IATF16949标准条款细目

条款细目英文版1 Scope This International Standard specifies requirements for a quality management systemwhen an organization: a) needs to demonstrate its ability to consistently provide products andservices that meet customer and applicable statutory and regulatory requirements, and b) aimsto enhance customer satisfaction through the effective application of the system, includingprocesses for improvement of the system and the assurance of conformity to customer andapplicable statutory and regulatory requirements. All the requirements of this InternationalStandard are generic and are intended to be applicable to any organization, regardless of itstype or size, or the products and services it provides. NOTE 1 In this International Standard, theterms “product” or “service” only apply to products and services intended for, or required by, acustomer. NOTE 2 Statutory and regulatory requirements can be expressed as legalrequirements.1.1 Scope —automotive supplemental to ISO 9001:2015 This Automotive CAMS Standarddefines the quality management system requirements for the design and development,production and, when relevant, assembly, installation, and services of automotive-relatedproducts, including products with embedded software. This Automotive QMS Standard isapplicable to sites of the organization where manufacturing of customer-specified productionparts, service parts, and/or accessory parts occur. This Automotive QMS Standard should beapplied throughout the automotive supply chain.4.1 Understanding the organization and its context The organization shall determine externaland internal issues that are relevant to its purpose and its strategic direction and that affect itsability to achieve the intended result(s) of its quality management system. The organizationshall monitor and review information about these external and internal issues. NOTE 1 Issuescan include positive and negative factors or conditions for consideration. NOTE 2Understanding the external context can be facilitated by considering issues arising from legal,technological, competitive, market, cultural, social and economic environments, whetherinternational, national, regional or local. NOTE 3 Understanding the internal context can befacilitated by considering issues related to values, culture, knowledge and performance of theorganization.4.2 Understanding the needs and expectations of interested parties Due to their effect orpotential effect on the organization’s ability to consistently provide products and services thatmeet customer and applicable statutory and regulatory requirements, the organization shalldetermine: a) the interested parties that are relevant to the quality management system; b) therequirements of these interested parties that are relevant to the quality management system.The organization shall monitor and review information about these interested parties and theirrelevant requirements.4.3 Determining the scope of the quality management system The organization shalldetermine the boundaries and applicability of the quality management system to establish itsscope. When determining this scope, the organization shall consider: a) the external andinternal issues referred to in 4.1; b) the requirements of relevant interested parties referred toin 4.2; c) the products and services of the organization. The organization shall apply all therequirements of this International Standard if they are applicable within the determined scopeof its quality management system. The scope of the organization’s quality management systemshall be available and be maintained as documented information. The scope shall state thetypes of products and services covered, and provide justification for any requirement of thisInternational Standard that the organization determines is not applicable to the scope of itsquality management system. Conformity to this International Standard may only be claimed ifthe requirements determined as not being applicable do not affect the organization’s ability orresponsibility to ensure the conformity of its products and services and the enhancement ofcustomer satisfaction.4.3.1 Determining the scope of the quality management system — supplemental Supportingfunctions, whether on-site or remote (such as design centres, corporate headquarters, anddistribution centres), shall be included in the scope of the Quality Management System (QMS).The only permitted exclusion for this Automotive QMS Standard relates to the product designand development requirements within ISO 9001, Section 8.3. The exclusion shall be justifiedand maintained as documented information (see ISO 9001, Section 7.5). Permitted exclusionsdo not include manufacturing process design.4.3.2 Customer-specific requirements Customer-specific requirements shall be evaluated andincluded in the scope of the organization's quality management system.4.4.1 The organization shall establish, implement, maintain and continually improve a qualitymanagement system, including the processes needed and their interactions, in accordancewith the requirements of this International Standard. The organization shall determine theprocesses needed for the quality management system and their application throughout theorganization, and shall: a) determine the inputs required and the outputs expected from theseprocesses; b) determine the sequence and interaction of these processes; c) determine andapply the criteria and methods (including monitoring, measurements and related performanceindicators) needed to ensure the effective operation and control of these processes; d)determine the resources needed for these processes and ensure their availability; e) assign theresponsibilities and authorities for these processes; f) address the risks and opportunities asdetermined in accordance with the requirements of 6.1; g) evaluate these processes andimplement any changes needed to ensure that these processes achieve their intended results;h) improve the processes and the quality management system.中文版1 范围本标准为下列组织规定了质量管理体系要求：a）需要证实其具有稳定的提供满足顾客要求和使用法律法规要求的产品和服务的能力；b）通过体系的有效应用，包括体系改进的过程，以及保证符合顾客和使用的法律法规要求，旨在增强顾客满意。本标准规定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：在本标准中，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为法定要求11.11.1 范围---汽车行业对ISO 9001:2015的补充本汽车QMS标准规定了汽车相关产品（包括装有嵌入式软件的产品）的设计和开发、生产，以及（相关时）装配、安装和服务的质量管理体系要求。本汽车QMS标准使用于制造顾客指定生产件、服务件和/或配件的组织的现场。应当在整个汽车供应链中实施本汽车QMS标准。4.14.1 理解组织及其环境组织应确定与其目标和战略方向相关并影响其实现质量管理体系预期结果的各种外部和内部因素。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。注1：这些因素可以包括需要考虑的正面和负面要素或条件。注2：考虑国际、国内、地区和当地的各种法律法规、技术、竞争、市场、文化、社会和经济因素，有助于理解外部环境。注3：考虑组织的价值观、文化、知识和绩效等相关因素，有助于理解内部环境4.24.2 理解相关方的需求和期望由于相关方对组织持续提供符合顾客要求和适用法律法规要求的产品和服务的能力产生影响或潜在影响，因此，组织应确定：a）与质量管理体系有关的相关方；b）这些相关方的要求。组织应对这些相关方及其要求的相关信息进行监视和评审。4.34.3 确定质量管理体系的范围组织应明确质量管理体系的边界和适用性，以确定其范围。在确定范围时，组织应考虑：a）各种内部和外部因素，见4.1；b）相关方的要求，见4.2；c）组织的产品和服务。对于本标准中适用于组织确定的质量管理体系范围的全部要求，组织应予以实施。组织的质量管理体系范围应作为形成文件的信息加以保持。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围不适用本标准的某些要求，应说明理由。那些不适用组织的质量管理体系的要求，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准。4.3.14.3.1 确定质量管理体系的范围-补充支持功能，无论其在现场或外部场所（如设计中心、公司总部和配送中心），应包含在质量管理体系（QMS）的范围中。本汽车QMS标准唯一允许删减是ISO9001第8.3条中的产品设计和开发要求。删减应以形成文件的信息（见ISO9001第7.5条）的形式进行证明和保持。允许的删减不包括制造过程设计。4.3.24.3.2 顾客特定要求应对顾客特定要求进行评价，并将其包含在组织的质量管理体系范围内4.4质量管理体系及其过程4.4.1 组织应按照本标准的要求，建立、实施、保持和持续改进质量管理体系，包括所需过程及其相互作用。组织应确定质量管理体系所需的过程及其整个组织内的应用，而应：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、测量和相关绩效指标），以确保这些过程的运行和有效控制；d）确定并确保获得这些过程所需的资源；e）规定与这些过程相关的责任和权限；f）应对按照6.1的要求所确定的风险和机遇；g）评价这些过程，实施所需的变更，以确保实现这些过程的预期结果h）改进过程和质量管理体系4.4.14.4.1.14.4.1.1 Conformance of products and processes The organization shall ensure conformance of4.4.1.1产品和过程的符合性all products and processes, including service parts and those that are outsourced, to all组织应确保所有产品和过程，包括服务件及外包的产品和过程，符合一切适用的顾客和法律法applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2).规要求（见8.4.2.2条）4.4.1.2 Product safety The organization shall have documented processes for the managementof product-safety related products and manufacturing processes, which shall include but notbe limited to the following, where applicable: a) identification by the organization of statutoryand regulatory product-safety requirements; b) customer notification of requirements in itema); c) special approvals for design FMEA; d) identification of product safety-relatedcharacteristics; e) identification and controls of safety-related characteristics of product and atthe point of manufacture; f) special approval of control plans and process FMEAs; g) reactionplans (see Section 9.1.1.1); h) defined responsibilities, definition of escalation process and flowof information, including top management, and customer notification; i) training identified bythe organization or customer for personnel involved in product-safety related products andassociated manufacturing processes; j) changes of product or process shall be approved priorto implementation, including evaluation of potential effects on product safety from processand product changes (see ISO 9001, Section 8.3.6); k) transfer of requirements with regard toproduct safety throughout the supply chain, including customer-designated sources (seeSection 8.4.3.1); l) product traceability by manufactured lot (at a minimum) throughout thesupply chain (see Section 8.5.2.1); m) lessons learned for new product introduction. NOTE:Special approval of safety related requirements or documents may be required by thecustomer or the organization’s internal processes.4.4.1.2产品安全组织应有形成文件的过程，用于与产品安全有关的产品和制造过程管理：形成文件的过程应包括但不限于当情况下）：a）组织对产品安全法律法规要求的识别b）向客户通知a）项中的要求c）设计FMEA的特殊批准d）产品安全相关特性的识别e）产品及制造时安全相关特性的识别和控制f）控制计划和过程FMEA的特殊批准g）反应计划（见第9.1.1.1条）h）包括最高管理者在内的，明确的职责，升级过程和信息流的定义，以及顾客通知i）组织或顾客为与产品安全有关的产品和相关制造过程中涉及的人员确定的培训j）产品或过程的更改在实施之前应获得批准，包括对过程和产品更改带给产品安全潜在影响进行评价（见IS09001第8.3.6条）。k）整个供应链中关于产品安全的要求转移，包括顾客指定的货源（见第8.4.3.1条）l）整个供应链中按制造批次（至少）的产品可追溯性（件第8.5.2.1条）m）为新产品导入的经验教训。4.4.1.2条款细目英文版4.4.24.4.2 To the extent necessary, the organization shall: a) maintain documented information tosupport the operation of its processes; b) retain documented information to have confidencethat the processes are being carried out as planned.5.1.1 General Top management shall demonstrate leadership and commitment with respect tothe quality management system by: a) taking accountability for the effectiveness of the qualitymanagement system; b) ensuring that the quality policy and quality objectives are establishedfor the quality management system and are compatible with the context and strategicdirection of the organization; c) ensuring the integration of the quality management systemrequirements into the organization’s business processes; d) promoting the use of the processapproach and risk-based thinking; e) ensuring that the resources needed for the qualitymanagement system are available; f) communicating the importance of effective qualitymanagement and of conforming to the quality management system requirements; g) ensuringthat the quality management system achieves its intended results; h) engaging, directing andsupporting persons to contribute to the effectiveness of the quality management system; i)promoting improvement; j) supporting other relevant management roles to demonstrate theirleadership as it applies to their areas of responsibility. NOTE Reference to “business” in thisInternational Standard can be interpreted broadly to mean those activities that are core to thepurposes of the organization’s existence, whether the organization is public, private, for profitor not for profit.5.1.1.1 Corporate responsibility The organization shall define and implement corporateresponsibility policies, including at a minimum an anti-bribery policy, an employee code ofconduct, and an ethics escalation policy (\"whistle-blowing policy\").5.1.1.2 Process effectiveness and efficiency Top management shall review the productrealization processes and support processes to evaluate and improve their effectiveness andefficiency. The results of the process review activities shall be included as input to themanagement review (see Section 9.3 2.1 )中文版4.4.2在必要的程度上，组织应：a）保持形成文件的信息及支持过程运行b）保留确认其过程按策划进行的形成文件的信息5领导的作用5.1领导作用与承诺5.1.1总则最高管理者应证实其对质量管理体系的领导作用和承诺，通过：a）对质量管理体系的有效性承担责任b）确保制定质量管理体系的质量方针和质量目标，并与组织环境和战略方向向一致c）确保质量管理体系要求融入与组织的业务过程d）促进使用过程方法和基于风险的思维e）确保获得质量管理体系所需的资源f）沟通有效的质量管理和符合质量管理体系要求的重要性g）确保实现质量管理体系的预期结果h）促使、指导和支持员工努力提高质量管理体系的有效性i）推动改进j）支持其他管理者履行其相关领域的职责注：本标准使用的“业务”一词可大致理解为涉及组织存在目的的核心活动，无论是公营、私营、营利或或非营利组织5.1.1.1公司责任组织应明确并实施公司责任方针，至少包括反贿赂方针、员工行为准则及道德准则升级政策（举报政策）。5.1.1.2过程有效性和效率最高管理者应评审产品实现过程和支持过程，一评价并改进过程有效性和效率。过程评审活动的结果应作为管理评审的输入（见第9.3.2.1条）。5.1.15.1.1.15.1.1.25.1.1.35.1.1.3 Process owners Top management shall identify process owners who are responsible for5.1.1.3过程拥有者managing the organization's processes and related outputs. Process owners shall understand最高管理者应当确定过程拥有者，由其负责则指的个过程和相关输出的管理。过程拥有者用了their roles and be competent to perform those roles (see ISO 9001, Section 7.2).解他们的角色。并且具备胜任其角色的能力（见IS09001第7.2条）。5.1.2 Customer focus Top management shall demonstrate leadership and commitment withrespect to customer focus by ensuring that: a) customer and applicable statutory andregulatory requirements are determined, understood and consistently met; b) the risks andopportunities that can affect conformity of products and services and the ability to enhancecustomer satisfaction are determined and addressed; c) the focus on enhancing customersatisfaction is maintained.5.2.1 Establishing the quality policy Top management shall establish, implement and maintaina quality policy that: a) is appropriate to the purpose and context of the organization andsupports its strategic direction; b) provides a framework for setting quality objectives; c)includes a commitment to satisfy applicable requirements; d) includes a commitment tocontinual improvement of the quality management system.5.1.2以顾客为关注焦点最高管理者应证实其以顾客为关注焦点的领导作用和承诺，通过：a）确定、理解并持续满足顾客要求以及适用的法律法规要求b）确定和应对能够影响产品、服务符合性以及增强顾客满意能力的风险和机遇c）始终致力于增强顾客满意5.1.25.2.15.2 方针5.2.1 制定质量方针最高管理者应制定、实施和保持质量方针,质量方针应：a）适应组织的宗旨和环境并支持其战略方向；b）为制定质量目标提供框架；c）包括满足适用要求的承诺；d）包括持续改进质量管理体系的承诺。5.2.2 沟通质量方针质量方针应：a）作为形成文件的信息，可获得并保持；b）在组织内得到沟通、理解和应用；c）适宜时，可向有关相关方提供。5.3组织的作用、职责和权限最高管理者应确保整个组织内相关岗位的职责、权限得到委派、沟通和理解。最高管理者应委派职责和权限，以：a）确保质量管理体系符合本标准的要求b）确保各过程获得其预期输出c）报告质量管理体系绩效及改进机会（见10.），特别向最高管理者报告d）确保在整个组织推动以顾客为关注焦点e）确保在策划和实施质量管理体系变更时保持其完整性5.2.25.2.2 Communicating the quality policy The quality policy shall: a) be available and bemaintained as documented information; b) be communicated, understood and applied withinthe organization; c) be available to relevant interested parties, as appropriate.5.35.3 Organizational roles, responsibilities and authorities Top management shall ensure that theresponsibilities and authorities for relevant roles are assigned, communicated and understoodwithin the organization. Top management shall assign the responsibility and authority for: a)ensuring that the quality management system conforms to the requirements of thisInternational Standard; b) ensuring that the processes are delivering their intended outputs; c)reporting on the performance of the quality management system and on opportunities forimprovement (see 10.1), in particular to top management; d) ensuring the promotion ofcustomer focus throughout the organization; e) ensuring that the integrity of the qualitymanagement system is maintained when changes to the quality management system areplanned and implemented.5.3.1 Organizational roles, responsibilities, and authorities — supplemental Top managementshall assign personnel with the responsibility and authority to ensure that customerrequirements are met. These assignments shall be documented. This includes but is not limitedto the selection of special characteristics, setting quality objectives and related training,corrective and preventive actions, product design and development, capacity analysis, logisticsinformation, customer scorecards, and customer portals.5.3.2 Responsibility and authority for product requirements and corrective actions Topmanagement shall ensure that: a) personnel responsible for conformity to productrequirements have the authority to stop shipment and stop production to correct qualityproblems; NOTE Due to the process design in some industries, it might not always be possibleto stop production immediately. In this case, the affected batch must be contained andshipment to the customer prevented. b) personnel with authority and responsibility forcorrective action are promptly informed of products or processes that do not conform torequirements to ensure that nonconforming product is not shipped to the customer and thatall potential nonconforming product is identified and contained; c) production operationsacross all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuringconformity to product requirements.6.1.1 When planning for the quality management system, the organization shall consider theissues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks andopportunities that need to be addressed to: a) give assurance that the quality managementsystem can achieve its intended result(s); b) enhance desirable effects; c) prevent, or reduce,undesired effects; d) achieve improvement.5.3.15.3.1组织的作用、职责和权限---补充最高管理者应向人员指派职责和权限，以确保顾客要求得到满足。这些指派应形成文件。这包括但不限于：特殊特性的选择，质量目标和相关培训的设置，纠正和预防措施，产品设计和开发，产能分析，物流信息，顾客记分卡以及顾客门户。5.3.25.3.2产品要求和纠正措施的职责和权限最高管理者应确保：a）负责产品要求符合性的人员有权停止发运或生产以纠正质量问题：注：由于一些行业中的过程设计，并非总是能立即停止生产。在这种情况下，必须对受影响的批次进行控制，以防将其发运给顾客。B）拥有纠正措施权限和责任的人员能够及时获知与要求不符的产品和过程，以确保避免将不合格品发运给顾客，并确保所有潜在不合格得到识别与控制c）所有班次的生产作业都要安排有负责确保产品要求符合性的责任人员或代理责任人员。6.1.16.1 应对风险和机遇的措施6.1.1策划质量管理体系，组织应考虑到4.1所描述的因素和4.2所提及的要求，确定需要应对的风险和机遇，以便：a）确保质量管理体系能够实现其预期结果；b）增强有利影响；c）避免或减少不利影响；d）实现改进。条款细目英文版6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) how to:1) integrate and implement the actions into its quality management system processes (see 4.4);2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunitiesshall be proportionate to the potential impact on the conformity of products and services.NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue anopportunity, eliminating the risk source, changing the likelihood or consequences, sharing therisk, or retaining risk by informed decision. NOTE 2 Opportunities can lead to the adoption ofnew practices, launching new products, opening new markets, addressing new customers,building partnerships, using new technology and other desirable and viable possibilities toaddress the organization’s or its customers’ needs.中文版6.1.2 组织应策划：a）应对这些风险和机遇的措施；b）如何：1）在质量管理体系过程中整合并实施这些措施（见4.4）；2）评价这些措施的有效性。应对风险和机遇的措施应与其对于产品和服务符合性的潜在影响相适应。注1：应对风险可包括规避风险，为寻求机遇承担风险，消除风险源，改变风险的可能性和后果，分担风险，或通过明智决策延缓风险。注2：机遇可能导致采用新实践，推出新产品，开辟新市场，赢得新客户，建立合作伙伴关系，利用新技术以及能够解决组织或其顾客需求的其他有利可能性。6.1.26.1.2.16.1.2.1 Risk analysis The organization shall include in its risk analysis, at a minimum, lessons6.1.2.1 风险分析：learned from product recalls. product audits, field returns and repairs, complaints, scrap, and组织应在风险分析中至少包含从产品召回、产品审核、使用现场的退货和修理、投诉、报废及rework. The organization shall retain documented information as evidence of the results of risk返工中吸取和经验教训。组织应保留(retain)形成文件的信息，作为风险分析结果的证据。analysis.6.1.2.2 Preventive action The organization shall determine and implement action(s) to eliminatethe causes of potential nonconforrnities in order to prevent their occurrence. Preventive actionsshall be appropriate to the severity of the potential issues. The organization shall establish aprocess to lessen the impact of negative effects of risk including the following: a) determiningpotential nonconformities and their causes; b) evaluating the need for action to preventoccurrence of nonconformities; c) determining and implementing action needed; d)documented information of action taken; e) reviewing the effectiveness of the preventiveaction taken; f) utilizing lessons learned to prevent recurrence in similar processes (see ISO9001, Section 7.1.6).6.1.2.3 Contingency plans The organization shall: a) identify and evaluate internal and externalrisks to all manufacturing processes and infrastructure equipment essential to maintainproduction output and to ensure that customer requirements are met; b) define contingencyplans according to risk and impact to the customer; c) prepare contingency plans for continuityof supply in the event of any of the following: key equipment failures (also see Section8.5.6.1.1); interruption from externally provided products; processes, and services; recurringnatural disasters; fire; utility interruptions; cyber-attacks on information technology systems;labour shortages; or infrastructure disruptions; d) include, as a supplement to the contingencyplans, a notification process to the customer and other interested parties for the extent andduration of any situation impacting customer operations; e) periodically test the contingencyplans for effectiveness (e.g., simulations, as appropriate); f) conduct contingency plan reviews(at a minimum annually) using a multidisciplinary team including top management, and updateas required; g) document the contingency plans and retain documented information describingany revision(s), including the person(s) who authorized the change(s). The contingency plansshall include provisions to validate that the manufactured product continues to meet customerspecifications after the re-start of production following an emergency in which production wasstopped and if the regular shutdown processes were not followed.6.2.1 The organization shall establish quality objectives at relevant functions, levels andprocesses needed for the quality management system. The quality objectives shall: a) beconsistent with the quality policy; b) be measurable; c) take into account applicablerequirements; d) be relevant to conformity of products and services and to enhancement ofcustomer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate. Theorganization shall maintain documented information on the quality objectives.6.1.2.2 预防措施：组织应确定并实施措施，以消除潜在不不合格的原因，防止不合格发生。预防措施应与潜在问题的严重程度相适应。组织应建立一个用于减轻风险负面影响的过程，并包括： 1、确定潜在不合格及其原因； 2、评价防止不合格发生的措施的需求； 3、确定并实施所需的措施； 4、评审所采取的预防措施的有效性； 5、利用取得的经验教训预防过程中的再发生（见ISO9001条第7.1.6条）。6.1.2.3 应急计划 ：组织应：a）对保持生产输出并确保顾客要求得以满足而言必不可少的所有制造过程和基础设施设备，识别并评价相关的和外部风险；b）根据风险和对顾客的影响制定应急计划；c）准备应急计划，以在下列任一情况下保证供应的持续性：关键设备故障（另见第8.5.6.1.1条）；外部提供的产品、过程或服务中断；常见自然灾害；火灾；公共事业中断；劳动力短缺；或者基础设备破坏d）作为对应急计划的补充，包含一个通知顾客和相关方的过程，告知影响顾客作业的任何情况的程度和持续时间；e） 定期测试应急计划有有效性（如模拟，视情况而定）；f） 利用包括最高管理者在内的相关部门小组对应急计划进行评审（至少年每年一次），并在需要时进行更新；g）对应急计划形成文件，并保留(retain)描述修订以及更改授权人同的形成文件的信息应急计划应包含相关规定，用以在发生生产停止的紧急情况后重新开始生产之后，以及在常规停机过程未得到遵循的情况下，确认制造的产品持续符合规范。6.2 质量目标及其实现的策划6.2.1 组织应对质量管理体系所需的相关职能、层次和过程设定质量目标。质量目标应：a）与质量方针保持一致；b）可测量；c）考虑到适用的要求；d）与提供合格产品和服务以及增强顾客满意相关；e）予以监视；f）予以沟通；g）适时更新。组织应保留有关质量目标的形成文件的信息。6.1.2.26.1.2.36.2.16.2.26.2.2 When planning how to achieve its quality objectives, the organization shall determine: a)6.2.2 策划如何实现质量目标时，组织应确定：what will be done; b) what resources will be required; c) who will be responsible; d) when it willa）采取的措施；be completed; e) how the results will be evaluated.b）需要的资源；c）由谁负责；d）何时完成；e）如何评价结果。6.2.2.1 Quality objectives and planning to achieve them — supplemental Top managementshall ensure that quality objectives to meet customer requirements are defined, established,and maintained for relevant functions, processes, and levels throughout the organization. Theresults of the organization's review regarding interested parties and their relevant requirementsshall be considered when the organization establishes its annual (at a minimum) qualityobjectives and related performance targets (internal and external).6.3 Planning of changes When the organization determines the need for changes to the qualitymanagement system, the changes shall be carried out in a planned manner (see 4.4). Theorganization shall consider: a) the purpose of the changes and their potential consequences; b)the integrity of the quality management system; c) the availability of resources; d) theallocation or reallocation of responsibilities and authorities. 6.2.2.1质量目标及其实施的策划----补充：最高管理者应确保为整个组织内的相关职能、过程和级别，明确、建立并保持符合顾客要求的质量目标。组织在建立其年度（至少每年一次）质量目标和相关性能指标（内部和外部）时，应考虑组织对相关方及其有关要求的评审结果。6.2.2.16.36.3更改的策划当组织确定需要对质量管理体系进行变更时，此种变更应经策划并系统的实施（见4.4）。组织应考虑到：A）变更目的及其潜在后果b）质量管理体系的完整性c）资源的可获得性d）责任和权限的分配或再分配7.1 资源7.1.1 总则组织应确定并提供为建立、实施、保持和持续改进质量管理体系所需的资源。组织应考虑：a) 现有内部资源的能力和约束；b) 需要从外部供方获得的资源。7.1.2 人员组织应确定并提供所需要的人员，以有效实施质量管理体系并运行和控制其过程。7.1.17.1.1 General The organization shall determine and provide the resources needed for theestablishment, implementation, maintenance and continual improvement of the qualitymanagement system. The organization shall consider: a) the capabilities of, and constraints on,existing internal resources; b) what needs to be obtained from external providers.7.1.27.1.2 People The organization shall determine and provide the persons necessary for theeffective implementation of its quality management system and for the operation and controlof its processes.7.1.3 Infrastructure The organization shall determine, provide and maintain the infrastructurenecessary for the operation of its processes and to achieve conformity of products andservices. NOTE Infrastructure can include: a) buildings and associated utilities; b) equipment,including hardware and software; c) transportation resources; d) information andcommunication technology.7.1.37.1.3 基础设施组织应确定、提供和维护过程运行所需的基础设施，以获得合格产品和服务。注：基础设施可包括：a）建筑物和相关设施；b）设备，包括硬件和软件；c）运输资源；d）信息和通迅技术。条款细目英文版7.1.3.1 Plant facility, and equipment planning The organization shall use a multidisciplinaryapproach including risk identification and risk mitigation methods for developing andimproving plant, facility, and equipment plans. In designing plant layouts, the organizationshall: a) optimize material flow, material handling, and value-added use of floor spaceincluding control of nonconforming product, and b) facilitate synchronous material flow, asapplicable. Methods shall be developed and implemented to evaluate manufacturing feasibilityfor new product or new operations. Manufacturing feasibility assessments shall includecapacity planning. These methods shall also be applicable for evaluating proposed changes toexisting operations. The organization shall maintain process effectiveness, including periodicre-evaluation relative to risk, to incorporate any changes made during process approval,control plan maintenance (see Section 8.5.1.1), and verification of job set-ups (see Section8.5.1.3). Assessments of manufacturing feasibility and evaluation of capacity planning shall beinputs to management reviews (see ISO 9001, Section 9.3). NOTE 1 These requirements shouldinclude the application of lean manufacturing principles. NOTE 2 These requirements shouldapply to on-site supplier activities, as applicable.中文版7.1.3.1 工厂、设施及设备策划：组织应使用多方论证的方法，包括风险识别和风险缓解方法，来开发并改进工厂、设施和设备的计划。在设计工厂布局时，组织应：a）优化材料的流动和搬运，以及对空间场地的增值利用，包括对不合格品的控制，并且b）在适用时，便于材料的同步流动。 应开发并实施对新产品或新操作的制造可行性进行评价的方法。制造可行性评估应包 括产能策划。这些方法还应适用于评价对现有操作的提议更改。 组织应保持过程有效性，包括定期风险复评，以纳入在过程批准、控制计划维护（见 第8.5.1.1条）期间作出的任何更改。 制造可行性评估和产能策划的评价应为管理评审的输入（见ISO9001第9.3条）。注1：这些要求应当包括对精益制造原则的应用。注2：这些要求应当应用于现场供应商活动，如使用。7.1.4 过程运行环境组织应确定、提供并维护过程运行所需要的环境，以获得合格产品和服务。注：适当的过程运行环境可能是人文因素与物理因素的结合，例如：a）社会因素（如无歧视、和谐稳定、无对抗）；b）心理因素（如舒缓心理压力、预防过度疲劳、保护个人情感）；c）物理因素（如温度、热量、湿度、照明、空气流通、卫生、噪声等）。由于所提供的产品和服务不同，这些因素可能存在显著差异。7.1.3.17.1.47.1.4 Environment for the operation of processes The organization shall determine, provideand maintain the environment necessary for the operation of its processes and to achieveconformity of products and services. NOTE A suitable environment can be a combination ofhuman and physical factors, such as: a) social (e.g. non-discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionallyprotective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). Thesefactors can differ substantially depending on the products and services provided. NOTE Wherethird-party certification to ISO 45001 (or equivalent) is recognized, it may be used todemonstrate the organization's conformity to the personnel safety aspects of this requirement.7.1.4.1 Environment for the operation of processes — supplemental The organization shallmaintain its premises in a state of order, cleanliness, and repair that is consistent with theproduct and manufacturing process needs.7.1.5.1 General The organization shall determine and provide the resources needed to ensurevalid and reliable results when monitoring or measuring is used to verify the conformity ofproducts and services to requirements. The organization shall ensure that the resourcesprovided: a) are suitable for the specific type of monitoring and measurement activities beingundertaken; b) are maintained to ensure their continuing fitness for their purpose. Theorganization shall retain appropriate documented information as evidence of fitness forpurpose of the monitoring and measurement resources.7.1.4.17.1.4.1过程的运行环境—补充：组织应保持生产现场处于与产品和制造过程需求相协调的有序、清洁和整理的状态。7.1.5.17.1.5 监视和测量资源7.1.5.1总则当利用监视或测量活动来验证产品和服务符合要求时，组织应确定并提供确保结果有效和可靠所需的资源。组织应确保所提供的资源：a）适合特定类型的监视和测量活动；b）得到适当的维护，以确保持续适合其用途。组织应保留作为监视和测量资源适合其用途的证据的形成文件的信息7.1.5.1.1 测量系统分析：应进行统计研究来分析在控制计划所识别的每种检验、测量和试验设备系统 结果中呈现的变异，所采用分析方法及接收准则，应与测量系统分析的参考手册相一致。如果得到顾客的批准，其它分析方法和接收准则也可以应用。替代方法的顾客接受记录应与替代测量系统分析的结果一起保留（见9.1.1.1条）。注：测量系统分析研究的优先级应当着重于关键或特殊产品或过程特性。7.1.5.1.1 Measurement systems analysis Statistical studies shall be conducted to analyse thevariation present in the results of each type of inspection, measurement, and test equipmentsystem identified in the control plan. The analytical methods and acceptance criteria used shallconform to those in reference manuals on measurement systems analysis. Other analytical7.1.5.1.1methods and acceptance criteria may be used if approved by the customer. Records ofcustomer acceptance of alternative methods shall be retained along with results fromalternative measurement systems analysis (see Section 9.1.1.1). NOTE Prioritization of MSAstudies should focus on critical or special product or process characteristics.7.1.5.2 Measurement traceability When measurement traceability is a requirement, or isconsidered by the organization to be an essential part of providing confidence in the validity ofmeasurement results, measuring equipment shall be: a) calibrated or verified, or both, atspecified intervals, or prior to use, against measurement standards traceable to international ornational measurement standards; when no such standards exist, the basis used for calibrationor verification shall be retained as documented information; b) identified in order to determinetheir status; c) safeguarded from adjustments, damage or deterioration that would invalidatethe calibration status and subsequent measurement results. The organization shall determine ifthe validity of previous measurement results has been adversely affected when measuringequipment is found to be unfit for its intended purpose, and shall take appropriate action asnecessary. NOTE A number or another identifier traceable to the device calibration recordmeets the intent of the requirements in ISO 9001:2015.7.1.5.27.1.5.2 测量可追溯性当要求测量溯源时，或组织认为测量溯源是信任测量结果有效的前提时，则测量设备应：a）对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准和（或）检定（验证），当不存在上述标准时，应保留作为校准或检定（验证）依据的形成文件的信息；b）予以标识，以确定其状态；c）予以保护，防止可能使校准状态和随后的测量结果失效的调整、损坏或劣化。当发现测量设备不符合预期用途时，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7.1.5.2.1 Calibration/verification records The organization shall have a documented process formanaging calibration/verific.ation records. Records of the calibration/verification activity for allgauges and measuring and test equipment (including employee-owned equipment relevantfor measuring, customer-owned equipment, or on-site supplier- owned equipment) neededto provide evidence of conformity to internal requirements, legislative and regulatoryrequirements, and customer-defined requirements shall be retained. The organization shallensure that calibration/verification activities and records shall include the following details: a)revisions following engineering changes that impact measurement systems; b) any out-of-specification readings as received for calibration/verification; c) an assessment of the risk of theintended use of the product caused by the out-of-specification condition: d) when a piece ofinspection measurement and test equipment is found to be out of calibration or defective7.1.5.2.1during its planned verification or calibration or during its use, documented information on thevalidity of previous measurement results obtained with this piece of inspection measurementand test equipment shall be retained, including the associated standard's last calibration dateand the next due date on the calibration report; e) notification to the customer if suspectproduct or material has been shipped; f) statements of conformity to specification aftercalibration/verification; g) verification that the software version used for product and processcontrol is as specified; h) records of the calibration and maintenance activities for all gauging(including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment); i) production-related software verification used for product and processcontrol (including software installed on employee-owned equipment. customer-ownedequipment, or on-site supplier-owned equipment).7.1.5.3.1 internal laboratory An organization's internal laboratory facility shall have a definedscope that includes its capability to perform the required inspection, test, or calibrationservices. This laboratory scope shall be included in the quality management systemdocumentation. The laboratory shall specify and implement, as a minimum, requirements for:a) adequacy of the laboratory technical procedures; b) competency of the laboratory7.1.5.3.1personnel; c) testing of the product; d) capability to perform these services correctly, traceableto the relevant process standard (such as ASTM, EN, etc.); when no national or internationalstandard(s) is available, the organization shall define and implement a methodology to verifymeasurement system capability; e) customer requirements, if any; f) review of the relatedrecords. NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used todemonstrate the organization's in-house laboratory conformity to this requirement.7.1.5.2.1 校准/验证记录：组织应有一个形成文件的过程，用于管理校准|验证记录。用以提供符合内部要求、法律法规要求及顾客规定要求证明的所有量具、测量和试验设备（包括员工拥有的测量设备、顾客拥有的设备或现场供应商拥有的设备），其校准/验证活动的记录应予以保持。 组织应确保校准/验证活动和记录应包括以下细节：1.根据影响测量系统的工程更改进行的修订；2.校准/验证时获得的任何偏离规范的读数；3.对偏离规范情况导致的产品预期使用风险的评估；4. 当在计划验证或校准期间或在其使用期间，检验、测量和试验设备被查出偏离校准或存在缺陷，应保留有关此检验、测量和试验设备先前测量有效性的形成文件的信息，包括校准报告上显示的相关标准的最后一次校准日期和下一次校准到期日；5. 如果可疑产品或材料已被发运，对顾客的通知；6. 校准/验证后有关符合规范的声明；7. 对用于产品和过程控制的软件版本符合规定的验证；8. 所有量具（包括员工拥有的设备、顾客拥有的设备或现场供应商拥有的设备）校准和维护活动的记录；9. 对用于产品和过程控制和生产相关软件的验证（包括安装于员工拥有的设备、顾客拥有的设备或现场供应商拥有的设备软件）7.1.5.3实验室要求7.1.5.3.1 内部实验室组织的内部实验室设施应有一个确定的范围，包括其从事所要求的检验、试验或校准服务的能力。该实验室范围应包括在质量管理体系文件中。实验室至少应为以下事项明确规定并实施要求： 1、实验室技术程序的充分性； 2、实验室人员的资格； 3、产品试验； 4、正确执行这些服务的能力，可追溯到相关过程标准（如：ASTM、EN等）；如没有可用的国家或国际标准，组织应明确并实施一个验证测量系统能力的方法； 5、顾客要求，如有； 6、对有关记录的评审。 通过认证ISO/IEC17025第三方认可可证明符合这个要求。条款细目英文版7.1.5.3.2 External laboratory External/commercial/independent laboratory facilities used forinspection, test, or calibration services by the organization shall have a defined laboratoryscope that includes the capability to perform the required inspection, test, or calibration, andeither: - the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and includethe relevant inspection, test, or calibration service in the scope of the accreditation (certificate);the certificate of calibration or test report shall include the mark of a national accreditationbody; or - there shall be evidence that the external laboratory is acceptable to the customer.NOTE Such evidence may be demonstrated by customer assessment, for example, or by7.1.5.3.2customer-approved second-party assessment that the laboratory meets the intent of ISOPEC17025 or national equivalent. The second-party assessment may be performed by theorganization assessing the laboratory using a customer-approved method of assessment.Calibration services may be performed by the equipment manufacturer when a qualifiedlaboratory is not available for a given piece of equipment. In such cases, the organization shallensure that the requirements listed in Section 7.1.5.3.1 have been met. Use of calibrationservices, other than by quaffed (or customer accepted) laboratories, may be subject togovernment regulatory confirmation, if required.7.1.6 Organizational knowledge The organization shall determine the knowledge necessary forthe operation of its processes and to achieve conformity of products and services. Thisknowledge shall be maintained and be made available to the extent necessary. Whenaddressing changing needs and trends, the organization shall consider its current knowledgeand determine how to acquire or access any necessary additional knowledge and requiredupdates. NOTE 1 Organizational knowledge is knowledge specific to the organization; it isgenerally gained by experience. It is information that is used and shared to achieve theorganization’s objectives. NOTE 2 Organizational knowledge can be based on: a) internalsources (e.g. intellectual property; knowledge gained from experience; lessons learned fromfailures and successful projects; capturing and sharing undocumented knowledge andexperience; the results of improvements in processes, products and services); b) external sources ( e.g. s tandards; a cademia; conferences; gathering knowledge from customers orexternal providers).7.2 Competence The organization shall: a) determine the necessary competence of person(s)doing work under its control that affects the performance and effectiveness of the qualitymanagement system; b) ensure that these persons are competent on the basis of appropriateeducation, training, or experience; c) where applicable, take actions to acquire the necessarycompetence, and evaluate the effectiveness of the actions taken; d) retain appropriatedocumented information as evidence of competence. NOTE Applicable actions can include, forexample, the provision of training to, the mentoring of, or the reassignment of currentlyemployed persons; or the hiring or contracting of competent persons.中文版7.1.5.3.2 外部实验室为组织提供检验、试验或校准服务的外部/商业/独立实验室应有一个确定的范围，包括其从事所要求的检验、试验或校准的能力，并且： 实验室应通过ISO/IEC17025或等效的国家标准的认可，认可（证书）范围应包括相关检验、试验或校准服务；校准证书或试验报告应包含国家认可机构的标志；或 应有证据证明该外部实验室可以被顾客接受。 当某一设备没有具备资格的实验室时，校准服务可以由设备制造商进行。在这种情况下，组织应确保第7.1.5.3.1条中的要求得到满足。 校准服务的采用，除了具备资格的（或顾客接受的）实验室提供的以外，需要时，可能需要获得政府监管机构的确认。7.1.6 组织的知识组织应确定运行过程所需的知识，以获得合格产品和服务。这些知识应予以保持，并在需要范围内可得到。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，确定如何获取更多必要的知识，并进行更新。注1：组织的知识是从其经验中获得的特定知识，是实现组织目标所使用的共享信息。注2：组织的知识可以基于：a）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，过程、产品和服务的改进结果）；b）外部来源（例如标准；学术交流；专业会议，从顾客或外部供方收集的知识）。7.1.67.27.2 能力组织应：a）确定其控制范围内的人员所需具备的能力，这些人员从事的工作影响质量管理体系绩效和有效性；b）基于适当的教育、培训或经历，确保这些人员具备所需能力；c）适用时，采取措施获得所需的能力，并评价措施的有效性；d）保留适当的形成文件的信息，作为人员能力的证据。注：采取的适当措施可包括对在职人员进行培训、辅导或重新分配工作，或者招聘具备能力的人员等。7.2.1 能力—补充组织应建立并保持形成文件的过程，识别包括意识（见第7.3.1条）在内的培训需求，并使从事影响产品要求和过程要求符合性活动的人员具备能力。从事特定指派任务的人员应按要求进行资格认可，尤其关注对顾客要求的满足。7.2.17.2.1 Competence — supplemental The organization shall establish and maintain adocumented process(es) for identifying training needs including awareness (see Section 7.3.1)and achieving competence of all personnel performing activities affecting conformity toproduct and process requirements. Personnel performing specific assigned tasks shall bequalified, as required, with particular attention to the satisfaction of customer requirements.7.2.2 Competence — on-the-job training The organization shall provide on-the-job training(which shall include customer requirements training) for personnel in any new or modifiedresponsibilities affecting conformity to quality requirements, internal requirements, regulatoryor legislative requirements; this shall include contract or agency personnel. The level of detailrequired for on-the-job training shall be commensurate with the level of education thepersonnel possess and the complexity of the task(s) they are required to perform for their dailywork. Persons whose work can affect quality shall be informed about the consequences ofnonconformity to customer requirements.7.2.3 internal auditor competency The organization shall have a documented prooess(es) toverify that internal auditors are competent, taking into account any requirements defined bythe organization and/or customer-specific requirements. For additional guidance on auditorcompetencies, refer to ISO 19011. The organization shall maintain a list of qualified internalauditors. Quality management system auditors shall be able to demonstrate the followingminimum competencies: a) understanding of the automotive process approach for auditing,including risk-based thinking; b) understanding of applicable customer-specific requirements;c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope ofthe audit; d) understanding of applicable core tool requirements related to the scope of theaudit; e) understanding how to plan, conduct, report, and close out audit findings. At aminimum, manufacturing process auditors shall demonstrate technical understanding of therelevant manufacturing process(es) to be audited, including process risk analysis (such asPFMEA) and control plan. At a minimum, product auditors shall demonstrate competence inunderstanding product requirements and use of relevant measuring and test equipment toverify product conformity. If the organization’s personnel provide the training to achievecompetency, documented information shall be retained to demonstrate the trainer'scompetency with the above requirements. Maintenance of and improvement in, internalauditor competence shall be demonstrated through: f) executing a minimum number of auditsper year, as defined by the organization; and g) maintaining knowledge of relevantrequirements based on internal changes (e.g., process technology, product technology) andexternal changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements).7.2.4 Second-party auditor competency The organization shall demonstrate the competence ofthe auditors undertaking the second-party audits. Second-party auditors shall meet customerspecific requirements for auditor qualification and demonstrate the minimum following corecompetencies, including understanding of: a) the automotive process approach to auditing,including risk based thinking: b) applicable customer and organization specific requirements, c)applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit; d)applicable manufacturing process(es) to be audited, including PFMEA and control plan; e)applicable core tool requirements related to the scope of the audit; f) how to plan, conduct,prepare audit reports, and close out audit findings.7.3 Awareness The organization shall ensure that persons doing work under the organization’scontrol are aware of: a) the quality policy; b) relevant quality objectives; c) their contribution tothe effectiveness of the quality management system, including the benefits of improvedperformance; d) the implications of not conforming with the quality management systemrequirements.7.2.27.2.2能力—在职培训对于承担影响质量要求、内部要求、法规或法律要求符合性的新的或调整职责的人员，组织应对其进行在职培训（其中还应包括顾客要求培训），包括合同工或代理工。在职培训的详细程度应与人员的教育程度及其要在日常工作中执行的任务的复杂程度相称从事影响质量的工作的人员应被告知不符合顾客要求的后果。7.2.37.2.3 内部审核员能力组织应有形成文件的过程，用于验证内部审核员的能力，要考虑到顾客特定要求。关于审核员能力的更多参考，参考ISO19011.组织应保持一份合格内部审核员名单。 质量管理体系审核员、制造过程审核员和产品审核员应全部能够证实最少具备以下能力： 1、了解汽车审核过程方法，包括基于风险的思维； 2、了解适用的顾客特定要求； 3、了解ISO9001和IATF16949中适用的与审核范围有关的要求； 4、了解与审核范围有关的适用的核心工具要求； 5、了解如何计划审核、实施审核、报告审核以及关闭审核发现。另外，制造过程审核员还应证实对于待审核的相关制造过程，其具有技术知识，包括过程风险分析（如PFMEA）和控制计划。产品审核员还应证实其了解产品要求，并能够使用相关测量和试验设备验证产品符合性。在通过培训来取得人员能力的情况下，应保留形成文件的信息，证实培训师的能力符合上述要求。内部审核员能力的维持与改进应通过以下方法进行证实： 6、每年执行组织规定的最小的审核，并且 7、保持基于内部更改（如：过程技术、产品技术）和外部更改 （如：ISO9001、IATF16949、核心工具及顾客特定要求）对相关要求的认知。7.2.47.2.4 第二方审核员能力组织应证实从事第二方审核的审核员的能力。第二方审核中应符合顾客对审核员资质的特定要求，并证实最少具备以下核心能力，包括了解： 1、汽车审核过程方法，包括基于风险的思维； 2、适用的顾客特定和组织特定要求； 3、ISO9001和IATF16949中适用的与审核范围有关的要求； 4、适用的待审核制造过程，包括PFMEA和控制计划； 5、与审核范围有关的适用的核心工具要求； 6、如何计划审核、实施审核、编制审核报告并关闭审核发现。7.3 意识组织应确保其控制范围内的相关工作人员知晓：a）质量方针；b）相关的质量目标；c）他们对质量管理体系有效性的贡献，包括改进质量绩效的益处；d）不符合质量管理体系要求的后果7.37.3.17.3.1 Awareness — supplemental The organization shall maintain documented information7.3.1 意识----补充that demonstrates that all employees are aware of their impact on product quality and the组织应保持形成文件的信息，证实所有员工都认识到其对产品质量的影响，以及他们所从事的importance of their activities in achieving, maintaining, and improving quality, including活动在实现、保持并改进质量中的重要性，还包括顾客要求及不合格品带给顾客的风险。customer requirements and the risks involved for the customer with non¬conforming product.条款细目英文版7.3.2 Employee motivation and empowerment The organization shall maintain a documentedprocess(es) to motivate employees to achieve quality objectives, to make continualimprovements, and to create an environment that promotes innovation. The process shallinclude the promotion of quality and technological awareness throughout the wholeorganization.中文版7.3.2 员工激励和授权组织应保持形成文件的过程，激励员工实现质量目标，进行持续改进，并建立一个提倡创新的环境。该过程应包括促进整个组织对质量和技术的认知程度。7.3.27.47.4 Communication The organization shall determine the internal and external communications7.4 沟通relevant to the quality management system, including: a) on what it will communicate; b) when组织应确定与质量管理体系相关的内部和外部沟通，包括：to communicate; c) with whom to communicate; d) how to communicate; e) whoa）沟通什么； b）何时沟通；c）与谁沟通； d）如何沟通；e）由谁负责communicates.7.5.1 General The organization’s quality management system shall include: a) documentedinformation required by this International Standard; b) documented information determined bythe organization as being necessary for the effectiveness of the quality management system.NOTE The extent of documented information for a quality management system can differ fromone organization to another due to: - the size of organization and its type of activities,processes, products and services; - the complexity of processes and their interactions; - thecompetence of persons.7.5 形成文件的信息7.5.1 总则组织的质量管理体系应包括：a) 本标准要求的形成文件的信息；b) 组织确定的为确保质量管理体系有效性所需的形成文件的信息；注：对于不同组织，质量管理体系形成文件的信息的多少与详略程度可以不同，取决于：——组织的规模，以及活动、过程、产品和服务的类型；——过程的复杂程度及其相互作用；——人员的能力。7.5.17.5.1.17.5.1.1 Quality managernem system documentation The organization's quality managementsystem shall be documented and include a quality manual, which can be a series of documents(electronic or hard copy). The format and structure of the quality manual is at the discretion ofthe organization and will depend on the organization's size, culture, and complexity. If a seriesof documents is used, then a list shall be retained of the documents that comprise the qualitymanual for the organization. The quality manual shall include, at a minimum, the following: a)the scope of the quality management system, including details of and justification for anyexclusions; b) documented processes established for the quality management system, orreference to them; c) the organization's processes and their sequence and interactions (inputsand outputs), including type and extent of control of any outsourced processes: d) a document(for example, a table, a list, or a matrix) indicating where within the organization's qualitymanagement system their customer-specific requirements are addressed. NOTE A matrix ofhow the requirements of this Automotive QMS standard are addressed by the organization'sprocesses may be used to assist with linkages of the organization's processes and thisAutomotive QMS.7.5.2 Creating and updating When creating and updating documented information, theorganization shall ensure appropriate: a) identification and description (e.g. a title, date, author,or reference number); b) format (e.g. language, software version, graphics) and media (e.g.paper, electronic); c) review and approval for suitability and adequacy.组织的质量管理体系应形成文件，并包括一份质量手册，可由一系列（电子或硬拷贝形式的）文件构成。质量手册的格式和结构由组织自行决定，将取决于组织的规模、文化和复杂性。如果采用一系列文件，则应保留一份构成组织质量手册的文件的清单。 质量手册应至少包括以下内容： 1、质量管理体系的范围，包括任何删减的细节和正当理由； 2、为质量管理体系建立的形成文件的过程或对其引用； 3、组织的过程及其顺序和相互作用（输入和输出），包括任何外包过程控制的类型和程度； 4、一个显示组织质量管理体系内哪些地方满足了顾客特定要求的文件（即：矩阵）。 注：可采用一个显示组织过程如何满足本汽车QMS标准要求的矩阵来辅助在组织过程与本汽车QMS标准之间建立联系。7.5.27.5.2 创建和更新在创建和更新形成文件的信息时，组织应确保适当的：a）标识和说明（如：标题、日期、作者、索引编号等）；b) 格式（如：语言、软件版本、图示）和媒介（如：纸质、电子格式）；c) 评审和批准，以确保适宜性和充分性7.5.3 形成文件的信息的控制7.5.3.1 应控制质量管理体系和本标准所要求的形成文件的信息，以确保：a）无论何时何处需要这些信息，均可获得并适用；b）予以妥善保护（如：防止失密、不当使用或不完整）。7.5.3.2 为控制形成文件的信息，适用时，组织应关注下列活动：a）分发、访问、检索和使用；b）存储和防护，包括保持可读性；c）变更控制（比如版本控制）；d）保留和处置。对确定策划和运行质量管理体系所必需的来自外部的原始的形成文件的信息，组织应进行适当识别和控制。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。注：形成文件的信息的“访问”可能意味着仅允许查阅，或者意味着允许查阅并授权修改7.5.3.2.1 记录保存组织应有一个确定的、形成文件的、并且被执行的记录保存政策。对记录的控制应满足法律法规、及顾客要求。应保存生产件批准文件、工装记录（包括维护和所有权）、产品和过程设计记录、采购订单（如适用）或者合同和修正，保存时间为产品在现行生产和服务中要求的有效期，再加一个日历年，除非顾客或监管机构另有特殊要求。 注：生产件批准形成文件的信息可包括已批准产品、适用的试验设备记录或已批准试验数据。7.5.3.2.2 工程规范组织应有形成文件的过程，描述基于顾客要求的进度进行的所有顾客工程标准/规范及相关修订的评审、分发和实施。当工程标准/规范更改导致产品设计更改时，请参见ISO9001第8.3.6条的要求。当工程标准/规范更改导致产品实现过程更改时，请参见ISO9001第8.5.6.1条的要求。组织应保留每项更改在生产中实施日期的记录。实施应包括更新过的文件。应当在收到工程标准/规范更改通知后10个工作日内完成评审。注：当设计记录引用了这些规范或这些规范影响了生产件批准过程的文件，如：控制计划、风险分析（FMEA）等时，这些标准/规范的更改需要对顾客的生产件批准记录进行更新。7.5.3.17.5.3.1 Documented information required by the quality management system and by thisInternational Standard shall be controlled to ensure: a) it is available and suitable for use,where and when it is needed; b) it is adequately protected (e.g. from loss of confidentiality,improper use, or loss of integrity).7.5.3.27.5.3.2 For the control of documented information, the organization shall address the followingactivities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation,including preservation of legibility; c) control of changes (e.g. version control); d) retention anddisposition. Documented information of external origin determined by the organization to benecessary for the planning and operation of the quality management system shall be identifiedas appropriate, and be controlled. Documented information retained as evidence of conformityshall be protected from unintended alterations. NOTE Access can imply a decision regardingthe permission to view the documented information only, or the permission and authority toview and change the documented information.7.5.3.2.1 Record retention The organization shall define, document, and implement a recordretention policy. The control of records shall satisfy statutory, regulatory, organizational, andcustomer requirements. Production part approvals, tooling records (including maintenance andownership), product and process design records, purchase orders (if applicable), or contracts7.5.3.2.1and amendments shall be retained for the length of time that the product is active farproduction and service requirements, plus one calendar year, unless otherwise specified by thecustomer or regulatory agency. NOTE Production part approval documented information mayinclude approved product, applicable test equipment records, or approved test data.7.5.3.2.2 Engineering specifications The organization shall have a documented processdescribing the review, distribution, and implementation of all customer engineeringstandards/specifications and related revisions based an customer schedules, as required. Whenan engineering standard/specification change results in a product design change, refer to therequirements in ISO 9001, Section 8.3.6. When an engineering standard/specification changeresults in a product realization process change, refer to the requirements in Section 8.5.6.1. The7.5.3.2.2organization shall retain a record of the date on which each change is implemented inproduction. Implementation shall include updated documents. Review should be completedwithin 10 working days of receipt of notification of engineering standards/specificationschanges. NOTE A change in these standards/specifications may require an updated record ofcustomer production part approval when these specifications are referenced on the designrecord or if they affect documents of the production part approval process, such as controlplan, risk analysis (such as FMEAs), etc.8.1 Operational planning and control The organization shall plan, implement and control theprocesses (see 4.4) needed to meet the requirements for the provision of products andservices, and to implement the actions determined in Clause 6, by: a) determining therequirements for the products and services; b) establishing criteria for: 1) the processes; 2) theacceptance of products and services; c) determining the resources needed to achieveconformity to the product and service requirements; d) implementing control of the processesin accordance with the criteria; e) determining, maintaining and retaining documentedinformation to the extent necessary: 1) to have confidence that the processes have beencarried out as planned; 2) to demonstrate the conformity of products and services to theirrequirements. The output of this planning shall be suitable for the organization’s operations.The organization shall control planned changes and review the consequences of unintendedchanges, taking action to mitigate any adverse effects, as necessary. The organization shallensure that outsourced processes are controlled (see 8.4).8.18.1 运行策划和控制组织应通过采取下列措施，策划、实施和控制满足产品和服务要求所需的过程（见4.4），并实施第6章所确定的措施：a）确定产品和服务的要求；b）建立下列内容的准则：1）过程；2）产品和服务的接收。c）确定符合产品和服务要求所需的资源；d）按照准则实施过程控制；e）在需要的范围和程度上，确定并保持、保留形成文件的信息：1）证实过程已经按策划进行；2）证明产品和服务符合要求。策划的输出应适合组织的运行需要。组织应控制策划的更改，评审非预期变更的后果，必要时，采取措施消除不利影响。组织应确保外包过程受控（见8.4）。条款细目英文版8.1.1 Operational planning and control — supplemental When planning for product realization,the following topics shall be included: a) customer product requirements and technicalspecifications: b) logistics requirements; c) manufacturing feasibility; d) project planning (referto ISO 9001, Section 8.3.2); e) acceptance criteria. The resources identified in ISO 9001, Section8.1 c), refer to the required verification, validation, monitoring, measurement, inspection, andtest activities specific to the product and the criteria for product acceptance.中文版 8.1.1 运行策划和控制---补充在对产品实现进行策划时，应包含以下主题： 1、顾客产品要求和技术规范； 2、物流要求； 3、制造可靠性； 4、项目策划（参见ISO9001第8.3.2条）； 5、接收准则。ISO9001第8.1条3项中的资源是指所要求的产品特定的验证、确认、监视、测量、检验和试验以及产品接收准则。8.1.2 保密---补充组织应确保正在开发中的顾客签约产品和项目及有关产品信息的保密。8.2 产品和服务的要求8.2.1 顾客沟通与顾客沟通的内容应包括：a）提供有关产品和服务的信息；b）处理问询、合同或订单，包括变更；c）获取有关产品和服务的顾客反馈，包括顾客抱怨；d）处置或控制顾客财产；e）关系重大时，制定有关应急措施的特定要求。8.2.1 顾客沟通---补充应按顾客同意的语言进行书面或口头沟通。组织应有能力按顾客规定的语言和形式来沟通必要的信息，包括按顾客规定的计算机语言和格式的数据（如计算机辅助设计数据、电子数据交换等）。8.2.2 与产品和服务有关的要求的确定在确定向顾客提供的产品和服务的要求时，组织应确保：a）产品和服务的要求得到规定，包括：1）适用的法律法规要求；2）组织认为的必要要求。b）对其所提供的产品和服务，能够满足组织声称的要求8.2.2.1 与产品和服务有关的要求的确定—补充这些要求应包括回收再利用、对环境的影响，以及根据组织对产品和制造过程的认知所识别的特性。遵守ISO9001第8.2.2条1项A的要求应包括但不限于：所有适用的与材料的获得、存储、搬运、回收、销毁或废弃有关的政府、安全和环境法规8.1.18.1.28.1.2 Confidentiality The organization shall ensure the confidentiality of customer-contractedproducts and projects under development. including related product information.8.2.1 Customer communication Communication with customers shall include: a) providinginformation relating to products and services; b) handling enquiries, contracts or orders,including changes; c) obtaining customer feedback relating to products and services, includingcustomer complaints; d) handling or controlling customer property; e) establishing specificrequirements for contingency actions, when relevant.8.2.18.2.1.18.2.1.1 Customer communication — supplemental Written or verbal communication shall be inthe, language agreed with the customer. The organization shall have the ability tocommunicate necessary information, including data in a customer-specified computerlanguage and format (e.g., computer-aided design data, electronic data interchange).8.2.2 Determining the requirements for products and services When determining therequirements for the products and services to be offered to customers, the organization shallensure that: a) the requirements for the products and services are defined, including: 1) anyapplicable statutory and regulatory requirements; 2) those considered necessary by theorganization; b) the organization can meet the claims for the products and services it offers.8.2.28.2.2.18.2.2.1 Determining the requirements for products and services — supplemental Theserequirements shall include recycling, environmental impact, and characteristics identified as aresult of the organization's knowledge of the product and manufacturing processes.Compliance to ISO 9001, Section 8.2.2 item a) 1), shall include but not be limited to thefollowing: all applicable government, safety, and environmental regulations related toacquisition, storage, handling, recycling, elimination, or disposal of material.8.2.3.1 The organization shall ensure that it has the ability to meet the requirements forproducts and services to be offered to customers. The organization shall conduct a reviewbefore committing to supply products and services to a customer, to include: a) requirementsspecified by the customer, including the requirements for delivery and postdelivery activities; b)requirements not stated by the customer, but necessary for the specified or intended use,when known; c) requirements specified by the organization; d) statutory and regulatoryrequirements applicable to the products and services; e) contract or order requirementsdiffering from those previously expressed. The organization shall ensure that contract or orderrequirements differing from those previously defined are resolved. The customer’srequirements shall be confirmed by the organization before acceptance, when the customerdoes not provide a documented statement of their requirements. NOTE In some situations,such as internet sales, a formal review is impractical for each order. Instead, the review cancover relevant product information, such as catalogues.8.2.3.18.2.3 与产品和服务有关的要求的评审8.2.3.1 组织应确保有能力满足向顾客提供的产品和服务的要求。在承诺向顾客提供产品和服务之前，组织应对如下各项要求进行评审：a）顾客规定的要求，包括对交付及交付后活动的要求；b）顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；c）组织规定的要求；d）适用于产品和服务的法律法规要求；e）与先前表述存在差异的合同或订单要求。若与先前合同或订单的要求存在差异，组织应确保有关事项已得到解决。若顾客没有提供形成文件的要求，组织在接受顾客要求前应对顾客要求进行确认。注：在某些情况下，如网上销售，对每一个订单进行正式的评审可能是不实际的，作为替代方法，可对有关的产品信息，如产品目录、产品广告内容进行评审。8.2.3.1.1 产品和服务要求的评审---补充组织应保留形成文件的证据，证明对ISO9001第8.2.3.1条中正式评审要求的弃权有顾客授权。8.2.3.1.1 Review of the requirements For products and services — supplemental The8.2.3.1.1organization shall retain documented evidence of a customer-authorized waiver for therequirements stated in ISO 9001, Section 8.2.3.1, far a formal review.8.2.3.1.2 Customer-designated special characteristics The organization shall conform to8.2.3.1.2customer requirements for designation, approval documentation, and control of specialcharacteristics.8.2.3.1.3 Organization manufacturing feasibility The organization shall utilize a multidisciplinaryapproach to conduct an analysis to determine if it is feasible that the organization'smanufacturing processes are capable of consistently producing product that meets all of theengineering and capacity requirements specified by the customer. The organization shall8.2.3.1.3conduct this feasibility analysis for any manufacturing or product technology new to theorganization and for any changed manufacturing process or product design. Additionally, theorganization should validate through production runs, benchmarking studies, or otherappropriate methods, their ability to make product to specifications at the required rate. 8.2.3.1.2 顾客指定的特殊特性组织应符合顾客对特殊特性的指定、批准文件和控制的要求。8.2.3.1.3 组织制造可行性组织应采用多方论证方法来进行分析，以确定组织的制造过程是否是可行的，能够始终生产出符合顾客规定的全部工程和产能要求的产品。组织应为任何对其而言新的制造或产品技术，以及任何更改过的制造过程或产品设计进行本可行性分析。此外，组织应当通过生产运行、标杆管理研究或其它适当的方法，确认其能够以所要求的速率生产出符合规范的产品。8.2.3.28.2.3.2 The organization shall retain documented information, as applicable: a) on the results of8.2.3.2 适用时，组织应保留下列形成文件的信息：the review; b) on any new requirements for the products and services.a）评审结果；b）针对产品和服务的新要求。8.2.4 Changes to requirements for products and services The organization shall ensure thatrelevant documented information is amended, and that relevant persons are made aware ofthe changed requirements, when the requirements for products and services are changed.8.3.1 General The organization shall establish, implement and maintain a design anddevelopment process that is appropriate to ensure the subsequent provision of products andservices.8.2.4 产品和服务要求的更改若产品和服务要求发生更改，组织应确保相关的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。8.3 产品和服务的设计和开发8.3.1 总则组织应建立、实施和保持设计和开发过程，以便确保后续的产品和服务的提供。8.2.48.3.18.3.1.18.3.1.1 Design and development of products and services — supplemental The requirements of8.3.1.1 产品设计和开发—补充ISO 9001, Section 8.3.1, shall apply to product and manufacturing process design andISO9001 第8.3.1条的要求应适用于产品和制造过程的设计和开发，并且应着重于预防，而不是探development and shall focus on error prevention rather than detection. The organization shall测。组织应对设计和开发过程形成文件。document the design and development process.条款细目英文版8.3.2 Design and development planning In determining the stages and controls for design anddevelopment, the organization shall consider: a) the nature, duration and complexity of thedesign and development activities; b) the required process stages, including applicable designand development reviews; c) the required design and development verification and validationactivities; d) the responsibilities and authorities involved in the design and developmentprocess; e) the internal and external resource needs for the design and development ofproducts and services; f) the need to control interfaces between persons involved in the designand development process; g) the need for involvement of customers and users in the designand development process; h) the requirements for subsequent provision of products andservices; i) the level of control expected for the design and development process by customersand other relevant interested parties; j) the documented information needed to demonstratethat design and development requirements have been met.中文版8.3 产品和服务的设计和开发8.3.2 设计和开发策划在确定设计和开发的各个阶段及其控制时，组织应考虑：a）设计和开发活动的性质、持续时间和复杂程度；b）所要求的过程阶段，包括适用的设计和开发评审；c）所要求的设计和开发验证和确认活动；d）设计和开发过程涉及的职责和权限；e）产品和服务的设计和开发所需的内部和外部资源：f）设计和开发过程参与人员之间接口的控制需求；g）顾客和使用者参与设计和开发过程的需求；h）后续产品和服务提供的要求；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）证实已经满足设计和开发要求所需的形成文件的信息。 8.3.2.1 设计和开发策划—补充组织应确保设计和开发策划涵盖组织内部所有受影响的利益相关者及其（适当的）供应链使用多方论证方法的方面包括但不限于：a）项目管理（APQP或VDA-RGA）；b）产品和制造过程设计活动（DFM和DFA），例如：考虑使用替代的设计和制造过程；c）产品设计风险分析（FMEA）的开发和评审，包括降低潜在风险的措施；d）制造过程风险分析（FMEA、过程流程、控制计划和标准的工作指导书）的开发和评审8.3.28.3.2.18.3.2.1 Design and deveiopment pfanning — supplemental The organization shall ensure thatdesign and development planning includes all affected stakeholders within the organizationand, as appropriate, its supply chain. Examples of areas for using such a multidisciplinaryapproach include but are not limited to the following: a) project management (for example,APQP or VDA-RGA) b) product and manufacturing process design activities (for example, DFMand DFA), such as consideration of the use of alternative designs and manufacturing processes;c) development and review of product design risk analysis (FMEAs), including actions to reducepotential risks; d) development and review of manufacturing process risk analysis (for example,FMEAs, process flows, control plans, and standard work instructions). NOTE A multidisciplinaryapproach typically includes the organization's design, manufacturing, engineering, quality,production, purchasing, supplier, maintenance, and other appropriate functions.8.3.2.2 Product design skills The organization shall ensure that personnel with product designresponsibility are competent to achieve design requirements and are skilled in applicableproduct design tools and techniques. Applicable tools and techniques shall be identified by theorganization. NOTE An example of product design skills is the application of digitizedmathematically based data.8.3.2.3 Development of products with embedded software The organization shall use a processfor quality assurance for their products with internally developed embedded software. Asoftware development assessment methodology shall be utilized to assess the organization'ssoftware development process. Using prioritization based on risk and potential impact to thecustomer, the organization shall retain documented information of a software developmentcapability self-assessment. The organization shall include software development within thescope of their internal audit programme (see Section 9.2.2.1)8.3.3 Design and development inputs The organization shall determine the requirementsessential for the specific types of products and services to be designed and developed. Theorganization shall consider: a) functional and performance requirements; b) informationderived from previous similar design and development activities; c) statutory and regulatoryrequirements; d) standards or codes of practice that the organization has committed toimplement; e) potential consequences of failure due to the nature of the products and services.Inputs shall be adequate for design and development purposes, complete and unambiguous.Conflicting design and development inputs shall be resolved. The organization shall retaindocumented information on design and development inputs.8.3.2.2 8.3.2.2 产品设计技能组织应确保负有产品设计职责的人员有能力达成设计要求，并具备适用的产品设计工具和技术技能。适合的工具和技术应得到组织的识别。注：基于数学的数字化数据的应用便是一种产品设计技能。8.3.2.38.3.2.3 带有嵌入式软件的产品开发组织应有一个质量保证过程，用于其带有内部开发的嵌入式软件的产品。应采用软件开发评估方法来评估组织的软件开发过程。组织应按照风险和对顾客潜在影响的优先级，为软件开发能力自评估保留形成文件的信息。组织应将软件开发纳入内部审核方案的范围（见第9.2.2.1条）。8.3.38.3.3 设计和开发输入组织应针对具体类型的产品和服务，确定设计和开发的基本要求。组织应考虑： a）功能和性能要求；b）来源于以前类似设计和开发活动的信息；c）法律法规要求；d）组织承诺实施的标准和行业规范；e）由产品和服务性质所决定的、失效的潜在后果。设计和开发输入应完整、清楚，满足设计和开发的目的。应解决相互冲突的设计和开发输入。组织应保留有关设计和开发输入的形成文件的信息。8.3.3.18.3.3.1 Product design input The organization shall identify, document, and review productdesign input requirements as a result of contract review. Product design input requirementsinclude but are not limited to the following: a) product specifications including but not limitedto special characteristics (see Section 8.3.3.3); b) boundary and interface requirements; c)identification, traceability, and packaging; d) consideration of design alternatives; e)assessment of risks with the input requirements and the organization's ability tomitigate/manage the risks, including from the feasibility analysis; f) targets for conformity toproduct requirements including preservation, reliability, durability. serviceability, health, safety,environmental, development timing, and cost; g) applicable statutory and regulatoryrequirements of the customer-identified country of destination, if provided; h) embeddedsoftware requirements. The organization shall have a process to deploy information gainedfrom previous design projects, competitive product analysis (benchmarking), supplier feedback,internal input, field data, and other relevant sources for current and future projects of a similarnature. NOTE One approach for considering design alternatives is the use of trade-off curves. 8.3.3.1 产品设计输入组织应对作为合评审结果的产品设计输入要求进行识别、形成文件并进行评审。产品设计输入要求包括但不限于： 1、产品规范，包括但不限于特殊特性（见第8.3.3.3条）； 2、边界和对接要求； 3、标识、可追溯性和包装； 4、对设计的替代选择的考虑； 5、对输入要求风险的评估，以及对组织缓解/管理风险（包括来自可行性分析的风险）的能力的评估； 6、产品要求符合性的目标，包括防护、可靠性、耐久性、可服务性、健康、安全、环境、开发时程安排和成本等方面； 7、顾客确定的目的国（如有提供）的适用法律要求；组织应有一个过程，将从以前的设计项目、竞争产品分析（标杆）、供应商反馈、内部输入、使用现场数据和其它相关资源中获取的信息，推广应用于当前和未来相似性质的项目。注：使用权衡曲线是考虑设计和替代选择的一种方法。 8.3.3.2 制造过程设计输入组织应对制造过程设计输入要求进行识别、形成文件并进行评审，包括但不限于： 1、产品设计输出的数据，包括特殊特性； 2、生产力、过程能力、时程安排及成本的目标； 3、制造技术替代选择； 4、顾客要求，如有； 5、以往的开发经验； 6、新材料； 7、产品搬运和人体工学要求；以及 8、制造设计和装配设计。制造过程设计应包括：针对问题适当的重要性程度和所遭遇到风险相称的程度来使用防错方法。 8.3.3.3 特殊特性组织应采用多方论证方法来建立、形成文件并实施用于识别特殊特性的过程，包括顾客确定的以及组织风险分析所确定的特殊特性，应包括： 1、将所有特殊特性记录进图纸（按要求）、风险分析（例如FMEA）、控制计划和标准的工作/操作说明书；特殊特性用特定的标记进行标识，并且贯穿这些文件中的每一个； 2、为产品和生产过程的特殊特性开发控制和策略； 3、顾客规定的批准，如有要求； 4、遵守顾客规定的定义和符号或组织的等效符号或标记，如符号转换表所示。如有要求，应向顾客提交符号转换表。8.3.3.28.3.3.2 Manufacturing process design input The organization shall identify, document, andreview manufacturing process design input requirements including but not limited to thefollowing: a) product design output data including special characteristics; b) targets forproductivity, process capability, timing, and cost: c) manufacturing technology alternatives: d)customer requirements, if any; e) experience from previous developments; f) new materials;g) product handling and ergonomic requirements: and h) design for manufacturing anddesign for assembly. The manufacturing process design shall include the use of error-proofingmethods to a degree appropriate to the magnitude of the problem(s) and commensurate withthe risks encountered.8.3.3.38.3.3.3 Special characteristics The organization shall use a multidisciplinary approach toestablish, document, and implement its process(es) to identify special characteristics, includingthose determined by the customer and the risk analysis performed by the organization, andshall include the following: a) documentation of special characteristics in the product and/ormanufacturing documents (as required), relevant risk analysis (such as process FMEA), controlplans. and standard work/operator instructions; special characteristics are identified withspecific markings and are documented in the manufacturing documents which show thecreation of, or the controls required, for these special characteristics; b) development of controland monitoring strategies for special characteristics of products and production processes; c)customer-specified approvals, when required; d) compliance with customer-specifieddefinitions and symbols or the organization's equivalent symbols or notations, as defined in asymbol conversion table. The symbol conversion table shall be submitted to the customer. ifrequired.条款细目英文版8.3.4 Design and development controls The organization shall apply controls to the design anddevelopment process to ensure that: a) the results to be achieved are defined; b) reviews areconducted to evaluate the ability of the results of design and development to meetrequirements; c) verification activities are conducted to ensure that the design anddevelopment outputs meet the input requirements; d) validation activities are conducted toensure that the resulting products and services meet the requirements for the specifiedapplication or intended use; e) any necessary actions are taken on problems determined duringthe reviews, or verification and validation activities; f) documented information of theseactivities is retained. NOTE Design and development reviews, verification and validation havedistinct purposes. They can be conducted separately or in any combination, as is suitable forthe products and services of the organization.中文版8.3.4 设计和开发控制组织应对设计和开发过程进行控制，以确保：a）规定拟获得的结果；b）实施评审活动，以评价设计和开发的结果满足要求的能力；c）实施验证活动，以确保设计和开发输出满足输入的要求；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）针对评审、验证和确认过程中确定的问题采取必要措施；f）保留这些活动的形成文件的信息。注：设计和开发的评审、验证和确认具有不同目的。根据组织的产品和服务的具体情况，可以单独或以任意组合进行。 8.3.4.1 监视产品和过程的设计和开发期间特定阶段的测量应被确定、分析，以汇总结果的形式来报告，作为对管理评审的输入（见第9.3.2.1条）。在顾客有所要求时，应在顾客规定或同意的阶段向顾客报告对产品和过程开发活动的测量。注：在适当的情况下，这些测量可包括质量风险、成本、前置期、关键路径和其它测量。8.3.48.3.4.18.3.4.1 Monitoring Measurements at specified stages during the design and development ofproducts and processes shall be defined, analysed, and reported with summary results as aninput to management review (see Section 9.3.2.1). When required by the customer;measurements of the product and process development activity shall be reported to thecustomer at stages specified, or agreed to, by the customer. NOTE When appropriate, thesemeasurements may include quality risks, costs, lead times, critical paths, and othermeasurements.8.3.4.2 Design and development validation Design and development validation shall beperformed in accordance with customer requirements, including any applicable industry andgovernmental agency-issued regulatory standards. The timing of design and developmentvalidation shall be planned in alignment with customer-specified timing, as applicable. Wherecontractually agreed with the customer, this shall include evaluation of the interaction of theorganization's product, including embedded software, within the system of the final customer'sproduct.8.3.4.3 Prototype programme When required by the customer, the organization shall have aprototype programme and control plan. The organization shall use, whenever possible, thesame suppliers, tooling, and manufacturing processes as will be used in production. Allperformance-testing activities shall be monitored for timely completion and conformity torequirements. When services are outsourced, the organization shall include the type and extentof control in the scope of its quality management system to ensure that outsourced servicesconform to requirements (see ISO 9001, Section 8.4).8.3.4.4 Product approval process The organization shall establish, implement, and maintain aproduct and manufacturing approval process conforming to requirements defined by thecustomer(s). The organization shall approve externally provided products and services per ISO9001, Section 8.4.3, prior to submission of their part approval to the customer. Theorganization shall obtain documented product approval prior to shipment, if required by thecustomer. Records of such approval shall be retained. NOTE Product approval should besubsequent to the verification of the manufacturing process.8.3.5 Design and development outputs The organization shall ensure that design anddevelopment outputs: a) meet the input requirements; b) are adequate for the subsequentprocesses for the provision of products and services; c) include or reference monitoring andmeasuring requirements, as appropriate, and acceptance criteria; d) specify the characteristicsof the products and services that are essential for their intended purpose and their safe andproper provision. The organization shall retain documented information on design anddevelopment outputs.8.3.4.28.3.4.2设计和开发确认应根据顾客要求，包括适用的行业和政府机构发布的监管标准，对设计和开发进行确认。设计和开发确认的时程安排应与顾客规定的时程相符。在与顾客有合同约定的情况下，设计和开发确认应包括评价组织的产品，包括嵌入式软件在最终顾客产品系统内的相互作用8.3.4.38.3.4.3 原型样件方案当顾客要求时，组织应制定原型样件方案和控制计划。组织应尽可能地使用与正式生产相同的供应商、工装和制造过程。应监视所有的性能试验活动的及时完成和要求符合性。当服务被外包时，应将控制的类型和程度纳入其质量管理体系的范围，以确保外包服务符合要求（见ISO9001第8.4条）。8.3.4.48.3.4.4 产品批准过程组织应建立、实施并保持一个符合顾客规定要求的产品和制造批准过程。在向顾客提交其零件批准之间，组织应根据ISO9001第8.4.3条，对外部提供的产品和服务进行审批。如顾客有所要求，组织应在发运之前获得形成文件的产品批准。此类批准的记录应予以保存。注：产品的批准应当是制造过程验证的后续步骤。8.3.5 设计和开发输出组织应确保设计和开发输出：a）满足输入的要求；b）对于产品和服务提供的后续过程是充分的；c）包括或引用监视和测量的要求，适当时，包括接收准则；d）规定对于实现预期目的、保证安全和正确提供（使用）所必须的产品和服务特性。组织应保留有关设计和开发输出的形成文件的信息。8.3.5.1 设计和开发输出---补充产品设计输出的陈述方式应适合于对照产品设计输入要求进行验证和确认。产品设计输出应包括但不限于（如适用）： 1、设计风险分析（FMEA）； 2、可靠性研究结果； 3、产品特殊特性； 4、产品的设计防错结果，如DFSS\\DFMA\\FTA； 5、产品定义，包括三维模型、技术数据包、产品制造信息及几何尺寸与公差（GD&T）； 6、二维图纸、产品制造信息及几何尺寸与公差； 7、产品设计评审结果； 8、服务诊断指南及修理和可服务性说明； 9、服务件要求； 10、运输的包装和标签要求。 注：临时设计输出应当包含通过权衡过程正在解决的工作问题。 8.3.5.2 制造过程设计输出---补充组织应对制造过程设计输出形成文件，采用的方式应能够对照制造过程设计输入进行验证。组织应对照制造过程设计输入要求对输出进行验证。制造过程设计输出应包括量不限于： 1、规范和图纸。 2、产品和制造过程的特殊特性； 3、对影响特性的过程输入的识别； 4、用于生产和控制的工装和设备，包括设备和过程的能力研究； 5、制造过程流程图\\制造过程平面布置图，包括产品、过程和工装的联系； 6、产能分析； 7、制造过程FMEA； 8、维护计划和说明； 9、控制计划（见附录A）； 10、标准作业和工作指导书； 11、过程批准的接收准则； 12、质量、可靠性、或维护性和可测量性的数据； 13、适用时，防错识别和验证的结果； 14、产品/制造过程不符合的快速探测、反馈和纠正的方法。 8.3.6 设计和开发更改组织应识别、评审和控制产品和服务设计和开发期间以及后续所做的更改，以便避免不利影响，确保符合要求。组织应保留下列形成文件的信息：a）设计和开发变更；b）评审的结果；c）变更的授权；d）为防止不利影响而采取的措施。8.3.58.3.5.18.3.5.1 Design and development outputs — supplemental The product design output shall beexpressed in terms that can be verified and validated against product design inputrequirements. The product design output shall include but is not limited to the following, asapplicable: a) design risk analysis (FMEA); b) reliability study results; c) product specialcharacteristics; d) results of product design error-proofing, such as DFSS, DFMA, and FTA; e)product definition including 3D models, technical data packages, product manufacturinginformation, and geometric dimensioning & tolerancing (GD&T); f) 2D drawings, productmanufacturing information, and geometric dimensioning & tolerancing (GD&T); g) productdesign review results; h) service diagnostic guidelines and repair and serviceability instructions;i) service part requirements; j) packaging and labeling requirements for shipping. NOTE Interimdesign outputs should include any engineering problems being resolved through a trade-offprocess.8.3.5.28.3.5.2 Manufacturing process design output The organization shall document themanufacturing process design output in a manner that enables verification against themanufacturing process design inputs. The organization shall verify the outputs againstmanufacturing process design input requirements. The manufacturing process design outputshall include but is not limited to the following: a) specifications and drawings; b) specialcharacteristics for product and manufacturing process; c) identification of process inputvariables that impact characteristics; d) tooling and equipment for production and control,including capability studies of equipment and process(es); e) manufacturing process flowchartsflayout, including linkage of product, process, and tooling; f) capacity analysis; g)manufacturing process FMEA; h) maintenance plans and instructions; i) control plan (see AnnexA); j) standard work and work instructions; k) process approval acceptance criteria; I) data forquality, reliability, maintainability, and measurability; m) results of error-proofing identificationand verification, as appropriate; n) methods of rapid detection, feedback, and correction ofproduct/manufacturing process nonconformities.8.3.68.3.6 Design and development changes The organization shall identify, review and controlchanges made during, or subsequent to, the design and development of products andservices, to the extent necessary to ensure that there is no adverse impact on conformity torequirements. The organization shall retain documented information on: a) design anddevelopment changes; b) the results of reviews; c) the authorization of the changes; d) theactions taken to prevent adverse impacts.条款细目英文版8.3.6.1 Design and development changes —supplemental The organization shall evaluate alldesign changes after initial product approval, including those proposed by the organization orits suppliers, for potential impact on fit, form, function, performance, and/or durability. Thesechanges shall be validated against customer requirements and approved internally, prior toproduction implementation. If required by the customer, the organization shall obtaindocumented approval, or a documented waiver, from the customer prior to productionimplementation. For products with embedded software, the organization shall document therevision level of software and hardware as part of the change record.8.4.1 General The organization shall ensure that externally provided processes, products andservices conform to requirements. The organization shall determine the controls to be appliedto externally provided processes, products and services when: a) products and services fromexternal providers are intended for incorporation into the organization’s own products andservices; b) products and services are provided directly to the customer(s) by external providerson behalf of the organization; c) a process, or part of a process, is provided by an externalprovider as a result of a decision by the organization. The organization shall determine andapply criteria for the evaluation, selection, monitoring of performance, and re-evaluation ofexternal providers, based on their ability to provide processes or products and services inaccordance with requirements. The organization shall retain documented information of theseactivities and any necessary actions arising from the evaluations.中文版8.3.6.1 设计和开发更改----补充组织应评价初始产品批准之后的所有设计更改，包括组织或其供应商提议的更改，评价这些更改对可装配性、形式、功能、性能和/或耐久性的影响。这些更改应对照顾客要求确认，并在生产实施之前得到内部批准。 如顾客有所要求，组织应在生产实施之前从顾客处获得形成文件的批准或弃权。 对于带有嵌入式软件的产品，组织应对软硬件的版本级别形成文件，作为更改记录的一部分。8.3.6.18.4 外部提供过程、产品和服务的控制8.4.1总则组织应确保外部提供的过程、产品和服务符合要求。在下列情况下，组织应确定对外部提供的过程、产品和服务实施的控制：a) 外部供方的过程、产品和服务构成组织自身的产品和服务的一部分；b) 外部供方替组织直接将产品和服务提供给顾客；c) 组织决定由外部供方提供过程或部分过程。组织应基于外部供方提供所要求的过程、产品或服务的能力，确定外部供方的评价、选择、绩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，组织应保留所需的形成文件的信息。8.4.1.1 总则—补充 组织应将影响顾客要求的所有产品和服务，如子总成、排序、挑选、返工和校准服务，纳入其对外部提供的产品、过程和服务的定义范围。8.4.18.4.1.18.4.1.1 General— supplemental The organization shall include all products and services thataffect customer requirements such as sub¬assembly, sequencing, sorting, rework, andcalibration services in the scope of their definition of externally provided products, processes,and services.8.4.1.2 Supplier selection process The organization shall have a documented supplier selectionprocess. The selection process shall include: a) an assessment of the selected supplier's risk toproduct conformity and uninterrupted supply of the organization's product to their customers:b) relevant quality and delivery performance; c) an evaluation of the supplier's qualitymanagement system; d) multidisciplinary decision making, and e) an assessment of softwaredevelopment capabilities, if applicable. Other supplier selection criteria that should beconsidered include the following: volume of automotive business (absolute and as apercentage of total business); — financial stability; — purchased product, material, or servicecomplexity; — required technology (product or process); — adequacy of available resources(e.g., people, infrastructure); — design and development capabilities (including projectmanagement); — manufacturing capability; — change management process; — businesscontinuity planning (e.g disaster preparedness, contingency planning); — logistics process; —customer service.8.4.1.2 8.4.1.2 供应商选择过程 (1/2) 组织应有一个形成文件的供应商选择过程。选择过程应包括： 1、对所选供应商产品符合性 及组织向其顾客不间断产品供应的风险评估； 2、相关质量和交付绩效； 3、对供应商质量管理体系的评价； 4、多方论证决策；以及 5、对软件开发能力的评估，如适用。8.4.1.2 供应商选择过程 (2/2) 应当考虑的其他供应商选择准则包括：汽车业务量（绝对值，以及占业务总量的百分比）财务稳定性采购的产品，材料或服务的复杂性所需技术（产品和过程）可用资源（如:人员，基础设施）的充分性设计和开发能力（包括项目管理）制造能力更改管理过程业务连续性规划（如：灾难准备，应急计划）物流过程顾客服务8.4.1.38.4.1.3 Customer•directed sources (also known as \"Directed-Buy\") When specified by thecustomer, the organization shall purchase products, materials, or services from customer-directed sources. All requirements of Section 8.4 (except the requirements in IATF 16949,Section 8.4.1.2) are applicable to the organization's control of customer-directed sourcesunless specific agreements are otherwise defined by the contract between the organizationand the customer.8.4.2 Type and extent of control The organization shall ensure that externally providedprocesses, products and services do not adversely affect the organization’s ability toconsistently deliver conforming products and services to its customers. The organization shall:a) ensure that externally provided processes remain within the control of its qualitymanagement system; b) define both the controls that it intends to apply to an externalprovider and those it intends to apply to the resulting output; c) take into consideration: 1) thepotential impact of the externally provided processes, products and services on theorganization’s ability to consistently meet customer and applicable statutory and regulatoryrequirements; 2) the effectiveness of the controls applied by the external provider; d)determine the verification, or other activities, necessary to ensure that the externally providedprocesses, products and services meet requirements. 8.4.1.3 顾客指定的货源当顾客指定时，组织应从顾客指定的货源处采购产品、材料或服务。第8.4条的所有要求（除了IATF16949第8.4.1.2条中的要求）适用于组织对顾客指定货源的控制，除非组织与顾客之间的合同另有特殊约定。8.4.28.4.2 控制类型和程度组织应确保外部提供的过程、产品和服务不会对组织稳定地向顾客交付合格产品和服务的能力产生不利影响。组织应：a)确保外部提供的过程保持在其质量管理体系的控制之中；b）规定对外部供方的控制及其输出结果的控制；c）考虑：1）外部提供的过程、产品和服务对组织稳定地提供满足顾客要求和适用的法律法规要求的能力的潜在影响；2）外部供方自身控制的有效性；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。 8.4.2.1 控制类型和程度—补充组织应有一个形成文件的过程，以识别外包过程并选择控制的类型和程度，用于验证外部提供的产品、过程和服务对内部（组织的）要求和外部顾客要求的符合性。该过程应包括根据供应商绩效和产品、材料或服务风险评估，增加或减少控制类型和程度以及开发活动的准则和措施。8.4.2.18.4.2.1 Type and extent of control — supplemental The organization shall have a documentedprocess to identify outsourced processes and to select the types and extent of controls used toverify conformity of externally provided products, processes, and services to internal(organizational) and external customer requirements. The process shall include the criteria andactions to escalate or reduce the types and extent of controls and development activities basedon supplier performance and assessment of product, material, or service risks. Wherecharacteristics or components “pass through” the organization’s quality management systemwithout validation or controls, the organization shall ensure that the appropriate controls are inplace at the point of manufacture.8.4.2.2 Statutory and regulatory requirements The organization shall document their process toensure that purchased products, processes, and services conform to the current applicablestatutory and regulatory requirements in the country of receipt, the country of shipment, andthe customer-identified country of destination, if provided. If the customer defines specialcontrols for certain products with statutory and regulatory requirements, the organization shallensure they are implemented and maintained as defined, including at suppliers.8.4.2.28.4.2.2 法律法规要求组织应有形成文件的过程，确保所采购的产品、过程和服务符合收货国、发运国和顾客确定的目的国（如有提供）的现行适用法律法规要求。如果顾客为特定产品符合法律法规要求确定了特殊控制，组织应确保按照规定实施并保持这些控制，包括在供应商处。条款细目英文版8.4.2.3 Supplier quality management system development The organization shall require theirsuppliers of automotive products and services to develop, implement, and improve a qualitymanagement system (QMS) with the ultimate objective of becoming certified to thisAutomotive QMS Standard. Using a risk-based model, the organization shall define aminimum acceptable level of QMS development and a target QMS development level for eachsupplier. Unless otherwise authorized by the customer a QMS certified to ISO 9001 is the initialminimum acceptable level of development. Based on current performance and the potentialrisk to the customer, the objective is to move suppliers through the following QMSdevelopment progression: a) certification to ISO 9001 through third-party audits; unlessotherwise specified by the customer, suppliers to the organization shall demonstrateconformity to ISO 9001 by maintaining a third-party certification issued by a certification bodybearing the accreditation mark of a recognized IAF MLA (International Accreditation ForumMultilateral Recognition Arrangement) member and where the accreditation body's mainscope includes management system certification to ISO/IEC 17021; b) certification to ISO 9001with compliance to other customer-defined QMS requirements (such as Minimum AutomotiveQuality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent)through second-party audits; c) certification to IS0 9001 with compliance to IATF 16949through second-party audits; d) certification to IATF 16949 through third-party audits (validthird-party certification of the supplier to IATF 16949 by an IATF-recognized certificationbody). NOTE: The minimum acceptable level of QMS development may be compliance to ISO9001 through second-party audits, if authorized by the customer.中文版8.4.2.3 供应商质量管理体系开发组织要求其汽车产品和服务供应商开发、实施并改进一个通过ISO9001认证的质量管理体系，除非顾客另行授权【如下文项1】，最终目标是通过本汽车QMS标准的认证。除非顾客另有规定，应当根据以下顺序来达成本要求： 1、经由第二方审核符合ISO9001； 2、经由第三方审核ISO9001认证；除非顾客另有规定，组织的供应商应通过保持认证机构出具的第三方认证证明来证实对ISO9001的符合性，证明上应有被承认的IAF MLA（国际认可论坛多边相互承认协议）成员的认可标志，其中，认可机构的主要范围包括ISO/IEC17021管理体系认证（质量管理体系认证机构的要求）； 3、经由第二方审核通过ISO9001认证，同时符合其它顾客确定的质量管理体系要求（如次级供应商最低汽车质量管理体系要求【MAQMSR】或等效要求）； 4、通过ISO9001认证，同时经由第二方审核符合IATF16949； 5、经由第三方审核通过IATF16949认证（IATF认可的认证机构进行的有效的供应商IATF16949第三方认证）。8.4.2.38.4.2.3.1 Automotive product-related software or automotive products with embeddedsoftware The organization shall require their suppliers of automotive product-related software,or automotive products with embedded software, to implement and maintain a process forsoftware quality assurance for their products. A software development assessment8.4.2.3.1methodology shall be utilized to assess the supplier's software development process. Usingprioritization based on risk and potential impact to the customer, the organization shall requirethe supplier to retain documented information of a software development capability self-assessment.8.4.2.4 Supplier monitoring The organization shall have a documented process and criteria toevaluate supplier performance in order to ensure conformity of externally provided products,processes, and services to internal and external customer requirements. At a minimum, thefollowing supplier performance indicators shall be monitored: a) delivered product conformityto requirements; b) customer disruptions at the receiving plant, including yard holds and stopships; c) delivery schedule performance; d) number of occurrences of premium freight. Ifprovided by the customer, the organization shall also include the following, as appropriate, intheir supplier performance monitoring: e) special status customer notifications related toquality or delivery issues; f) dealer returns, warranty, field actions, and recalls. 8.4.2.3.1 汽车产品相关软件或带有嵌入式软件的汽车产品组织应要求其汽车产品相关软件或带有嵌入式软件的汽车产品的供应商为各自产品实施并保持一个软件质量保证过程。应采用软件开发评估方法来评估供应商的软件开发过程。组织应按照风险和对顾客潜在影响的优先级，要求供应商为软件开发能力自评估保存形成文件的信息。8.4.2.4 8.4.2.4 供应商监视组织应为供应商绩效评价制定形成文件的过程和准则，以便确保外部提供的产品、过程和服务符合内部要求和外部顾客要求。至少应监视以下供应商绩效指标： 1、已交付产品对要求的符合性； 2、在收货工厂对顾客造成的干扰，包括整车候检和停止出货物； 3、交付排程的绩效； 4、超额运费发生的次数。 如顾客有所规定，组织还应视情况在供应商绩效监视中包括： 5、与质量或交付有关的特殊状态顾客通知； 6、经销商退货、保修、使用现场措施和召回。 8.4.2.4.1 第二方审核组织的供应商管理方法中应包括一个第二方审核过程。第二审核可以用于： 1、供应商风险评估； 2、供应商监视； 3、供应商质量管理体系开发； 4、产品审核； 5、过程审核。基于风险分析，包括产品安全/法规要求、供应商和质量管理体系认证水平，组织应至少对第二方名审核的需求、类型、频率和范围的确定准则形成文件。组织应保留第二方审核报告的记录。如果第二方审核的范围是评估供应商的质量管理体系，则方法应与汽车过程方法相符。8.4.2.4.1 Second-party audits The organization shall include a second-party audit process intheir supplier management approach. Second-party audits may be used for the following: a)supplier risk assessment, b) supplier monitoring; c) supplier QMS development; d) productaudits; e) process audits. Based on a risk analysis, including product safety/regulatoryrequirements, performance of the supplier, and QMS certification level, at a minimum, theorganization shall document the criteria for determining the need, type, frequency, and scope8.4.2.4.1of second-party audits. The organization shall retain records of the second-party audit reports.If the scope of the second-party audit is to assess the supplier's quality management system,then the approach shall be consistent with the automotive process approach. NOTE Guidancemay he found in the IATF Auditor Guide and ISO 19011.8.4.2.58.4.2.5 Supplier development The organization shall determine the priority, type, extent, andtiming of required supplier development actions for its active suppliers. Determination inputsshall include but are not limited to the following: a) performance issues identified throughsupplier monitoring (see Section 8.4.2.4); b) second-party audit findings (see Section 8.4.2.4.1);c) third-party quality management system certification status; d) risk analysis. The organizationshall implement actions necessary to resolve open (unsatisfactory) performance issues andpursue opportunities for continual improvement.8.4.3 Information for external providers The organization shall ensure the adequacy ofrequirements prior to their communication to the external provider. The organization shallcommunicate to external providers its requirements for: a) the processes, products and servicesto be provided; b) the approval of: 1) products and services; 2) methods, processes andequipment; 3) the release of products and services; c) competence, including any requiredqualification of persons; d) the external providers’ interactions with the organization; e) controland monitoring of the external providers’ performance to be applied by the organization; f)verification or validation activities that the organization, or its customer, intends to perform atthe external providers’ premises. 8.4.2.5 供应商开发组织应为其活跃供应确定所需供应商开发行动的优先级、类型、程度和时程安排。用于确定的输入应包括但不限于： 1、通过供应商监视（见第8.4.2.4条）识别的绩效问题； 2、第二方审核发现（见第8.4.2.4.1条）； 3、第三方质量管理体系认证状态； 4、风险分析。组织应采取必要措施，以解决未决的（不符合要求的）绩效问题并寻求持续改进的机会。8.4.3 外部供方的信息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。组织应与外部供方沟通以下要求：a) 所提供的过程、产品和服务；b) 对下列内容的批准：1）产品和服务；2）方法、过程和设备；3）产品和服务的放行；c) 能力，包括所要求的人员资质；d）外部供方与组织的接口；e）组织对外部供方绩效的控制和监视；f）组织或其顾客拟在外部供方现场实施的验证或确认活动。 8.4.3.1 外部供方的信息—补充组织应向其供应商传达所有适用的法律法规要求以及产品和过程特殊特性，并要求供应商沿着供应链直到制造，贯彻所有适用的要求。8.4.38.4.3.18.4.3.1 Information for external providers — supplemental The organization shall pass downall applicable statutory and regulatory requirements and special product and processcharacteristics to their suppliers and require the suppliers to cascade all applicablerequirements down the supply chain to the point of manufacture8.5.1 Control of production and service provision The organization shall implement productionand service provision under controlled conditions. Controlled conditions shall include, asapplicable: a) the availability of documented information that defines: 1) the characteristics ofthe products to be produced, the services to be provided, or the activities to be performed; 2)the results to be achieved; b) the availability and use of suitable monitoring and measuringresources; c) the implementation of monitoring and measurement activities at appropriatestages to verify that criteria for control of processes or outputs, and acceptance criteria forproducts and services, have been met; d) the use of suitable infrastructure and environment forthe operation of processes; e) the appointment of competent persons, including any requiredqualification; f) the validation, and periodic revalidation, of the ability to achieve plannedresults of the processes for production and service provision, where the resulting outputcannot be verified by subsequent monitoring or measurement; g) the implementation ofactions to prevent human error; h) the implementation of release, delivery and post-deliveryactivities. NOTE Suitable infrastructure includes appropriate manufacturing equipment requiredto ensure product compliance. Monitoring and measuring resources include appropriatemonitoring and measuring equipment required to ensure effective control of manufacturingprocesses.8.5.18.5 生产和服务提供8.5.1 生产和服务提供的控制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：a）可获得形成文件的信息，以规定以下内容：1）所生产的产品、提供的服务或进行的活动的特征；2）拟获得的结果。b）可获得和使用适宜的监视和测量资源；c）在适当阶段实施监视和测量活动，以验证是否符合过程或输出的控制准则以及产品和服务的接收准则；d）为过程的运行提供适宜的基础设施和环境；e）配备具备能力的人员，包括所要求的资格；f）若输出结果不能由后续的监视或测量加以验证，应对生产和服务提供过程实现策划结果的能力进行 确认和定期再确认；g） 采取措施防止人为错误；h） 实施放行、交付和交付后活动。条款细目英文版8.5.1.1 Control plan The organization shall develop control plans (in accordance with Annex A)at the system, subsystem, component, and/or material level for the relevant manufacturing siteand all product supplied, including those for processes producing bulk materials as well asparts. Family control plans are acceptable for bulk material and similar parts using a commonmanufacturing process. The organization shall have a control plan for pre-launch andproduction that shows [inkage and incorporates information from the design risk analysis (ifprovided by the customer), process flow diagram, and manufacturing process risk analysisoutputs (such as FMEA). The organization shall, if required by the customer, providemeasurement and conformity data collected during execution of either the pre-launch orproduction control plans. The organization shall include in the control plan: a) controls used forthe manufacturing process control, including verification of job set-ups; b) first-off/last-offpart validation, as applicable; c) methods for monitoring of control exercised over specialcharacteristics (see Annex A) defined by both the customer and the organization; d) thecustomer-required information, if any; e) specified reaction plan (see Annex A); whennonconforming product is detected, the process becomes statistically unstable or notstatistically capable. The organization shall review control plans, and update as required. forany of the following: f) the organization determines it has shipped nonconforming product tothe customer; g) when any change occurs affecting product, manufacturing process,measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)(see Annex A); h) after a customer complaint and implementation of the associated correctiveaction, when applicable; i) at a set frequency based on a risk analysis. If required by thecustomer, the organization shall obtain customer approval after review or revision of thecontrol plan.8.5.1.2 Standardised work— operator Instructions and visual standards The organization shallensure that standardised work documents are: a) communicated to and understood by theemployees who are responsible for performing the work; b) legible; c) presented in thelanguage(s) understood by the personnel responsible to follow them; d) accessible for use atthe designated work area(s). The standardised work documents shall also include rules foroperator safety.中文版 8.5.1.1 控制计划 1/2组织应针对相关制造现场和所有提供的产品，在系统、子系统、部件和/或材料各层次上（根据附录A）制定控制计划，包括那些生产散装材料和零件的的过程。采用共同制造过程的散装材料和相似零件可接受使用控制计划族。组织应制定投产前控制计划和量产控制计划，显示设计风险分析（如果顾客提供了）、过程流程图和制造过程风险分析输出（如FMEA）的联系，并在计划中包含从这些方面获得的信息。如果顾客要求，组织应提供在投产前或量产控制计划执行期间收集的测量和符合性数据。组织应在控制计划中包含以下内容： 1.用于制造过程的控制手段，包括作业准备验证； 2.首件/末件确认，如适用； 3、用于顾客和组织确定的特殊特性（见附录A）控制的监视方法； 4、顾客要求的信息，如有；5、规定的反应计划（附录A）；当检测到不合格品，过程会变得不稳定或统计能力不足时。 组织应针对如下任一情况对控制计划进行评审，并在需要时更新： 6、当组织确定其已经向顾客发运了不合格品； 7、当发生任何影响产品、制造过程、测量、物流、供应货源、生产量或风险分析（FMEA）的变更（见附录A）； 8、在收到顾客投诉并实施了相关纠正措施之后，当适用时； 9、以基于风险分析的设定频率。 如果顾客要求，组织应在控制计划评审和修订后获得顾客批准。8.5.1.18.5.1.2 8.5.1.2 标准化作业—操作指导书和目视 组织应确保标准化作业文件： 1、被传达给负责相关工作的员工，并被员工理解； 2、是清晰易读的； 3、用有责任遵守这文件的人员能够理解的语言表述； 4、在指定的工作区域易于得到。8.5.1.38.5.1.3 Verification of job set-ups The organization shall: a) verify job set-ups whenperformed, such as an initial run of a job, material changeover, or job change that requires anew set-up; b) maintain documented information for set-up personnel; c) use statisticalmethods of verification, where applicable; d) perform first-off/last-off part validation, asapplicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-offparts in subsequent runs; e) retain records of process and product approval following set-upand first-off/last-off part validations. 8.5.1.3 作业准备的验证组织应 1、当执行作业准备时进行作业准备验证，如需要新作业准备的一项工作的首次运行、材料的更换或工作的变更； 2、保持有关准备人员的形成文件的信息； 3、适用时采用统计的验证方法； 4、进行首/末件确认，如适用；适当时，应当保留首件用于与末件比较；适当时，应当保留末件用 于与后续运行中的首件比较； 5、保留作业准备和首件/末件确认之后过程和产品批准的记录。 8.5.1.4 停工后的验证 组织应确定并采取必要的措施，确保在计划或非计划生产停工期之后，产品对要求的符合性。8.5.1.48.5.1.4 Verification after shutdown The organization shall define and implement the necessaryactions to ensure product compliance with requirements after a planned or unplannedproduction shutdown period.8.5.1.5 Total productive maintenance The organization shall develop, implement, and maintaina documented total productive maintenance system. At a minimum, the system shall includethe following: a) identification of process equipment necessary to produce conforming productat the required volume; b) availability of replacement parts for the equipment identified in itema); c) provision of resource for machine, equipment, and facility maintenance; d) packaging andpreservation of equipment, tooling, and gauging; e) applicable customer-specificrequirements; f) documented maintenance objectives, for example: OEE (Overall EquipmentEffectiveness), MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair), andPreventive Maintenance compliance metrics. Performance to the maintenance objectives shallform an input into management review (see ISO 9001, Section 9.3); g) regular review ofmaintenance plan and objectives and a documented action plan to address corrective actionswhere objectives are not achieved; h) use of preventive maintenance methods; i) use ofpredictive maintenance methods, as applicable; j) periodic overhaul.8.5.1.5 8.5.1.5 全面生产维护 组织应制定、实施并保持一个形成文件的全面生产维护系统。 该系统应至少包含： 1、对按照要求产量生产合格产品所必需的过程设备和识别； 2、项1中被识别设备的替换件的可用性； 3、机器、设备和设施维护的资源提供； 4、设备、工装和量具的包装和防护； 5、适用的顾客特定要求； 6、形成文件的维护目标，如OEE(全局设备效率)、MTBF（平均故障间隔时间）和MTTR(平均维修时间)以及预防性维护符合性指标。维护目标的绩效应作为管理评审的输入（见ISO9001第9.3条 ）； 7、维护计划和目标以及形成文件的措施计划的定期评审，以在未达到目标时采取纠正措施； 8、对预防性维护方法的使用； 9、对预测性维护方法的使用，如适用； 10、周期性检修。8.5.1.6 生产工装及制造、试验、检验工装和设备的管理组织应针对生产和服务材料和散装材料（如适用），为工具、量具的设计、制造和验证活动提供资源组织应在建立并实施一个生产工装管理体系，不管归组织或顾客所有，其中包括： 1、维护、维修设施与人员； 2、存储与修复； 3、工装准备； 4、易损工具的工具更换方案； 5、工具设计修改的文件，包括产品的工程变更等级； 6、工具的修改和文件的修订； 7、工具标识，如：序列号或资产编号；状态，如生产、修理或废弃；所有权；以及位置。组织应验证顾客拥有的工具、制造设备和试验/检验设备是在明显的位置永久标记的，以便能够确定每件工具或设备的所有权和用途。 8.5.1.7 生产排程组织应确保为满足顾客订单/需求来安排生产，如准时生产（JIT）,并且确保生产由一个信息系统支持，该系统允许在过程的关键阶段取得生产信息，并且是订单驱动的。组织应在生产排程期间包含相关策划信息，如顾客订单、供应商准时交付绩效、产能、共享载荷（共线工位）、前置期、库存水平、预防性维护及校准。8.5.1.68.5.1.6 Management of production tooling and manufacturing, rest, inspection tooling andequipment The organization shall provide resources for tool and gauge design, fabrication, andverification activities for production and service materials and for bulk materials, as applicable.The organization shall establish and implement a system for production tooling management,whether owned by the organization or the customer, including: a) maintenance and repairfacilities and personnel; b) storage and recovery; c) set-up; d) tool-change programmes forperishable tools; e) tool design modification documentation, including engineering changelevel of the product; f) tool modification and revision to documentation; g) tool identification,such as serial or asset number; the status, such as production, repair or disposal; ownership;and location. The organization shall verify that customer-owned tools, manufacturingequipment, and test/inspection equipment are permanently marked in a visible location so thatthe ownership and application of each item can be determined. The organization shallimplement a system to monitor these activities if any work is outsourced.8.5.1.7 Production scheduling The organization shall ensure that production is scheduled inorder to meet customer orders/demands such as Just-In-Time (JIT) and is supported by aninformation system that permits access to production information at key stages of the processand is order driven. The organization shall include relevant planning information duringproduction scheduling, e.g., customer orders, supplier on-time delivery performance, capacity,shared loading (multi-part station), lead time, inventory level, preventive maintenance, andcalibration.8.5.2 Identification and traceability The organization shall use suitable means to identifyoutputs when it is necessary to ensure the conformity of products and services. Theorganization shall identify the status of outputs with respect to monitoring and measurementrequirements throughout production and service provision. The organization shall control theunique identification of the outputs when traceability is a requirement, and shall retain thedocumented information necessary to enable traceability. NOTE Inspection and test status isnot indicated by the location of product in the production flow unless inherently obvious, suchas material in an automated production transfer process. Alternatives are permitted if thestatus is clearly identified, documented, and achieves the designated purpose.8.5.1.78.5.2 标识和可追溯性需要时，组织应采用适当的方法识别输出，以确保产品和服务合格。组织应在生产和服务提供的整个过程中按照监视和测量要求识别输出状态。若要求可追溯，组织应控制输出的唯一性标识，且应保留实现可追溯性所需的形成文件的信息8.5.2条款细目英文版8.5.2.1 Identification and traceability — supplemental The purpose of traceability is to supportidentification of clear start and stop points for product received by the customer or in the fieldthat may contain quality and/or safety-related nonconformities. Therefore, the organizationshall implement identification and traceability processes as described below. The organizationshall conduct an analysis of internal, customer, and regulatory traceability requirements for allautomotive products, including developing and documenting traceability plans, based on thelevels of risk or failure severity for employees, customers, and consumers. These plans shalldefine the appropriate traceability systems, processes, and methods by product, process, andmanufacturing location that: a) enable the organization to identify nonconforming and/orsuspect product; b) enable the organization to segregate nonconforming and/or suspectproduct; c) ensure the ability to meet the customer and/or regulatory response timerequirements; d) ensure documented information is retained in the format (electronic,hardcopy, archive) that enables the organization to meet the response time requirements; e)ensure serialized identification of individual products, if specified by the customer or regulatorystandards; f) ensure the identification and traceability requirements are extended to externallyprovided products with safety/regulatory characteristics.8.5.3 Property belonging to customers or external providers The organization shall exercisecare with property belonging to customers or external providers while it is under theorganization’s control or being used by the organization. The organization shall identify, verify,protect and safeguard customers’ or external providers’ property provided for use orincorporation into the products and services. When the property of a customer or externalprovider is lost, damaged or otherwise found to be unsuitable for use, the organization shallreport this to the customer or external provider and retain documented information on whathas occurred. NOTE A customer’s or external provider’s property can include materials,components, tools and equipment, premises, intellectual property and personal data.中文版 8.5.2.1 标识和可追溯性---补充可追溯性的目的在于支持对顾客所收产品的开始点和停止点的清楚识别，或者用于发生质量和/安全相关不符合的情况。因此，组织应按照下文描述实施标识和可追溯过程。 组织应对所有汽车产品的内部、顾客及法规可追溯性要求进行分析，包括根据风险等级或失效对员工、顾客的严重程度，制定可追溯性计划并形成文件。这些计划应按产品、过程和制造位置明确适当的可追溯系统、过程和方法，应： 1、使组织能够识别不合格品和/或可疑产品； 2、使组织能够隔离不合格品和/或可疑产品； 3、确保能够满足顾客要求和和/或法规响应时间的要求； 4、确保保留了形成文件的信息，保留的形式（电子、硬拷贝、档案）使组织能够满足响应时间要求； 5、确保各单个产品的序列化标识，如顾客或监管标准有所规定。 6、确保标识和可追溯性要求被扩展应用至外部提供的具有安全/监管特性的产品。8.5.2.18.5.38.5.3 顾客或外部供方的财产组织在控制或使用顾客或外部供方的财产期间，应对其进行妥善管理。对组织使用的或构成产品和服务一部分的顾客和外部供方财产，组织应予以识别、验证、保护和维护。若顾客或外部供方的财产发生丢失、损坏或发现不适用情况，组织应向顾客或外部供方报告，并保留相关形成文件的信息。注：顾客或外部供方的财产可能包括材料、零部件、工具和设备，顾客的场所，知识产权和个人信息。 8.5.48.5.4 Preservation The organization shall preserve the outputs during production and service8.5.4防护provision, to the extent necessary to ensure conformity to requirements. NOTE Preservation组织应在生产和服务提供期间对输出进行必要防护，以确保符合要求。can include identification, handling, contamination control, packaging, storage, transmission or注：防护可包括标识、处置、污染控制、包装、储存、传送或运输以及保护。transportation, and protection.8.5.4.1 Preservation— supplemental Preservation shall include identification, handling,contamination control, packaging, storage, transmission or transportation, and protection.Preservation shall apply to materials and components from external and/or internal providersfrom receipt through processing, including shipment and until delivery to/acceptance by thecustomer. In order to detect deterioration, the organization shall assess at appropriate plannedintervals the condition of product in stock, the place/type of storage container, and the storageenvironment The organization shall use an inventory management system to optimizeinventory turns over time and ensure stock rotation, such as \"first-in-first-out' (FIFO). Theorganization shall ensure that obsolete product is controlled in a manner similar to that ofnonconforming product. Organizations shall comply with preservation, packaging, shipping,and labeling requirements as provided by their customer.8.5.5 Post-delivery activities The organization shall meet requirements for post-deliveryactivities associated with the products and services. In determining the extent of post-deliveryactivities that are required, the organization shall consider: a) statutory and regulatoryrequirements; b) the potential undesired consequences associated with its products andservices; c) the nature, use and intended lifetime of its products and services; d) customerrequirements; e) customer feedback. NOTE Post-delivery activities can include actions underwarranty provisions, contractual obligations such as maintenance services, and supplementaryservices such as recycling or final disposal.防护应包括标识、搬运、污染控制、包括、存储、输送或运输及保护。应对来自外部和/或内部供方的材料和部件，在从收货到处理的期间提供防护，包括发运并直到交付给顾客/被顾客验收。组织应按适当计划的时间间隔来评估库存品状况、存储容器放置/类型以及存储环境，以便及时探测变质情况。组织应使用库存管理系统以优化库存的周转期，确保库存周转，如“先进先出（FIFO）”。组织应确保过期产品按对待不合格品的类似方法进行控制。组织应满足其顾客规定的防护、包装、发运和标签要求。8.5.4.18.5.5 交付后的活动组织应满足与产品和服务相关的交付后活动的要求。在确定交付后活动的覆盖范围和程度时，组织应考虑：a）法律法规要求；b）与产品和服务相关的潜在不期望的后果；c）其产品和服务的性质、用途和预期寿命；d）顾客要求；e）顾客反馈。注：交付后活动可能包括担保条款所规定的相关活动，诸如合同规定的维护服务，以及回收或最终报废处置等附加服务等。8.5.58.5.5.18.5.5.1 Feedback of information from service The organization shall ensure that a process forcommunication of information on service concerns to manufacturing, material handling,logistics, engineering, and design activities is established, implemented, and maintained. NOTE1 The intent of the addition of \"service concerns\" to this sub-clause is to ensure that theorganization is aware of nonconforming product(s) and materials) that may be identified at thecustomer location or in the field. NOTE 2 \"Service concerns\" should include the results of fieldfailure test analysis (see Section 10.2.6) where applicable.8.5.5.2 Service agreement with customer When there is a service agreement with the customer,the organization shall: a) verify that the relevant service centres comply with applicablerequirements; b) verify the effectiveness of any special purpose tools or measurementequipment; c) ensure that all service personnel are trained in applicable requirements.8.5.5.1 服务信息的反馈 组织应确保建立、实施并保持一个在制造、材料搬运、物流、 工程和设计活动之间沟通服务问题信息的过程。 注1：将“服务问题”增加到这个子条款，是为了确保组织知晓可能在顾客地点或使用现场被识别的不合格品和材料。 注2：“服务问题”应当在适用时包括使用现场失效试验分析（见10.2.6）的结果。8.5.5.28.5.5.2 与顾客的服务协议 当与顾客达成服务协议时，组织应： 1、验证相关服务中心满足适用要求； 2、验证任何特殊用途的工具或测量设备的有效性； 3、确保所有服务人员得到了对适用要求的培训。8.5.6 更改控制组织应对生产和服务提供的更改进行必要的评审和控制，以确保稳定地符合要求。组织应保留形成文件的信息，包括有关更改评审结果、授权进行更改的人员以及根据评审所采取的必要措施。8.5.68.5.6 Control of changes The organization shall review and control changes for production orservice provision, to the extent necessary to ensure continuing conformity with requirements.The organization shall retain documented information describing the results of the review ofchanges, the person(s) authorizing the change, and any necessary actions arising from thereview.8.5.6.1 Control of changes — supplemental The organization shall have a documented processto control and react to changes that impact product realization. The effects of any change,including those changes caused by the organization, the customer, or any supplier, shall beassessed. The organization shall: a) define verification and validation activities to ensurecompliance with customer requirements; b) validate changes before implementation; c)document the evidence of related risk analysis; d) retain records of verification and validation.Changes, including those made at suppliers, should require a production trial run forverification of changes (such as changes to part design, manufacturing location, ormanufacturing process) to validate the impact of any changes on the manufacturing process.When required by the customer, the organization shall: e) notify the customer of any plannedproduct realization changes after the most recent product approval; f) obtain documentedapproval, prior to implementation of the change; g) complete additional verification oridentification requirements, such as production trial run and new product validation.8.5.6.18.5.6.1 更改控制—补充组织应有一个形成文件地的过程，对影响产品实现的更改进行控制和反应。任何更改的影响，包括由组织、顾客或任何供应商所引起的更改，都应进行评估。组织应： 1、明确验证和确认活动，以确保与顾客要求相一致； 2、在实施前对更改予以确认； 3、对相关风险分析的证据形成文件； 4、保留验证和确认的记录。应当对更改（如：对零件设计、制造地点或制造过程的更改），包括供应商作出的更改，进行以验证为目的的试生产，以便确认更改对制造过程带来的影响。当顾客要求时，组织应： 1、向顾客通知最近一次产品批准之后任何计划产品实现的更改； 2、在实施更改之前获得形成文件的批准； 3、达成额外验证或标识要求，如：试生产和新产品确认。条款细目英文版8.5.6.1.1 Temporary change of process controls The organization shall identify, document, andmaintain a list of the process controls, including inspection measuring, test, and error-proofingdevices, that includes the primary process control and the approved back-up or alternatemethods. The organization shall document the process that manages the use of alternatecontrol methods. The organization shall include in this process, based on risk analysis (such asFMEA), severity, and the internal approvals to be obtained prior to production implementationof the alternate control method. Before shipping product that was inspected or tested usingthe alternate method, if required, the organization shall obtain approval from the customer(s).The organization shall maintain and periodically review a list of approved alternate processcontrol methods that are referenced in the control plan. Standard work instructions shall be8.5.6.1.1available for each alternate process control method. The organization shall review theoperation of alternate process controls on a daily basis, at a minimum, to verifyimplementation of standard work with the goal to return to the standard process as defined bythe control plan as soon as possible. Example methods include but are not limited to thefollowing: a) daily quality focused audits (e.g., layered process audits, as applicable); b) dailyleadership meetings. Restart verification is documented for a defined period based on severityand confirmation that all features of the error-proofing device or process are effectivelyreinstated. The organization shall implement traceability of all product produced while anyalternate process control devices or processes are being used (e.g., verification and retention offirst piece and last piece from every shift).8.6 Release of products and services The organization shall implement planned arrangements,at appropriate stages, to verify that the product and service requirements have been met. Therelease of products and services to the customer shall not proceed until the plannedarrangements have been satisfactorily completed, unless otherwise approved by a relevantauthority and, as applicable, by the customer. The organization shall retain documentedinformation on the release of products and services. The documented information shallinclude: a) evidence of conformity with the acceptance criteria; b) traceability to the person(s)authorizing the release.8.6.1 Release of products and services — supplemental The organization shall ensure that theplanned arrangements to verify that the product and service requirements have been metencompass the control plan and are documented as specified in the control plan (see AnnexA). The organization shall ensure that the planned arrangements for initial release of productsand services encompass product or service approval. The organization shall ensure thatproduct or service approval is accomplished after changes following initial release, accordingto ISO 9001, Section 8.5.6.8.6.2 Layout inspection and functional testing A layout inspection and a functional verificationto applicable customer engineering material and performance standards shall be performedfor each product as specified in the control plans. Results shall be available for customerreview. NOTE 1 Layout inspection is the complete measurement of all product dimensionsshown on the design record(s). NOTE 2 The frequency of layout inspection is determined bythe customer.8.6.3 Appearance items For organizations manufacturing parts designated by the customer as\"appearance items.' the organization shall provide the following: a) appropriate resources,including lighting, for evaluation: b) masters for colour, grain, glass, metallic brilliance, texture,distinctness of image (DOI), and haptic technology, as appropriate; c) maintenance and controlof appearance masters and evaluation equipment; d) verification that personnel makingappearance evaluations are competent and qualified to do so.8.6.4 Verification and acceptance of conformity of externally provided products and servicesThe organization shall have a process to ensure the quality of externally provided processes,products, and services utilizing one or more of the following methods: a) receipt andevaluation of statistical data provided by the supplier to the organization; b) receivinginspection and/or testing, such as sampling based on performance; c) second-party or third-party assessments or audits of supplier sites when coupled with records of acceptabledelivered product conformance to requirements: d) part evaluation by a designated laboratory;e) another method agreed with the customer.8.6.5 Statutory and regulatory conformity Prior to release of externally provided products intoits production flow, the organization shall confirm and be able to provide evidence thatexternally provided processes, products, and services conform to the latest applicablestatutory, regulatory, and other requirements in the countries where they are manufacturedand in the customer-identified countries of destination, if provided.8.6.6 Acceptance criteria Acceptance criteria shall be defined by the organization and, whereappropriate or required, approved by the customer. For attribute data sampling, theacceptance level shall be zero defects (see Section 9.1.1.1).8.7.1 The organization shall ensure that outputs that do not conform to their requirements areidentified and controlled to prevent their unintended use or delivery. The organization shalltake appropriate action based on the nature of the nonconformity and its effect on theconformity of products and services. This shall also apply to nonconforming products andservices detected after delivery of products, during or after the provision of services. Theorganization shall deal with nonconforming outputs in one or more of the following ways: a)correction; b) segregation, containment, return or suspension of provision of products andservices; c) informing the customer; d) obtaining authorization for acceptance underconcession. Conformity to the requirements shall be verified when nonconforming outputs arecorrected.8.7.1.1 Customer authorization for concession The organization shall obtain a customerconcession or deviation permit prior to further processing whenever the product ormanufacturing process is different from that which is currently approved. The organizationshall obtain customer authorization prior to further processing for \"use as is\" and for repair(see 8.7.1.5) of nonconforming product. If sub-components are reused in the manufacturingprocess, that sub-component reuse shall be clearly communicated to the customer in theconcession or deviation permit. The organization shall maintain a record of the expiration dateor quantity authorized under concession. The organization shall also ensure compliance withthe original or superseding specifications and requirements when the authorization expires.Material shipped under concession shall be properly identified on each shipping container (thisapplies equally to purchased product). The organization shall approve any requests fromsuppliers before submission to the customer8.7.1.2 Control of nonconforming product — customer-specified process The organizationshall comply with applicable customer-specified controls for nonconforming product(s)中文版 8.5.6.1.1 过程控制和临时更改组织应识别过程控制手段，包括检验、测量、试验和防错装置，形成文件化的清单并予以保持，清单包含主要过程控制和经批准的备用或替代方法。组织应有一个形成文件的过程，对替代控制方法的使用进行管理。组织应基于风险分析（如FMEA）和严重程度，在本过程中包含要在生产中实施替代控制方法之前获得的内部批准。在发运采用替代方法检验或试验的产品之前，如有要求，组织应获得顾客批准。组织应保持一份控制计划中提及的经批准替代过程方法的清单并定期评审。每个替代过程控制方法应有标准的工作指导书。组织应至少每日评审替代过程控制手段的运行，以验证标准作业的实施，旨在尽早返回到控制计划规定的标准过程。方法范例包括但不限于： 1、以质量为关注的每日审核（如：分层过程审核，如适用）； 2、每日领导会议。基于严重程度，并在确认防错装置或过程的所有特征均得以有效恢复的基础上，在规定时期内对重新启动验证形成文件。在使用替代过程控制装置或过程期间，组织应实现生产的所有的产品的可追溯（如验证并每个班次首件或末件）。8.68.6 产品和服务的放行组织应在适当阶段实施策划的安排，以验证产品和服务的要求已被满足。除非得到有关授权人员的批准，适用时得到顾客的批准，否则在策划的安排已圆满完成之前，不应向顾客放行产品和交付服务。组织应保留有关产品和服务放行的形成文件的信息。形成文件的信息应包括：a）符合接收准则的证据；b）授权放行人员的可追溯信息8.6.1 产品和服务的放行---补充组织应确保用于验证产品和服务要求得以满足的所策划的安排围绕控制计划进行，并且形成文件规定在控制计划中（见附录A）。组织应确保为产品和服务初始放行所策划的安排围绕产品或服务批准进行。根据ISO9001第8.5.6条，组织应确保在初始放行后作出更改之后，完成产品或服务批准。8.6.18.6.28.6.2 全尺寸检验和功能性能试验应按控制计划中的规定，根据顾客的工程材料和性能标准，对每一种产品进行全尺寸检验和功能性验证。其结果应可供顾客评审。 注1：全尺寸检验是对设计记录上显示的所有产品尺寸进行完整的测量。 注2：全尺寸检验频率由顾客确定。8.6.3 外观项目 若组织制造的零件被顾客指定为“外观项目”，则组织应提供： 1、适当的资源，包括评价用的照明； 2、适当的颜色、纹理、金属亮度、织物结构、映像清晰度（DOI）和触感技术的原版样件； 3、外观原版样件及评价设备的维护和控制； 4、验证执行外观评价的人员有从事该工作的能力和资格。8.6.4 外部提供的产品和服务符合性的验证和接受组织应有一个过程来确保外部提供的过程、产品和服务的质量，可采用以下一种或多种方法： 1、接收并评价组织供应商提供的统计数据； 2、接收检验和/或试验，如基于绩效的抽样检查； 3、结合可接受的已交付产品对要求的符合性的记录，由第二方或第三方机构对供应商现场进行 评估或审核； 4、指定实验室的零件评价； 5、顾客同意的其它方法。8.6.5 法律法规的符合性在放行外部提供的产品进入生产流程之前，组织应确认并能够提供证据证明，外部提供的过程、产品和服务符合制造国以及顾客确定的目的国（如有提供）最新的适用法律、法规和其它要求。8.6.38.6.48.6.58.6.68.6.6 接收准则接收准则应由组织确定，当被要求时，由顾客批准。对于计数型数据的抽样，其接收水平应是零缺陷（见第9.1.1.1条）。8.7不合格输出的控制8.7.1组织应确保对不符合要求的输出进行识别和控制，以防止非预期的使用或交付。组织应根据不合格的性质及其对产品和服务的影响采取适当措施。这也适用于在产品交付之后发现的不合格产品，以及在服务提供期间或之后发现的不合格服务。组织应通过下列一种或几种途径处置不合格输出：a）纠正；b）对提供产品和服务进行隔离、限制、退货或暂停；c）告知顾客；d）获得让步接收的授权。对不合格输出进行纠正之后应验证其是否符合要求。8.7.1.1 顾客的让步授权无论何时，当产品或制造过程与当前批准的不同时，组织在进一步加工之前应获得顾客的让步或对偏离的许可。组织应在进一步加工之前，获得顾客对不合格品“照现状使用”和返工处置的授权。如果在制造过程中有子部件的再使用，应在让步或偏离许可中向顾客清楚传达该子部件的再使用。组织应保持有效期限或让步授权数量方面的记录。当授权期满时，组织还应确保原有的或接替的规范与要求的符合性。让步的物料装运时，应在每个发运集装箱上做适当的标识（此要求同样适用于采购的产品）。在提交给顾客之前，组织应批准由供应商所提出的请求。8.7.18.7.1.18.7.1.28.7.1.2 不合格品的控制—顾客规定的过程 组织应遵守顾客规定的适用的不合格品控制。条款细目英文版中文版8.7.1.38.7.1.3 Control of suspect product The organization shall ensure that product with unidentified8.7.1.3 可疑产品的控制or suspect status is classified and controlled as nonconforming product. The organization shall组织应确保处于未经标识或可疑状态下的产品被归类为不合格品进行控制。组织应确保所有适ensure that all appropriate manufacturing personnel receive training for containment of当的制造人员都接受了关于可疑产品和不合格品遏制的培训。suspect and nonconforming product.8.7.1.4 Control of reworked product The organization shall utilize risk analysis (such as FMEA)methodology to assess risks in the rework process prior to a decision to rework the product. Ifrequired by the customer, the organization shall obtain approval from the customer prior tocommencing rework of the product. The organization shall have a documented process forrework confirmation in accordance with the control plan or other relevant documentedinformation to verify compliance to original specifications. Instructions for disassembly orrework, including re-inspection and traceability requirements, shall be accessible to andutilized by the appropriate personnel. The organization shall retain documented informationon the disposition of reworked product including quantity, disposition, disposition date, andapplicable traceability information.8.7.1.5 Control of repaired product The organization shall utilize risk analysis (such as FMEA)methodology to assess risks in the repair process prior to a decision to repair the product. Theorganization shall obtain approval from the customer before commencing repair of theproduct. The organization shall have a documented process for repair confirmation inaccordance with the control plan or other relevant documented information. Instructions fordisassembly or repair, including re-inspection and traceability requirements, shall be accessibleto and utilized by the appropriate personnel. The organization shall obtain a documentedcustomer authorization for concession for the product to be repaired. The organization shallretain documented information on the disposition of repaired product including quantity,disposition, disposition date, and applicable traceability information.8.7.1.6 Customer notification The organization shall immediately notify the customer(s) in theevent that nonconforming product has been shipped. Initial communication shall be followedwith detailed documentation of the event.8.7.1.7 Nonconforming product disposition The organization shall have a documented processfor disposition of nonconforming product not subject to rework or repair. For product notmeeting requirements, the organization shall verify that the product to be scrapped isrendered unusable prior to disposal. The organization shall not divert nonconforming productto service or other use without prior customer approval.8.7.2 The organization shall retain documented information that: a) describes thenonconformity; b) describes the actions taken; c) describes any concessions obtained; d)identifies the authority deciding the action in respect of the nonconformity.8.7.1.4 返工产品的控制组织应在决定对产品进行返工之前，利用风险分析（如FMEA）方法来评估返工过程中的风险。如顾客有所要求，组织应在开始产品返工之前获得顾客批准。组织应有一个形成文件的符合控制计划的返工确认过程，或其它形成文件的相关信息，用于验证对原始规范的符合性。包含了重新检验和可追溯性要求的拆卸或返工指导书，应易于被适当的人员取得和使用。组织应保留与返工产品处置有关的形成文件的信息，包括数量、处置、处置日期及可适用的可追溯性信息。8.7.1.48.7.1.58.7.1.5 返修产品的控制组织应在决定对产品进行返修之前，利用风险分析（如FMEA）方法来评估返修过程中的风险。组织应在开始产品返修之前获得顾客批准。组织应有一个形成文件的符合控制计划的返修确认过程或其它形成文件的相关信息。包含了重新检验或可追溯性要求的拆卸或返修指导书。应易于被适当的人员取得和使用。组织应获得顾客对待返修产品的形成文件的让步授权。组织应保留与返修产品处置有关的形成文件的信息，包括数量、处置、处置日期及适用的可追溯性信息。8.7.1.68.7.1.6 顾客通知当不合格品被发运时，组织应立刻通知顾客。初始通知应随附事件的详细文件。8.7.1.78.7.1.7 不合格品的处置组织应有一个形成文件的过程，用于不进行返工或返修的不合格品的处置。对于不符合要求的产品，组织应验证待报废产品在废弃之前已被变得无用。若无顾客提前批准，组织不得将不合格品用于服务或其它用途。8.7.28.7.2 组织应保留下列形成文件的信息：a）有关不合格的描述；b）所采取措施的描述；c）获得让步的描述；d）处置不合格的授权标识。9.1 监视、测量、分析和评价9.1.1 总则组织应确定：a）需要监视和测量的对象；b）确保有效结果所需要的监视、测量、分析和评价方法；c）实施监视和测量的时机；d）分析和评价监视和测量结果的时机。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，作为结果的证据。9.1.1.1 制造过程的监视和测量 （1/2）组织应对所有新的制造（包括装配或排序）进行过程研究，以验证过程能力，并为过程控制提供附加的输入，包括有特殊性的过程。 注：在一些制造过程中，可能无法通过过程能力证实产品的符合性。对于这些过程，可采用替代方法， 如：批次对规范的符合性。 组织应保持由顾客零件批准过程要求所规定的制造过程能力或绩效。组织应验证已实施了过程流程图、PFMEA和控制计划，包括遵守规定的： 测量技术；抽样计划；接收准则；计量数据实际测量值和/或试验结果的记录；当不满足接受准则时的反应计划和升级过程。应记录重要的过程活动，如更换工具或修理机器等，并将其当作形成文件的信息予以保留。 组织应对统计能力不足或不稳定的特性启动已在控制计划中标识，并且经过规范符合性影响评价的反应计划。这些反应计划应包括适当的产品遏制和100%检验。为确保过程变得稳定且有统计能力，组织应制定并实施一份显示明确进度、时程安排和指派责任的纠正措施计划。当被要求时，此计划应由顾客评审和审批。 组织应保持过程变更生效日期的记录。9.1.1.2 统计工具的确定 组织应确定统计工具的恰当使用。组织应验证产品质量先期策划（或等效策划）过程中包含了适当的统计工具、作为策划的一部分，并且适当的统计工具还包含在设计风险分析（如DFMEA）（适用时）、过程风险分析（如PFMEA）和控制计划中。9.1.19.1.1 General The organization shall determine: a) what needs to be monitored and measured;b) the methods for monitoring, measurement, analysis and evaluation needed to ensure validresults; c) when the monitoring and measuring shall be performed; d) when the results frommonitoring and measurement shall be analysed and evaluated. The organization shall evaluatethe performance and the effectiveness of the quality management system. The organizationshall retain appropriate documented information as evidence of the results.9.1.1.19.1.1.1 Monitoring and measurement of manufacturing processes The organization shallperform process studies on all new manufacturing (including assembly or sequencing)processes to verify process capability and to provide additional input for process control,including those for special characteristics. NOTE For some manufacturing processes, it may notbe possible to demonstrate product compliance through process capability. For thoseprocesses, alternate methods such as batch conformance to specification may be used. Theorganization shall maintain manufacturing process capability or performance results asspecified by the customer's part approval process requirements. The organization shall verifythat the process flow diagram, PFMEA, and control plan are implemented, including adherenceto the following: a) measurement techniques; b) sampling plans; c) acceptance criteria; d)records of actual measurement values and/or test results for variable data; e) reaction plansand escalation process when acceptance criteria are not met. Significant process events, suchas tool change or machine repair, shall be recorded and retained as documented information.The organization shall initiate a reaction plan indicated on the control plan and evaluated forimpact on compliance to specifications for characteristics that are either not statisticallycapable or are unstable. These reaction plans shall include containment of product and 100percent inspection, as appropriate. A corrective action plan shall be developed andimplemented by the organization indicating specific actions, timing, and assignedresponsibilities to ensure that the process becomes stable and statistically capable. The plansshall be reviewed with and approved by the customer, when required. The organization shallmaintain records of effective dates of process changes.9.1.1.2 Identification of statistical tools The organization shall determine the appropriate use ofstatistical tools. The organization shall verify that appropriate statistical tools are included aspart of the advanced product quality planning (or equivalent) process and included in thedesign risk analysis (such as DFMEA) (where applicable), the process risk analysis (such asPFMEA), and the control plan.9.1.1.29.1.1.39.1.1.3 Application of statistical concepts Statistical concepts, such as variation, control9.1.1.3 统计概念的应用(stability), process capability, and the consequences of over-adjustment, shall be understood and used by employees involved in the collection, analysis, and management of statistical data.从事统计数据收集、分析和管理的员工应了解和使用统计概念，列如：变差、控制（稳定性）、过程能力和过度调整后果。9.1.2 Customer satisfaction The organization shall monitor customers’ perceptions of thedegree to which their needs and expectations have been fulfilled. The organization shalldetermine the methods for obtaining, monitoring and reviewing this information. NOTEExamples of monitoring customer perceptions can include customer surveys, customerfeedback on delivered products and services, meetings with customers, market-share analysis,compliments, warranty claims and dealer reports.9.1.2 顾客满意组织应监视顾客对其需求和期望获得满足的程度的感受。组织应确定这些信息的获取、监视和评审方法。注：监视顾客感受的例子可包括顾客调查、顾客对交付产品或服务的反馈、顾客会晤、市场占有率分析、赞扬、担保索赔和经销商报告。9.1.2条款细目英文版9.1.2.1 Customer satisfaction — supplemental Customer satisfaction with the organization shallbe monitored through continual evaluation of internal and external performance indicators toensure compliance to the product and process specifications and other customerrequirements. Performance indicators shall be based on objective evidence and include but notbe limited to the following: a) delivered part quality performance; b) customer disruptions; c)field returns, recalls, and warranty (where applicable); d) delivery schedule performance(including incidents of premium freight); e) customer notifications related to quality or deliveryissues, including special status. The organization shall monitor the performance ofmanufacturing processes to demonstrate compliance with customer requirements for productquality and process efficiency. The monitoring shall include the review of customerperformance data including online customer portals and customer scorecards, where provided.中文版9.1.2.1 顾客满意——补充 应通过对内部和外部绩效指标的持续评价来监视顾客对组织的满意度，以确保符合产品和过程规范及其它顾客要求。 绩效指标应基于客观证据，包括但不限于： 已交付零件的质量绩效；对顾客造成的干扰；使用现场退货、召回和保修（在适用情况下）；交付时间安排的绩效（包括超额运费的情况）；与质量或交付问题有关的顾客通知，包括特殊状态。 组织应监视制造过程的绩效以证明符合顾客对产品质量和过程效率的要求。监视应包括顾客绩效数据的评审，其中包含所有提供在线顾客门户和顾客计分卡。9.1.3 分析与评价组织应分析和评价通过监视和测量获得的适宜数据和信息。应利用分析结果评价：产品和服务的符合性；顾客满意程度；质量管理体系的绩效和有效性；策划是否得到有效实施；针对风险和机遇所采取措施的有效性；外部供方的绩效；质量管理体系改进的需求。注：数据分析方法可包括统计技术。9.1.2.19.1.39.1.3 Analysis and evaluation The organization shall analyse and evaluate appropriate data andinformation arising from monitoring and measurement. The results of analysis shall be used toevaluate: a) conformity of products and services; b) the degree of customer satisfaction; c) theperformance and effectiveness of the quality management system; d) if planning has beenimplemented effectively; e) the effectiveness of actions taken to address risks andopportunities; f) the performance of external providers; g) the need for improvements to thequality management system. NOTE Methods to analyse data can include statistical techniques.9.1.3.19.1.3.1 Prioritization Trends in quality and operational performance shall be compared with9.1.3.1 优先级 progress toward objectives and lead to action to support prioritization of actions for improving质量和运行绩效的趋势应与朝向目标的进展来进行比较，并形成措施以支持顾客满意度改进措customer satisfaction.施的优先级。9.2.1 The organization shall conduct internal audits at planned intervals to provide informationon whether the quality management system: a) conforms to: 1) the organization’s ownrequirements for its quality management system; 2) the requirements of this InternationalStandard; b) is effectively implemented and maintained.9.2 内部审核9.2.1组织应按照策划的时间间隔进行内部审核，以提供有关质量管理体系的下列信息：a）是否符合：1）组织自身的质量管理体系要求；2）本标准的要求。b）是否得到有效的实施和保持。9.2.2 组织应：a） 依据有关过程的重要性、对组织产生影响的变化和以往的审核结果，策划、制定、实施和保持审核方案，审核方案包括频次、方法、职责、策划要求和报告；b）规定每次审核的审核准则和范围；c）选择可确保审核过程客观公正的审核员实施审核；d）确保相关管理部门获得审核结果报告；e）及时采取适当的纠正和纠正措施；f）保留作为实施审核方案以及审核结果的证据的形成文件的信息。9.2.19.2.29.2.2 The organization shall: a) plan, establish, implement and maintain an audit programme(s)including the frequency, methods, responsibilities, planning requirements and reporting, whichshall take into consideration the importance of the processes concerned, changes affecting theorganization, and the results of previous audits; b) define the audit criteria and scope for eachaudit; c) select auditors and conduct audits to ensure objectivity and the impartiality of theaudit process; d) ensure that the results of the audits are reported to relevant management; e)take appropriate correction and corrective actions without undue delay; f) retain documentedinformation as evidence of the implementation of the audit programme and the audit results.NOTE See ISO 19011 for guidance.9.2.2.1 Internal audit programme The organization shall have a documented internal auditprocess. The process shall include the development and implementation of an internal auditprogramme that covers the entire quality management system including quality managementsystem audits, manufacturing process audits, and product audits. The audit programme shallbe prioritized based upon risk, internal and external performance trends, and criticality of theprocess(es). Where the organization is responsible for software development, the organizationshall include software development capability assessments in their internal audit programme.The frequency of audits shall be reviewed and, where appropriate, adjusted based onoccurrence of process changes, internal and external nonconformities, and/or customercomplaints. The effectiveness of the audit programme shall be reviewed as a part ofmanagement review.9.2.2.1 内部审核方案 组织应有一个形成文件的内部审核过程。该过程应包括制定并实施一个涵盖整个质量管理体系的内部审核方案，其中包含质量管理体系审核、制造过程审核和产品审核。 应根据风险、内部和外部绩效趋势和过程的关键程度确定审核方案的优先级。 在负责软件开发的情况下，组织应在其内部审核方案中包含软件开发能力评估。 应对审核频率进行评审，并在适当时，根据发生的过程更改、内部和外部不符合及/或顾客投诉进行调整。应对审核方案有效性进行评审，作为管理评审的一部分。9.2.2.2 质量管理体系审核 组织应根据年度方案，每三个日历年采用过程方法审核一次全部的质量管理体系过程，以验证与本汽车 QMS 标准的符合性。结合这些审核，组织应对顾客特定的质量管理体系要求进行抽样，检查是否得到有效实施。 9.2.2.19.2.2.29.2.2.2 Quality management system audit The organization shall audit all quality managementsystem processes over each three-year calendar period, according to an annual programme,using the process approach to verify compliance with this Automotive QMS Standard.Integrated with these audits, the organization shall sample customer-specific qualitymanagement system requirements for effective implementation.9.2.2.3 Manufacturing process audit The organization shall audit all manufacturing processesover each three-year calendar period to determine their effectiveness and efficiency usingcustomer-specific required approaches for process audits. Where not defined by the customer,the organization shall determine the approach to be used. Within each individual audit plan,each manufacturing process shall be audited on all shifts where it occurs, including theappropriate sampling of the shift handover. The manufacturing process audit shall include anaudit of the effective implementation of the process risk analysis (such as PFMEA), control plan,and associated documents.9.2.2.4 Product audit The organization shall audit products using customer-specific requiredapproaches at appropriate stages of production and delivery to verify conformity to specifiedrequirements. Where not defined by the customer, the organization shall define the approachto be used.9.2.2.39.2.2.3 制造过程审核 组织应采用顾客特定要求的过程审核方法，每三个日历年审核一次全部制造过程，以确定其有效性和效率。如果顾客未指定，组织应确定要采用的审核方法。 在每个审核计划内，每个制造过程的审核应涵盖所有发生的班次，包括适当的交接班抽样。 制造过程审核应包括对过程风险分析（如PFMEA）、控制计划和相关文件有效执行的审核。9.2.2.49.2.2.4 产品审核  组织应采用顾客特定要求的方法，在生产及交付的适当阶段对产品进行审核，以验证对所有规定要求的符合性。如果顾客未指定，组织应确定要采用的审核方法。9.3.19.3.1 General Top management shall review the organization’s quality management system, at9.3 管理评审 planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment9.3.1 总则with the strategic direction of the organization.最高管理者应按照策划的时间间隔对组织的质量管理体系进行评审，以确保其持续的保持适宜性、充分性和有效性，并与组织的战略方向一致。9.3.1.1 Management review— supplemental Management review shall be conducted at leastannually. The frequency of management review(s) shall be increased based on risk tocompliance with customer requirements resulting from internal or external changes impactingthe quality management system and performance-related issues.9.3.1.1 管理评审---补充管理评审应至少每年进行一次。应基于由影响质量管理体系和绩效相关问题的内部或外部更改造成的顾客要求符合性的风险，提高管理评审的频率。9.3.1.1条款细目英文版9.3.2 Management review inputs The management review shall be planned and carried outtaking into consideration: a) the status of actions from previous management reviews; b)changes in external and internal issues that are relevant to the quality management system; c)information on the performance and effectiveness of the quality management system,including trends in: 1) customer satisfaction and feedback from relevant interested parties; 2)the extent to which quality objectives have been met; 3) process performance and conformityof products and services; 4) nonconformities and corrective actions; 5) monitoring andmeasurement results; 6) audit results; 7) the performance of external providers; d) theadequacy of resources; e) the effectiveness of actions taken to address risks and opportunities(see 6.1); f) opportunities for improvement.中文版9.3.2管理评审输入策划和实施管理评审时应考虑下列内容：a）以往管理评审所采取措施的实施情况；b）与质量管理体系相关的内外部因素的变化；c）有关质量管理体系绩效和有效性的信息，包括下列趋势性信息：1）顾客满意和相关方的反馈；2）质量目标的实现程度；3）过程绩效以及产品和服务的符合性；4）不合格以及纠正措施；5）监视和测量结果；6）审核结果；7）外部供方的绩效。d）资源的充分性；e）应对风险和机遇所采取措施的有效性（见6.1）；f）改进的机会。9.3.2.1 管理评审输入---补充 管理评审的输入应包括： 1、不良质量成本（内外部不符合要求）； 2、过程有效性的衡量； 3、过程效率的衡量； 4、产品符合性； 5、对现有操作更改和新设施或新产品进行的制造可行性评估（见第7.1.3.1） 6、顾客满意（见ISO9001第9.1.2条）； 7、对照维护目标的绩效评审（OEE\\MTBF\\MTRR)； 8、保修绩效（在适用情况下）； 9、通过风险分析（如FMEA）识别的潜在使用现场失效标识； 10、实际使用现场失效及其对安全或环境的影响。9.3.3 管理评审输出管理评审的输出应包括与下列事项相关的决定和措施：a）改进的机会；b）质量管理体系所需的变更；c）资源需求。组织应保留作为管理评审结果证据的形成文件的信息。9.3.3.1管理评审输出---补充当未实现顾客绩效目标时，最高管理者应形成一个文件化的措施计划并实施。10.1总则组织应确定并选择改进机会，采取必要措施，满足顾客要求和增强顾客满意。这应包括：a）改进产品和服务以满足要求并关注未来的需求和期望；b）纠正、预防或减少不利影响；c）改进质量管理体系的绩效和有效性。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。10.2 不合格和纠正措施10.2.1 若出现不合格，包括投诉所引起的不合格，组织应：a）对不合格做出应对，适用时：1）采取措施予以控制和纠正；2）处置产生的后果。b）通过下列活动，评价是否需要采取措施，以消除产生不合格的原因，避免其再次发生或者在其他场合发生：1）评审和分析不合格；2）确定不合格的原因；3）确定是否存在或可能发生类似的不合格。c）实施所需的措施；d）评审所采取的纠正措施的有效性；e）需要时，更新策划期间确定的风险和机遇；f） 需要时，变更质量管理体系。10.2.2 组织应保留形成文件的信息，作为下列事项的证据：a）不合格的性质以及随后所采取的措施；b）纠正措施的结果。10.2.3 问题解决组织应有形成文件的问题解决过程，包括：用于各种类型和规模的问题（如：新产品开发、当前制造问题、使用现场失效、审核发现）的明确方法；控制不符合输出所必要的遏制、临时措施及相关活动（见ISO 9001第8.7条）；根本原因分析、采用的方法、分析及结果；系统性纠正措施的实施，包括考虑对相似过程和产品的影响；对已实施纠正措施有效性的验证；对适当形成文件的信息（如：PFMEA、控制计划）的评审，必要时进行更新。若顾客对问题解决有特别规定的过程、工具或系统，组织应采用这些过程、工具或系统、除非顾客另行批准。10.2.4 防错组织应有一个形成文件的过程，用于确定适当防错方法的使用。所采用方法的详细信息应在过程风险分析中（如 PFMEA）形成文件，试验频率应记录在控制计划中。过程应包括防错装置失效或模拟失效的试验。应保持记录。若使用挑战件，则应在可行时对挑战件进行标识、控制、验证和校准。防错装置失效应有一个反应计划。9.3.29.3.2.19.3.2.1 Management review inputs — supplemental Input to management review shall include:a) cost of poor quality (cost of internal and external nonconformance); b) measures of processeffectiveness; c) measures of process efficiency; d) product conformance; e) assessments ofmanufacturing feasibility made for changes to existing operations and for new facilities or newproduct (see Section 7.1.3.1); f) customer satisfaction (see ISO 9001; Section 9.1.2); g) review ofperformance against maintenance objectives; h) warranty performance (where applicable); i)review of customer scorecards (where applicable); j) identification of potential field failuresidentified through risk analysis (such as FMEA); k) actual field failures and their impact onsafety or the environment.9.3.39.3.3 Management review outputs The outputs of the management review shall includedecisions and actions related to: a) opportunities for improvement; b) any need for changes tothe quality management system; c) resource needs. The organization shall retain documentedinformation as evidence of the results of management reviews.9.3.3.19.3.3.1 Management review outputs — supplemental Top management shall document andimplement an action plan when customer performance targets are not met.10.1 General The organization shall determine and select opportunities for improvement andimplement any necessary actions to meet customer requirements and enhance customersatisfaction. These shall include: a) improving products and services to meet requirements aswell as to address future needs and expectations; b) correcting, preventing or reducingundesired effects; c) improving the performance and effectiveness of the quality managementsystem. NOTE Examples of improvement can include correction, corrective action, continualimprovement, breakthrough change, innovation and re-organization.10.2.1 When a nonconformity occurs, including any arising from complaints, the organizationshall: a) react to the nonconformity and, as applicable: 1) take action to control and correct it;2) deal with the consequences; b) evaluate the need for action to eliminate the cause(s) of thenonconformity, in order that it does not recur or occur elsewhere, by: 1) reviewing andanalysing the nonconformity; 2) determining the causes of the nonconformity; 3) determining ifsimilar nonconformities exist, or could potentially occur; c) implement any action needed; d)review the effectiveness of any corrective action taken; e) update risks and opportunitiesdetermined during planning, if necessary; f) make changes to the quality management system,if necessary. Corrective actions shall be appropriate to the effects of the nonconformitiesencountered.10.110.2.110.2.210.2.2 The organization shall retain documented information as evidence of: a) the nature ofthe nonconformities and any subsequent actions taken; b) the results of any corrective action.10.2.310.2.3 Problem solving The organization shall have a documented process(es) for problemsolving including: a) defined approaches for various types and scale of problems (e.g., newproduct development, current manufacturing issues, field failures, audit findings); b)containment, interim actions, and related activities necessary for control of nonconformingoutputs (see ISO 9001, Section 8.7); c) root cause analysis, methodology used, analysis, andresults; d) implementation of systemic corrective actions, including consideration of the impacton similar processes and products; e) verification of the effectiveness of implementedcorrective actions; f) reviewing and, where necessary, updating the appropriate documentedinformation (e.g., PFMEA, control plan). Where the customer has specific prescribed processes,tools, or systems for problem solving, the organization shall use those processes, tools, orsystems unless otherwise approved by the customer.10.2.4 Error-proofing The organization shall have a documented process to determine the useof appropriate error-proofing methodologies. Details of the method used shall be documentedin the process risk analysis (such as PFMEA) and test frequencies shall be documented in thecontrol plan. The process shall include the testing of error-proofing devices for failure orsimulated failure. Records shall be maintained. Challenge parts, when used, shall be identified,controlled, verified, and calibrated where feasible. Error-proofing device failures shall have areaction plan.10.2.5 Warranty management systems When the organization is required to provide warrantyfor their product(s), the organization shall implement a warranty management process. Theorganization shall include in the process a method for warranty part analysis, including NTF (notrouble found). When specified by the customer, the organization shall implement the requiredwarranty management process.10.2.6 Customer complaints and field failure test analysis The organization shall performanalysis on customer complaints and field failures, including any returned parts, and shallinitiate problem solving and corrective action to prevent recurrence. Where requested by thecustomer, this shall include analysis of the interaction of embedded software of theorganization's product within the system of the final customer's product. The organization shallcommunicate the results of testing/analysis to the customer and also within the organization.10.2.410.2.510.2.5 保修管理体系当组织被要求为其产品提供保修时，组织应实施一个保修管理过程。组织应在该过程中包含一个保修件分析法，包括NTF（未发现故障）。当顾客指定时，组织应实施所要求的保修管理过程。10.2.610.2.6 顾客投诉和使用现场失效试验分析组织应对顾客投诉和使用现场失效，包括退货零件，进行分析，并且应采取问题解决和纠正措施以预防再次发生。在顾客要求的情况下，这应包括最终顾客产品系统内，组织产品嵌入式软件相互作用的分析。组织应向顾客并且在组织内部传达试验/分析的结果。条款细目英文版10.3 Continual improvement The organization shall continually improve the suitability,adequacy and effectiveness of the quality management system. The organization shall considerthe results of analysis and evaluation, and the outputs from management review, to determineif there are needs or opportunities that shall be addressed as part of continual improvement.10.3.1 Continual improvement — supplemental The organization shall have a documentedprocess for continual improvement. The organization shall include in this process the following:a) identification of the methodology used, objectives, measurement, effectiveness, anddocumented information; b) a manufacturing process improvement action plan with emphasison the reduction of process variation and waste; c) risk analysis (such as FMEA). NOTEContinual improvement is implemented once manufacturing processes are statistically capableand stable or when product characteristics are predictable and meet customer requirements.A.1 Phases of the control plan A control plan covers three distinct phases, as appropriate: a)Prototype: a description of the dimensional measurements, material, and performance teststhat will occur during building of the prototype. The organization shall have a prototypecontrol plan, if required by the customer. b) Pre-launch: a description of the dimensionalmeasurements, material, and performance tests that occur after prototype and before fullproduction. Pre-launch is defined as a production phase in the process of product realizationthat may be required after prototype build. c) Production: documentation of product/processcharacteristics, process controls, tests, and measurement systems that occur during massproduction. Control plans are established at a part number level; but in many cases, familycontrol plans may cover a number of similar parts produced using a common process. Controlplans are an output of the quality plan. NOTE 1 It is recommended that the organizationrequire its suppliers to meet the requirements of this Annex. NOTE 2 For some bulk materials,the control plans do not list most of the production information. This information can be foundin the corresponding batch formulation/recipe details.A.2 Elements of the control plan A control plan includes, as a minimum, the following contents:General data a) control plan number; b) issue date and revision date, if any; c) customerinformation (see customer requirements); d) organization's name/site designation; e) partnumber(s); f) part name/description; g) engineering change level; h) phase covered (prototype,pre-launch, production); i) key contact; J) part/process step number, k) processname/operation description; I) functional group/area responsible. Product control a)product-related special characteristics; b) other characteristics for control (number, product orprocess); c) specification/tolerance; Process control a) process parameters (including processsettings and tolerances); b) process-related special characteristics; c) machines, jigs, fixtures,tools for manufacturing (including identifiers, as appropriate); Methods a) evaluationmeasurement technique; b) error-proofing; c) sample size and frequency; d) control method;Reaction plan a) reaction plan (include or reference);Rules 1.0 Eligibility for certification to ISO/TS 16949 All manufacturing sites where productionand/or service parts are manufactured and supplied to automotive customers are eligible forISO/TS 16949 certification.Rules 3.1. Certification agreement with the client. Break of contract with Bureau VeritasCertification.Rules 3.2. Notice of changes by a client. Failure by the client to inform the certification body ofa change is considered as a breach of the legally enforceable agreement.Rules 5.5 Supporting functions on site or remote (e.g. product design, contract review,purchasing, warehouse, etc.) shall be audited as required to support a site, but shall beincluded in the initial stage 2 audit at least once more during the surveillance audit cycle andthe recertification audit.Rules 5.5 The design function(s), on site or remote, shall be audited at least once within eachconsecutive twelve (12) month period.Rules 5.5 Bureau Veritas Certification may accept the audit by another certification body of theremote supporting locations subject to the following conditions met prior to each audit: 1) theaudit was conducted to ISO/TS 16949 by an IATF recognized certification body, 2) the auditcovered the complete product scope of those functions, consistent with the process basedaudit approach.Rules 5.5 Bureau Veritas Certification may accept the audit by another certification body of theremote supporting locations subject to the following conditions met prior to each audit: 3) theclient provides to the certification body, prior to the audit, a copy of the audit plan, auditreport, all findings, all corrective actions, and all verification actions by the other certificationbody. This information shall be in the language agreed between the client and the certificationbody,Rules 5.5 Bureau Veritas Certification may accept the audit by another certification body of theremote supporting locations subject to the following conditions met prior to each audit: 4) theinformation confirms that all the interfaces between the remote supporting location and thesite were audited by the other certification body,Rules 5.5 Bureau Veritas Certification may accept the audit by another certification body of theremote supporting locations subject to the following conditions met prior to each audit: 5)verification of the client´s corrective actions are conducted by the certification body thataudited the remote supporting location. Copies of all onsite verification activities reports shallbe provided by the client to the certification bodyRules 5.7 Audit planning - All onsite audits The audit planning activity shall be undertakenprior to arrival on site and shall include as inputs to the plan a review of the followinginformation supplied by the client: a)The client´s quality management system documentation,including evidence about conformity to ISO/TS 16949 requirements and showing the linkagesand interfaces to any remote support functions and/or outsourced processesRules 5.7 Audit planning - All onsite audits The audit planning activity shall be undertakenprior to arrival on site and shall include as inputs to the plan a review of the followinginformation supplied by the client: b)customer and internal performance data since theprevious audit, c) customer satisfaction and complaint summary since the previous audit,including a copy of the latest customer reports and/or scorecards中文版10.3 持续改进组织应持续改进质量管理体系的适宜性、充分性和有效性。组织应考虑管理评审的分析、评价结果，以及管理评审的输出，确定是否存在持续改进的需求或机会。10.3.1 持续改进----补充组织应有一个形成文件的持续改进过程。组织在本过程中包括以下内容：对所采用发放、目标、测量、有效性和形成文件的信息的识别；一个制造过程改进行动计划，重点放在减少过程变差和浪费。风险分析（例如 FMEA）。注：持续改进是当过程有统计能力且稳定，或者产品特性为可预测且满足顾客要求时实施的。10.310.3.1条款细目英文版Rules 5.7 Audit planning - All onsite audits The audit planning activity shall be undertakenprior to arrival on site and shall include as inputs to the plan a review of the followinginformation supplied by the client: d)identification of any customer special status conditionsince the previous audit, e)notification about any new customers since the previous audit, f)results of internal audits and management review since the previous auditRules 6.1 Application for ISO/TS 16949 certification The certification body shall require anauthorized representative of the applicant client to provide the necessary information toenable the certification body to establish a complete quotation based on the following: a) thedesired scope of the certification, b) the general features of the applicant client, including itsname and the address(es) of the site and all associated remote support location(s), significantaspects of its process and operations, and any relevant legal obligations,Rules 6.1 Application for ISO/TS 16949 certification The certification body shall require anauthorized representative of the applicant client to provide the necessary information toenable the certification body to establish a complete quotation based on the following: c)general information, relevant for the scope of certification applied for, concerning the applicantclient, such as its activities, human and technical resources, functions and relationship in alarger corporation, if any,Rules 6.1 Application for ISO/TS 16949 certification The certification body shall require anauthorized representative of the applicant client to provide the necessary information toenable the certification body to establish a complete quotation based on the following: d)information concerning all outsourced processes used by the client that should affectconformity to requirements, e) information concerning the use of consultancy relating to themanagement system, f) information concerning product design responsibility, g) informationon automotive customers, including IATF OEM supplier codes, h) total number of employees,including full time, part time, temporary, or contract.CSR: The client advises Bureau Veritas Certification of a special status condition from an IATFsubscribing OEM. Notification from the client to the certification body shall occur within ten(10) calendar days from receipt of the special status condition or otherwise specified by thecustomer. GM requires notification within 5 business days.中文版