipment,products.设计和开发输入应完整、清楚，满足设计和开发Inputs shall be adequatefor designanddevelopmentpurposes,的目的complete andunambiguous.应解决相互冲突的设计和开发输入Conflicting designanddevelopmentinputs shall be resolved.组织应保留有关设计和开发输入的形成文件的The organizationshall retaindocumented information on designanddevelopment inputs.信息NOTE The organization canalso consideras designanddevelopment注:组织也可考虑其它信息如标杆管理,外部供方inputs otherinformation such as benchmarking,external provider反馈,内部产生数据和服务中数据作为设计和开发feedback,internally generateddata andin-service data.的输入
8.
3.4Design anddevelopment controls设计和开发控制
8.
3.4The organizationshall applycontrols to the designanddevelopmentprocess to ensurethat:组织应对设计和开发过程进行控制，以确保a the results to be achievedare defined;）规定拟获得的结果；ab reviewsare conducted to evaluatethe abilityof the results ofdesignand developmenttomeet requirements;）实施评审活动，以评价设计和开发的结果满b足要求的能力；c verification activities areconducted to ensurethat the designanddevelopment outputsmeet the input requirements;c）实施验证活动，以确保设计和开发输出满足输入的要求；dvalidationactivities areconductedto ensurethat the resultingproducts andservices meet therequirementsfor the specifiedapplicationorintendeduse;d）实施确认活动，以确保产品和服务能够满足规定的使用要求或预期用途要求；e any necessary actionsare takenon problemsdetermined duringthereviews,orverification and validationactivities;）针对评审、验证和确认过程中确定的问题采e取必要的措施；fdocumented informationof these activitiesis retained;）保留这些活动的形成文件的信息fg whenoutputs arenot met,they are identified andnecessaryactions aredefined;g）当输出不能满足时,应被识别并确定必要措施;h progressionto the next stageis authorized.Participants indesignanddevelopment reviewsshall includeh）进展到下一阶段应被授权批准representatives offunctions concernedwith the designanddevelopmentstages beingreviewed.设计和开发评审的参与者应包括与评审的设计和开发阶段有关的职能代表NOTE Design anddevelopmentreviews,verification and validation havedistinctpurposes.They can be conductedseparately orin anycombination,as issuitablefor theproducts andservices of the organization.注设计和开发的评审、验证和确认具有不同的目的根据组织的产品和服务的具体情况，可
8.347When testsare necessaryfor verificationandvalidation,these以单独或以任意组合进行tests shall be planned,controlled,reviewed anddocumented to ensureand provethe following:
8.
3.
4.1当试验对验证和确认是必要时,应对这些a testplans orspecifications identifythe test item beingtested and试验进行策划、控制、评审并形成文件，以确保the resourcesbeing used,define testobjectives andconditions,证明下列要求:parameters to be recordedand relevantacceptance criteria;a.试验计划或规范确定了要进行试验的项目和需b testprocedures describethe testmethods tobe used,how to要使用的资源;规定了试验目的和条件、要记录perform the test,and howto record of the results;的参数以及相关接收准则;c thecorrect configurationof the testitemis submittedfor the test;b.试验程序描述了使用的测试方法、如何进行试验,和如何记录结果;d therequirements of thetestplanand thetestprocedures areobserved;c.提交试验项目正确的技术状态;Monitoringandmeasuring devicesused fore.满足了接收准则试验中使用的监视和测量设备应按条款
7.
1.5控d.遵守了试验计划和试验程序的要求;ethe acceptancecriteriaare met制.testing shall be controlledas definedin clause
7.
1.
5.在设计和开发完成时,组织应确保报告、计算、试At thecompletion ofdesignanddevelopment,验结果等能展示在所有规定的运行条件下,产品定the organizationshall ensurethat reports,义满足规范要求calculations,test results,eta,are abletodemonstrate that theproductdefinition meets设计和开发输出
8.
3.5the specificationrequirementsfor all identifiedoperationalconditions.组织应确保设计和开发输出
8.
3.5Design anddevelopment outputs满足输入的要求；bThe organizationshall ensurethatdesignanddevelopment outputs:对于产品和服务提供的后续过程是充分c的；a meettheinputrequirements;areadequatefor thesubsequent processesfor theprovisionofaproducts andservices;binclude or reference monitoring andmeasuringrequirements,asappropriate,and acceptancecriteria;包含或引用监视和测量的要求，适当时，包cd specifythe characteristics of products andservicesthat areessential括接收准则；for theirintendedpurposeand theirsafe andproper provision;d规定对于实现预期目的、保证安全和正确提specify,as applicable,any criticalitems,including anykey供（使用）所必须的产品和服务特性echaracteristics,and specific actionstobe takenfor theseitems;e适用时,规定任何关键项目包括任何关键特性,以及对这些项目要采取的特殊措施f areapproved prior to release.f）放行前得到批准The organizationshall define the datarequired toallow theproduct to组织应确定对产品进行标识、制造、验证、使用be identified,manufactured,verified,usedand maintained.和维修所需要的数据NOTE Datacan include:-the drawings,part listsand specificationsnecessary todefinethe注:数据可包括:configuration and thedesignfeatures of theproduct;-确定产品的技术状态和设计特性的图纸,零件清-the material,process,manufacturing,assembly,handling,单和规范;packaging andpreservation dataneeded to provide andmaintain aconformingproductorservice;-提供和维护产品和服务符合性需要的材料、过程、-the technical data andrepair schemesfor operatingand制造和装配,处理,包装和防护的数据maintaining theproduct-运行和维护产品的技术数据和修理方案The organizationshall retaindocumented informationon designanddevelopment outputs.组织应保留有关设计和开发输出的形成文件的
8.
3.6Designanddevelopment changes信息The organizationshall identify,review andcontrol changesmade设计和开发变更
8.
3.6during,orsubsequentto,thedesignanddevelopmentof products andservices,to the extent necessary to ensurethat thereis noadverse组织应识别、评审和控制在产品和服务设计和impact onconformitytorequirements.开发期间以及后续所做的变更，以避免不利影The organizationshall implement aprocessand criteria for notifying响，确保符合要求its customer,prior toimplementation,about changesthat affectcustomerrequirements.组织应履行过程和准则保证在更改实施前,通知顾客影响到顾客要求的任何更改The organizationshall retaindocumented informationon:adesignanddevelopment changes;组织应保留下列形成文件的信息b the results ofreviews;）设计和开发变更；a）评审的结果；c theauthorization of the changes;bd theactions takento preventadverse impacts.）变更的授权；c总则
8.
4.1）为防止不利影响所采取的措施dDesign anddevelopmentchangesshall becontrolled in accordancewith theconfiguration managementprocess.设计和开发的更改应按技术状态管理的过程控
8.4Control of externally provided processes,products and制services外部提供过程、产品和服务的控制
8.
48.
4.1GeneralThe organizationshall ensurethat externally provided processes,products,andservicesconform torequirements.The organizationshall beresponsible forthe conformity of all组织应确保外部提供的过程、产品和服务符合要externally provided processes,products andservices,including from求sources definedby thecustomer.组织必须对所有从外部提供的过程,产品和服务的The organizationshall ensure,when required,that符合性负责,包括顾客指定的来源customer-designated orapproved external providers,includingprocess sources eg,special processes,are used.当要求时,组织应确保使用顾客指定或批准的外部The organizationshall identifyandmanagethe risksassociatedto the供方,包括过程来源（如特殊过程）；external provisionof processes,products andservices,as wellas theselection anduse of external providers eg,direct andsub-tier组织应识别和管理与外部提供的过程,产品和服external providersand sourcesidentified by thecustomer.务,以及在挑选和使用外部供方时面对的相关风险（如直接和次级的外部供方,和顾客识别的来源）The organizationshall requiretheir external providers to applyappropriate controlsto theirsub-tier providers,toensurethatrequirements aremet组织应要求外部供方对他们的次级供方进行适当The organizationshall determinethe controlstobeapplied to externally的控制，以保证满足要求provided processes,products andservices when:a products andservices fromexternal providersare intendedfor incorporation into the在下列情况下，组织应确定对外部提供的过程、organizations ownproducts andservices;产品和服务实施的控制b productsandservicesare provideddirectly to the customersby）外部供方的过程、产品和服务构成组织自身aexternal providerson behalfof the organization;的产品和服务的一部分；caprocess,or part ofaprocess,is providedby an external provideras a resultofadecision by the organization.）外部供方代替组织直接将产品和服务提供给b顾客；The organizationshall determineand applycriteria forthe evaluation,）庙织决定由外部供方提供过程或部分过程cselection,monitoring ofperformance,andre-evaluation of externalproviders,based on their abilitytoprovideprocesses orproductsandservices in accordancewith requirements.The organizationshall retain组织应基于外部供方提供所要求的过程、产品documented informationof theseactivities and any necessary actions和服务的能力，确定外部供方的评价、选择、绩arising fromthe evaluations.效监视以及再评价的准则，并加以实施对于这些活动和由评价引发的任何必要的措施，组NOTE Duringexternal providerselectionand evaluation,the织应保留所需的形成文件的信息organization canuse qualitydata fromobjective andreliable externalsources,as evaluatedbytheorganization eg,information fromaccreditedquality management system orprocess certification注:在选择和评价外部供方时,可使用来自客观和bodies,external providerapprovals fromgovernment authorities,可靠外部提供的质量数据作为组织自己的评估（例Use ofsuch datawould beonly oneelement ofan organizations如:信息来自授信的质量管理体系或过程认证机external providercontrol processand theorganization remains构,政府机构对外部供方的批准）使用这种数据responsible forverifying that externallyprovided processes,只能是组织对外部供方控制过程的一个组成部productsandservices meetspecified requirements.分,组织仍然有验证采购的产品满足规定采购要求的责任
8.
4.
1.1The organizationshall:a definetheprocess,responsibilities andauthority forthe approvalstatusdecision,changes of the approval status andconditions
8.
4.
1.1组织应:foracontrolled use of external providers dependingon theirapprovalstatus;a）确定批准状态决定,批准状态更改的过程，职b maintain a registerof itsexternal providers that includes责和授权,以及根据其批准状态进行控制使用approvalstatuseg,approved,conditional,disapproved and the供方的条件scope of the approvaleg,product type,process family;b）保持一份外部供方名录,包括批准状态（如批准,有条件批准,不批准）和批准范围（如产品类型、过程类别）;c periodicallyreview externalprovider performanceincluding c）周期性地评估外部供方的业绩,包括产品和服product andservice conformity and on-time delivery务的符合性和准时交付能力;performance;d）当外部供方不能满足要求时,确定采取必要的d definethe necessaryactionstotake whendealing with external措施;providersthat do not meet requirements;e）确定过程控制由外部供方生成和/或保留的文edefinetheprocess for controllingdocumented information件的信息created by and/or retainedby external providers.
8.
4.2Type andextent ofcontrol控制类型和程度The organizationshall ensurethat externallyprovided processes,productsandservices do not adverselyaffect the organizations ability组织应确保外部提供的过程、产品和服务不会to consistentlydeliver conformingproductsandservicesto its对组织稳定地向顾客交付合格产品和服务的能customers.力产生潜在影响The organizationshall:组织应:a ensurethatexternallyprovidedprocessesremain within thea确保外部提供的过程保持在其质量管理control of its quality management system;体系的控制之中；b defineboth thecontrols that it intends toapply to anexternal）规定对外部供方的控制及其输出结果的控bprovider andthose itintends toapplyto the resulting output;制；c take into consideration:1the potentialimpact of the externallyprovidedprocesses,products）考虑cand serviceson the organizations abilityto consistentlymeet）外部提供的过程、产品和服务对组织稳定地1customer and applicable statutoryand regulatoryrequirements;提供满足顾客和适用的法律法规要求的能力的潜在影响；2the effectiveness of thecontrols appliedbythe externalprovider;）外部供方自身控制的有效性23the results of theperiodicreview of externalprovider performancesee
8.
4.
1.1c;3）定期评审外部供方业绩的结果（见）
8.
4.
1.1c;d determinethe verification,or otheractivities,necessary toensurethat the externallyprovidedprocesses,productsandservices meetrequirements see
8.
421.d）确定必要的验证或其他活动，以确保外部提供的过程、产品和服务满足要求Verification activitiesof externallyprovidedprocesses,products,andservices shall be performedaccording to the risksidentified.These外部提供的过程,产品和服务的验证活动应按识别shall includeinspection orperiodic testing,as applicable,when there的风险进行,当存在不合格品或假冒件的高风险情is highriskof nonconformities orcounterfeitproduct况下,在适用时应包括检验或定期测试NOTE1Customer verificationactivities performed at anylevel of thesupply chaindoes notabsolve theorganization ofits responsibilityto注1顾客对任何层次的供应链所做的验证活动不provide acceptableprocess,productsandservices and to comply能免除组织提供可接受的过程,产品和服务,以及with allrequirements.符合所有要求的责任NOTE2Verification activities can include:-review ofobjective evidence of the conformityof the processes,注2验证活动可以包括:productsandservices fromthe externalprovider eg,accompanying-评审从外部供方处获得的过程,产品和服务的符documentation,certificate ofconformity,test documentation,合性客观证据（如随产品文件,合格证明,测试文statistical documentation,processcontroldocumentation,results of件,统计文件,过程控制文件,生产过程验证的结production process verificationand assessment ofchanges to the果,和后续生产过程更改的评估）;production processthereafter;-inspection andaudit atthe external providers premises;-review oftherequireddocumentation;-在外部供方处的检验和审核;-review of production partapproval processimplementation;一对要求文件的评审;-inspection of products orverification ofservices uponreceipt;-评审生产件批准过程的执行情况;-reviewofdelegations ofproduct verification to the external-按收货单进行产品检验或服务验证;provider.-评审委托的外部供方的产品验证结果When externallyprovided productsare releasedfor production usepending completion of all required verificationactivities,it shall beidentified andrecorded toallow recalland replacementif itis在所有要求的验证活动完成前,当外部提供的产品subsequently foundthat theproduct doesnot meet requirements.被放行用于生产,应对其进行标识和记录,做到如果后续结果发现产品不符合要求,能够对其进行召When theorganization delegatesverificationactivities to the external回和更换provider,the scopeand requirementsfor delegationshall bedefinedand aregisterofdelegations maintained.The organizationshallperiodically monitortheexternal providers delegatedverification当组织委托代表对外部供方进行验证时,应确定委activities.托的范围和要求,并保持一份委托清单组织应定期监控外部供方的委托验证活动情况When externalprovider test reports areutilized to verify externallyprovidedproducts,theorganizationshall haveaprocessto evaluatethedata inthetestreports toconfirm that theproductmeetsrequirements.When a customer ororganization haveidentified rawmaterialasasignificant operationrisk egcriticalitems,the当利用外部供方的测试报告来验证外部提供的产organizationshall implemented aprocesstovalidatetheaccuracy of品时,组织应评估测试报告中的数据用以确认产品testreports.满足要求当顾客或组织已经识别原材料是一个重要的运行风险时（如关键项目）,组织应验证测
8.
4.3Information for externalproviders试报告的准确性The organizationshall ensurethe adequacy of requirementspriorto theircommunication to theexternalprovider.外部供方的信息
8.
4.3The organizationshall communicatetoexternalproviders itsrequirementsfor:组织应确保在与外部供方沟通之前所确定的要求是充分的a the processes,productsandservicestobe providedincluding theidentification of relevanttechnicaldatae.g.组织应与外部供方沟通以下要求specifications,drawings,process requirements,workinstructions;）所提供的过程、产品和服务，包括相关技术ab the approval of:数据的标识（如规范,图纸,过程要求，和工作指导书）；1productsandservices;2methods,processesand equipment;3the release of productsandservices;b）对下列内容的批准c competence,including anyrequired qualificationof persons;）产品和服务；1）方法、过程和设备；2d theexternalproviders,interactions with theorganization;）产品和服务的放行3control and monitoring oftheexternalproviders performanceto]ebe appliedbytheorganization;）能力，包括所要求的人员资质；cf verificationor validationactivities that theorganization,orits外部供方与组织的接口;customer,intendstoperform attheexternalproviders5）组织对外部供方绩效的控制和监视;epremises;）组织或其顾客拟在外部供方现场实施的验证f或确认活动g designanddevelopmentcontrol;）设计和开发控制;gh specialrequirement,criticalitems,including keycharacteristics;）特殊要求,关键项目,包括关键特性;i test,inspection andverification includingproduction processhverification;）试验,检验和验证（包括生产过程的验ij the useofstatistical techniquesforproductacceptance and证）；related instructionsfor acceptancebytheorganization;）使用组织能接受的统计技术来进行产品验收和jk theneed to:相关说明,-implementaquality management system;）需要-use customer-designated orapproved externalproviders,kincluding processsourcese.g,,special processes;•执行的质量管理体系;-notify theorganization ofnonconforming processes,products or・使用顾客指定或批准的外部供方,包括过程services and obtain approvalfor theirdisposition;来源（如特殊过程）；-prevent theuseofcounterfeit productssee
8.
1.4;•向组织通报不合格的过程,产品或服务并获得处置批准;notify theorganization ofchanges toprocesses,products orservices,including changesofexternalproviders orlocation of•预防假冒件的使用（见）manufacture,andobtaintheir approval;
8.
1.4;-flow downto theirexternalprovidersapplicable requirements•通知组织过程/产品或服务的更改,包括外部供方including customerrequirements;的更改,生产地点的更改,并获得批准;provide testspecimens eg,production method,number,storageconditions fordesign approval,inspection/verification,investigation•向外部供方传递适用的要求,包括顾客要求;or auditing;•提供试验件用于设计批准、检验/验证、调查或-retaindocumented information,including retentionperiods and审核（例如生产方法,编号,储存条件）;disposition requirements;•需要保留的文件信息,包括保留期和处置要l theright ofaccess bytheorganization,their customer andregulatory authoritiestotheapplicable areasof facilitiesand to求applicable documented information,at anylevel ofthe supply chain;）在供应链的任何层次,组织及其顾客和法规机构im ensuringpersonsareawareof可接触进入到任何适用的场所，和适用文件信息-theircontributiontoproduct andserviceconformity;的权利-theircontributiontoproductsafety;-the importance ofethicalbehavior.）保证人员意识到m
8.5Production andservice provision•他们对产品和服务符合性的贡献;•他们对产品安全的贡献;
8.
5.1Control ofproduction andservice provision•道德行为的重要性°The organizationshall implementproduction andservice provisionunder生产和服务提供
8.5controlled conditions.Controlled conditionsshallinclude,as applicable:生产和服务提供的控制
8.
5.1a theavailability ofdocumented informationthat defines:组织应在受控条件下进行生产和服务提供适用时，受控条件应包括）可获得形成文件的信息，以规定以下内a容1the characteristicsoftheproducts tobe produced,the servicesto beprovided,ortheactivities tobe performed;）所生产的产品、提供的服务或进行的活动的1特性；2the resultstobeachieved;）拟获得的结果2NOTE1Documented informationthat definescharacteristicsof）可获得并使用适宜的监测和测量资源;productsandservices can include drawings,parts lists,materials andb注1确定产品和服务特征的文件的信息包括有process specifications.图纸、零件清单、材料和工艺规范NOTE2Documented informationfor activitiestobeperformed andresultstobeachieved can include processflow charts,control plans,注2活动执行和结果取得的文件的信息包括有production documentseg,manufacturing plans,travelers,routers,过程流程图、控制计划,生产文件（如:制造计划、work orders,process cardsandverificationdocuments.路线图、流程卡、工作指令和工艺卡）和验证文件b theavailability anduseofsuitable monitoring and measuringcthe implementation ofmonitoring and measurementactivities atappropriate stages to verify thatcriteria forcontrol of processes oroutputs,andacceptancecriteria forproductsandservices,havebeen met;1ensuring thatdocumented informationfor monitoringandmeasurement activityforproductacceptance includes:-criteria foracceptance andrejection;-where inthe sequenceverification operationsare tobeperformed;-measurement resultstobe retained ata minimuman indicationofacceptance orrejection;-any specificmonitoringand measurement equipmentrequiredand instructionsassociated with their use;2ensuring thatwhen sampling isusedasameans ofproductacceptance,the samplingplan isjustified onthe basisof recognizedstatisticalprinciples and appropriate for use i.e.,matching thesamplingplan tothe criticalityoftheproduct andtotheprocesscapability.dtheuseofsuitable infrastructureand environmentforthe operationof processes;NOTE Suitableequipment can include productspecific toolse.g.Jigs,fixtures,molds and software programs.etheappointment ofcompetentpersons,including anyrequiredqualification;fthevalidation,and periodicrevalidation,ofthe abilitytoachieveplanned results ofthe processesfor production andserviceprovision,where theresulting outputcannot beverified bysubsequent monitoring or measurement;NOTE Theseprocesses can be referredto asspecial processessee
851.
2.gthe implementation ofactionstoprevent humanerror;htheimplementationofrelease,deliveryandpost-deliveryresources;）在适当的阶段实施监视和测量活动，以验证是否符合过程或输出c的控制准则以及产品和服务的接收准则；1）确保监视和测量产品接收活动的文件的信息包括有:-接收和拒收准则;-按顺序进行验证操作;-保留测量的结果（至少表明接收或拒收）;-要求的任何特定的监视和测量设备及其相关的使用说明;••••2）当使用抽样检验作为产品接收的方法时,抽样计划应基于认可的统计原理,并适于使用（抽样计划应与产品的重要性和过程能力相匹配））为过程的运行提供适宜的基础设施和环d境；注:矗宜的设备包括有产品专用工装（如型架、夹具、模具）和软件程序）配备具备能力的人员，包括所要求的资e格；）若输出结果不能由后续的监测或测量加以验证，应对生产和服务f提供过程实现策划结果的能力进行确认和定期再确认；注:这些过程也被称为特殊过程（见）
8.
5.
1.2°）采取措施防止人为错误；gactivities;）实施放行、交付和交付后活动hi theestablishment of criteriaforworkmanshipfe.g.written i）工艺准则的建立（如书面标准、代表性样本,standards,representative samples,illustrations;插图）;j accountability forallproduct during production e.gr partsj）在生产中对所有产品负有责任（如零件数量、quantities,split orders,nonconforming product;分作业指令、不合格品）;k controland monitoringof identifiedcriticalitems,including keyk）按建立的过程,控制和监视已识别的关键项目,characteristics,in accordancewith establishedprocesses;包括关键特性;l determinationof methodsto measurevariable dataeg,tooling,i）确定方法来测量可变数据（如工具,在线探测，on-machine probing,inspection equipment;检验设备）;m identifyingin-process inspection/verification pointswhenm）在后续阶段不能进行足够验证时,识别过程中adequate verificationof conformancecannot beperformedatlater的检验/验证点;stages;ntheavailability ofevidence that all productionandinspection/verification operationshavebeencompleted asn）可得到所有生产和检验/验证操作已按计划完planned,orasotherwise documentedand authorized;成的证据,或者另外文件批准和授权;o provisionfortheprevention,detection andremoval offoreign）提供预防、检测和去除外来物;objects;p controlandmonitoringof utilitiesand supplieseg,water,compressed air,electricity,chemical productstotheextent theyP）对会影响产品要求符合性的公用设施和供给affect conformitytoproductrequirementssee
7.
1.3;物（如水、压缩空气、电及化学产品）进行监视和控制,q the identificationandrecording of products releasedforsubsequent productionuse pendingcompletionofall requiredq）在所有要求的测量和监视活动完成前,产品被measuring andmonitoring activities,to recalland replacementif it放行到后道工序，应对其进行标识和记录,做到如is alater foundthat theproduct doesnot meetrequirement果后来发现产品不符合要求,能够对其进行召回和更换
8.5A AControl ofproduction equipment,tools andsoftware
8.
5.
1.1生产设备、工装和软件程序的控制programs生产设备、工装和用于自动操作,控制，监视或测Equipment,tools andsoftware programsused toautomate,control,量生产过程的软件程序在最终放行生产前应进行monitor ormeasure production processesshallbe validatedpriorto确认,并维护final releaseforproductionand shallbe maintained.Storage requirementsshallbedefined forproduction equipmentor对储存中的生产设备或工装必须确定储存要求,tooling instorage includinganynecessaryperiodic preservationor包括任何必要的定期防护或状况检查condition checks.
851.2Validation andcontrolofspecial processes
8.
5.
1.2特殊过程的验证和控制For processeswhere theresultingoutputcannot beverified by当过程输出不能由后续的监视或测量加以验证,subsequentmonitoringormeasurement,theorganizationshall组织应对任何这些过程作出安排,适用时包括:establish arrangementsfor these processes including,as applicable:a）规定过程的评审和批准准则;a definitionofcriteriaforthereview andapproval ofthe processes;b）确定保持批准的条件;b determinationof conditionsto maintain theapproval;c approvalof facilitiesandequipment;c）设施和设备的批准;d qualificationofpersons;d）人员资质;euseof specificmethods andprocedures forimplementation ande）对过程的执行和监控使用特定的方法和程序;monitoring theprocesses;f）要求保留的文件的信息frequirementsfor documented informationtoberetained.
8.
5.
1.3生产过程验证
8.
5.
1.3Production processverification组织应执行生产过程验证活动以保证生产过程有The organizationshall implementproduction processverification能力持续生产出满足要求的产品activitiestoensuretheproductionprocessis capableof producingproductsthat consistentlymeetrequirements.NOTE Theseactivitiescaninclude riskassessments,capacity studies,注:这些活动包括风险评估,产能研究,能力研究capability studies,andcontrolplans.和控制计划The organizationshall usea representativeitem fromthe first组织应使用从首批生产的新零件或组件中确定的production runofanew partor assemblytoverifythat theproduction有代表性的项目来验证生产过程、生产文件和工processes,production documentationand toolingare capableof装能够生产满足要求的零件和部件当发生使原producing partsand assembliesthat meetrequirements.Thisactivity来验证结果无效的更改时,应进行重新验证过程shallberepeated whenchanges occurthat invalidatethe original（如工程更改,制造过程更改,工装更改）results eg,engineering changes,productionprocesschanges,tooling changes.NOTE Thisactivity can be referredtoasfirst articleinspection.注:此项活动通常被称为首件检验The organizationshall retaindocumented informationonthe results组织应保留生产过程验证结果的文件的信息ofproductionprocessverification.
8.
5.2Identification andtraceability标识和可追溯性
8.
5.2The organizationshall usesuitable meansto identifyoutputs when itis需要时，组织应采用适当的方法识别输出，以确necessary toensurethe conformityof productsandservices.保产品和服务合格The organizationshall maintain theidentificationoftheconfiguration组织应保持产品和服务技术状态的识别,以识别oftheproductsandservicesin ordertoidentify anydifferences产品实际技术状态和所需技术状态之间的任何不between theactual configurationand therequired configuration.同The organizationshall identifythe status of outputswith respect to组织应在产品和服务提供的整个过程中按照monitoringandmeasurement requirementsthroughout productionand监视和测量要求识别输出状态service provision.When acceptanceauthority mediaare usedeg,stamps,electronic当使用可接受授权媒介时（如印章、电子签名、signatures,passwords,theorganizationshall establishappropriate密码）,组织应对媒介建立适当的控制controlsforthe media.The organizationshall controlthe uniqueidentificationofthe outputs若要求可追溯，组织应控制输出的唯一性标识，when traceabilityisarequirement,and shall retain thedocumented且应保留实现追溯性所需的形成文件的信information necessary to enabletraceability.NOTE Traceabilityrequirementscaninclude:注:追溯要求包括:-theidentificationtobemaintained throughouttheproductlife;-在产品寿命期内能保持标识;The organizationshall determineexternal and internal issues that are组织应确定与其目标和战略方向相关并影响relevant toits purposeand itsstrategic directionand thataffect itsability其实现质量管理体系预期结果的各种外部和toachievethe intended results ofits quality management system.内部因素The organizationshall monitorand reviewinformation abouttheseexternal andinternal issues.组织应对这些内部和外部因素的相关信息进行监视和评审NOTE1Issues caninclude positiveand negativefactors orconditions forconsideration.注这些因素可以包括需要考虑的正面和负面1NOTE2Understanding theexternal contextcanbefacilitated byconsidering要素或条件；issues arisingfrom legal,technological,competitive,market,cultural,social,and注通过考虑国际、国家、地区或当地的法律2economic environments,whether international,national,regional orlocal.法规、技术、竞争、市场、文化、社会和经济NOTE3Understanding theinternal contextcanbefacilitated byconsidering因素，有助于理解外部环境issues relatedto values,culture,knowledgeandperformance of theorganization.注考虑组织的价值观、文化、知识和绩效等
34.2Understanding theneeds andexpectations of interested相关因素，有助于理解内部环境parties理解相关方的需求和期望
4.2Due totheir effector potentialeffect onthe organizations ability toconsistentlyprovide productsandservicesthatmeetcustomerand由于相关方对组织持续提供符合顾客要求和适applicable statutoryandregulatoryrequirements,theorganizationshalldetermine:用法律法规要求的产品和服务的能力产生影响a theinterested parties that are relevanttothe quality management或潜在影响，因此，组织应确定system;b therequirements of these interested partiesthat are relevantto thequality management system.a）与质量管理体系有关的相关方；The organizationshall monitorand reviewinformation aboutthese）这些相关方的要求；binterested partiesand theirrelevant requirements.组织应对与这些相关方及其要求的相关信息进
4.3Determining the scope ofthe quality management system行监视和评审The organizationshall determinethe boundariesand applicabilityofthe确定质量管理体系的范围
4.3quality management system toestablish itsscope.When determiningthis scope,theorganizationshall consider:组织应明确质量管理体系的边界和适用性，以a theexternal andinternal issues referredto in
4.1;确定其范围b therequirements ofrelevant interestedparties referredto in
4.2;cthe productsandservicesoftheorganization.在确定范围时，组织应考虑The organizationshall applyall therequirementsofthis International）各种内部和外部因素，见；a
4.1Standard if they areapplicable withinthe determinedscope ofits quality）相关方的要求，见；b
4.2management system.）组织的产品和服务cThe scopeofthe organizationsquality management system shallbe对于本标准中适用于组织确定的质量管理体available andbemaintained as documented information.The scope系范围的全部要求，组织应予以实施shall statethe typesof productsandservicescovered,and providejustificationfor anyrequirement ofthisInternational Standard that theorganization determinesis notapplicabletothe scopeofits quality组织的质量管理体系范围应作为形成文件的信management system.息加以保持该范围应描述所覆盖的产品和服务类型若组织认为其质量管理体系的应用范Conformity tothisInternationalStandard mayonly beclaimed if therequirements determinedas notbeing applicabledonotaffect the围不适用本标准的某些要求，应说明理由那些不适用于组织的质量管理体系要求，不能影响组织确保产品和服务合格以及增强顾客满意的能力或责任，否则不能声称符合本标theabilityto traceall productsmanufactured fromthe same-所有产品能追溯至U由同一批原材料制造,或来自相同制造批次,以及最终去向（如交付、报废）;batch ofraw material,or fromthe samemanufacturing batch,to thedestinatione.g.,delivery,scrap;-对于组件，能追溯其组件以及后面更高一级的组■foranassembly,theabilityto traceits componentstothe件;assembly and then tothenexthigher assembly;-对于产品,能追溯其生产的一系列记录（制造、装•foraproduct,a sequentialrecordofits productionmanufacture,配、检验/验证）assembly,inspection/verificationtobe retrievable.顾客或外部供方的财产
8.
5.3Property belongingtocustomers or externalproviders
8.
5.3防护
8.
5.4The organizationshall exercisecare withproperty belongingto组织在控制或使用顾客或外部供方的财产期customers orexternalproviderswhile itis underthe organizations组间织，应应在对生其产进和行服妥务善提管供理过程中对输出进行control orbeing usedbytheorganization.必要防护，以确保符合要求对组织使用的或构成产品和服务一部分的顾客The organizationshall identify,verify,protect andsafeguardNOTE Preservationcanincludeidentification,handling,contamination control,注和外防部护供可方包财括产标，识组、织处应置予、以污识染别控、制验、证包、装保、customers5orexternalproviders5property providedforuseorpackaging,storage,transmission ortransportation,and protection.incorporationinto theproductsandservices.储护存和、维传护送或运输以及保护Preservation ofoutputs shallalsoinclude,when applicableinWhen theproperty ofa customer orexternalprovider islost,accordancewithspecifications andapplicablestatutoryand在若适顾用客处或,外按部产供品规方范的和财适产用发的生法丢律失法、规损要坏求或,发产damaged orotherwise foundtobeunsuitable foruse,theregulatory requirements,provisions for:品现的不防适护用还情应况包，括组下织列应规向定顾:客或外部供方报告，organizationshallreport thistothecustomerorexternalprovider并保留相关形成文件的信息and retaindocumented informationonwhathas occurred.a cleaning;a.清洁;NOTE Acustomersorexternalprovidersproperty caninclude material,注顾客或外部供方的财产可能包括原材料、零b prevention,detection andremovalofforeignobjects;components,tools andequipment,premises,intellectual propertyandb.预防、检测并去除外来物;部件、工具和设备、顾客的场所、知识产权和personal data.c specialhandling andstorage forsensitive products;个人信息C.对敏感产品的特殊处理和保存;d markingand labelingincluding safetywarnings andcautions;d.标记和挂签,包括安全警示和告诫;e shelflife controland stockrotation;e.有效期控制和库存周转;fspecialhandling andstorage forhazardous materials.f,对危险材料的特殊处理和保存
8.
5.5Post-delivery activities交付后的活动
8.
5.
58.
5.4PreservationThe organizationshall preservethe outputsduringproductionandservice provision,totheextent necessarytoensureconformity torequirements.The organizationshall meetrequirementsforpost-delivery activities组织应满足与产品和服务相关的交付后活动的associated withtheproductsandservices.要求In determiningtheextentof post-delivery activitiesthat arerequired,theorganization shall consider:在确定交付后的活动的覆盖范围和程度时，组织应考虑a statutoryandregulatoryrequirements;）法律法规要求；ab the potential undesiredconsequences associatedwith itsproductsand services;）与产品和服务相关的潜在的不期望的后果；bc thenature,useandintended lifetimeofitsproductsandservices;）其产品和服务的特性、用途和预期寿命；cd customerrequirements;ecustomer feedback;）顾客要求；d）顾客反馈；ef collectionand analysisofin-service dataeg,performance,reliability,lessons learned;f）对使用中数据的收集和分析（如性能,可靠性,gcontrol,updating,and provisionof technicaldocumentation经验教训）;relatingtoproduct use,maintenance,repair andoverhaul;h controlsrequired forwork undertakenexternal totheg）控制,更新和提供关于产品使用,维护,修理和organization eg,off-site work;大修的技术文件;i product/customer supporte.g.,queries,training,warranties,h）在组织外部现场工作的控制要求（如外场工maintenance,replacement parts,resources,obsolescence.作）;When problemsare detectedafter delivery,theorganizationshalltake appropriate action includinginvestigation andreporting.1）产品/客户支援（如询问,培训，索赔,维修,更换零件,资源,报废）当交付后发现问题时,组织应采取的措施,包括调查和报告NOTE Post-delivery activitiescanincludeactions注交付后活动可能包括担保条款所规定的相under warrantyprovisions,contractual obligations关活动，诸如合同规定的维护服务，以及回收或such asmaintenance services,and supplementary最终报废处置等附加服务services suchas recyclingorfinaldisposal.
8.
5.6Control ofchanges更改控制
8.
5.6The organizationshall reviewandcontrol组织应对生产和服务提供的更改进行必要的评changes forproduction orservice provision,tothe extent necessarytoensure continuing审和控制，以确保稳定地符合要求conformity withrequirements.应识别批准提供生产或服务更改的授权人员Persons authorizedto approveproduction orservice provision changesshallbeidentified.注:提供生产或服务更改会包括影响过程,生产设备,工具或软件程序的更改NOTE:production orserviceprovisionchangescan includethe changes affecting processes,production equipment,tools,or software组织应保留形成文件的信息，包括有关更改评program.审结果、授权进行更改的人员以及根据评审所采取的必要措施The organizationshall retaindocumentedinformation describingthe resultsofthereview ofchanges,the persons authorizing thechange,and anynecessaryactions arisingfromthereview.产品和服务的放行
8.
68.6Release ofproductsandservicesThe organizationshallimplementplanned arrangements,atappropriatestages,toverifythat theproductandservice组织应在适当阶段实施策划的安排，以验证产requirements havebeen met.品和服务的要求已被满足When productis releasedfor subsequentproductionusependingcompletion ofallrequiredmeasurement andmonitoring activities,it在所有要求的测量和监视活动完成前产品被放行shallbeidentified andrecorded toallow recalland replacementif itis到后续生产,应对其进行标识和记录,做到如果后later foundthat theproduct doesnotmeetrequirements.来发现产品不符合要求,能够对其进行召回和更换The releaseofproductsandservicestothecustomer shallnot组织应根据不符合的性质及其对产品和服务的除非得到有关授权人员的批准，适用时得到顾proceed untilthe plannedarrangements havebeen satisfactorily影响采取适当的措施，这也适用于产品交付之completed,unless otherwiseapproved bya relevantauthority and,as客的批准，否则在策划的安排已圆满完成之前，后发现的不合格产品，以及在服务提供期间或applicable,bythecustomer.不应向顾客放行产品和交付服务之后发现的不合格服务The organizationshall retaindocumentedinformationonthe releaseof组织应保留有关产品和服务放行的形成文件的productsandservices.The documentedinformation shallinclude:组织不符合控制过程应保持下列文件的信息,包信息形成文件的信息应包括括:a evidence ofconformitywiththeacceptancecriteria;）符合接收准则的证据；ab traceabilitytothe personsauthorizingtherelease.）授权放行人员的可追溯信息bWhen required to demonstrateproduct qualification,the organizationshall ensurethatretained documentedinformation providesevidence当要求展示产品合格时,组织应保证保留的文件that theproductsandservicesmeetthe definedrequirements.的信息提供证据表明产品和服务已满足确定的要求The organizationshall ensurethatalldocumentedinformation组织应保证所有要求的文件的信息应随同产品和requiredtoaccompany theproductsandservicesarepresent at服务交付时一起提供delivery.
8.7Control ofnonconforming outputs不符合输出的控制
8.
78.
7.1The organizationshallensurethat outputsthatdonot conformto组织应确保对不符合要求的输出进行识
8.
7.1their requirementsareidentifiedandcontrolledtopreventtheir别和控制，以防止其非预期的使用或交付unintended useor delivery.NOTE Theterm nonconforming outputs includesnonconforming注术语“不符合输出”包括内部生成,收到的productorservice generatedinternally,received fromanexternal外部供方或顾客识别的不合格产品或服务provider,or identifiedbyacustomer.The organizationshalltakeappropriateactionbased onthenature ofthe nonconformity anditseffectonthe conformityofproductsandservices.This shallalso applyto nonconforming productsandservicesdetected after delivery ofproducts,during orafter theprovision ofservices.The organizationsnonconformance controlprocessshallbemaintained asdocumentedinformationincluding theprovisions for:-规定对不符合输出的评审和处置的职责和权限,以及批准人员作出决定的过程;-defining the responsibility andauthority forthereviewand-采取必要的措施，控制不符合在其它过程,产品disposition ofnonconformingoutputsand theprocessforapproving或服务的影响;persons makingthese decisions;-给顾客或相关利益方及时报告影响到已交付的-taking actionsnecessarytocontain theeffect ofthe产品和服务的不符合情况;nonconformity onother processes,products orservices;-timely reportingofnonconformitiesaffecting deliveredproductsandservicestothecustomerandto relevant interestedparties;-不合格产品和服务在交付后发现时，应确定纠正-defining corrective actions fornonconforming productsand措施,同时适合于它们的影响services detectedafterdelivery,as appropriatetotheirimpacts see
10.
2.（见
10.2）；NOTE Interestedparties requiringnotification ofnonconforming注:要求通知不合格产品和服务的利益相关方可能productsandservices caninclude externalproviders,internal包括外部供方、内部组织、顾客、分销商和法规organizations,customers,distributors andregulatory authorities.机构The organizationshall deal with nonconformingoutputs inone ormore组织应通过下列一种或多种途径处置不合格输ofthefollowing ways:出a correction;）纠正；ab segregation,containment,return orsuspension ofprovisionof）对提供产品和服务进行隔离、限制、退货或bproducts andservices;暂停；c informingthecustomer;c）告知顾客；d obtainingauthorization foracceptance underconcession bya）逋过拓关注规极蹴得让步接收的授权，适用drelevant authorityand,whenapplicable,bythecustomer.时,由顾客批准Dispositions ofuse-as-is orrepair fortheacceptanceof原样超差使用或返修处置来接受不合格品应满足nonconformingproductsshall onlybe implemented:下列要求:-after approvalby anauthorized representativeoftheorganization-只有经过负责设计组织的授权代表或者是设计组responsible fordesign orby personshaving delegatedauthority from织的委托授权人员批准;thedesignorganization;-after authorizationbythecustomer,ifthe nonconformity results-如果不合格导致偏离合同要求,应经过顾客授权inadeparture fromthe contractrequirements.批准Product dispositionedfor scrapshallbeconspicuously and处置为报废的产品,必须做出明显的和永久性的标permanently marked,or positivelycontrolled,until physically记,或进行肯定地控制,直至在物理上不可能被使rendered unusable.用Counterfeit,or suspectcounterfeit,parts shallbecontrolledto假冒件或者是怀疑的假冒件应控制防止再次进prevent reentryintothesupplychain.入供应链Conformity totherequirementsshallbeverified whennonconformingoutputs arecorrected.对不合格输出进行纠正之后应验证其是否符合要求
1.
1.2The organizationshall retaindocumentedinformationthat:组织应保留下列形成文件的信息:
8.
7.2a describesthe nonconformity;）有关不合格的描述；ab describestheactions taken;）所采取措施的描述；bc describesany concessionsobtained;）获得让步的描述；cd identifiesthe authoritydeciding theaction inrespect of thenonconformity.）处置不合格的授权标识d9Performance evaluation绩效评价
91.2Monitoring,measurement,analysis andevaluation监视、测量、分析和评价
9.1组织应确定a whatneeds tobe monitoredand measured;）需要监视和测量的对象;ab themethods formonitoring,measurement,analysis and）确保有效结果所需的监视、测量、分析和评evaluation needed toensurevalid results;b价方法；c whenthemonitoringandmeasuringshallbeperformed;）实施监视和测量的时机；cd whentheresultsfrom monitoringandmeasurementshall beanalysedand evaluated.）分析和评价监视和测量结果的时机dThe organizationshall evaluatethe performance and theeffectiveness ofthe quality management system.组织应评价质量管理体系的绩效和有效性组织应保留适当的形成文件的信息，作为结果的The organizationshall retainappropriate documentedinformation as证据evidenceoftheresults.顾客满意
9.
1.2Customer satisfaction
9.
1.2The organizationshall monitorcustomers,perceptions ofthe degreeto组织应监视顾客对其需求和期望获得满足的程which theirneeds andexpectations havebeen fulfilled.The度的感受组织应确定这些信息的获取、监视organizationshall determinethemethods forobtaining,monitoringand和评审方法reviewing thisinformation.注监视顾客感受的例子可包括顾客调查、顾客NOTE Examplesofmonitoringcustomer perceptionscaninclude customersurveys,customerfeedbackon deliveredproductsandservices,meetings with对交付产品或服务的反馈、顾客会晤、市场占customers,market-share analysis,compliments,warranty claimsand dealer有率分析、赞扬、担保索赔和经销商报告reports.监视和用于评价顾客满意的信息应包括,但不限Information tobe monitoredand usedfortheevaluation of customer于:产品和服务的符合性,准时交付业绩,顾客抱怨satisfaction shallinclude,but isnot limitedto,productandserviceconformity,on-time deliveryperformance,customercomplaintsand和纠正措施请求corrective actionrequests.The organizationshall developand implementplans forcustomer组织应开发和实施顾客满意度改进计划来解决satisfaction improvementthat addressdeficiencies identifiedby评价而识别出的不足，并评估结果的有效性these evaluations,andassessthe effectiveness oftheresults.The organizationshall determine:
9.
1.3Analysis andevaluation分析与评价The organizationshall analyseand evaluateappropriate dataand组织应分析和评价通过监视和测量获得的适宜information arisingfrom monitoringandmeasurement.数据和信息NOTE Appropriatedata caninclude informationon productand注:适宜数据包括来源于外部报告的关于产品和service problemsreported byexternalsourcese.g.,服务问题的信息（如政府或行业通报,公告）government/industry alerts,advisories.The resultsof analysisshallbeusedtoevaluate:应利用分析结果评价）产品和服务的符合性；aa conformityofproductsandservices;）顾客满意程度；b thedegree ofcustomer satisfaction;bc the performance and effectiveness ofthe quality management）质量管理体系的绩效和有效性；csystem;）策划是否得到有效实施；dd ifplanning hasbeen implementedeffectively;ethe effectivenessofactions takento address risks and）针对风险和机遇所采取措施的有效性;eopportunities;）外部供方的绩效；ff theperformance ofexternalproviders;gtheneed for improvements tothe quality management system.g）质量管理体系改进的需求NOTE Methodsto analysedata caninclude statisticaltechniques.注数据分析方法可以包括统计技术内部审核
9.
29.2Internal audit
9.
2.1The organizationshallconductinternal auditsat plannedintervals组织应按照策划的时间间隔进行内部审
9.
2.1toprovideinformationonwhether the quality management system;核，以提供有关质量管理体系的下列信息:是否符合.a conformsto:）组织篇的质量管理体系要求；1the organizations own requirementsforits quality management1system;注:组织自身要求包括顾客和适用法规机构对质NOTE The organizationsownrequirementscanincludecustomer量管理体系的要求andapplicablestatutoryandregulatory quality management systemrequirements.）本标准的要求22therequirementsofthisInternationalStandard;）得到有效的实施和保持bb iseffectively implemented andmaintained.注:进行内部审核时,绩效指标用来评估确定质量NOTE Whenconducting internalaudits,performance indicatorscan管理体系是否得到有效实施和维护be evaluatedto determinewhether the qualitymanagement system iseffectivelyimplementedandmaintained.组织应
9.
2.
29.
2.2The organizationshall:）依据有关过程的重要性、对组织产生影响的aplan,establish,implement andmaintain anaudit programmesa变化和以往的审核结果，策划、制定、实including thefrequency,methods,responsibilities,planningrequirements andreporting,which shalltakeintoconsideration the施和保持审核方案，审核方案包括频次、importanceoftheprocessesconcerned,changesaffectingthe方法、职责、策划要求和报告；organization,and theresultsofprevious audits;b definethe auditcriteria andscope foreach audit;b）规定每次审核的审核准则和范围；选择可确保审核过程客观公正的审核员ccselect auditorsand conductaudits toensure objectivityand the实施审核；impartiality ofthe auditprocess;d ensurethat theresultsofthe auditsare reportedto relevantd）确保相关管理部门获得审核结果的报告;management;）及时采取适当的纠正和纠正措施；ee takeappropriate correctionand corrective actions withoutunduedelay;）保留作为实施审核方案以及审核结果的证f据的形成文件的信息f retaindocumentedinformationasevidenceof theimplementationoftheaudit programmeand theaudit results.注相关指南参见ISO19011oNOTE SeeISO19011for guidance.管理评审
9.
39.3Management review总则
9.
3.1General
9.
3.1最高管理者应按策划的时间间隔对组织的质量Top managementshall reviewtheorganizationsquality管理体系进行评审，以确保其持续的保持适management system,at plannedintervals,toensureits continuing宜性、充分性和有效性，并与组织的战略方向一suitability,adequacy,effectiveness andalignment withthe strategic致direction oftheorganization.管理评审输入
9.
3.
29.
3.2Management reviewinputsThe management reviewshallbe planned and carriedout takinginto策划和实施管理评审时应考虑下列内容a）consideration:以往管理评审所采取措施的实施情况;a thestatusofactions fromprevious management reviews;b与质量管理体系相关的内外部因素的变化；b changesin externalandinternalissuesthatarerelevanttothe qualitymanagement system;有关质量管理体系绩效和有效性的信息,cc informationontheperformanceandeffectivenessofthe quality包括下列趋势性信息顾客满意和相关方management system,including trendsin:1的反馈；1customer satisfactionand feedbackfrom relevantinterested）质量目标的实现程度;2parties;2theextentto whichquality objectiveshavebeenmet;3）过程绩效以及产品和服务的符合性;3process performanceand conformityofproductsandservices;）不合格以及纠正措施;44nonconformities and corrective actions;）监视和测量结果;55monitoringandmeasurement results;6）审核结果；6audit results;）外部供方的绩效77theperformance ofexternalproviders;8）准时交付业绩;8on-time deliveryperformance;）资源的充分性；dd theadequacyofresources;）应对风险和机遇所采取措施的有效性（见ee the effectivenessofactionstakento address risks andopportunitiessee
6.1;
6.1）；）改进的机会ff opportunities for improvement.管理评审输出
9.
3.39-3-3Management reviewoutputs管理评审的输出应包括与下列事项相关的决The outputsofthe managementreviewshallincludedecisions and定和措施actions relatedto:）改进的机会；aa opportunitiesfor improvement;）质量管理体系所需的变更;bb anyneed for changes tothe qualitymanagement system;）资源需求；cc resourceneeds;d）风险识别drisksidentified.组织应保留作为管理评审结果证据的形成文The organizationshall retaindocumentedinformationasevidenceof件的信息theresultsof managementreviews.改进1010Improvement
10.1General组织应确定和选择改进的机会，采取必要的措The organizationshall determineand selectopportunitiesfor施，满足顾客要求和增强顾客满意improvement and implement anynecessaryactionstomeetcustomerrequirements andenhance customer satisfaction.这应包括These shallinclude:）改进产品和服务以满足要求并关注未来aa improvingproductsandservicestomeetrequirementsas wellas to的需求和期望；address futureneedsandexpectations;）纠正、预防或减少不利影响；bb correcting,preventing orreducing undesired effects;）改进质量管理体系的绩效和有效性cc improvingtheperformanceandeffectivenessofthe qualitymanagement system.注改进的例子可包括纠正、纠正措施、持续改进、突变、创新和重组NOTE Examplesofimprovementcanincludecorrection,corrective action,continual improvement,breakthrough change,innovation andreorganization.不合格和纠正措施
10.
210.2Nonconformity andcorrective action若出现不合格，包括由投诉所引起的不
10.
2.1合格，组织应
10.
2.1Whenanonconformity occurs,includinganyarising fromcomplaints,theorganizationshall:）对不合格做出应对，适用时aa reacttothenonconformity and,as applicable:）采取控制措施予以控制和纠正；11take actiontocontrolandcorrectit;）处置产生的后果22dealwiththe consequences;）通过下列活动，评价是否需要采取措施，以b消除产生不合格的原因，避免其再次发生b evaluatetheneedfor actionto eliminatethe causes ofthenonconformity,inorderthatitdoesnotrecur oroccur或者在其他场合发生elsewhere,by:）评审和分析不合格；11reviewing andanalysing thenonconformity;2determiningthecausesofthenonconformity,including those2）确定不合格的原因，包括人为因素、relatedtohuman factors,）确定是否存在或可能发生类似的不合格33determining ifsimilar nonconformitiesexist,or couldpotentiallyoccur;）实施所需的措施；cc implementany actionneeded;评审所采取的纠正措施的有效性；dd reviewthe effectivenessof any correctiveactiontaken;需要时，更新策划期间确定的风险和机遇；e updaterisks and opportunities determinedduring planning,ifnecessary;需要时，变更质量管理体系f makechanges tothe qualitymanagement system,if necessary;g当确定是外部供方对不符合负责时,向外部供g flowdown correctiveaction requirementstoanexternalprovider方传递纠正措施的要求;whenitis determinedthattheexternalprovideris responsiblefor thenonconformity;,、当不能及时和有效地采取纠正措施时,需采取h特定措施h takespecificactionswhen timelyandeffectivecorrective actionsarenot achieved;纠正措施应与所产生的不合格的影响相适应Corrective actionsshallbeappropriatetothe effectsofthe组nonconformities encountered.织The organizationshall maintaindocumentedinformationthat应defines thenonconformityandcorrectiveactionmanagement保process.持
10.
2.2The organizationshallretaindocumentedinformationas规evidenceof:定管理不合格和纠正措施过程的文件的信息）纠正措施的结果b组织应保留形成文件的信息，作为下列事项的证据
10.
2.2持续改进
10.3）不合格的性质及随后所采取的措施；a组织应持续改进质量管理体系的适宜性、充分性和有效性a thenatureofthe nonconformitiesandanysubsequent actionstaken;b theresultsofanycorrectiveaction.组织应考虑管理评审的分析和评价的结果，以及管理评审的输出，确定是否存在持续改进的
10.3Continual Improvement需求或机会The organizationshall continually improve thesuitability,adequacy and组织应监视改进活动的实施情况，并评价结果的effectivenessofthe qualitymanagement system.有效性The organizationshall considertheresultsof analysisandevaluation,andthe outputs frommanagementreview,to determineifthereare注:持续改进机会来自经验教训、问题的解决和最needs oropportunities thatshallbe addressed aspartofcontinual佳实践的标杆管理improvement.The organizationshall monitortheimplementationof improvementactivitiesand evaluatetheeffectivenessoftheresults.NOTE Continualimprovement opportunitiescan resultfrom lessonslearned,problem resolutionsandthebenchmarking ofbest practices.organizationsabilityor responsibilitytoensuretheconformityofits准productsandservices andthe enhancementofcustomersatisfaction.质量管理体系及其过程
4.
410.4Quality managementsystemandits processes组织应按本标准的要求，建立、实施、保
4.
4.
110.
4.1The organizationshall establish,implement,maintain and持和持续改进质量管理体系、包括所需过程及continuallyimproveaqualitymanagementsystem,including the其相互作用processes neededand theirinteractions,inaccordancewith therequirementsofthisInternationalStandard.The organizationsqualitymanagementsystemshallalso address组织的质量管理体系也应考虑顾客和适用法律customerandapplicablestatutoryandregulatoryquality法规对质量管理体系要求managementsystemrequirements.组织应确定质量管理体系所需的过程及其在The organizationshall determinetheprocesses needed forthe quality整个组织中的应用，且应managementsystemand theirapplication throughouttheorganization,and shall:）确定这些过程所需的输入和预期的输出;aa determinethe inputsrequired andtheoutputsexpected fromtheseprocesses;）确定这些过程的顺序和相互作用;bb determinethe sequenceand interactionofthese processes;c确定和应用所需的准则和方法（包括监视、c determineand applythe criteriaand methodsincluding monitoring,测量和相关绩效指标），以确保这些过程measurements andrelated performanceindicators neededtoensure有效运行和有效控制；theeffectiveoperation andcontrolofthese processes;dd determinethe resourcesneeded for theseprocessesand ensuretheiravailability;e确定并确保获得这些过程所需的资源;e assignthe responsibilities and authorities for theseprocesses;规定与这些过程相关的责任和权限；f addresstherisks and opportunitiesas determinedin accordancewiththerequirementsof
6.1;f）应对按照
6.1的要求所确定的风险和机遇;g evaluatetheseprocessesandimplementany changesneededto）评价这些过程，实施所需的变更，以确保实gensure thattheseprocessesachieve theirintended results;现这些过程的预期结果；h improvetheprocessesandthequalitymanagementsystem.）改进过程和质量管理体系hNOTE Subclausesa throughh areconsidered essentialto theadoptionofaprocess approachas describedin clause03注:条款a）至此）被认为是对章节
0.3中描述的过程方法的采纳
10.
4.2To theextentnecessary,theorganizationshall:在必要的程度上，组织应
4.
4.2a maintaindocumentedinformationtosupportthe operation of itsprocesses;）保持形成文件的信息以支持过程运行；ab retaindocumentedinformationto haveconfidence thatthe）保留确认其过程按策划进行的形成文件的信bprocesses arebeing carriedoutasplanned.息The organizationshall establishandmaintaindocumentedinformation thatincludes:组织应建立和维护一个文件的信息,包括:-a generaldescription ofrelevantinterestedparties see42；a-相应相关方的通用描述（见
4.2a）；-质量管理体系的范围，包括边界和适用性（见-thescopeofthequalitymanagementsystem,includingboundaries andapplicability see
4.3;）；
4.3-质量管理体系所需的过程和其在组织中应用的-a descriptionoftheprocesses neededforthequalitymanagement systemand theirapplication throughoutthe描述;organization;-the sequenceand interactionoftheseprocesses;-这些过程的次序和关系;-assignmentoftheresponsibilities andauthoritiesforthese-这些过程的职责分配和权限;processes;-为质量管理体系而建立或者引用的文件的信息•thedocumentedinformation established forthequalitymanagement system,orreferencetoit注:上述质量管理系统的描述可以遵从一个单一NOTE Theabove descriptionofthequalitymanagementsystem文件的信息的来源，称为质量手册canbecomplied intoa singlesource ofdocumented informationandreferredtoasaquality manual.领导作用55Leadership领导作用和承诺
5.
15.1Leadership andcommitment总则
5.
1.1General最高管理者应证实其对质量管理体系的领导Top managementshall demonstrateleadership andcommitment作用和承诺，通过with respecttothequalitymanagementsystem by:a takingaccountabilityfortheeffectivenessofthequality）对质量管理体系的有效性承担责任；amanagement system;）确保制定质量管理体系的质量方针和质量bb ensuringthatthequality policyand quality objectives are目标，并与组织环境和战略方向相一致；establishedforthequalitymanagementsystemand arecompatiblewiththecontext andstrategic directionoftheorganization;）确保质量管理体系要求融入组织的业务过c程；c ensuringthe integrationofthequalitymanagementsystemrequirements intotheorganizationsbusiness processes;）促进使用过程方法和基于风险的思维；dd promotingtheuseoftheprocess approachand risk-basedthinking;）确保获得质量管理体系所需的资源；ee ensuringthattheresourcesneededforthequality managementsystemare available;f communicatingtheimportanceof effectivequalitymanagement）沟通有效的质量管理和符合质量管理体系要fand ofconforming tothequalitymanagementsystem求的重要性；requirements;）确保实现质量管理体系的预期结果；g ensuringthatthequalitymanagementsystem achievesits gintended results;h engaging,directing andsupporting personsto contributetothe）促使、指导和支持员工努力提高质量管理体heffectiveness ofthequalitymanagementsystem;系的有效性；i promotingimprovement;）推动改进；ij supportingother relevantmanagement rolestodemonstrate）支持其他管理者履行其相关领域的职责jtheir leadershipas itapplies totheir areasof responsibility.注本标准使用的“业务”一词可大致理解为NOTE Referenceto“business inthisInternationalStandard canbe interpretedbroadlyto meanthose activitiesthatarecore tothe purposesof涉及组织存在目的的核心活动无论是公营theorganizationsexistence,whether theorganization ispublic,private,for profitor not私营:盈利或非盈利组for profit.织、
5.
1.2Customer focus以顾客为关注焦点Top managementshall demonstrateleadership andcommitment withrespecttocustomer focusby ensuringthat:导最作高用管和理承者诺应，证通实过其以顾客为关注焦点的领acustomerandapplicablestatutoryandregulatoryrequirementsare）确定、理解并持续满足顾客要求以及适用的adetermined,understood andconsistently met;法律法规要求；b therisks andopportunities thatcan affectconformityofproductsandservices andtheabilitytoenhance customersatisfaction are）确定和应对能够影响产品和服务的符合性，bdetermined andaddressed;以及增强顾客满意能力的风险和机遇；）始终致力于增强顾客满意cc thefocus onenhancing customersatisfaction ismaintained;d）产品和服务的符合性和及时交付业绩应得到测dproductandserviceconformityandon-time deliveryperformanceare measuredandappropriateaction istaken if量,如果期望的结果不能或将不能实现时,应intendedresultsarenot,or willnotbe,achieved.采取适当的措施
5.2Policy方针
5.2制定质量方针
5.
2.
15.
2.1Developing thequality policy最高管理者应制定、实施和保持质量方针质量Top managementshall establish,implement andmaintainaqualitypolicy that:方针应）适应组织的宗旨和环境并支持其战略方aa isappropriatetothepurposeand contextoftheorganizationand向；supports itsstrategic direction;b providesa frameworkfor settingquality objectives;b）为制定质量目标提供框架;c includesa commitmentto satisfyapplicable requirements;）包括满足适用要求的承诺;cd includesa commitmentto continualimprovement ofthequality）包括持续改进质量管理体系的承诺dmanagement system.沟通质量方针
5.
2.2Communicating thequality policy
5.
2.2The qualitypolicy shall:质量方针应a beavailableandmaintainedasdocumentedinformation;）作为形成文件的信息，可获得并保持;ab becommunicated,understood andapplied withintheorganization;）在组织内部得到沟通、理解和应用；bc beavailable torelevantinterestedparties,as appropriate.）适当时，可向有关相关方提供C
5.3Organizational roles,responsibilities andauthorities组织的岗位、职责和权限
5.3最高管理者应确保整个组织内相关的职责、权Top managementshallensurethattheresponsibilitiesand限得到分配、沟通和理解authoritiesforrelevant rolesare assigned,communicated andunderstoodwithintheorganization.Top managementshall assigntheresponsibility andauthorityfor:最高管理者应分配职责和权限，以:a ensuringthatthequalitymanagementsystem conformsto therequirementsofthisInternationalStandard;）确保质量管理体系符合本标准的要求;ab ensuringthattheprocesses aredelivering theirintended）确保各过程获得其预期输出;boutputs;c reportingontheperformanceofthequalitymanagementsystemand报告质量管理体系的绩效及改进机会（见on opportunitiesforimprovementsee
10.1,in particulartoctopmanagement;）特别是向最高管理者报告；
10.1,d ensuringthe promotionofcustomerfocus throughoutthe）确保在整个组织推动以顾客为关注焦点;dorganization;e ensuringthattheintegrity ofthequalitymanagementsystemis）确保在策划和实施质量管理体系变更时保持emaintained whenchanges tothequalitymanagementsystemare其完整性plannedandimplemented.Top managementshall appointa specificmember ofthe最高管理者应在管理层中任命一个特定人员作为organizations management,identifiedasthemanagement管理者代表,应具有监督上述要求的职责和授权representative,who shallhave theresponsibilityandauthority foroversightoftheabove requirements.The managementrepresentative shallhave organizationalfreedom管理者代表应具有解决有关质量管理问题上的组and unrestrictedaccess totop managementto resolvequality织自主权和不受限制地可接触到最高管理层management issues.NOTE Theresponsibility ofa managementrepresentative can注:管理者代表的职责可包括与质量管理体系有关include liaisonwithexternalparties onmatters relatingtothequality事宜的外部联络managementsystem.6Planning策划
66.1Actions to addressrisksandopportunities应对风险和机遇的措施
6.
16.
1.1When planningforthequalitymanagementsystem,the策划质量管理体系时、组织应考虑所描述的
4.1organizationshallconsidertheissuesreferredto in
4.1andthe因素和所提及的要求，确定需要应对的风requirements referredtoin
4.2and determinetherisksand
4.2opportunities thatneed tobeaddressedto:险和机遇，以便a giveassurance thatthequalitymanagementsystemcan）确保质量管理体系能够实现其期望结果;aachieve itsintendedresults;b enhancedesirable effects;b）增强有利影响；c prevent,or reduce,undesiredeffects;）避免或减少不利影响；cd achieveimprovement.）实现改进d
6.
1.2The organizationshallplan:组织应策划
6.
1.2a actionsto addressthese risksandopportunities;）应对这些风险和机遇的措施;ab howto:）如何b）在质量管理体系过程中整合并实施这些措施11integrate andimplement theactions intoitsqualitymanagementsystem processessee
4.4;（见
4.4）；2evaluatetheeffectivenessofthese actions.）评价这些措施的有效性2Actions takentoaddressrisksandopportunities shallbe应对风险和机遇的措施都应与其对于产品和服务符合性的潜在影响相适应proportionate tothepotentialimpact ontheconformityofproductsandservices.注应对风险可包括规避风险、为寻求机遇而1NOTE1Options toaddressriskscanincludeavoiding risk,taking riskinorder承担风险、消除风险源、改变风险的可能性和to pursuean opportunity,eliminating therisk source,changing thelikelihoodor consequences,sharing therisk,or retainingrisk byinformed decision.后果、分担风险、或通过明智决策延缓风险注机遇可能会导致采用新实践、推出新产品、2NOTE2Opportunities canlead tothe adoptionof newpractices,launching new开辟新市场、赢得新客户、建立合作伙伴关系、products,opening newmarkets,addressing newclients,building partnerships,using newtechnology andother desirableand viablepossibilities toaddressthe利用新技术以及能够解决组织或其顾客需求的organizations orits customers1needs.其它有利的可能性
6.2Quality objectivesand planningtoachievethem质量目标及其实现的策划
6.
26.
2.1The organizationshall establishquality objectivesatrelevant组织应对质量管理体系所需的相关职
6.
2.1functions,levels andprocessesneededforthequalitymanagement能、层次、过程设定质量目标system.质量目标应The quality objectives shall:a beconsistent withthequalitypolicy;）与质量方针保持一致;ab bemeasurable;）可测量；b）考虑到适用的要求；cc takeinto accountapplicable requirements;dberelevanttoconformityofproductsandservicesandto）与提供合格产品和服务以及增强顾客满意denhancement ofcustomersatisfaction;相关；ebemonitored;）予以监视；ef becommunicated;）得到沟通；fg beupdated asappropriate.）适时更新gThe organizationshall maintaindocumentedinformationonthe组织应保留有关质量目标的形成文件的信息qualityobjectives.策划如何实现质量目标时，组织应确定
6.
2.2When planninghowtoachieve itsqualityobjectives,the
6.
2.2organizationshall determine:）采取的措施；aa whatwill bedone;）需要的资源；bb whatresources w川be required;）由谁负责；cc whowill beresponsible;）何时完成；dd whenitwillbe completed;ehowtheresultswillbeevaluated.）如何评价结果e变更的策划
6.
36.3Planning ofchanges当组织确定需要对质量管理体系进行变更时,When theorganization determinestheneedforchangestothequality此种变更应经策划并系统地实施（见）组
4.4managementsystem,the changesshallbecarriedoutinaplanned织应考虑到manner see
4.
4.）变更的目的及其潜在后果；aThe organizationshallconsider:a thepurposeofthe changesand theirpotentialconsequences;）质量管理体系的完整性;bb theintegrity ofthequalitymanagementsystem;）资源的可获得性；cc theavailability ofresources;）职责和权限的分配和再分配dtheallocation orreallocation ofresponsibilitiesandauthorities.d支持77Support资源
7.
17.1Resources总则
7.
1.
17.
1.1General组织应确定并提供为建立、实施、保持和持续改The organizationshall determineand providetheresourcesneeded fortheestablishment,implementation,maintenance andcontinual进质量管理体系所需的资源improvementofthequalitymanagementsystem.组织应考虑Theorganizationshallconsider:a thecapabilities of,and constraintson,existing internala）现有内部资源的能力和约束；resources;）需要从外部供方获得的资源bb whatneedstobeobtainedfromexternalproviders.人员
7.
1.
27.
1.2PeopleThe organizationshall determineand providethepersons组织应确定并提供所需要的人员，以有效实施necessaryfortheeffectiveimplementationofitsquality质量管理体系并运行和控制其过程managementsystemand forthe operationandcontrolof itsprocesses.基础设施
7.
1.
37.
1.3Infrastructure组织应确定、提供并维护过程运行所需的基础Theorganizationshalldetermine,provide andmaintainthe设施，以获得合格产品和服务infrastructure necessaryfortheoperationofits processesand toachieve conformityofproductsandservices.注基础设施可包括NOTE Infrastructurecaninclude:a buildingsand associatedutilities;）建筑物和相关设施；ab equipmentincluding hardwareandsoftware;）设备，包括硬件和软件；bc transportationresources;）运输资源；cd informationandcommunicationtechnology.）信息和通讯技术d
7.
1.4Environment fortheoperationofprocesses过程运行环境
7.
1.5Theorganizationshalldetermine,provide andmaintainthe组织应确定、提供并维护过程运行所需的环environment necessaryfortheoperationofits processesandto境，以获得合格产品和服务achieveconformityofproductsandservices.注适当的过程运行的环境可以是人为因素和NOTE Asuitable environmentcanbea combinationof humanand physicalfactors,suchas:物理因素的组合，例如absp oscyc iahlo leo.g gi.c naol ne-d.gis.cs rtir mesins a-r teod ryu,c cinag lm,,bu nron no-cu otnp frre ovne tantt iioo nna,le;motionally a）社会因素（如无歧视，和谐稳定，无对抗）;protective;）心理因素（如舒缓心理压力、预防过度疲劳、b保护个人情感）；。
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