4 组织的环境
4 Context of the organization
Understanding the organization and
理解组织及其环境
见 ISO 9001:2021 的要求。
its context
See ISO 9001:2021 requirements.
组织应确定与其目标和战略方向相关并影响实现其质量管理系统预期结果的各种外面和内部因素。
The organization shall determine external and internal
issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
组织对付这些内部和外面因素的相关信息进行监察和评审。
注1：这些因素能够包括需要考虑的正面或负面的因素或条件；
The organization shall monitor and review
information about these external and internal issues.
注2：能够经过考虑源于国际、国家、地区或当地的各种法律法规、技术、竞争、市场、文化、社会和经济因素的情况，有助于理解外面环境。
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
注3：能够经过考虑组织的价值观、文化、知识和组织绩效等相关因素情况，有助于理解内部环境。
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
理解相关方的需求和希望
见 ISO 9001:2021 的要求。
knowledge and performance of the organization.
由于相关方对组织连续供给满足顾客和适用的法律法规要求的产品和效劳的能力产生影响或潜藏影响，因此，组织应确定：
Understanding the needs and expectations of interested parties
See ISO 9001:2021 requirements.
a) 与质量管理系统相关的相关方；
b) 这些相关方的要求。
Due to their effect or potential effect on the organization ’s ability to consistently provide
products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
组织对付这些相关方及其要求的相关信息进行监察和评审。
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a) the interested parties that are relevant to the quality management system;
b) the requirements
of these interested parties that are
relevant to the quality management system. The organization shall monitor and review
information about these interested parties and their relevant requirements.
确定质量管理系统的范围
见 ISO 9001:2021 的要求。
Determining the scope of the quality management system
组织应确定质量管理系统的界线和适用性，以确定其范围。
See ISO 9001:2021 requirements.
在确定质量管理系统范围时，组织应试虑：
The organization shall determine the boundaries
a) 在中涉及的各种外面和内部因素； b) 在中涉及的相关相关方要求； c) 组织的产品与效劳。
and applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
关于本标准中适用于组织确定的质量管理系统范围的所有要求，组织应予以推行。
组织的质量管理系统范围应作为形成文件的信息加以保持。该范围应说明质量管理系统所覆盖的产品和效劳种类，假设组织认为其管理系统范围的应用范围不适用本标准的某些要求，应说明原因。
a) the external and internal issues referred to in ;
b) the requirements of relevant interested parties referred to in ;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
那些不适用组织的质量管理系统要求，不能够影响组织保证产品和效劳合格以及增强顾客满意的能力或责任，否那么不能够声称吻合本标准的要求。
The scope of the organization ’s quality management
system shall be available and be maintained as documented information.
The scope shall
state the types
of products and services covered, and provide justification
for any requirement of this
International
Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable
do not affect
the organization
’s ability or
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responsibility
satisfaction.
to ensure the conformity of its products
and services and the enhancement of customer
确定质量管理系统的范围 ---- 补充
Determining the scope of the quality management system - supplemental
支持功能，无论其在现场或外面场所〔比方：设计
中心、公司总部和配送中心〕 ，应包括在质量管理系统〔 QMS〕的范围中。
Supporting functions ， whether on-site or remote 〔such as design centres ， corporate
headquarters ， and distribution centres
be included in the scope of the Quality
ISO 9001 第条中
〕，shall
本汽车 QMS标准唯一赞成的删减是
Management System〔QMS〕.
的产品设计和开发要求。删减应以形成文件的信息〔见 ISO 9001 第条〕的形式进行证明和保持。
赞成的删减不包括制造过程设计。
The only permitted exclusion for this Automotive QMS Standard relates to the product design and
development requirements within ISO 9001 Section . The exclusion shall be justified and maintained as documented information 9001，Section 〕.
，
〔see ISO
Permitted exclusions do not include manufacturing process design.
顾客特定要求
Customer-specific requirements
对付顾客特定要求进行议论，并将其包括在组织的
质量管理系统范围内。
Customer-specific requirements shall be evaluated and included in the scope of the organization ’ s quality management system.
质量管理系统及其过程
Quality management system and its processes ISO 9001:2021 requirements
The organization
shall establish,
implement, maintain
见 ISO 9001:2021 的要求。
组织应按本标准的要求建立、推行、保持和连续改良质量管理系统，包括质量管理系统所需的过程及其相互作用。
and continually improve a quality management system,
including the processes needed and their interactions,
in accordance with the requirements of
组织应确定质量管理系统所需的过程及其在整个
this International Standard.
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组织中的应用，组织应：
a) 确定这些过程所需的输入和希望的输出；
b) 确定这些过程的序次和相互作用；
c) 确定和应用所需的准那么和方法〔包括监察、测量和相关的绩效指标〕，以保证这些过程的有效运行和控制；
d) 确定并保证获取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) 应依照的要求确定风险和时机；
g) 议论这些过程，推行所需的改正，以保证这些过程实现预期的结果；
h) 改良过程和质量管理系统。
The organization shall determine the processes needed
for the quality management system and their application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods
(including monitoring, measurements and related
performance indicators)
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 the responsibilities and authorities for
these processes;
f) address the risks
and opportunities as determined in
accordance with the requirements of ;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
. 1. 1 Conformance of products and processes
The organization
产品和过程的吻合性
shall ensure conformance of all
service parts all applicable requirements
products and processes ， including and those that are outsourced ， to customer ，statutory ，and regulatory 〔see Section
组织应保证所有的产品和过程，包括效劳件及外包的产品和过程，吻合所有适用的顾客和法律法规要求〔见条〕。
〕.
Product safety
The organization shall have documented processes
产品安全
for the management of product-safety related
products and manufacturing processes shall include but not be limited to the
，which
组织应有形成文件的过程，用于与产品安全相关的
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产品和制造过程管理；形成文件的过程包括但不限于〔在适用情况下〕 ：
following ， where applicable:
a 〕identification by the organization of
a〕 组织对付产品安全法律法规要求的鉴别； b〕 向顾客通知 a〕项中的要求； c〕 设计 FMEA的特别赞成； d〕 产品安全相关特色的鉴别；
e〕 产品及制造时安全相关特色的鉴别和控制；
statutory and regulatory product-safety requirements ；
b 〕customer notification of requirements in item a 〕；
c 〕special approvals for design FMEA d 〕identification characteristics
；
；
of product safety-related
f 〕 控制方案和过程 FMEA的特别赞成；
g〕 反响方案〔见第条〕 ；
h〕 包括最高管理者在内的，明确的职责，升级
e 〕identification and controls of safety-related characteristics of product and at the point of
过程和信息流的定义，以及顾客通知；
manufacture ；
f 〕special approval of control plans and process FMEAs；
i 〕 组织或顾客为与产品安全相关的产品和相
关制造过程中涉及的人员确定的培训；
j 〕 产品或过程的改正在推行以前应获取赞成，包括对过程和产品改正带给产品安全的潜藏影响进行议论〔见 ISO 9001 第条〕；
g 〕reaction plans 〔 see Section
〕；
h 〕defined responsibilities ，definition of
，
k〕 整个供给链中关于产品安全的要求转移，
括顾客指定的货源〔见第条〕 ；
包
escalation process and flow of information including top management ， and customer notification ；
l 〕 整个供给链中按制造批次〔最少〕的产品
可追想性〔见第条〕 ；
i 〕training identified by the organization
m〕 为新产品导入的经验教训。
or customer for personnel involved in product 画 safety related products and associated
注：顾客也许组织内部程序可要求与安全相关的要
manufacturing processes ；
j 〕changes of product or process shall be
approved prior to implementation ， including evaluation of potential effects on product
safety from process and product changes〔see ISO 9001，Section 〕；
求也许文件的特别赞成。
k 〕transfer of requirements with regard to
product safety throughout the supply chain including customer-designated sources Section
l
〕；
，
〔see
〕product traceability by manufactured lot
〔at a minimum〕throughout the supply chain 〔see
iatf16949中英文比较版1013新版
Section
〕；
m 〕lessons learned for new product introduction.
NOTE: Special approval of safety related
requirements or documents may be required by the
customer or the organization processes.
’s internal
ISO 9001:2021 requirements.
To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence
that the processes are being carried out as planned.
5 Leadership
在必要的程度上，组织应：
Leadership and commitment General
见 ISO 9001:2021 的要求。
a) 保持形成文件的信息以支持过程运行；
b) 保存确认其过程是按筹办进行的形成文件的信息。
See ISO 9001:2021 requirements.
General
总那么
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality
objectives are established for the quality management
iatf16949中英文比较版1013新版
system and are compatible with the context and strategic direction of the organization;
5 领导作用
领导作用与承诺 总那么
c) ensuring the integration of the quality management
system requirements into the organization ’s business processes;
见 ISO 9001:2021 的要求。
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality
最高管理者应证明其对质量管理系统的领导作用和承诺，经过：
a) 对质量管理系统的有效性担当责任；
b) 保证拟定质量管理系统的质量目标和质量目标，并与组织环境和战略方向保持一致；
c) 保证将质量管理系统要求融入组织的业务过程；
d) 促使使用过程方法和基于风险的思想；
e) 保证获取质量管理系统所需的资源；
f) 沟通有效的质量管理系统和吻合质量管理系统要求的重要性；
g) 保证明现质量管理系统的预期结果；
h) 促使、指导和支持员工努力提高质量管理系统的有效性；
i) 推动改良；
j) 支持其他管理者履行其相关领域的职责。
management and of conforming to the quality
management
system requirements;
g) ensuring that the quality
management system achieves
its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
NOTE Reference to “business 〞 in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization ’s existence, whether the organization is public, private, for profit or not for profit.
注：本标准中的“业务〞一词可大体理解为涉及组织存在目的的核心价值活动，组织能够是公有的、
私有的、盈利或非盈利的。
Corporate responsibility
The organization shall define and implement corporate responsibility policies ， including at
a minimum an anti-bribery policy ， an employee
code of conduct ，and an ethics escalation policy 〔“whistle-blowing policy
〞〕.
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Process effectiveness and efficiency Top management shall review the product
realization processes and support processes to
evaluate and improve their effectiveness and efficiency. The results of the process review activities shall be included as input to the management review 〔see Section .
〕 .
Process owners
process owners who
公司责任
Top managementshall identify are responsible
for managing the organization's
组织应明确并推行公司责任目标，最少包括反贿赂目标、员工行为准那么以及道德准那么升级〔“举报〞〕。
processes and related outputs. Process owners
shall understand their roles and be competent to perform those roles
〔see ISO 9001 ，Section
〕 .
Customer focus
See ISO 9001:2021 requirements.
过程有效性和效率
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
最高管理者应评审产品实现过程和支持过程，以议论并改良过程有效性和效率。过程评审活动的结果应作为管理评审的输入〔见第条〕 。
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) the risks and opportunities that can affect
conformity of products and services and the
ability to
enhance customer satisfaction are determined and
过程拥有者
addressed;
最高管理者应确定过程拥有者，由其负责组织的各过程和相关输出的管理。过程拥有者应认识他们的
c) the focus on enhancing customer satisfaction is
maintained.
角色，并且具备胜任其角色的能力〔见 ISO 9001 第条〕 .
Policy
Establishing the qualify policy
以顾客为关注焦点
See ISO 9001:2021 requirements.
iatf16949中英文比较版1013新版
见 ISO 9001:2021 的要求。 Top management shall establish,implement and maintain
最高管理者应经过以下方面，证明其对以顾客为关 注焦点的领导作用和承诺：
a quality policy that:
a) is appropriate to the purpose and context of the
a) 确定、理解和连续满足顾客要求以及适用的法律 和法规要求；
b) 确定和对付能够影响产品和效劳吻合性以及增 强顾客满意能力的风险与时机； c) 向来致力于增强顾客满意。
organization and supports its strategic direction; b) provides
a framework for setting
quality objectives;
c) includes a commitment to satisfy applicable requirements; d) includes
a commitment to continual
improvement of the
quality management system.
Communicating the quality policy
See ISO 9001:2021 requirements.
目标
建立质量目标
The quality policy shall:
a) be available and be maintained as documented
见 ISO 9001:2021 的要求。
information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
最高管理者应拟定、推行和保持质量目标，目标应：
a) 与组织的要旨和环境相适应，并支持其战略方向；
b) 供给拟定质量目标的框架
c) 包括对满足适用要求的承诺；
d) 包括对连续改良质量管理系统的承诺。
Organizational roles ，responsibilities and
authorities
See ISO 9001:2021 requirements.
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
Top management shall assign the responsibility
沟通质量目标
见 ISO 9001:2021 的要求。
and authority for:
a) ensuring that the quality
management system conforms
Standard;
to the requirements of this International
质量目标应：
b) ensuring that the processes are delivering their intended outputs;
a) 作为形成文件的信息，可获取并保持；
iatf16949中英文比较版1013新版
b) 在组织内获取沟通、理解和应用
c) 适合时，可向相关相关方供给。
c) reporting on the performance of the quality management system and on opportunities for improvement (see , in particular to top management;
d) ensuring the promotion of customer focus throughout the
组织的作用、职责和权限
见 ISO 9001:2021 的要求。
organization;
e) ensuring that the integrity
of the quality management
system is maintained when changes to the quality management system are planned and implemented.
最高管理者应保证相关角色的职责和权限在整个组织内获取分配、沟通和理解。
最高管理者应分配职责和权限，以：
Organizational roles ，responsibilities ，and
a) 保证质量管理系统吻合本标准的要求；
b) 保证各过程获取其预期的输出；
c) 报告质量管理系统的绩效和改良机会，特别向最高管理者；
d) 保证在整个组织推动以顾客为关注焦点；
e) 保证在筹办和推行质量管理系统的改正时保持其完满性。
authorities - supplemental
Top management shall assign personnel with the responsibility and authority to ensure that
customer requirements are met. These assignments shall be documented. This includes but is not limited to the selection of special characteristics related training
， setting quality objectives ，corrective and Preventive
，customer
and
actions ，product design and development ，capacity analysis ，logistics information scorecards ，and customer portals.
Responsibility and authority for product requirements and corrective actions
Top management shall ensure that:
a 〕personnel responsible for conformity to
to stop
product requirements have the authority
shipment and stop production to correct quality problems ；
NOTE Due to the process design in some industries ，it might not always be possible to
stop production immediately. In this case
，the
组织的作用、职责和权限 ---- 补充
affected batch must be contained and shipment to the customer prevented.
最高管理者应向人员指派职责和权限，以保证顾客
要求获取满足。这些指派应形成文件。这包括但不
b 〕personnel with authority and responsibility for corrective action are
限于：特别特色的选择，质量目标和相关培训的设
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置，纠正和预防措施，产品设计和开发，产能解析，
promptly informed of products or processes
do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming
that
物流信息，顾客计分卡以及顾客门户。
product is identified and contained
；
c 〕production operations across all shifts
，or
，ensuring
are staffed with personnel in charge of delegated responsibility for
conformity to product requirements.
产品要求和纠正措施的职责和权限
6 Planning
最高管理者应保证：
Actions to address risks and opportunities and ISO 9001:2021 requirements.
When planning for the quality management system,
a〕 负责产品要求吻合性的人员有权停止发
运或生产以纠正质量问题；
the organization shall consider the issues referred to in
注：由于一些行业中的过程设计，其实不是总是能马上停止生产。在这种情况下，必定对受影响批次进行控制，以防将其发运给顾客。
and the requirements referred to in and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
b〕 拥有纠正措施权限和职责的人员能够及时
获知与要求不符的产品或过程， 以保证防范将不合格品发运给顾客， 并保证所有潜藏不合格品获取鉴别与控制；
c〕 所有班次的生产作业都安排有负责保证产品
要求吻合性的负责人员或代理职责人员。
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 ;
2) evaluate the effectiveness of these actions.
and opportunities
shall be
Actions taken to address risks
proportionate to the potential impact on the conformity of products and services.
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NOTE1 Options to address risks can include
taking risk in order to pursue an opportunity, the risk
avoiding risk,
eliminating
6 筹办
source, changing the likelihood
or retaining
or consequences,
decision.
风险和时机的对付措施
和见 ISO 9001:2021 的要求。
sharing the risk,
risk by informed
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets,
筹办质量管理系统时，组织应试虑 所描述的因素和 所提及的要求，并确定需要对付的风险和时机以：
addressing new customers, building partnerships, using new technology and other desirable and viable
possibilities to address the organization ’s or its customers ’
a) b) c) d)
保证质量管理系统能够实现其预期的结果； 增强有利影响； 防范或减少不利影响； 实现改良。
needs.
Risk analysis
The organization shall include in its risk
analysis ，at a minimum ，lessons learned from product recalls
， product audits ，field returns
and repairs ，complaints ，scrap ，and rework.
组织应筹办：
a) 对付这些风险和时机的措施；
b) 如何：
1) 在质量管理系统过程中融入整合和推行这些
The organization shall retain documented information as evidence of the results of risk analysis.
措施〔见 〕；
2) 议论这些措施的有效性。
Preventive action
The organization shall determine and implement action 〔 s〕 to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues.
注1：对付风险的选择能够包括：防范风险、为
所采用的对付风险和时机的措施应与其对产品和效劳吻合性的潜藏影响相适应。
获取时机而接受风险、除掉风险源、改变风险的可能性和结果、分担风险或经过决策而延缓风险。
注2：时机能够带来新实践的采用、推出新产品、翻开新市场、获取新客户、建立合作关系、使用新技术以及能够解决组织或其他顾客需求的其他有利可能性。
The organization shall establish a process to lessen the impact of negative effects of risk including the following:
a 〕determining potential nonconformities and their causes ；
风险解析
b 〕evaluating the need for action to prevent
；
occurrence of nonconformities
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组织应在风险解析中最少包括从产品召回、产品审察、使用现场的退货和维修、投诉、报废及返工的经验教训。
c 〕determining and implementing action needed；
d 〕documented information of action taken e 〕reviewing the effectiveness of the
；
；
组织应保存形成文件的信息，作为风险解析结果的凭据。
preventive action taken
f 〕utilizing lessons learned to prevent
预防措施
recurrence in similar processes 〔see ISO 9001 ， Section 〕.
组织应确定并推行措施，以除掉潜藏不合格的原因，防范不合格发生。预防措施应与潜藏问题的严重程度相适应。
Contingency plans
组织应建立一个用于减少风险负面影响的过程，过程包括以下方面：
The organization shall:
a 〕identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that
customer requirements are met ；
a〕 确定潜藏不合格及其原因；
b〕 议论防范不合格发生的措施的需求； c〕 确定并推行所需的措施； d〕 所采用措施的成文信息；
e〕 评审所采用的预防措施的有效性；
f 〕 利用获取的经验教训预防近似过程中的再
次发生〔见 ISO 9001 第条〕。
b 〕define contingency plans according to risk and impact to the customer ；
c 〕prepare contingency plans for continuity of supply in the event of any of the following:
key equipment failures 〔also see Section .1 〕；
interruption
from externally provided products ，
；
processes ， and services ； recurring natural
disasters ； fire ； utility interruptions
cyber-attacks on information technology
systems; labour shortages ； or infrastructure
disruptions ；
d 〕include ，as a supplement to the contingency plans ，a notification process to the customer and other interested parties for the extent and
duration of any situation impacting customer operations ；
e〕periodically test the contingency plans for effectiveness 〔. ，simulations ，as
appropriate 〕；
应急方案
f 〕conduct contingency plan reviews 〔at a
team
minimumannually 〕using a multidisciplinary
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组织应：
a〕 对保持生产输出并保证顾客要求得以满足而
言必不能少的所有制造过程和基础设施设施，鉴别并议论相关的内部和外面风险。
including top management，and update as required ；
g〕document the contingency plans and retain documented information describing any revision
（ s〕，including the person〔 s〕who authorized the change〔 s〕 .
b〕 依照风险和对顾客的影响拟定应急方案； c〕 准备应急方案， 以在以下任一情况下保证供
应的连续性： 重点设施故障 〔另见第 .1 条〕； The contingency plans shall include provisions
外面供给的产品、过程和效劳中断；常有自 然灾害；火灾；公共事业中断；
信息技术系
to validate that the manufactured product continues to meet customer specifications the re-start of production following an the regular shutdown processes were not followed.
after
统碰到网络攻击； 劳动力短缺；也许基础设 施损坏；
emergency in which production was stopped and if
d〕 作为应急方案的补充， 包括一个通知顾客和
其他相关方的过程， 见告影响顾客作业的任 何情况的程度和连续时间；
Quality objectives and planning to achieve
e〕 如期测试应急方案的有效性〔如：模拟，视
情况而定〕；
them
and ISO 9001:2021 requirements.
f 〕 利用包括最高管理者在内的跨部门小组对
应急方案进行评审〔最少每年一次〕
，并在
The organization shall establish quality objectives at relevant functions, levels and processes the quality management system.
需要时进行更新；
needed for
g〕 对应急方案形成文件， 并保存描述校正以及
改正授权人员的形成文件的信息。
The quality objectives shall:
a) be consistent with the quality policy;
应急方案应包括相关规定，用以在发生生产停止的紧急情况后重新开始生产此后，以及在老例停机过程未获取依照的情况下，确认制造的产品连续吻合顾客标准。
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services
and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization
shall maintain documented information
on the quality objectives.
When planning how to achieve its quality objectives,
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the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
质量目标及其推行的筹办
和见 ISO 9001:2021 的要求。
组织应在质量管理系统所需的相关职能、 层次和过程上设定质量目标。
Quality objectives and planning to achieve them - supplemental
质量目标应：
a) b) c) d)
与质量目标保持一致； 可测量；
考虑到适用的要求；
Top management shall ensure that quality objectives to meet customer requirements are defined ，
established ，and maintained for relevant functions ， processes ，and levels throughout the organization.
与供给合格产品和效劳以及增强顾客满意相关；
e) 予以监察；
f) 予以沟通；
g) 合时更新。
组织应保持质量目标的形成文件的信息。
The results of the organization
’s review
regarding interested parties and their relevant requirements shall be considered when the
organization establishes its annual
minimum〕quality objectives and related
performance targets
〔 at a
〔internal and external 〕.
Planning of changes
See ISO 9001:2021 requirements.
筹办如何实现其质量目标时，组织应确定：
When the organization determines the need for changes
to the quality management system, the changes shall be carried out in a planned manner (see .
a) 采用的措施； b) 需要的资源；
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) 由谁负责；
d) 什么时候完成；
e) 如何议论结果。
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c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
质量目标及其推行的筹办
最高管理者应保证为整个组织内的相关职能、过程和级别，明确、建立并保持吻合顾客要求的质量目标。
7 Support Resources General
组织在建立其年度〔最少每年一次〕质量目标和相关性能指标〔内部和外面〕时，应试虑组织对相关方及其相关要求的评审结果。
See ISO 9001:2021 requirements.
General
总那么
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
改正的筹办
b) what needs to be obtained from external providers.
见 ISO 9001:2021 的要求。
当组织确定需要对质量管理系统进行改正时〔见〕 ，此种改正应经筹办并系统的推行。
People
See ISO 9001:2021 requirements.
The organization shall determine and provide the persons necessary for the effective implementation of
组织应试虑：
a) 改正的目的及其潜藏结果；
b) 质量管理系统的完满性； c) 资源的可获取性；
d) 职责和权限的分配或再分配。
its quality management system and for the operation and control of its processes.
Infrastructure
See ISO 9001:2021 requirements.
shall determine, provide and maintain
The organization
the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
7 支持
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资源 总那么
NOTE Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
见 ISO 9001:2021 的要求。
组织应确定并供给建立、推行、保持和连续改良质量管理系统所需的资源。
组织应试虑：
a) 现有内部资源的能力和拘束；
b) 需要从外面供方获取的资源。
Plant ，facility ，and equipment planning
The organization shall use a multidisciplinary approach including risk mitigation
identification
and risk
methods for developing and improving
， and equipment plans. In
人员
见 ISO 9001:2021 的要求。
plant ，facility
designing plant layouts ，the organization shall:
a 〕optimize material flow ，material handling ， and value-added use of floor space including control of nonconforming product
， and
组织应确定并供给所需的人员，以有效推行质量管理系统并运行和控制其过程。
b 〕facilitate synchronous material flow as applicable.
基础设施
，
见 ISO 9001:2021 的要求。
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments shall include capacity planning.
组织应确定、供给并保护过程运行所需的基础设施，以获取合格的产品和效劳。
注：基础设施可包括：
These methods shall also be applicable
建筑物和相关的设施； 设施，包括硬件和软件； 运输资源； 信息和通讯技术。
a) b) c) d)
for evaluating proposed changes to existing operations.
The organization shall maintain process effectiveness ，including periodic re-evaluation relative to risk ，to incorporate any changes made during process
approval ，control plan maintenance 〔see Section 〕， and verification of job set-ups 〔see Section 〕.
工厂、设施及设施筹办
组织应使用多方论证的方法，包括风险鉴别细风险
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缓解方法，来开发并改良工厂、设施和设施的方案。
在设计工厂布局时，组织应：
Assessments of manufacturing feasibility and
a〕 优化资料的流动和搬运， 以及对空间场所的
增值利用，包括对不合格品的控制，并且
evaluation of capacity planning
shall be inputs
to managementreviews 〔 see ISO 9001，Section 〕.
b〕 在适用时，便于资料的同步流动。
应开发并合时对新产品或新操作的制造可行性进行议论的方法。制造可行性评估应包括产能筹办。这些方法还应适用于议论对现有操作的建议改正。
NOTE 1 These requirements should include the application of lean manufacturing principles.
NOTE2 These requirements should apply to on-site
组织应保持过程有效性，包括如期风险复评，以纳入在过程赞成、控制方案保护〔见第条〕及作业准备的考据〔见第条〕时期做出的任何改正。
supplier activities
，as applicable.
Environment for the operation of processes
制造可行性评估和产能筹办的议论应为管理评审的输入〔见 ISO 9001 第条〕。
See ISO 9001:2021 requirements.
The organization
shall determine, provide and maintain
the environment necessary for the operation of its processes and to achieve conformity of products and services.
注 1：这些要求应当包括对精益制造原那么的应用。 注 2：这些要求应当应用于现场供给商活动，
如适用。 NOTEA suitable environment
and physical factors, such as:
can be a combination
of human
a) social . non-discriminatory, calm, non-confrontational);
b) psychological . stress-reducing, burnout prevention, emotionally protective); c) physical . temperature, hygiene, noise).
heat, humidity, light,
airflow,
These factors can differ substantially depending on the products and services provided.
NOTE Where third-party certification to ISO
45001〔or equivalent 〕is recognized ， it may be used to demonstrate the organization's
conformity to the personnel safety aspects of this requirement.
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Environment for the operation of processes - supplemental
The organization shall maintain
its premises in
a state of order ，cleanliness ， and repair that is consistent with the product and manufacturing process needs.
Monitoring and measuring resources General
过程操作的环境
见 ISO 9001:2021 的要求。
See ISO 9001:2021 requirements.
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.
组织应确定、供给并保护过程运行所需的环境，以获取合格的产品和效劳。
注：适合的过程运行所需的环境可能是人文因素与物理因素的组合，比方：
a) 社会因素〔如无歧视的、友善牢固、无抗衡〕 ；
b) 心理因素〔如舒缓心里压力、 预防过分疲倦、 保护个人感情〕
c) 物理因素〔如：温度、热量、湿度、照明、空气流通、卫生、噪音〕
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
由于所供给的产品和效劳不同样，这些因素可能有明显的差异。
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
注：在 ISO 45001〔或等效标准〕第三方认证被认可的情况下，该认证能够证明组织吻合本要求的人员安全方面。
.1 Measurement systems analysis
Statistical studies shall be conducted to
analyse the variation present in the results of each type of inspection
， measurement，and test
equipment system identified
过程操作的环境 ---- 补充
in the control plan. manuals
The analytical methods and acceptance criteria used shall conform to those in reference on measurement systems analysis. Other
analytical methods and acceptance criteria may
组织应保持生产现场处于与产品和制造过程相协调
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的有序、干净和整理的状态。
be used if approved by the customer.
Records of customer acceptance of alternative methods shall be retained along with results from
监察和测量资源
总那么
alternative measurement systems analysis 〔see Section 〕.
见 ISO 9001:2021 的要求。
NOTEPrioritization of MSA
总那么
studies should focus
on critical or special product or process characteristics.
当利用监察或测量来考据产品和效劳吻合要求时，组织应确定并供给所需的资源，以保证结果有效和可靠。
Measurement traceability
组织应保证所供给的资源：
a) 适合特定种类的监察和测量活动；
b) 获取适合的保护，以保证连续适合其用途。
See ISO 9001:2021 requirements.
Measurement traceability
When measurement traceability is a requirement, or is
组织应保存作为监察和测量资源适合其用途的凭据的形成文件的信息。
considered by the organization to be
an essential part
of measurement
of providing
confidence in the validity
results, measuring equipment shall be:
a) calibrated or verified, or both, at specified
intervals, or prior to use, against measurement
.1 测量系统解析
standards traceable to international or national
measurement standards; when no such standards exist,
应进行统计研究来解析在控制方案所识其他每种检验、测量和试验设施系统的结果中表现的变异。所采用的解析方法及接受准那么，应与测量系统解析的参照手册相一致。若是获取顾客的赞成，其他解析方法和接收准那么也能够应用。
the basis used for calibration
or verification shall be
retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
取代方法的顾客接受记录应与取代测量系统解析的结果一起保存〔见第条〕 。
and subsequent measurement results.
The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
注：测量系统解析研究的优先级应当重视于重点或特别产品或过程特色。
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NOTEA number or another identifier
traceable to
the device calibration record meets the intent of the requirements in ISO 9001:2021.
.1 Calibration/verification records
The organization shall have a documented process for managing calibration/verification records.
测量可追想性
Records of the calibration/verification
activity for all gauges and measuring and test
见 ISO 9001:2021 的要求。
equipment 〔 including employee-owned equipment
当要求测量溯源时，或组织认为测量溯源是相信测量结果有效的基础时，测量设施应：
relevant for measuring ，customer-owned equipment ， or on-site supplier-owned equipment 〕 needed to provide evidence of conformity to internal requirements ， legislative and regulatory requirements ，and customer-defined requirements shall be retained.
a) 比较能溯源到国际或国家标准的测量标准，依照规定的时间间隔或在使用前进行校准和〔或〕检定〔考据〕，当不存在上述标准时，应保存作为校准或检定〔考据〕依照的形成文件的信息；
b) 予以表记，以确定其状态；
c) 予以保护，防范由于调整、损坏或衰减所以致的准状态和随后的测量结果的无效。
The organization shall ensure that
calibration/verification activities and records shall include the following details:
a 〕revisions following engineering changes that impact measurement systems ；
当发现测量设施不吻合预期用途时，组织应确定过去测量结果的有效性可否碰到不利影响，必要时应采用适合的措施。
b 〕any out-of-specification readings as
；
received for calibration/verification
注：一个可追想到装置校准记录的编号或其他表记
c 〕an assessment of the risk of the intended use of the product caused by the
out-of-specification condition ；
符，满足 ISO 9001 ： 2021 要求的妄图。
d 〕when a piece of inspection measurementand test equipment is found to be out of calibration
or defective during its planned verification or
calibration or during its use ，documented
this piece
of
information on the validity of previous measurement results obtained with
.1 校准 / 考据记录
inspection measurement and test equipment shall be retained ，including the associated standard's last calibration date and the next due date on
/ 考据
组织应有一个形成文件的过程，用于管理校准
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记录。用以供给吻合内部要求、法律法规要求及顾客规定要求证明的所有量具、测量和试验设施〔包括员工拥有的测量设施、顾客拥有的设施或现场供给商拥有的设施〕 ，其校准 / 考据活动的记录应予以保持。
the calibration report
；
e 〕notification to the customer if suspect
；
product or material has been shipped
f 〕statements of conformity to specification
；
after calibration/verification
组织应保证校准 / 考据活动和记录应包括以下细节：
g 〕verification that the software version used for product and process control is as specified ；
a〕 依照影响测量系统的工程改正进行的校正； b〕 校准 / 考据时获取的任何偏离标准的读数： c〕对偏离标准情况以致的产品预期使用风险的
h 〕records of the calibration and maintenance
activities for all gaugin
〔including
评估；
employee-owned equipment ， customer-owned equipment ，or on-site supplier-owned equipment 〕；
d〕当在方案考据或校准时期， 或在其试用时期，
检验、测量和试验设施被查出偏离校准或存在弊端，应保存相关此检验、测量和试验设施先前测量结果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；
i 〕production-related software verification used for product and process control 〔including software installed on employee-owned equipment ， customer-owned equipment ， or on-site supplier-owned equipment 〕 .
e〕若是可疑产品或资料已被发运，对顾客的通
知；
f 〕校准 / 考据后，相关吻合标准的声明； g〕对用于产品或过程控制的软件版本吻合规定
Laboratory requirements
.1 Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its
的考据；
h〕所有量具〔包括员工拥有的设施、顾客拥有
的设施或现场供给商拥有的设施〕校准和保护活动
capability to perform the required inspection test ，or calibration services. This laboratory
scope shall be included in the quality management system documentation. The laboratory shall
，
的记录；
i 〕对用于产品和过程控制的生产相关软件的考据〔包括安装于员工拥有的设施、顾客拥有的设施或现场供给商拥有的设施的软件〕 。
specify and implement ，as a minimum，requirements for:
a 〕adequacy of the laboratory technical procedures ；
b 〕competency of the laboratory personnel c 〕testing of the product
；
；
d 〕capability to perform these services correctly ， traceable to the relevant process standard 〔such as ASTM，EN，etc. 〕； when no
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national or international standard 〔s〕is
available ， the organization shall define and implement a methodology to verify measurement system capability
；
e 〕customer requirements ，if any ； f 〕review of the related records. NOTEThird-party accreditation
to ISO/IEC 17025
（ or equivalent 〕 may be used to demonstrate the organization's in-house laboratory conformity to this requirement.
.2 External laboratory
External/commercial/independent laboratory
，test ，or facilities used for inspection
calibration services by the organization shall have a defined laboratory scope that includes the
， capability to perform the required inspection
test ，or calibration ，and either: - the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include
，test ，or calibration the relevant inspection
service in the scope of the accreditation 〔certificate 〕； the certificate of calibration or test report shall include the mark of a
； or national accreditation body
实验室要求
.1 内部实验室
- there shall be evidence that the external laboratory is acceptable to the customer.
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、试验或校准效劳的额能力。该实验室范围应包括在质量管理系统文件中。实验室最少应为以下事项明确规定并推行要求：
a〕 实验室技术程序的充分性； b〕 实验室人员的资格； c〕 产品试验；
d〕 正确履行这些效劳的能力， 可追想到相关过程
标准〔比方： ASTM、 EN等〕；若是没有可用的国家或国际标准， 组织应明确并推行一
NOTE Such evidence may be demonstrated by
customer assessment ，for example ， or by
customer-approved second-party assessment that
the laboratory meets the intent of ISO/IEC 17025
or national equivalent. The second-party
assessment may be performed by the organization
assessing the laboratory using a
customer-approved method of assessment.
Calibration services may be performed by the
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个考据测量系统能力的方法； e〕 顾客要求，如有： f 〕 对相关记录的评审。
equipment manufacturer when a qualified
laboratory is not available for a given piece of equipment In such cases，the organization shall ensure that the requirements listed in Section .1 have been met.
注：经过 ISO/IEC 17025〔或等效标准〕第三方认可
能够证明组织内部实验室吻合这个要求。
Use of calibration services
， other than by
qualified 〔 or customer accepted 〕laboratories ， may be subject to government regulatory confirmation ， if required.
Organizational knowledge
See ISO 9001:2021 requirements.
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
This knowledge shall be maintained and be madeavailable to the extent necessary.
.2 外面实验室
When addressing changing needs and trends, the organization shall consider its current knowledge and
/商业 /独
determine how to acquire or access any necessary additional knowledge and required updates.
为组织供给检验、试验或校准效劳的外面
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：
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is gained by experience. It is information that is used and shared to achieve the organization ’s objectives.
- 实验室应经过 ISO/IEC 17025 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
验或校准效劳；校准证书或试验报告应包括国家认可机构的标志；或
- 应有凭据证明该外面实验室能够被顾客接受。
NOTE 2 Organizational knowledge can be based on:
a) internal sources . intellectual property; knowledge
gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
b) external sources . standards; academia; conferences; gathering knowledge from customers or external providers).
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注：这些凭据能够经过顾客评估来证明，或由顾客 赞成的第二方机构评估，来证明该实验室满足了
Competence
ISO/IEC 17025 或等效国家标准的妄图。第二方机构
See ISO 9001:2021 requirements.
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the
评估可由评估实验室的组织，采用顾客赞成的评估方法进行。
performance and effectiveness system; .
of the quality management
b) ensure that
these persons are competent on the basis
of appropriate education, training, or experience; c) where applicable, take actions to acquire the
当某一设施没有具备资格的实验室时，校准效劳能够由设施制造商进行。在这种情况下，组织应保证第 .1 条中的要求获取满足。
necessary competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment
of currently employed persons; or the hiring or contracting of competent persons.
校准效劳的采用，除了由具备资格的〔或顾客接受的〕实验室供给的以外，需要时，可能需要获取看守机构确实认。
Competence - supplemental
and maintain a
The organization shall establish
组织知识
见 ISO 9001:2021 的要求。
组织应确定必要的知识，以运行过程，并获取合格产品和效劳。
documented process〔es〕for identifying training needs including awareness 〔see Section 〕and achieving competence of all personnel performing activities affecting conformity to product and process requirements. Personnel performing
specific assigned tasks shall be qualified ，as
required ，with particular attention to the satisfaction of customer requirements.
这些知识应予以保持，并能在所需的范围内获取。
为对付不断变化的需求和睁开趋势，组织应审察现有的知识，确定如何获取或接触更多必要的知识和知识更新。
Competence - on-the-joh training
The organization shall provide on-the-job
training 〔which shall include customer
requirements training 〕for personnel in any new
or modified responsibilities affecting
注1：组织的知识是组织特有的知识，平常从其经验中获取，是以实现组织目标所使用和共享的信息。
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注2：组织的知识能够基于：
a) 内部资源〔例知识产权；从经验获取的知识；从失败和成功工程吸取的经验教训；获取和分享未成文的知识和经验；过程、产品和效劳的改良结果〕 ；
b) 外面资源〔比方标准；学术沟通；专业会议，从顾客或外面供方收集的知识〕。
，internal conformity to quality requirements
requirements ， regulatory or legislative
requirements ； this shall include contract or
agency personnel. The level of detail required for on-the-job training shall be commensurate
with the level of education the personnel possess
〔s〕they are and the complexity of the task
required to perform for their daily work. Persons
whose work can affect quality shall be informed about the consequences of nonconformity to customer requirements.
Internal auditor competency
The organization shall have a documented process （ es〕to verify that internal auditors are
能力
competent ， taking into account any requirements defined by the organization and/or customer-specific requirements. For additional guidance on auditor competencies ， refer to ISO
见 ISO 9001:2021 的要求。
组织应：
19011. The organization shall maintain a list of
a) 确定其控制下工作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系统绩效和有效性；
b) 基于适合的教育、培训或经验，保证这些人员是胜任的；
c) 适用时，采用措施以获取所需的能力，并议论措施的有效性；
d) 保存适合的成文信息，作为人员能力的凭据。
qualified internal auditors.
Quality managementsystem auditors shall be able to demonstrate the following minimum competencies:
a 〕understanding of the automotive process approach for auditing ， including risk-based thinking ；
注：适合措施能够包括对任职人员进行培训、指导或重新分配工作，也许招聘、外包胜任的人员。
b 〕understanding of applicable customer-specific requirements ；
c 〕understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit ；
d 〕understanding of applicable core tool requirements related to the scope of the audit
；
能力 ---- 补充
e 〕understanding how to plan ，conduct ，report ， and close out audit findings.
组织应建立并保持形成文件的过程，鉴别包括意识
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〔见第条〕在内的培训需求，并使所有从事影响产 品要求和过程要求吻合性的活动的人员具备能力。
从事特定指派任务的人员应按要求认可，特别关注
对顾客要求的满足。
At a minimum, manufacturing process auditors
shall demonstrate technical understanding of the
relevant manufacturing process 〔es〕to be
audited ，including process risk analysis 〔 such
as PFMEA〕and control plan.
At a minimum, product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity.
能力 ---- 任职培训
关于担当影响质量要求、内部要求、法规或法律要
If the organization
’s personnel provide the
求吻合性的新的或调整职责的人员，组织对付其进
行任职培训〔其中还应包括顾客要求培训〕
，包括合
同工或代理工。任职培训的详细程度应与人员的教 育程度及其要在平常工作中履行的任务的复杂程度
training to achieve competency ，documented information shall be retained to demonstrate the
trainer ’s competency with the above requirements.
相当。从事影响质量的工作人员应被见告不吻合顾客要求的结果。
Maintenance of and improvement in internal auditor competence shall be demonstrated through:
f 〕executing a minimum number of audits
；and
per
year ，as defined by the organization
g 〕maintaining knowledge of relevant requirements based on internal changes
〔 . ，
process technology ， product technology 〕 and external changes〔. ，ISO 9001，IATF 16949， core tools ，and customer specific requirements 〕 .
Second-party auditor competency
The organization shall demonstrate the competence of the auditors undertaking the
second-party audits. Second-party auditors 组织应有形成文件的过程，用于考据内部审察员的
shall meet customer specific requirements for 能力，要考虑到 组织规定的要求和 / 或顾客特定要
求。关于审察员能力的更多参照， 拜会 ISO 19011 。 auditor qualification and demonstrate the
内部审察员能力
组织应保持一份合格内部审察员名单。
minimum following core competencies understanding of:
，including
质量管理系统审察员应 能够证明最少具备以下能
a 〕the automotive process approach to auditing ，including risk based thinking
；
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力：
a〕 认识汽车审察过程方法， 包括基于风险的思
想；
b 〕applicable customer and organization specific requirements ；
c 〕applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit
；
b〕 认识适用的顾客特定要求；
c〕 认识 ISO 9001 和 IATF 16949 中适用的与审
核范围相关的要求；
d 〕applicable manufacturing process 〔es〕 to be audited ， including PFMEAand 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.
d〕 认识与审察范围相关的适用的核心工具
要求；
e〕 认识如何方案审察、 推行审察、 报告审察以
及关闭审察发现。
Awareness
See ISO 9001:2021 requirements.
The organization shall ensure that persons doing work under the organization
’s control are aware of:
最少 ，制造过程审察员还应证明关于待审察的相关
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the
quality management system, including the benefits of improved performance;
制造过程， 其拥有技术知识， 包括过程风险解析 〔比方 PFMEA〕和控制方案。
d) the implications of not conforming with the quality management system requirements.
最少 ，产品审察员还应证明其认识产品要求，并能够使用相关测量和试验设施考据产品吻合性。
Awareness - supplemental
The organization shall maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving ， maintaining ，and improving quality ，including customer requirements and the risks involved for the customer with non- conforming product.
若是由组织的人员供给培训
来获取人员能力的情况
下，应保存形成文件的信息，证明培训师的能力符
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合上述要求。
Employee motivation and empowerment
The organization shall maintain a documented process 〔es〕to motivate employees to achieve quality objectives ， to make continual improvements ， and to create an environment that promotes
innovation. The process shall include the promotion of quality and technological
awareness throughout the whole organization.
内部审察员能力的保持与改良应经过以下方法进行
证明：
a〕 每年履行组织规定的最小数量的审察，
并且
Communication
b〕 保持基于内部改正〔如：过程技术、产品技
See ISO 9001:2021 requirements.
The organization shall determine the internal and external communications relevant to the quality management system, including:
术〕和外面改正〔如：ISO 9001、IATF 16949、核心工具及顾客特定要求〕 对相关要求的认知。
第二方审察员能力
组织应证明从事第二方审察的审察员的能力。第二方审察员应吻合顾客对审察员资质的特定要求，并证明最少具备以下核心能力，包括认识：
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
a〕 汽车审察过程方法，包括基于风险的思想；
b〕 适用的顾客特定和组织特定要求；
Documented information General
c〕 ISO 9001 和 IATF 16949 中适用的与审察范围有
关的要求；
See ISO 9001:2021 requirements.
PFMEA和控制计
d〕 适用的待审察制造过程，包括
划；
The organization ’s quality management system shall include:
e〕 与审察范围相关的适用的核心工具要求；
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
f 〕 如何方案审察、 推行审察、 编制审察报告并关闭
审察发现。
NOTE The extent of documented information for a quality
management system can differ from one organization to
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another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
意识
Quality management system documentation
见 ISO 9001 ： 2021 的要求。
组织应保证在其控制下工作人员认识：
a) 质量目标；
b) 相关的质量目标；
c) 他们对质量管理系统有效性的奉献，包括改良质量绩效的利处；
d) 不吻合质量管理系统要求的结果。
The organization ’s quality management system 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 of the organization and will
depend on the organization ’s size ，culture ，
and complexity. If a series of documents is used， then a list shall be retained of the documents that comprise the quality manual for the organization.
意识——补充
组织应保持形成文件的信息，证明所有员工都认识
The quality manual shall
include ，at a minimum ，
the following:
a 〕the scope of the quality management system， including details of and justification
for any exclusions ；
到其对产质量量的影响，以及他们所从事的活动在
实现、保持并改良质量中的重要性，还包括顾客要
求及不合格品带给顾客的风险。
b 〕documented processes established for the
quality managementsystem， or reference to them；
c 〕the organization ’s processes and their
员工激励和授权
sequence and interactions 〔 inputs and outputs 〕， including type and extent of control of any outsourced processes ；
组织应保持形成文件的信息，激励员工实现质量目
标，进行连续改良，并建立一个倡议创新的环境。
d 〕a document〔 for example, a table, a list,
该过程应包括促使整个组织对质量和技术的认知程
度。
or a matrix 〕indicating where within the
organization's quality management system their
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customer-specific requirements are addressed.
NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS ，
沟通
见 ISO 9001:2021 的要求。
Creating and updating
组织应确定与质量管理系统相关的内部和外面沟通，包括：
See ISO 9001:2021 requirements.
Whencreating and updating documented information, organization shall ensure appropriate:
a) b) c) d) e)
沟通什么； 何时沟通； 与谁沟通； 如何沟通； 由谁沟通。
the
a) identification and description . a title, date, author, or reference number);
b) format . language, software version, graphics) and media . paper, electronic);
c) review and approval for suitability and adequacy.
形成文件的信息
Control of documented information
总那么
and
见 ISO 9001:2021 的要求。
See ISO 9001:2021 requirements.
组织的质量管理系统应包括：
Documented information required by the quality
a) 本标准要求的成文信息；
b) 组织确定的为保证质量管理系统有效运行所需
management system and by this International Standard
shall be controlled to ensure:
的成文信息。
注：关于不同样组织，质量管理系统成文信息的多少 与详略程度可不同样，取决于：
a) it is available and suitable for use, where and when
it is needed;
b) it is adequately protected . from loss of
confidentiality, improper use, or loss of integrity).
-- 组织的规模，以及活动、过程、产品和效劳
的种类；
-- 过程及其相互作用的复杂程度；
For the control of documented information, the
organization shall address the following activities, as
applicable:
-- 人员的能力。
a) distribution, access, retrieval and use;
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b) storage and preservation, including preservation of legibility;
c) control of changes . version control); d) retention and disposition.
质量管理系统文件
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
组织的质量管理系统应形成文件，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。
Documented information retained as evidence of conformity shall be protected from unintended alterations.
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。若是采用一系列文件，那么应保存一份构成组织质量手册文件的清单。
NOTEAccess can imply a decision
regarding the permission
to view the documented information only, or the permission and authority
to view and change the documented
质量手册应最少包括以下内容：
a〕 质量管理系统的范围， 包括任何删减的细节
和正当的原因；
information.
b〕 为管理系统建立的形成文件的过程或对
其引用；
.1 Record retention
The organization shall define
，document，and
c〕 组织的过程及其序次和相互作用 〔输入和输
出〕，包括任何外包过程控制的种类和程度；
implement a record retention policy. The control of records shall satisfy statutory ，regulatory ， organizational ，and customer requirements.
d〕 一个显示组织质量管理系统内哪些地方满
足了顾客特定要求的文件〔 如：一张表格，清单或矩阵〕。
Production part approvals ，tooling records
〔including maintenance and ownership 〕， product
QMS
注：可采用一个显示组织过程如何满足本汽车标准要求的矩阵来辅助在组织过程与本汽车准之间建立联系。
QMS标
and process design records ，purchase orders 〔if
applicable 〕，or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements ， plus one calendar year ，unless
otherwise specified by the customer or regulatory agency.
NOTE Production part approval documented
information may include approved product
，
applicable test equipment records ，or approved
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test data.
.2 Engineering specifications
The organization shall have a documented process describing the review ， distribution ， and
implementation of all customer engineering standards/specifications and related revisions based on customer schedules ， as required.
When an engineering standard/specification
change results in a product design change，refer
to the requirements in ISO 9001 ，Section When
an engineering standard/specification change
results in a product realization process change，
refer to the requirements in Section . The
organization shall retain a record of the date on which each change is implemented
创立和更新
in production. Implementation shall include updated documents.
见 ISO 9001:2021 的要求。
在创立和更新成文信息时，组织应保证适合的：
Review should be completed within 10 working days
a)
表记和说明〔如：标题、日期、作者、索引编号〕；
of receipt of notification of engineering
standards/specifications changes.
b) 形式〔如语言、软件版本、图表〕和载体〔如纸 质的、电子的〕；
c) 评审和赞成，以保证适合性和充分性。
NOTEA change in these standards/specifications
may require an updated record of customer
production part approval when these
specifications are referenced on the design
record or if they affect documents of the
成文信息的控制
和
production part approval process ，such as control
plan ，risk analysis
〔such as FMEAs〕， etc.
见 ISO 9001:2021 的要求。
8 Operation
应控制质量管理系统和本标准所要求的成文信息，以保证：
Operational planning and control
a) 在需求的场合和机会，均可获取并适用；
See ISO 9001:2021 requirements.
The organization shall plan, implement and control to meet the requirements for
the the
b) 予以稳当保护〔如防范泄密、不当使用或缺失〕 。 processes (see needed
provision of products
and services, and to implement the
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actions determined in Clause 6, by:
为控制成文信息，适用时，组织应进行以下活动： a) 发散、接见、检索和使用； b) 储藏和防范，包括保持可读性； c) 改正控制〔如版本控制〕； d) 保存和办理。
关于组织确定的筹办和运行质量管理系统所需的来 自外面的成文信息，组织应进行适合鉴别，并予以 控制。
对所保存的、作为吻合性凭据的成文信息应予以保 护，防范非预期的改正。
a) determining the requirements for the products and
services;
b) establishing criteria for:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product and service requirements;
d) implementing control of the processes in accordance
with the criteria;
e) determining, maintaining and retaining documented
information to the extent necessary:
注：对成文信息的“接见〞可能意味着仅赞成查阅，或意味着赞成查阅并授权改正。
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.
The output of this planning shall be suitable for the organization ’s operations.
The organization shall control planned changes and review the consequences of unintended changes, taking
.1 记录保存
action to mitigate any adverse effects, as necessary.
The organization
shall ensure that outsourced processes
组织应有一个确定的、形成文件的并且被履行的记录保存。对记录的控制应满足法律法规、组织及顾客要求。
are controlled (see .
8.. Operational planning and control - supplemental
应保存生产件赞成文件、工装记录〔包括保护和所有权〕、产品和过程设计记录、采买订单〔如适用〕也许合同和修正，保存时间为产品在现行生产和效劳中要求的有效期，再加一个日历年，除非顾客和看守机构还有特别要求。
When planning for product realization
，the
following topics shall be included:
a 〕customer product requirements and
；
；
；
technical specifications
注：生产件赞成形成文件的信息可包括已赞成产品、适用的试验设施记录或已赞成试验数据。
b 〕logistics requirements
c 〕manufacturing feasibility
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d 〕project planning 〔refer to ISO 9001 ， Section 〕；
e 〕acceptance criteria.
The resources identified in ISO 9001
，Section
，
c〕，refer to the required verification
validation ，monitoring ，measurement，inspection ， and test activities specific to the product and the criteria
.2 工程标准
for product acceptance.
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 / 标准及相关校正的评审、发散和推行。
Confidentiality
The organization shall ensure the
confidentialityof customer-contracted products and projects under development ，including related product information.
当工程标准 / 标准改正以致产品设计改正时，请拜会 ISO 9001 第条的要求。当工程标准 / 标准改正以致产 品实现过程改正时，请拜会
ISO 9001 第条的要求 .
组织应保存每项改正在生产中推行日期的记录。实
施应包括更新过的文件。
Requirements for products and services Customer communication
应当在收到工程标准 / 标准改正通知后 10 个工作日内完成评审。
See ISO 9001:2021 requirements.
Communication with customers shall include: a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency
注：当设计记录引用了这些标准，或这些标准影响了生产件赞成过程的文件，比方：控制方案、风险
解析〔如 FMEA〕等时，这些标准 / 标准的改正需要对顾客的生产件赞成记录进行更新。
actions, when relevant.
Customer communication - supplemental Written or verbal communication shall be in the
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language agreed with the customer. The
organization shall have the ability to communicate necessary information
，including
，
data in a customer-specified computer language and format 〔. ，computer-aided design data electronic data interchange
〕 .
8 运行
Determining the requirements for products and services
运行筹办和控制
见 ISO 9001:2021 的要求。
See ISO 9001:2021 requirements.
Whendetermining the requirements for the products and services to be offered to customers, the organization shall ensure that:
为满足产品和效劳供给的要求，并推行第 6章确定的措施，组织应经过以下措施对所需的过程〔见〕进行筹办、推行和控制：
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
a) 确定产品和效劳的要求；
b) 建立以下内容的准那么：
1) 过程；
2) 产品和效劳的接收。
c) 确定所需的资源以使产品和效劳吻合要求；
d) 依照准那么推行过程控制；
e) 在必要的范围和程度上， 确定并保持、保存成文信息，以：
1) 确信过程已按筹办进行；
2) 证明产品和效劳吻合要求。筹办的输出应适于组织的运行。
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.
Determining the requirements for products and services - supplemental
These requirements shall include recycling
，
environmental impact ，and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes.
组织应控制筹办的改正，评审非预期改正的结果，必要时，采用措施减少不利影响。
组织应保证外包过程受控〔见〕。
Compliance to ISO 9001 ，Section item a 〕1 〕， shall include but not be limited to the
following: all applicable government
，safety ，
and environmental regulations related to acquisition ，storage ，handling ，recycling ，
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elimination ，or disposal of material.
Review of the requirements for products and services
See ISO 9001:2021 requirements.
The organization shall ensure that it has the ability
运行筹办和控制 ---- 补充
to meet the requirements for products and services to
在对产品实现进行筹办时，应包括以下主题：
be offered to customers. The organization
shall conduct
a review before committing to supply
a〕 顾客产品要求和技术标准； b〕 物流要求； c〕 制造可行性；
d〕 工程筹办〔参加 ISO 9001 第条〕； e〕 接受准那么。
products and services to a customer, to include:
a) requirements specified 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;
ISO 9001 第条 c〕项中的资源是指所要求的产品特定的考据、确认、监察、测量、检验和试验活动以
c) requirements specified by the organization;
及产品接收准那么。
d) statutory
and regulatory requirements applicable to
the products and services; e) contract
or order requirements differing from those
previously expressed.
The organization shall ensure that contract or order requirements differing from those previously defined are resolved.
The customer ’s requirements
shall be confirmed by the
organization
before acceptance, when the customer does
not provide a documented statement of their requirements.
NOTEIn some situations,
such as internet for each order.
sales, a formal
the review
review is impractical
Instead,
can cover relevant product information, such
保密
as catalogues.
组织应保证正在开发中的顾客签约产品和工程及有
关产品信息的保密。
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产品和效劳要求
.1 Review of the requirements for products and services —supplemental
The organization shall retain documented
顾客沟通
evidence of a customer-authorized waiver for the requirements stated in ISO 9001，Section ， fora formal review.
见 ISO 9001:2021 的要求。
与顾客沟通的内容应包括：
a) 供给相关产品和效劳的信息；
b) 办理咨询，合同或订单，包括改正；
c) 获取相关产品和效劳的顾客反响，包括顾客抱怨；
d) 办理或控制顾客财产；
e) 关系重要时，拟定应急措施的特定要求。
.2 Customer-designated special characteristics
The organization shall conform to customer
requirements for designation ，approval documentation ，and control of special characteristics.
.3 Organization manufacturing feasibility
The organization shall utilize a
顾客沟通 ---- 补充
multidisciplinary approach to conduct an
analysis to determine if it is feasible that the organization's manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. The organization shall conduct this feasibility
应按顾客赞成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 〔比方：计算机辅助设计数据、电子数据交换等〕 。
analysis for any manufacturing or product technology
与产品和效劳要求确实定
new to the organization and for any changed manufacturing process or product design.
见 ISO 9001:2021 的要求。
在确定向顾客供给的产品和效劳的要求时，组织应保证：
Additionally ， the organization should validate through production runs ， benchmarking studies ， or other appropriate methods ，their ability to
make product to specifications at the required rate.
a) 产品和效劳的要求获取规定，包括：
1) 适用的法律法规要求；
2) 组织认为的必要要求。
b) 供给的产品和效劳能够满足所声明的要求。
See ISO 9001:2021 requirements.
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The organization
shall retain documented information, as
applicable:
a) on the results of the review;
b) on any new requirements for the products
与产品和效劳要求确实定
---- 补充
and services.
这些要求应包括回收再利用、对环境的影响，以及依照组织对产品和制造过程的认知所识其他特色。
Changes to requirements for products and services
遵守 ISO 9001 第条 a〕1〕项的要求应包括但不限于：
所有适用的与资料的获取、储藏、搬运、回收、销毁或荒弃相关的。安全和环境法规。
See ISO 9001:2021 requirements.
The organization shall ensure that relevant documented
information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
Design and development of products and services
General
See ISO 9001:2021 requirements.
The organization shall establish, implement and
产品和效劳要求的评审
maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
见 ISO 9001:2021 的要求。
组织应保证有能力向顾客供给满足要求的产品和效劳。在承诺向顾客供给产品和效劳以前，组织对付以下各项要求进行评审：
Design and development of products and services —supplemental
a) 顾客规定的要求，包括对交付和交付后活动的要求；
b) 顾客诚然没有明示，但规定的用途或的预期用途所必要的要求；
c) 组织规定的要求；
d) 适用于产品和效劳的法律法规要求；
The requirements of ISO 9001 ，Section ， shall
apply to product and manufacturing process design and development and shall focus on error prevention rather than detection.
The organization shall document the design and development process.
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e) 与以前表述不一致的合同或订单要求。
Design and development planning
假设与先期的的合同或订单的要求存在差异，组织应保证相关事项已经获取解决。
See ISO 9001:2021 requirements.
In determining the stages and controls for design and development, the organization shall consider:
假设顾客没有供给成文的要求，组织在接受顾客要求前对付顾客要求进行确认。
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable
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质的。作为取代方法，可评审相关的产品信息，如产品目录。
design and development reviews;
c) the required
design and development verification and
validation activities; d) the responsibilities
and authorities involved in the
design and development process;
e) the internal and external resource needs for the design and development of products and services; f) the need to control interfaces between persons involved in the design and development process;
.1 产品和效劳要求的评审 ----
补充
g) the need for involvement of customers and users in
组织应保存形成文件的凭据，证明对 中正式评审要求的弃权有顾客授权。
ISO 9001 第条 the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other
.2 顾客指定的特别特色
relevant interested parties;
组织应吻合顾客对特别特色的指定、赞成文件和控
j) the documented information needed to demonstrate
制的要求。
that design and development requirements have been met.
Design and development planning supplemental
—
.3 组织制造可行性
The organization shall ensure that design and development planning includes all affected
组织应采用多方论证方法来进行解析，以确定组织 的制造过程是否是可行的，能够始一生产出吻合顾
客规定的所有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，以及任何更改正
stakeholders within the organization and ，as
appropriate ，its supply chain. Examples of areas for using such a multidisciplinary approach
include but are not limited to the following:
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的制造过程或产品设计进行可行性解析。
其他，组织应当经过生产运行、标杆管理研究或其他适合的方法，确认其能够以所要求的速率生产出吻合标准的产品。
a 〕project management〔for example，APQPor VDA-RGA〕；
b 〕product and manufacturing process design activities 〔for example ，DFM and 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
reduce potential risks ；
d 〕development and review of manufacturing process risk analysis 〔for example，FMEAs，process
flows ，control plans ，and standard work instructions 〕 .
NOTE A multidisciplinary approach typically
includes the organization ’s design ， manufacturing ，engineering ，quality ，production ， purchasing ，supplier ，maintenance ，and other appropriate functions.
见 ISO 9001:2021 的要求。
适用时，组织应保存与以下方面相关的成文信息：
a) 评审结果；
b) 产品和效劳的新要求。
Product design skills
The organization shall ensure that personnel
with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and
techniques. Applicable tools and techniques shall be identified by the organization.
产品和效劳要求的改正
见 ISO 9001:2021 的要求。
假设产品和效劳要求发生改正，组织应保证相关的成
NOTE An example of product design skills is the application of digitized mathematically based data.
文信息获取改正，并保证相关人员知道已改正的要
求。
Development of products with embedded software
产品和效劳的设计和开发
总那么
见 ISO 9001:2021 的要求。
The organization shall use a process for quality assurance for their products with internally developed embedded software ， A software development assessment methodology shall be
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组织应建立、推行和保持适合的设计和开发过程，以便保证后续的产品和效劳的供给。
产品和效劳的设计和开发
---- 补充
utilized to assess the organization's software development process. Using prioritization based
， on risk and potential impact to the customer
the organization shall retain documented
information of a software development capability self-assessment.
ISO 9001 第条的要求应适用于产品和制造过程的设
计和开发，并且应重视于错误预防，而不是探测。
组织对付设计和开发过程形成文件。
The organization shall include software development within the scope of their
internal audit programme 〔 see Section 〕.
Design and development inputs
See ISO 9001:2021 requirements.
设计和开发筹办
The organization shall determine the requirements essential for the specific types of products and
见 ISO 9001:2021 的要求。
services to be designed and developed. The organization shall consider:
在确定设计和开发的各个阶段和控制时，组织应试虑：
a) b) c) d) e)
设计和开发活动的性质、连续时间和复杂程度； 所需的过程阶段，包括适用的设计和开发评审；
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
所需的设计和开发的考据及确认活动； 设计和开发过程涉及的职责和权限；
d) standards or codes of practice that the organization has committed to implement;
产品和效劳的设计和开发所需的内部和外面资源；
f) 设计和开发过程参加人员之间接口的控制需求；
g) 顾客和使用者参加设计和开发过程的需求；
h) 对后续产品和效劳供给的要求；
i) 顾客和其他相关方希望的设计和开发过程的控制水平；
j) 证明已经满足设计和开发要求所需的成文信息。
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 retain documented information on design and development inputs.
Product design input
，document，and
The organization shall identify
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review product design input requirements as a result of contract review. Product design input requirements include but are not limited to the following:
a 〕product specifications limited to special characteristics Section 〕；
including but not
〔see
b 〕boundary and interface requirements
；
设计和开发筹办 ---- 补充
c 〕identification ， traceability ， and packaging ；
组织应保证设计和开发筹办含该组织内部所有受影响的利益相关者及其〔适合的〕供给链。使用多方论证方法的方面包括但不限于：
d 〕consideration of design alternatives ；
a〕 工程管理〔比方： APQP或 VDA-RGA〕； b〕 产品和制造过程设计活动 〔如：DFM
和 DFA〕，
e 〕assessment of risks with the input requirements and the organization's ability to
mitigate/manage the risks ，including from the
feasibility analysis ；
f 〕targets for conformity to product requirements including preservation ，
reliability ，durability ，serviceability ，health ，
safety ， environmental ， development timing ，and cost ；
比方：考虑使用取代的设计和制造过程；
c〕 产品设计风险解析〔 FMEA〕的开发和评审，
包括降低潜藏风险的措施；
d〕 制造过程风险解析〔如： FMEA、过程流程、
g 〕applicable statutory and regulatory
控制方案和标准的工作指导书〕 的开发和评审。 requirements of the customer-identified
of destination ，if provided ；
country
注：多方论证方法平常包括组织的设计、制造、工程、质量、生产、采买、供给、保护和其他适合职能。
h 〕embedded software requirements.
The organization shall have a process to deploy
information gained from previous design projects ，competitive product analysis
〔benchmarking 〕， supplier feedback ，internal
input ，field data ，and other relevant sources for current and future projects
of a similar nature.
NOTE One approach for considering design alternatives is the use of trade-off curves.
Manufacturing process design input
The organization shall identify ，document，and review manufacturing process design input requirements including but not limited to the
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following:
a 〕product design output data including special characteristics ；
产品设计技术
组织应保证负有产品设计职责的人员有能力完成设计要求，并具备适用的产品设计工具和技术技术。适合的工具和技术应获取组织的鉴别。
b 〕targets for productivity ，process capability ，timing ， and cost ；
c 〕manufacturing technology alternatives d 〕customer requirements
，if any ；
； ；
e 〕experience from previous developments f 〕new materials ；
注：基于数学的数字化数据的应用即是一种产品设计技术。
g 〕product handling and ergonomic requirements ； and
h 〕design for manufacturing and design for assembly.
带有嵌入式软件的产品的开发
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。组织应依照风险和对顾客潜藏影响的优先级，为软件开发能力自评估保存形成文件的信息。
The manufacturing process design shall include the use of error-proofing methods to a degree appropriate to the magnitude of the problem 〔s〕 and commensurate with the risks encountered.
Special characteristics
组织应将软件开发纳入其内部审察方案的范围〔见第条〕。
The organization shall use a multidisciplinary
approach to establish ，document，and implement its process 〔es〕 to identify special characteristics ， including those determined by the customer and the risk analysis performed by
the organization ，and shall include the following:
设计和开发输入
a〕documentation of special characteristics
in the product and/or manufacturing documents 〔as required 〕， relevant risk analysis 〔such as
Process FMEA〕，control plans ，and standard
work/operator instructions ；special
characteristics are identified with specific
markings and are documented in the manufacturing
documents which show the creation of , or the
controls required, for these special characteristics ；
见 ISO 9001:2021 的要求。
b 〕development of control and monitoring strategies for special characteristics of
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组织应针对所设计和开发的详细种类的产品和效劳，确定必要的要求，要求应试虑：
products and production processes
；
a)
b) c) d) e)
功能和性能要求；
本源于以前近似设计和开发活动的信息； 法律法规要求；
组织承诺推行的标准或行业标准；
由产品和效劳性质所以致的潜藏无效结果。
c 〕customer-specified approvals ， when required ；
d 〕compliance with customer-specified definitions and symbols or the organization's
equivalent symbols or notations ，as defined in a symbol conversion table. The symbol conversion
table shall be submitted to the customer ，if
required.
针对设计和开发的目的，输入应是充分和适合的，且应完满、清楚。
Design and development controls
See ISO 9001:2021 requirements.
相互矛盾的设计和开发输入应获取解决。
The organization
shall apply controls to the design and
组织应保存相关设计和开发输入的成文信息。
development process to ensure that: a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability
of the
results of design and development to meet requirements; c) verification
activities are conducted to ensure that
the design and development outputs meet the input requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the
产品设计输入
requirements for the specified use;
application or intended
组织对付作为合同评审结果的产品设计输入要求进行鉴别、形成文件并进行评审。产品设计输入要求包括但不限于：
e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;
a〕 产品标准，包括但不限于特别特色〔见
第条〕；
f) documented information of these activities is retained.
b〕 界线和对接要求；
c〕 表记、可追想性和包装； d〕 对涉及的取代选择的考虑；
e〕 对输入要求风险的评估，以及对组织缓解
管理风险〔包括来自可行性解析的风险〕的 能力的评估；
NOTE Design and development reviews, verification and validation have distinct purposes. They can be
conducted separately or in any combination, as is suitable for the products and services of the organization.
/
Monitoring
f 〕 产品要求吻合性的目标， 包括防范、 可靠性、
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长久性、可效劳性、健康、安全、环境、开发时程安排和本钱等方面；
g〕 顾客确定的目的国〔如有供给〕的使用法
律法规要求；
Measurements at specified stages during the
design and development of products and processes shall be defined ，analysed ，and reported with summaryresults as an input to managementreview
（ see Section 〕.
h〕 嵌入式软件的要求。
When required by the customer ， measurements of the product and process development activity
shall be reported to the customer at stages specified ， or agreed to ，by the customer.
组织应有一个过程，将从以前的设计工程、竞争产品解析〔标杆〕 、供给商反响、内部输入、使用现场数据和其他相关资源中获取的信息，推行应用于当前和未来相似性质的工程。
NOTE When appropriate ， these measurements may include quality risks ，costs ，lead times ，critical paths ，and other measurements.
Design and development validation
注：使用权衡曲线是考虑设计的取代选择的一种方法。
Design and development validation shall be performed in accordance with customer
requirements ， including any applicable industry and governmental agency-issued regulatory standards. The timing of design and development validation shall be planned in alignment with
，as applicable. customer-specified timing
制造过程设计输入
组织对付制造过程设计输入要求进行鉴别、形成文件并进行评审，包括但不限于：
Where contractually agreed with the customer ，
this shall include evaluation of the interaction
of the organization's product ，including
embeddedsoftware ，within the system of the final customer's product.
a〕 产品设计输出的数据，包括特别特色；
b〕 生产力、过程能力、时程安排及本钱的目标； c〕 制造技术取代选择； d〕 顾客要求，如有； e〕 过去的开发经验； f 〕 新资料；
g〕 产品搬运和人体工学要求；以及
Prototype programme
Whenrequired by the customer ，the organization shall have a prototype programme and control plan.
The organization shall use ， whenever possible ，
the same suppliers ，tooling ，and manufacturing processes as will be used in production.
All performance-testing activities shall be monitored for timely completion and conformity
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h〕 制造设计和装置设计。
to requirements.
制造过程设计应包括，针对问题适合的重要性程度，和所遭碰到的风险相当的程度来使用防错方法。
When services are outsourced ，the organization
shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements 〔 see ISO 9001 ，Section 〕.
Product approval process
， implement ，
The organization shall establish
and maintain a product and manufacturing approval process conforming to
requirements defined by the customer 〔s〕.
特别特色
The organization shall approve externally
provided products and services per ISO 9001
，
组织应采用多方论证方法来建立、形成文件并推行用于鉴别特别特色的过程，包括顾客确定的以及组织风险解析所确定的特别特色，应包括：
Section ，prior to submission of their part approval to the customer.
a) 将特别特色记录进产品和 / 或生产文件〔按
要求〕、相关风险解析〔比方过程
FMEA〕、
The organization shall obtain documented product
approval prior to shipment ， if required by the
customer . Records of such approval shall be retained.
控制方案和标准的工作 / 操作说明书；特别特色用特定的标志进行表记， 并且记录在创立的生产文件中， 也许关于这些特别特色要求的控制；
NOTEProduct approval should be subsequent to the verification of the manufacturing process.
b) 为产品和生产过程的特别特色开发控制和
监察策略；
c) 顾客规定的赞成，如有要求；
d) 依照料客规定的定义和符号或组织的等效
符号或标志， 如符号变换表所示。 如有要求，应向顾客提交符号变换表。
Design and development outputs
See ISO 9001:2021 requirements.
The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring
requirements, as appropriate, and acceptance criteria;
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d) specify the characteristics of the products and
services that are essential for their intended purpose and their safe and proper provision.
The organization
shall retain documented information
.
on
设计和开发控制
design and development outputs
见 ISO9001： 2021 的要求
组织对付设计和开发过程进行控制，以保证：
Design and development outputs supplemental
—
a) 规定拟获取的结果；
b) 推行评审活动，以议论设计和开发的结果满足要求的能力；
c) 推行考据活动，以保证设计和开输出满足输入的要求；
d) 推行确认活动，以保证产品和效劳能够满足规定的使用要求也许预期用途；
e) 针对评审、考据和确认过程中确定的问题采用必要措施；
f) 保存这些活动的成文信息。
The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include but is not limited to the following ，as applicable:
a〕design risk analysis b〕reliability study results
〔 FMEA〕；
；
；
c〕product special characteristics
d〕results of product design error-proofing, such as DFSS, DFMA, and FTA ；
注：设计和开发的评审、考据和确认拥有不同样的目
的。依照组织的产品和效劳的详细情况，可单独或
e〕product definition including 3D models, technical data packages, product
manufacturing information, and geometric dimensioning & tolerancing 〔GD&T〕；
以任意组合的方式进行。
f 〕2D drawings, product manufacturing information, and geometric dimensioning & tolerancing 〔GD&T〕；
g〕product design review results ；
and repair
h〕service diagnostic guidelines
and serviceability instructions ；
监察
i 〕service part requirements ；
产品和过程的设计和开发时期特定阶段的测量应被确定、解析，以汇总结果的形式来报告，作为对管理评审的输入〔见第条〕。
j 〕packaging and labeling requirements for shipping.
NOTE Interim design outputs should include any engineering problems being resolved through a trade-off process.
在顾客有要求时，应在顾客规定或赞成的阶段向顾
客报告对产品和过程开发活动的测量。
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Manufacturing process design output
注：在适合的情况下，这些测量可包括质量风险、本钱、前置期、重点路径和其他测量。
The organization shall document the
manufacturing process design output in a manner that enables verification against the
manufacturing process design inputs. The organization shall verify the outputs against manufacturing process design input requirements. The manufacturing process design output shall include but is not limited to the following:
设计和开发确认
a 〕specifications and drawings ；
应依照顾客要求，包括适用的行业和机构宣布的监控标准，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吻合。
b 〕special characteristics for product and manufacturing process ；
c 〕identification of process input variables
；
that impact characteristics
在与顾客有合同约定的情况下，设计和开发确认应包括议论组织的产品，包括嵌入式软件在最后顾客产品系统内的相互作用。
d 〕tooling and equipment for production and control ，including capability studies of
equipment and process 〔 es〕；
e 〕manufacturing process flow charts/layout ，
including linkage of product tooling ；
原型样件方案
，process ，and
f 〕capacity analysis ；
g 〕manufacturing process FMEA ； h 〕maintenance plans and instructions i j
〕control plan 〕
〔see Annex A 〕；
当顾客要求时，组织应拟定原型样件方案和控制方案。组织应尽可能地使用与正式生产同样的供给商、工装和制造过程。
；
应监察所有的性能试验活动的及时性完成和要求符号性。
standard work and work instructions ； ；
k 〕process approval acceptance criteria I
〕
data for quality
，reliability
；
当效劳被外包时，组织应将控制的种类和程度纳入其质量管理系统的范围，以保证外包效劳吻合要求〔见 ISO 9001 第条〕。
，
maintainability
m 〕results and verification
， and measurability of error-proofing ，as appropriate
identification ；
n 〕methods of rapid detection and correction
，feedback ，
process
of product/manufacturing
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nonconformities.
Design and development changes
产品赞成过程
See ISO 9001:2021 requirements.
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
组织应建立、推行并保持一个吻合顾客规定要求的产品和制造赞成过程。
The organization shall retain documented information on:
在向顾客提交其部件赞成以前， 组织应依照 ISO 9001 第条，对外面供给的产品和效劳进行审批。
如顾客要求，组织应在发运以前获取形成文件的产品赞成。此类赞成的记录应予以保存。
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
注：产品的赞成应当是制造过程考据的后续步骤。
Design and development changes - supplemental
The organization shall evaluate all design changes after initial product approval
，
including those proposed by the organization or its suppliers ，for potential impact on fit ，form ， function ，performance ，and/or durability. These changes shall
设计和开发输出
be validated against customer
见 ISO 9001:2021 要求。
requirements and approved internally
，prior to
production implementation.
组织应保证设计和开发输出：
a) 满足输入的要求；
b) 满足后续产品和效劳供给过程的需要；
c) 包括或引用监察和测量的要求，合合时，包括接收准那么；
d) 规定产品和效劳特色，这些特色关于预期目的、安全和正确供给是必要的。
If required by the customer
， the organization
shall obtain documented approval ，or a documented waiver ， from the customer prior to production implementation.
For products with embedded software ， the organization shall document the revision level
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组织应保存相关设计和开发输出的成文信息。
of software and hardware as part of the change record.
Control of externally provided processes ，
products and services General
设计和开发输出——补充
See ISO 9001:2021 requirements.
The organization
产品设计输出的表达方式应适合于比较产品设计输入要求进行考据和确认。产品设计输出应包括但不限于〔如适用〕 ：
shall ensure that externally provided
processes, products and services conform to requirements.
a〕 设计风险解析〔
FMEA〕；
The organization shall determine the controls to be
b〕 可靠性研究结果； c〕 产品特别特色；
d〕 产品设计防错结果，比方： DFSS、 DFMA和
FTA；
applied to externally provided processes, products
and services when:
a) products and services from external providers are
intended for incorporation into the organization ’s own products and services;
e〕 产品定义，包括三维模型、技术数据包、产
品制造信息， 以及几何尺寸与公差
〔 GD&T〕；
b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
f 〕 二维图纸、 产品制造信息以及几何尺寸与
公差〔 GD&T〕；
c) a process, or part of a process, is provided by an external provider as a result of a decision by the
g〕 产品设计评审结果；
h〕 效劳诊断指南及维修和可效劳性说明； i 〕 效劳件要求；
j 〕 运输的包装和标签要求。
organization.
The organization
shall determine and apply criteria for
the evaluation, selection, monitoring of performance, and re-evaluation
of external providers, based on their
ability to provide processes or products and services in accordance with requirements.
The organization shall
retain documented information of these activities and any necessary actions arising from the evaluations.
注：临时设计输出应当包括经过权衡过程正在解决 的过程问题。
.
General-supplemental
The organization shall include
all products
and such
services that affect customer requirements
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as sub- assembly ，sequencing ，sorting ， rework ， and calibration services in the scope of their
制造过程设计输出
definition of externally provided products ， processes ， and services.
组织对付制造过程设计输出形成文件，采用的方式应能够比较制造过程设计输入进行考据。组织应比较制造过程设计输入要求对输出进行考据。制造过程设计输出应包括但不限于：
Supplier selection process
The organization shall have a
documented supplier selection process. The selection process shall include:
a〕 标准和图纸；
b〕 产品和制造过程的特别特色；
a 〕an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their customers ；
b 〕relevant quality and delivery
c〕 对影响特色的过程输入变量的鉴别；
d〕 用于生产和控制的工装和设施， 包括设施和过程的
能力研究；
performance ；
品、过程和工装的联系；
e〕 制造过程流程图 / 制造过程平面部署图，包括产
c 〕an evaluation of the supplier's quality management system；
f 〕 产能解析；
d 〕multidisciplinary decision making ； and
g〕 制造过程 FMEA;
h〕 保护方案和说明；
e 〕an assessment of software development capabilities ， if applicable.
i 〕 控制方案〔见附录
A〕；
Other supplier selection criteria that should be considered include the following:
j 〕 标准作业和工作指导书；
k〕 过程赞成的接收准那么；
- volume of automotive business〔absolute and
〕；
as a percentage of total business
- financial stability
；
l 〕 质量、可靠性、可保护性和可测量性的数据；
m〕 适用时，防错鉴别和考据的结果；
- purchased product ，material ，or service complexity ；
n〕 产品 / 制造过程不吻合的快速探测、反响和纠
正的方法。
-
required technology 〔 product or process 〕；
- adequacy of available resources〔. ，people ， infrastructure 〕；
- design and development capabilities
〕；
〔including project management
- manufacturing capability
；
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- change management process -
；
business continuity planning 〔. ，disaster
〕；
preparedness ， contingency planning
- logistics process - customer service.
；
Customer-directed sources 〔 also known as
“Directed-Buy 〞〕
Whenspecified by the customer ，the organization
设计和开发改正
shall purchase products ，materials ，or services from customer-directed sources.
见 ISO 9001:2021 要求。
组织对付产品和效劳设计和开发时期以及后续所做的改正供给适合的鉴别、评审和控制，以保证这些改正对满足要求不会产生不利影响。
All requirements of Section
〔except the
requirements in IATF 16949 ，Section 〕are applicable to the organization's control of customer-directed sources unless specific agreements are otherwise defined by the contract between the organization and the customer.
组织应保存以下方面的成文信息：
b) 评审的结果；
c) 改正的授权；
d) 为防范不利影响而采用的措施。
a) 设计和开发改正
Type and extent of control
See ISO 9001:2021 requirements.
The organization
shall ensure that externally provided
processes, products and services do not adversely affect the organization
设计和开发改正——补充
’s ability to consistently
deliver conforming products and services to its customers.
组织应议论初始产品赞成此后的所有设计改正，包括组织或其供给商建议的改正，议论这些改正对可
The organization shall:
装置性、外形、功能、性能和 / 或长久性的影响。这些改正应比较顾顾客要求进行确认，并在生产推行
a) ensure that externally provided processes remain within the control of its quality management system;
以前获取内部赞成。
b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
如顾客有要求，组织应在生产推行以前，从顾客处 c) take into consideration:
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获取形成文件的赞成和弃权。
1) the potential impact of the externally provided
processes, products and services on the organization ’s ability to consistently meet
关于带有嵌入式软件的产品，组织对付软硬件的版
customer and applicable statutory and regulatory
本级别形成文件，作为改正记录的一局部。
requirements;
2) the effectiveness
of the controls
applied by the
external provider;
d) determine the verification, or other activities, necessary to ensure that the externally provided
processes, products and services meet requirements. .
Type and extent of control - supplemental
外面供给的过程、产品和效劳的控制
总那么
见 ISO 9001:2021 的要求。
The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify
conformity of externally provided products ，
processes ， and services to internal
（ organizational 〕and external customer requirements.
组织应保证外面供给的过程、产品和效劳吻合要求。
在以下情况下，组织应确定对外面供给的过程、产品和效劳推行的控制：
a) 外面供方的产品和效劳构成组织自己的产品和效劳的一局部；
b) 外面供方代表组织直接将产品和效劳供给给顾客；
c) 组织决定由外面供方供给过程或局部过程。
The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities
based on supplier performance and assessment of product ，material ，or service risks.
组织应基于外面供方依照要求供给过程、产品和服
Where characteristics or components “pass
through 〞 the organization ’s quality
management system without validation of
controls, the organization shall ensure that the
appropriate controls are in place at the point of manufacture.
务的能力，确定并推行外面供方的议论、选择、绩效监察以及再议论的准那么。关于这些活动和由议论
引起的任何必要的措施，组织应保存成文信息。
Statutory and regulatory requirements
The organization shall document their process to
ensure that purchased products ，processes ，and
services conform to the current applicable
statutory and regulatory requirements in the
country of receipt ， the country of shipment ，
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and the customer-identified country of destination ，if provided.
If the customer defines special controls for certain products with statutory and regulatory requirements ，the organization shall ensure they
are implemented and maintained as defined ， including at suppliers.
总那么——补充
Supplier quality management system development
The organization shall require their suppliers
of automotive products and services to develop ， implement ， and improve a quality management
system (QMS) with the ultimate objective of becoming certified to this Automotive QMS Standard.
组织应将影响顾客要求的所有产品和效劳，比方子总成、排序、优选、返工和校准效劳，纳入其对外面供给的产品、过程和效劳的定义范围。
供给商选择过程
组织应有一个形成文件的供给商选择过程。选择过程应包括：
Using a risk-based model, the organization shall define a minimum acceptable level of QMS
development and a target QMS development level for each supplier.
a〕 对所有供给商产品吻合性以及组织向其
顾客不中断产品供给的风险评估；
b〕 相应质量和交付需求；
c〕 对供给质量管理系统的议论； d〕 多方论证决策；以及
e〕 对软件开发能力的评估，如适用。
Unless otherwise authorized by the customer, a QMS certified to ISO9001 is the initial minimum acceptable level of deveiopment. Based on
current performance and the potential risk to the customer, the objective is to move suppliers through the following QMS development perogression:
应当考虑的其他供给商选择标准那么包括：
——汽车业务量〔绝对值，以及包括占总业务量的百分比〕；
——财务牢固性；
——采买的产品、资料和效劳的复杂性；
——所需技术〔产品和过程〕；
a 〕certification to ISO 9001 through third-party audits ； unless otherwise specified
by the customer ， suppliers to the organization shall demonstrate conformity to ISO 9001 by
maintaining a third- party certification issued
by a certification body bearing the
accreditation mark of a recognized lAF MLA （ International Accreditation Forum
Multilateral Recognition Arrangement 〕memberand where the accreditation body's main scope
includes management system certification to ISO/IEC 17021 ；
——可用资源〔如：人员、基础设施〕的充分性；
b 〕certification to ISO 9001 with compliance to other customer-defined QMSrequirements 〔 such
as Minimum Automotive Quality ManagementSystem
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——设计和开发能力〔包括工程管理〕； ——制造能力；
Requirements for Sub-Tier Suppliers [MAQMSR]or
equivalent 〕through second-party audits ；
——改正管理过程；
c 〕certification to IS09001 with compliance to IATF 16949 through second-party audits ；
——业务连续性规划〔如：防灾准备、应急方案〕；
——物流过程；
d 〕certification to IATF 16949 through third-party audits 〔 valid third-party
certification of the supplier to IATF 16949 by
an lATF-recognized certification body 〕.
——顾客效劳。
NOTE: The minimum acceptable level of QMS
development maybe compliance to ISO 9001 through second-party audits, if authorized by the
customer.
.1 Automotive product-related software or automotive products with embedded software
The organization shall require their suppliers
of automotive product-related software ， or
automotive products with embedded software ，to
implement and maintain a process for software quality assurance for their products.
顾客指定的货源〔亦称“指向性购置〞〕
A software development assessment
methodology shall be utilized to assess the
supplier's software development process. Using prioritization based on risk and potential
impact to the customer ，the organization shall require the supplier to retain documented
information of a software development capability self-assessment.
顾客指准时，组织应从顾客指定的货源处采买产品、资料和效劳。
Supplier monitoring
第条的所有要求〔除了 IATF16949 第条中的要求〕适用于组织对顾客指定货源的控制，除非组织与顾
客之间的合同还有特别约定。
The organization shall have a documented process
and criteria to evaluate supplier performance in
order to ensure conformity of externally
provided products ，processes ，and services to internal and external customer requirements.
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At a minimum，the following supplier performance indicators shall be monitored:
a〕delivered product conformity to requirements ；
控制的种类和程度
b〕customer disruptions at the receiving plant ，including yard holds and stop ships
；
见 ISO 9001:2021 要求。
c〕delivery schedule performance ；
组织应保证外面供给的过程、产品和效劳不会对组织牢固地向顾客交付合格的产品和效劳的能力产生不利影响。
d〕number of occurrences of premium freight.
组织应：
If provided by the customer ， the organization
a) 保证外面供给的过程保持在其质量管理系统的控制之中；
b) 确定对外面供方的控制及其输出结果的控制；
c) 考虑：
1) 外面供给的过程、产品和效劳对组织牢固地满足顾客要求和适用的法律法规要求的能力的潜藏影响；
2) 外面供方推行控制的有效性。
d) 确定必要的考据或其他活动，以保证外面供给的过程、产品和效劳满足要求。
shall also include the following ，as appropriate ， in their supplier performance monitoring:
e〕special status customer notifications
；
related to quality or delivery issues
f 〕dealer returns ， warranty ，field actions ， and recalls.
.1 Second-party audits
The organization shall include a second-party
audit process in their supplier management
approach. Second-party audits maybe used for the
following:
控制的种类和程度 ---- 补充
a) supplier risk assessment; b) supplier monitoring; c) supplier QMS development; d) product audits; e) process audits.
组织应有一个形成文件的过程，以鉴别外包过程并选择控制的种类和程度，用于考据外面供给的产品、过程和效劳对内部〔组织的〕要求和外面顾客要求的吻合性。
Based on a risk analysis, including product
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safety/regulatory requirements, performance of
the supplier, and QMS certification level
，at a
该过程应包括依照供给商绩效和产品、资料和效劳风险评估，增加或减少控制种类和程度以及开发活动的准那么和措施。
minimum，the organization shall document the
criteria for determining the need ，type ，
frequency ， and scope of second-party audits.
当特色或部件未经考据也许控制在组织的质量管理系统“传达〞时，组织应保证其在制造过程中适合地址的适合控制。
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 managementsystem， then the approach shall be consistent with the automotive process approach.
NOTE Guidance may be found in the IATF
法律法规要求
Auditor Guide and ISO 19011.
组织应有形成文件的过程，保证所采买的产品、过程和效劳吻合收货国、发运国和顾客确定的目的国〔如有供给〕的现行适用法律法规要求。
Supplier development
The organization shall determine the priority
，
若是顾客为特定产品吻合法律法规要求确定了特别控制，组织应保证依照规定推行并保持这些控制，包括在供给商处。
type ，extent ， and timing of required supplier development actions for its active suppliers. Determination inputs shall include but are not limited to the following:
a〕performance issues identified through supplier monitoring 〔see Section 〕；
供给商质量管理系统开发
b〕second-party audit findings Section .1 〕；
〔see
组织应要求其汽车产品和效劳供给商开发、推行并改良质量管理系统 (QMS)，最后目标是经过本汽车QMS标准的认证。
c〕third-party quality management system certification status ；
d〕risk analysis.
采用基于风险的方式，组织应为每个供给约定义质
量管理系统开发的最低可接受水平和目标质量管理
系统的开发水平。
The organization shall implement actions necessary to resolve open 〔unsatisfactory 〕
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获取顾客授权，质量管理系统初始最低要求是经过 第三方认证的 ISO9001。基于当前的绩效以及对顾客的潜藏风险，目标是推动供给商经过以下的开发进展：
performance issues and pursue opportunities for continual improvement.
a〕 经由第三方审察经过
ISO 9001 认证，除非
Information for external providers
顾客还有规定， 组织的供给商应经过保持认 证机构出具的第三方认证证明来证明对 9001 的吻合性，证明上应有被成认的 MLA〔国际认可论坛多边相互成认协议〕成 员的认可标志，其中，认可机构的主要范围 包括 ISO /IEC 17021 b〕 经由第二方审察经过
管理系统认证；
See ISO 9001:2021 requirements.
The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
ISO IAF
The organization shall communicate to external providers its requirements for:
ISO 9001 认证，同时
吻合其他顾客确定的质量管理系统要求 如：次级供给商最低汽车质量管理系统要求 [MAQMSR]或等效要求〕；
〔例 a) the processes,
products and services to be provided;
c〕 经过 ISO 9001 认证，同时经由第二方审察
吻合 IATF 16949 ； d〕 经由第三方审察经过
IATF 16949 认证〔 IATF
IATF
b) the approval of:
1) products and services;
2) methods, processes and equipment
3) the release of products and services;
认可的认证机构进行的有效的供给商
16949 第三方认证〕。
c) competence, including
any required qualification of
persons;
d) the external providers
’ interactions with the
注： 若是由顾客赞成，质量管理系统开发的最低可 接受水平能够是经由第二份审察吻合
ISO9001.
organization;
e) control and 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 at the
external providers
’ premises.
Information for external providers supplemental
.1 汽车产品相关软件或带有嵌入式软件的汽 车产品
–
The organization shall pass down all applicable
statutory and regulatory requirements and
组织应要求其汽车产品相关软件或带有嵌入式软件
special product and process characteristics to their suppliers and require the suppliers to
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的汽车产品的供给商为各自产品推行并保持一个软件质量保证过程。
cascade all applicable requirements down the supply chain to the point of manufacture.
应采用软件开发评估方法来评估供给商软件开发过程。组织应依照风险和对顾客潜藏影响的优先级，要求供给商为软件开发能力自评估保存形成文件的信息。
Production and service provision
Control of production and service provision
See ISO 9001:2021 requirements.
shall implement production
and service
The organization
provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that
供给商监察
defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2) the results to be achieved;
use of suitable monitoring and
组织应为供给商绩效议论拟定形成文件的过程和准那么，以便保证外面供给的产品、过程和效劳吻合内部要求和外面顾客要求。
b) the availability and measuring resources;
最少应监察以下供给商绩效指标：
c) the implementation of monitoring and measurement
a〕 已交付产品对要求的吻合性；
b〕 在收货工厂对顾客造成的搅乱， 包括整车候检
和停止出货；
activities at appropriate stages to verify that
criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
c〕 交付排程的绩效； d〕 超额运费发生次数；
d) the use of suitable infrastructure and environment
for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the
如顾客有所规定，组织还应视情况在供给商绩效监控中包括：
ability
to achieve planned results of the processes for
production and service provision, where the resulting output cannot be verified by subsequent monitoring or
e〕 与质量或交付相关的特别状态顾客通知； f 〕 经销商退货、保修、使用现场措施和召回。
measurement;
g) the implementation
of actions to prevent human error;
h) the implementation of release, delivery and
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post-delivery activities.
.
NOTESuitable infrastructure includes
appropriate manufacturing equipment required to ensure product compliance. Monitoring and measuring resources include appropriate monitoring and measuring equipment required to ensure effective control of manufacturing processes.
.1 第二方审察
组织的供给商管理方法中包括一个第二方审察过程。第二方审察能够用于：
Control plan
a〕 供给商风险评估； b〕 供给商监察；
c〕 供给商质量管理系统开发； d〕 产品审察； e〕 过程审察。
The organization shall develop control plans 〔in
， accordance with Annex A 〕 at the system
subsystem， component，and/or material level for the relevant manufacturing site and all product supplied ，including those for processes
producing bulk materials as well as parts. Family
control plans are acceptable for bulk material and similar parts using a common manufacturing process.
基于风险解析，包括产品安全 / 法规要求、供给商绩效和质量管理系统认证水平，组织应最少对第二方
The organization shall have a control plan for
pre-launch and production that shows linkage and
审察的需求、种类、频次和范围确实定准那么形成文件。
incorporates information from the design risk
analysis 〔if provided by the customer 〕， process
flow diagram ， and manufacturing process risk
analysis outputs
〔such as FMEA〕.
组织应保存第二方审察报告的记录；
The organization shall ，if required by the customer ，provide measurement and conformity data collected during execution of either the pre-launch or production control plans. The
若是第二方审察的范围是评估供给商的质量管理系统，那么方法应与汽车过程方法吻合。
organization shall include in
the control plan:
a〕controls used for the manufacturing process
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注：可从 IATF 审察员指南和
ISO 19011 获取指导。
control ，including verification
b〕first-off/last-off part validation applicable ；
of job set-ups ；
，as
c〕methods for monitoring of control
over special
characteristics
exercised
〔see Annex A〕
defined by both the customer and the organization ；
d〕the customer-required information ，if any； e〕specified reaction plan〔see Annex A〕；when
nonconforming product is detected process becomes statistically not statistically capable.
，the
unstable or
供给商开发
组织应为其爽朗供给商确定所需供给商开刊行动的优先级、种类、程度和时程安排。用于确定的输入应包括但不限于：
a〕 经过供给商监察〔见第
条〕识其他绩效问
The organization shall review control plans
，
题；
and update as required ，for any of the following:
b〕 第二方审察发现〔见第 .1 条〕； c〕 第三方质量管理系统认证状态； d〕 风险解析。
f 〕the organization determines it has shipped
；
product ，
nonconforming product to the customer
g〕when any change occurs affecting
manufacturing process ， measurement， logistics ， supply sources ，production volume changes ，or risk analysis 〔 see Annex A 〕；
h〕after a customer complaint and implementation of the associated corrective action ，when applicable ；
〔 FMEA〕
组织应采用必要措施，以解决未决的〔不吻合要求 的〕绩效问题并追求连续改良的机会。
i 〕at a set frequency based on a risk analysis.
If required by the customer
， the organization
shall obtain customer approval after review or revision of the control plan.
供给给外面供方的信息 Standardised work -- operator instructions
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见 ISO 9001 ： 2021 的要求。
and visual standards
组织应保证在与外面供方沟通以前所确定的要求是
充分和适合的。
The organization shall ensure that standardised work documents are:
组织应与外面供方沟通以下要求：
a) 需供给的过程、产品和效劳；
b) 对以下内容的
1) 产品和效劳；
2) 方法、过程和设施；
3) 产品和效劳的放行；
c) 能力，包括所要求的人员资格；
d) 外面供方与组织之间的接口；
e) 组织使用的对外面供方绩效的控制和监察；
f) 组织或其顾客拟在外面供方现场推行的考据或确认活动。
a〕communicated to and understood by the employees who are responsible for performing the work；
b〕legible ；
c〕presented in the language(s
〕 understood
by the personnel responsible to follow them
d〕accessible for use at the designated work area(s 〕 .
；
The standardised work documents shall also include rules for operator safety.
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 a new set-up ；
外面供方的信息 ---- 补充
组织应向其供给商传达所有适用的法律法规要求以及产品和过程特别特色，并要求供给商沿着供给链直至制造，贯彻所有适用的要求。
b〕maintain documented information for set-up personnel ；
c〕use statistical methods of verification ，
where applicable ；
d〕perform first-off/last-off part
validation ，as applicable ； where appropriate ，first-off parts should be
retained for comparison with the last-off
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parts ； where appropriate ，last-off-parts should be retained for comparison with
first-off parts in subsequent runs ；
生产效劳供给
生产和效劳供给的控制
e〕retain records of process and product
approval following set-up and first-off/last-off part validations.
见 ISO 9001 ： 2021 的要求。
组织应在受控条件下进行生产和效劳的供给。
Verification after shutdown
适用时，受控条件包括：
a) 可获取成文信息，以规定以下内容：
1) 拟生产的产品、供给的效劳或进行的活动的特
征
2) 拟获取的结果；
The organization shall define
necessary
actions
to
and implement the
ensure
product
compliance with requirements after a planned or unplanned production shutdown period.
b) 可获取和使用适合的监察和测量资源；
c) 在适合阶段推行监察和测量活动，以考据可否吻合过程或输出的控制准那么以及产品和效劳的接收准那么；
d) 为过程的运行供给适合的基础设施，并保持适合的环境；
e) 装备胜任的人员，包括所要求的资格；
f) 假设输出的结果不能够由后续的监察或测量加以考据，对付生产和效劳供给过程实现筹办结果的能力进行确认，并如期再确认；
g) 采用措施防范人为错误；
h) 推行放行、交付和交付后活动。
Total productive maintenance
The organization shall develop
，implement ，and
maintain a documented total productive maintenance system.
At a minimum ， the system shall include the following:
a〕identification of process equipment necessary to produce conforming product at the required volume ；
b〕availability of replacement parts for the
equipment identified in item a 〕；
注：适合的基础设施包括保证产品吻合性所需的适 当制造设施。监察和测量资源包括保证制造过程有
c〕provision of resource for machine
；
，
equipment ， and facility maintenance
效控制所需的适合监察和测量设施。
d〕packaging and preservation of equipment ，
tooling ，and gauging ；
e〕applicable customer-specific requirements ；
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e〕 规定的反响方案〔见附录 A〕；当检测到不
控制方案
组织应针对相关制造现场和所有供给的产品，在系
统、子系统、部件和 / 或资料各层次上〔依照附录 A〕拟定控制方案，包括那些生产散装资料和部件的过
程。采用共同制造过程的散装资料和相似部件可接受使用控制方案族。
组织应拟定投产前控制方案和量产控制方案，显示设计风险解析〔若是顾客供给了〕、过程流程图和
制造过程风险解析输出〔比方 FMEA〕的联系，并在方案中包括从这些方面获取的信息。
如顾客要求，组织应供给在投产前或量产控制方案履行时期收集的测量和吻合性数据。组织应在控制方案中包括以下内容：
a〕 用于制造过程的控制手段， 包括作业准备考
据；
b〕 首件 / 末件确认，如适用；
c〕 用于顾客和组织确定的特别特色 〔见附录 A〕控
制的监察方法；
d〕 顾客要求的信息，如有；
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f 〕documented maintenance objectives ，d〕tool-change programmes for perishable for tools ；
example:OEE〔Overall Equipment
e〕tool design modification documentation ，
Effectiveness 〕， including engineering change level of the
MTBF〔MeanTime Between Failure 〕，and MTTR〔 Mean
Time To Repair 〕， and Preventive Maintenance
compliance metrics. Performance to the
maintenance objectives shall form an input
management review 〔see ISO 9001 ，Section
into
〕；
g〕regular review of maintenance plan and objectives and a documented action plan to address corrective
not achieved ；
actions where objectives are
h〕use of preventive maintenance methods ； ，
i 〕use of predictive maintenance methods as applicable ；
j 〕 periodic overhaul.
Management of production tooling and manufacturing, test,inspection tooling and equipment
The organization shall provide resources for
tool and gauge design ， fabrication ，and verification 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 repair facilities and personnel ；
b〕storage and recovery
；
c〕set-up ；
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合格品时， 过程变得不牢固或统计能力缺乏时。
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 ， manufacturing equipment ， and test/inspection
equipment are permanently marked in a visible location so that the
ownership and application of each item can be determined.
The organization shall implement a system to monitor these activities if any work is outsourced.
Production scheduling
组织应针对以下任一情况对控制方案进行评审，并在需要时更新：
The organization shall ensure that production is
scheduled in order to meet customer
orders/demands such as Just-In-Time 〔JIT 〕 and is supported by an information system that
permits access to production information at key
stages of the process and is order driven.
f 〕 当组织确定其已经向顾客发运了不合格品； g〕 当发生任何影响产品、制造过程、测量、物
流、供给货源、生产量或风险解析〔 FMEA〕的改正〔见附录 A〕；
The organization shall include relevant planning information during production scheduling ，. ，
customer orders ， supplier on-time delivery
performance ，capacity ，shared loading〔 multi-part station 〕，lead time ，inventory level ，preventive maintenance ，and calibration.
h〕 在收到顾客投诉并推行了相关纠正措施
此后，当适用时；
Identification and traceability
i 〕 以基于风险解析的设定频次。
See ISO 9001:2021 requirements.
The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
The organization shall identify the status of outputs
with respect to monitoring and measurement requirements throughout production and service provision.
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如顾客要求，组织应在控制方案评审和校正后获取
The organization shall control the unique
identification of the outputs when traceability is a requirement, and shall retain the documented
顾客赞成。
information necessary to enable traceability.
标准化作业 ---- 操作指导书和目视标准
NOTE Inspection and test status is not indicated by the location of product in the
production flow unless inherently obvious ， such as material in an automated production transfer process. Alternatives are permitted if the
status is clearly identified ，documented，and achieves the designated purpose.
组织应保证标准化作业文件：
Identification and
traceability — supplemental
a〕 被传达给负责相关工作的员工， 并被员工理解；
b〕 是清楚易读的；
c〕 拥有责任遵守这些文件的人员能够理解
的语言表述；
d〕 在指定的工作地区易于获取。
The purpose of traceability is to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related
，the organization nonconformities. Therefore
shall implement identification and traceability processes as described below.
标准化作业文件还应包括操作员安全规那么。
The organization shall conduct an analysis of internal ，customer ，and regulatory traceability requirements for all automotive products ， including developing and documenting traceability plans ，based on the levels of risk or failure severity for employees ，customers ，
and consumers.
These plans shall define the
appropriate traceability systems ， processes ， and methods by product ，process ，and manufacturing location that:
a〕enable the organization to identify nonconforming and/or suspect product
；
b〕enable the organization to segregate nonconforming and/or suspect product ；
c〕ensure the ability to meet the customer
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作业准备的考据
and/or regulatory response time requirements
；
组织应：
a〕 当履行作业准备时进行作业准备考据，
比方：需要新作业准备的一项工作的首次运行、资料的更换或工作的改正；
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 regulatory standards ； f 〕ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics.
b〕 保拥相关准备人员的形成文件的信息； c〕 适用时采用统计的考据方法；
d〕 进行首件 / 末件确认，如适用：合合时，应
当保存首件用于与末件比较；
合合时， 应当
保存末件用于与后续运行中的首件比较；
e〕 保存作业准备和首件 / 末件确认此后过程和
产品赞成的记录。
Property belonging to customers or external providers
See ISO 9001:2021 requirements.
The organization shall exercise care with property belonging to customers or external providers while it
is under t he organization ’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard customers ’ or external provided for use or incorporation services.
providers ’ property into
the products and
Whenthe property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization or external
provider
shall report and retain
this to the customer
documented information
on what has occurred.
NOTE A customer’s or external provider ’s property can
include material, components, tools and equipment,
停工后的考据
premises, intellectual property and personal data.
组织应确定并采用必要的措施，保证在方案或非方案生产停工期今后，产品对要求的吻合性。
Preservation
See ISO 9001:2021 requirements.
The organization shall preserve the outputs during
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全面生产保护
production and service provision, to the extent
necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling,
组织应拟定、推行并保持一个形成文件的全面生产保护系统。
contamination control, packaging, storage, transmission
or transportation, and protection
该系统应最少包括：
a〕 对依照要求产量生产合格产品所必要的
过程设施的鉴别；
Preservation – supplemental
b〕 a〕项中被鉴别设施的取代件的可用性； c〕 机器、设施和设施保护的资源供给； d〕 设施、工装和量具的包装和防范； e〕 适用的顾客特定要求；
f 〕 形成庄重的保护目标，比方：
OEE〔全局设
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
providers from receipt through processing ，
备效率〕、MTBF〔平均故障间隔时间〕 和 MTTR including shipment and until delivery to/acceptance
by the customer.
〔平均维修时间〕，以及预防性保护吻合性
指标。保护目标的绩效应作为管理评审的输入〔见 ISO 9001 第条〕；
g〕 保护方案和目标以及形成文件的措施方案
的如期评审， 以在未到达目标时采用纠正措
施；
In order to detect deterioration ， the
organization shall assess at appropriate planned
intervals the condition of product in stock ，
the place/type of storage container ， and the
storage environment.
h〕 对预防性保护方法的使用；
i 〕 对展望性保护方法的使用，如适用； j 〕 周期性检修。
The organization shall use an inventory
management system to optimize inventory turns over time and ensure stock rotation ， such as
“first-in-first-out〞〔 FIFO〕.
The organization shall ensure that obsolete
product is controlled in a manner similar to that of nonconforming product.
Organizations shall comply with preservation
packaging ， shipping ，and labeling requirements as provided by their customers.
，
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Post-delivery activities
See ISO 9001:2021 requirements.
The organization shall meet requirements for post-delivery activities associated with the products and
生产工装及制造、试验、检验工装和设施的管
services.
理
In determining the extent of post-delivery activities that are required, the organization shall consider:
组织应针对生产和效劳资料和散装资料〔如适用〕，为工具、量具的设计、制造和考据活动供给资源。
a) statutory and regulatory requirements;
组织应建立并推行生产工装管理系统，无论归组织或顾客所有，其中包括：
b) the potential
undesired consequences associated with
its products and services;
a〕 保护、维修设施与人员； b〕 储藏与修复； c〕 工装准备；
d〕 易损工具的工具更换方案；
e〕 工具设计改正的文件， 包括产品的工程改正
等级；
c) the nature,
use and intended lifetime of its products
and services;
d) customer requirements;
e) customer feedback.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as
f 〕 工具的改正和文件的校正；
g〕 工具表记， 比方：序列号或财产编号； 状态，
如生产、维修或荒弃；所有权；以及地址。
recycling or final disposal.
.
组织应试证顾客拥有的工具、制造设施和试验
/ 检验
设施是在明显的地址永久标志的，以便能够确定工
1 Feedback of information from service
具或设施的所有权和用途。
若是任何工作被外包，组织应推行监察这些活动的系统。
The organization shall ensure that a process for
communication of information on service concerns to manufacturing ，materia! handling ，logistics ， engineering ，and design activities is established ，implemented ， and maintained.
NOTE 1 The intent of the addition of “ service concerns 〞to this sub-clause is to ensure that the organization is aware of nonconforming product(s 〕 and material(s 〕 that may be identified at the customer location or in the field.
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生产排程
NOTE 2 “Service concerns 〞 should include the
results of field failure test analysis 〔 see Section 〕 where applicable.
组织应保证为满足顾客订单 / 需求来安排生产，比方准时生产〔 JIT 〕，并且保证生产由一个信息系统支持，该系统赞成在过程的重点阶段获取生产信息，并且是由订单驱动的。
Service agreement with customer
When there is a service agreement with the customer ，the organization shall:
组织应在生产排程时期包括相关筹办信息，如：顾
a〕verify that the relevant service centres comply with applicable requirements ；
客订单、 供给商准时交付绩效、 产能、 共享载荷 〔共线工位〕、前置期、库存水平、预防性保护及校准。
b〕verify the effectiveness of any special purpose tools or measurement equipment ； c〕ensure that all service personnel are trained in applicable requirements.
Control of changes
表记和可追想性
See ISO 9001:2021 requirements.
The organization shall review and control changes
见 ISO 9001 ： 2021 的要求。
for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
需要时，组织应采用适合的方法鉴别输出，以保证产品和效劳合格。
组织应在生产和效劳供给的整个过程中依照监察和测量要求鉴别输出状态。
The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary
当有可溯要求时，组织应控制输出的唯一性表记，并应保存所需的成文信息以实现可追想。
actions arising from the review.
.
Control of changes – supplemental
注：检验和试验状态下其实不能够以产品在生产流程中所处的地址来说明，除非产品自己状态明显〔如在自动化生产传达过程中的物料〕。若是该状态已清楚地表记、文件化且到达了指定的目的，赞成采用其他方法来表记。
The organization shall have a documented process to 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 be assessed.
表记和可追想性 ---- 补充
The organization shall:
可追想性的目的在于支持对顾客所收产品的开始点
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和停止点的清楚鉴别，也许用于发生质量和
/ 或安全
相关不吻合的情况。因此，组织应依照下文描述推行表记和可追想过程。
a〕define verification and validation
activities to ensure compliance with customer requirements ；
b〕validate changes before implementation
；
组织对付所有汽车产品的内部、顾客及法规可追想性要求进行解析，包括依照风险等级或无效对员工、顾客的严重程度，拟定可追想性方案并形成文件。这些方案应按产品、过程和制造地址明确适合的可追想系统、过程和方法，应：
c〕document the evidence of related risk analysis ；
d〕retain records of verification and validation.
a〕 使组织能够鉴别不合格品和 b〕 使组织能够隔断不合格品和 c〕 保证组织能够满足顾客要求和
/ 或可疑产品； / 或可疑产品；
/ 或法规对响
应时间的要求；
Changes，including those made at suppliers ，
should require a production trial run for
verification of changes〔such as changes to part
design ，manufacturing location ，or manufacturing
process 〕 to validate the impact of any changes
on the manufacturing process.
d〕 保证保存了成文信息，保存的形式〔电子、
硬拷贝、档案〕使组织能够满足响应时间要求；
Whenrequired by the customer ，the organization shall:
e〕 保证各单个产品的序列化表记， 如顾客或看守
标准有所规定；
a〕notify the customer of any planned product
realization changes after the most recent product approval ；
f 〕 保证表记和可追想性要求被扩展应用至外面供给的拥有安全 / 看守特色的产品。
b〕obtain documented approval ， prior to implementation of the change ；
c〕complete additional verification or
identification requirements ， such as production trial run and new product validation.
.1 Temporary change of process controls
The organization shall identify ，document，and
maintain a list of the process controls ，
including inspection ，measuring ，test ，and
error-proofing devices ，that includes the
primary process control and the approved back-up or alternate methods.
The organization shall document the process that managesthe use of alternate control methods. The organization shall include in this process ，based on risk analysis 〔such as FMEA〕，severity ，and the internal approvals to be obtained prior to production implementation of the alternate
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control method.
顾客或外面供方财产
见 ISO 9001 ： 2021 的要求。
Before shipping product that was inspected or
tested using the 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 process control methods that are referenced in the control plan.
组织应保护在组织控制下或组织使用的顾客或外面供方的财产。
对组织使用的或构成产品和效劳一局部的顾客和外面供方财产，组织应予以鉴别、考据、保护和防范。
假设顾客或外面供方财产丧失、损坏或发现不适用情况，组织应向顾客或外面供方报告，并保存所发生情况的成文信息。
Standard work instructions shall be available for each alternate process control method. The organization shall review the operation of alternate process controls on a daily basis at a minimum ， to verify implementation of standard work with the goal to return to the
standard process as defined by the control plan as soon as possible. Example methods include are not limited to the following:
，
but
注：顾客或外面供方的财产可能包括资料、零部件、工具和设施、顾客的场所、知识产权和个人资料。
a〕daily quality focused audits process audits ，as applicable
b〕daily leadership meetings.
〔., layered
〕；
Restart verification is documented for a defined period based on severity and confirmation that
all features of the error-proofing device or process are effectively reinstated.
防范
The organization shall implement traceability of all product produced while any alternate process control devices or processes are being used 〔. ， verification and retention of first piece and
last piece from every shift 〕 .
见 ISO 9001 ： 2021 的要求。
Release of products and services
组织应在生产和效劳供给时期对输出进行必要的防范，以保证吻合要求。
See ISO 9001:2021 requirements.
The organization shall implement planned arrangements,
注：防范可包括表记、办理、污染控制、包装、储藏、传输或运输以及保护。
at appropriate stages, to verify that the product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have
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been satisfactorily completed, unless otherwise
防范- 补充
approved by a relevant authority and, as applicable by the customer.
防范应保持表记、搬运、污染控制、包装、储藏、输送或运输以及保护。
The organization
shall retain documented information on
the release of products and services. The documented information shall include:
对付来自外面和 / 或内部供方的资料和部件，在从收货到办理的时期供给防范，包括发运并直到交付给顾客 / 被顾客查收。
a) evidence of conformity
with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
Release of products and services --- supplemental
组织应按适合方案的时间间隔来评估库存品情况、储藏容器放置 / 种类以及储藏环境，以便及时探测变质情况。
The organization shall ensure that the planned arrangements to verify that the product and
service requirements have been met encompassthe control plan and are documented as specified in
the control plan 〔see Annex A 〕.
组织应使用库存管理系统以优化库存的周转期，保证库存周转，如“先进先出〔 FIFO〕〞。
The organization shall ensure that the planned arrangements for initial release of products and services encompass product or service approval.
组织应保证过期产品按对待不合格品的近似方法进行控制。
The organization shall ensure that product or service approval is accomplished after changes
release ，according to ISO 9001， following initial
Section Layout inspection and functional testing
组织应满足顾客规定的防范、包装、发运和标签要求。
A layout inspection and a functional
verification to applicable customer engineering material and performance standards shall be
performed for each product as specified in the control plans. Results shall be available for customer review.
NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the design record(s 〕.
交付后的活动
NOTE 2 The frequency of layout inspection is
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见 ISO 9001:2021 的要求。
determined by the customer.
组织应满足与产品和效劳相关的交付后活动的要求。
Appearance items
在确定所要求的交付后活动的覆盖范围和程度时，组织应试虑：
For organizations manufacturing parts
法律法规要求；
与产品和效劳相关的潜藏不良的结果； 产品和效劳的性质、使用和预期寿命； 顾客要求； 顾客反响。
a) b) c) d) e)
designated by the customer as “appearance items 〞， the organization shall provide the following:
a〕appropriate resources ，including lighting ， for evaluation ；
注：交付后活动可包括保证条款所规定的措施、合同义务〔如保护效劳等〕、附加效劳〔如回收也许最后办理等〕。
b〕masters for colour ，grain ，gloss ，metallic
brilliance ，texture ，distinctness of image 〔 DOI〕， and haptic technology ， as appropriate ；
c〕maintenance and control of appearance masters and evaluation equipment ；
d〕verification that personnel making
appearance evaluations are competent and qualified to do so.
效劳信息的反响
Verification and acceptance of conformity of externally provided products and services
组织应保证建立、推行并保持一个在制造、资料搬运、物流、工程和设计活动之间沟通效劳问题信息的过程。
The organization shall have a process to ensure
the quality of externally provided processes ，
products ，and services utilizing one or more of
the following methods:
注 1：将“效劳问题〞增加到这个子条款， 是为了保证组织认识可能在顾客地址或使用现场被识其他不
合格品和资料。
a〕receipt and evaluation of statistical provided by the supplier to the organization data
；
注 2：“效劳问题〞应当在适用时包括使用现场无效试验解析〔见第条〕的结果。
b〕receiving inspection 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 acceptable delivered product conformance to requirements ；
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与顾客的效劳协议
d〕part evaluation by a designated laboratory ； e〕another method agreed with the customer.
当与顾客达见效劳协议时，组织应：
a〕 考据相关效劳中心满足适用要求； b〕 考据任何特别用途的工具或测量设施的
有效性；
Statutory and regulatory conformity
c〕 保证所有效劳人员获取了对适用要求的
培训。
改正的控制
Prior to release of externally provided products into its production flow ， the organization shall confirm and be able to provide evidence that
，products ，and externally provided processes
services conform to the latest applicable
statutory ，regulatory ，and other requirements in the countries where they are manufactured and in the customer-identified countries of destination ，if provided.
见 ISO 9001:2021 的要求。
组织对付生产或效劳供给的改正进行必要的评审和控制，以保证连续地吻合要求。
Acceptance criteria
Acceptance criteria shall be defined by the
organization and，where appropriate or required ，
approved by the customer. For attribute data sampling ，the acceptance level shall be zero defects 〔see Section 〕.
组织应保存成文信息，包括相关改正评审结果、授权进行改正的人员以及依照评审所采用的必要措施。
改正的控制 ---- 补充
组织应有一个形成文件的过程，对影响产品实现的改正进行控制和反响。任何改正的影响，包括由组织、顾客或任何供给商所引起的改正，都应进行评估。
Control of nonconforming outputs ISO 9001:2021 requirements.
shall take appropriate
action based on
The organization
the nature of the nonconformity and its effect on the conformity of products and services. This shall also
组织应：
apply to nonconforming products and services detected
a〕 明确考据和确认活动， 以保证与顾客要求相
一致；
after delivery of products, during or after the provision of services.
b〕 在推行前对改正予以确认；
c〕 对相关风险解析的凭据形成文件； d〕 保存考据和确认的记录。
The organization
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 and services;
应当对改正〔比方：对部件设计、制造地址或制造
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过程的改正〕，包括供给商作出的改正，进行以考据为目的的试生产，以便确认改正对制造过程带来的影响。
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
当顾客要求时，组织应：
a〕 向顾客通知近来一次产品赞成此后任何
方案产品实现的改正；
Customer authorization for concession
b〕 在推行改正以前获取形成文件的赞成； c〕 完成额外考据或表记要求，比方：试生产
和新产品确认。
The organization shall obtain a customer
concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.
The organization shall obtain customer authorization prior to further processing for
“use as is 〞 and repair 〔see 〕 of nonconforming product. If sub-components are reused in the manufacturing process ，that sub-component reuse
shall be clearly communicated to the customer in the concession or deviation permit.
.1 过程控制的临时改正
组织应鉴别过程控制手段，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，清单包括主要过程控制和经赞成的备用或取代方法。
The organization shall maintain a record of the expiration date or quantity authorized under concession. The organization shall also ensure compliance with the original or superseding
specifications and requirements when the authorization expires. Material shipped under concession shall be properly identified on each shipping container 〔 this applies equally to purchased product 〕. The
organization shall approve any requests from suppliers before submission to the customer.
组织应有一个形成文件的过程，对取代控制方法的
Control of nonconforming product-使用进行管理。组织应基于风险解析〔比方 FMEA 〕和严
customer-specified process
重程度，在本过程中包括要在生产中推行取代控制方法以前获取的内部赞成。
The organization shall comply with applicable customer-specified controls for nonconforming product 〔s〕.
在发运采用取代方法检验或试验的产品以前，如有要求，组织应获取顾客赞成。组织应保持一份控制方案中提及的经赞成取代过程控制方法的清单并如期评审。
Control of suspect product
The organization shall ensure that product
unidentified or suspect status is classified and controlled as nonconforming product. The
with
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organization shall ensure that all
appropriate manufacturing personnel
receive training for containment of suspect and nonconforming product.
每个取代过程控制方法应有标准的工作指导书。组织应最少每日评审取代过程控制手段的运行，以考据标准作业的推行，旨在尽早返回到控制方案规定的标准过程。方法模范包括但不限于：
Control of reworked product
a〕 以质量为关注的每日审察〔如：分层过程
审察，如适用〕；
b〕 每日领导会议
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. If required by the customer ，the organization shall obtain approval from the customer prior to commencing rework of the product.
基于严重程度，并在确认防错装置或过程的所有特色得以有效恢复的基础上，在规准时期内对重新启动考据形成文件。
The organization shall have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications.
， Instructions for disassembly or rework
including re-inspection and traceability
requirements ，shall be accessible to and utilized by the appropriate personnel.
在使用取代过程控制装置或过程时期，组织应实现生产的所有产品的可追想性〔如：考据并保存每个班次的首件和末件〕 。
The organization shall retain documented information on the disposition of reworked
product including quantity ，disposition ， disposition date ，and applicable traceability information.
Control of repaired product
产品和效劳的放行
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. The organization shall obtain
approval from the customer before commencing repair of the product.
见 ISO 9001:2021 的要求。
组织应在适合阶段推行筹办的安排，以考据产品和效劳的要求已获取满足。
The organization shall have a documented process for repair confirmation in accordance with the control plan or other relevant documented information.
除非获取相关授权人员的赞成，适用时获取顾客的赞成，否那么在筹办的安排已完成以前，不应向顾客放行产品和交付效劳。
， Instructions for disassembly or repair
including re-inspection and traceability
requirements ，shall be accessible to and utilized
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组织应保存相关产品和效劳放行的成文信息，成文信息应包括：
by the appropriate personnel.
a) 吻合接受准那么的凭据；
b) 可追想到授权放行人员的信息。
The organization shall obtain a documented customer authorization for concession for the product to be repaired.
The organization shall retain documented information on the disposition of repaired
产品和效劳的放行 ---- 补充
product including quantity ，disposition ， disposition date ，and applicable traceability information.
组织应保证用于考据产品和效劳要求得以满足的所筹办的安排围绕控制方案进行，并且形成文件规定在控制方案中〔见附录 A〕。
Customer notification
组织应保证为产品和效劳初始放行所筹办的安排围绕产品或效劳赞成进行。
The organization shall immediately notify the customer(s 〕 in the event that nonconforming
product has been shipped. Initial communication
shall be followed with detailed documentation of
the event.
Nonconforming product disposition
依照 ISO 9001 第条，组织应保证在初始放行后作出改正此后，完成产品或效劳赞成。
全尺寸检验和功能性试验
应按控制方案中的规定，依照顾客的工程资料和性能标准，对每一种产品进行全尺寸检验和功能性考据。其结果应可供顾客评审。
The organization shall have a documented process for disposition of nonconforming product not subject to rework or repair. For product not meeting requirements ，the organization shall
verify that the product to be scrapped is rendered unusable prior to disposal.
The organization shall not divert nonconforming product to service or other use without prior customer approval.
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满的测量。
ISO 9001:2021 requirements.
注 2：全尺寸检验频次由顾客确定。
a) describes the nonconformity;
b) describes the actions taken;
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c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.
外观工程
假设组织制造的部件被顾客指定为“外观工程〞，那么组织应供给：
a〕 适合的资源，包括议论用的照明；
b〕 适合的颜色、纹理、金属亮度、织物结构、映像清楚度〔 DOI〕和触感技术的原版样件；
9 Performance evaluation
Monitoring ， measurement， analysis and evaluation
General
c〕 外观原版样件及议论设施的保护和控制； d〕 考据履行外观议论的人员有从事该工作
的能力和资格。
See ISO 9001:2021 requirements.
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis
and evaluation needed to ensure valid results;
c) when the monitoring
and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.
The organization
shall evaluate the performance and the
effectiveness of the quality management system.
外面供给的产品和效劳吻合性的考据和接受
The organization shall retain appropriate documented
information as evidence of the results.
.
组织应有一个过程来保证外面供给的过程、产品和效劳的质量，可采用以下一种或多种方法：
a〕 接收并议论组织供给商供给的统计数据； b〕 接受检验和 / 或试验，比方基于绩效的抽样
检查；
Monitoring and measurement of manufacturing processes
The organization shall perform process studies
c〕 结合可接受的已交付产品对要求的吻合性的
记录， 由第二方或第三方机构对供给商现场进行评估或审察；
d〕 指定实验室的部件议论； e〕 顾客赞成的其他方法。
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.
NOTEFor somemanufacturing processes ，it maynot
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be possible to demonstrate product compliance
through process capability. For those processes ， alternate methods such as batch conformance to specification may be used.
法律法规的吻合性
The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall
verify that the process flow diagram ，PFMEA，
and control plan are implemented ， including
在放行外面供给的产品进入生产流程以前，组织应
adherence to the following:
确认并能够供给凭据证明，外面供给的过程、产品
a〕measurement techniques ； b〕sampling plans ； c〕acceptance criteria
；
和效劳吻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、法规和其他要求。
d〕records of actual measurement values and/or test results for variable data ； e〕reaction plans and escalation process when acceptance criteria are not met.
接收准那么
接收准那么应由组织确定，当被要求时，由顾客赞成。
Significant process events ，such as tool change or machine repair ，shall be recorded and retained as documented information.
关于计数型数据的抽样， 其接收水平应是零弊端 〔见
第条〕。
The organization shall initiate a reaction
plan
indicated on the control plan and evaluated for impact on compliance to specifications for
不吻合输出的控制
characteristics that are either not
statistically capable or are unstable. These reaction plans shall include containment of
，as product and 100 percent inspection
appropriate. A corrective action plan shall be
见 ISO 9001:2021 的要求。
developed and implemented by the organization
indicating specific actions ，timing ，and assigned responsibilities to ensure that the process becomes stable and statistically capable. The plans shall be reviewed with and approved by the
customer ，when required.
组织应保证对不吻合要求的输出进行鉴别和控制，以防范非预期的使用或交付。
组织应依照不合格的性质及其对产品和效劳吻合性的影响采用适合措施。这也适用于在产品交付此后，
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以及在效劳供给时期或此后发现的不合格产品和效劳。
The organization shall maintain records of effective dates of process changes.
组织应经过以下一种或几种路子办理不合格的输出：
a) b) c) d)
纠正；
隔断、、退货或暂停对产品和效劳的供给；
Identification of statistical tools
The organization shall determine the appropriate
use of statistical tools. The organization shall verify that appropriate statistical tools are
见告顾客；
获取退步接收的授权。
对不合格输出进行纠正此后应试证其可否吻合要求。
included as part of the advanced product quality
planning 〔or equivalent 〕process and included in the design risk analysts 〔such as DFMEA〕〔where applicable 〕，the process risk analysis 〔such as PFMEA〕， and the control plan.
顾客的退步授权
Application of statistical concepts
无论何时，当产品的制造过程与当前赞成的不同样时，组织在进一步加工以前应获取顾客的退步或对偏离的赞成。
组织应在进一步加工以前，获取顾客对不合格品“照现状使用〞和 返修〔见〕 的授权。若是在制造过程中有子部件的再使用，应在退步也许偏离赞成中向顾客清楚传达该子部件的再使用。
Statistical concepts ，such as variation ，control〔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.
Customer satisfaction
See ISO 9001:2021 requirements.
The organization
组织应保拥有效限时或退步授权数量方面的记录。当授权期满时，组织还应保证原有的或接替的标准与要求的吻合性。退步的物料装运时，应在每个发运集装箱上做适合的表记〔此要求同样适用于采买的产品〕。在提交给顾客以前，组织应赞成由供给商所提出的央求。
shall monitor customers ’ perceptions
needs and expectations
have
of the degree to which their
been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.
NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on
delivered products and services, meetings with customers,
不合格品控制 ---- 顾客规定的过程
market-share analysis, compliments, warranty claims and
组织应遵守顾客规定的适用的不合格品控制。
dealer reports.
.
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Customer satisfaction – supplemental
可疑产品的控制
Customer satisfaction with the organization
shall be monitored through continual evaluation
of internal and external performance indicators
to ensure compliance to the product and process
组织应保证处于未经表记或可疑状态下的产品被归类为不合格品进行控制。组织应保证所有适合的制造人员都接受了关于可疑产品和不合格品截止的培训。
specifications and other customer requirements.
Performance indicators shall be based on
objective evidence and include but not be limited to
返工产品的控制
the following:
组织应在决定对产品进行返工以前，利用风险解析〔如 FMEA〕方法来评估返工过程的风险。如顾客有所要求，组织应在开始产品返工以前获取顾客赞成。
a〕delivered part quality performance b〕customer disruptions
；
；
c〕field returns ，recalls ，and warranty 〔where applicable 〕；
组织应有一个形成文件的吻合控制方案的返工确认过程，也许其他形成文件的相关信息，用于考据对原始标准的吻合性。
d〕delivery schedule performance incidents of premium freight 〕；
〔including
e〕customer notifications related to quality or delivery issues ， including special status.
包括了重新检验和可追想性要求的拆卸或返工指导书，应易于被适合的人员获取和使用。
组织应保存与返工产品办理相关的形成文件的信息，包括数量、办理方式、办理日期及适用的可追想性信息。
The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency. The
monitoring shall include the review of customer
performance data including online customer
portals and customer scorecards ，where provided.
返修产品的控制
Analysis and evaluation
组织应在决定对产品进行返修以前，利用风险解析〔如 FMEA〕方法来评估返修过程的风险。组织应在开始产品返修以前获取顾客赞成。
See ISO 9001:2021 requirements.
The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.
组织应有一个形成文件的吻合控制方案的返修确认过程，也许其他形成文件的相关信息。
The results of analysis shall be used to evaluate:
组织应获取顾客对待返修产品的形成文件的退步授
a) conformity of products and services;
b) the degree of customer satisfaction;
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权。
c) the performance and effectiveness of the quality management system;
d) if planning has been implemented effectively;
组织应保存与返修产品办理相关的形成文件的信息，包括数量、办理方式、办理日期及适用的可追想性信息。
e) the effectiveness and opportunities;
of actions taken to address risks
f) the performance of external providers;
g) the need for improvements to the quality
management
system.
NOTE Methods to analyse data can include statistical
techniques.
顾客通知
Prioritization
当不合格品被发运时，组织应马上通知顾客。初始通知应随附事件的详细文件。
Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support
prioritization of actions for improving customer satisfaction.
不合格品的办理
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办理。关于不吻合要求的产品，组织应试证待报废产品在荒弃以前已被变得无用。
Internal audit
AND ISO 9001:2021 requirements.
The organization shall conduct internal audits at
planned intervals to provide information on whether the quality management system:
假设无顾客提前赞成，组织不得将不合格品用于效劳或其他用途。
a) conforms to:
1) the
organization ’s own requirements for its
quality management system; 2) the requirements
of this International
Standard;
见 ISO 9001 ： 2021 的要求。
b) is effectively implemented and maintained.
The organization shall:
组织应保存以下成文信息：
a) plan, establish, implement and maintain an audit
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a) 描述不合格；
b) 描述所采用的措施；
c) 描述获取的退步；
d) 鉴别办理不合格的授权。
programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into consideration the importance of
the processes concerned, changes affecting the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure
objectivity
and the impartiality of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay;
9 绩效议论
监察、测量、解析和议论 总那么
f) retain documented information as evidence of the implementation of the audit programme and the
见 ISO 9001 ： 2021 的要求。
audit results.
组织应确定：
NOTE See ISO 19011 for guidance
a) 需要监察和测量什么；
b) 需要用什么方法进行监察、测量、解析和议论，以保证结果有效；
c) 何时推行监察和测量；
d) 何时对监察和测量结果进行解析和议论。组织应议论质量管理系统的绩效和有效性。
组织应保存适合的成文信息，以作为结果的凭据。
制造过程的监察和测量
Internal audit programme
The organization shall have a documented internal audit process. The process shall
include the development and implementation of an internal audit programme that covers the entire
quality management system including quality
managementsystem audits ，manufacturing process audits ， and product audits.
组织对付所有新的制造〔包括装置或排序〕进行过程研究，以考据过程能力，并为过程控制供给附加的输入，包括有特别特色的过程。
The audit programme shall be prioritized based upon risk ， internal and external performance
trends ， and criticality of the process 〔 es〕.
注：在一些制造过程中，可能无法经过过程能力证明产品的吻合性。关于这些过程，可采用取代方法，
Where the organization is responsible for
software development ，the organization shall include software development capability
assessments in their internal audit programme.
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如：批次对标准的吻合性。
The frequency of audits shall be reviewed and
，
where appropriate ， adjusted based on occurrence of process changes ， internal and external
nonconformities ，and/or customer complaints. The effectiveness of the audit programme shall be reviewed as a part of management review.
组织应保持由顾客部件赞成过程要求所规定的制造过程能力或绩效。组织应试证已推行了过程流程图、PFMEA和控制方案，包括遵守规定的：
Quality management system audit
a〕 测量技术； b〕 抽样方案； c〕 接收准那么；
d〕 计量数据实质测量值和 / 或试验结果的记录；
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 quality management system requirements for effective implementation.
e〕 当不满足接收准那么时的反响方案和升
级过程。
Manufacturing process audit
The organization shall audit all manufacturing processes over each three-year calendar period
to determine their effectiveness and efficiency using customer-specific required approaches for process audits. Where not defined by the customer ，the organization shall determine the approach to be used.
应记录重要的过程活动，如更换工具或维修机器等，并将其看作形成文件的信息予以保存。
Within each individual audit plan
，each
manufacturing process shall be audited on all
shifts where it occurs ，including the appropriate
sampling of the shift handover.
组织对付统计能力缺乏或不牢固的特色启动已在控制方案中表记，并且经过标准吻合性影响议论的反响方案。这些反响方案应包括合合时的产品截止和100%检验。为保证过程变得牢固且有统计能力，组
The manufacturing process audit shall include an audit of the effective implementation of the
织应拟定并推行一份显示明确进度、时程安排和指
process risk analysis 〔such as PFMEA〕， control plan ，and associated documents.
派责任人的纠正方案。当被要求时，此方案应由顾
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客评审和审批。
Product audit
组织应保持过程变重见效日期的记录。
The organization shall audit products using
customer-specific required approaches at
appropriate stages of production and delivery
to
verify conformity to specified requirements.
Where not defined by the customer ，the organization shall define the approach to be used.
Management review General
See ISO 9001:2021 requirements.
Top management shall review the organization ’s quality
统计工具确实定
management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and
组织应确定统计工具的适合使用。组织应试证产质量量先期筹办〔或等效筹办〕过程中包括了适合的统计工具，作为筹办的一局部，并且适合的统计工
alignment with the strategic direction of the organization.
具还包括在设计风险解析〔如 DFMEA〕〔适用时〕、过程风险解析〔如 PFMEA〕和控制方案中。
Management review – supplemental
Management review shall be conducted at least annually. The frequency of managementreview(s 〕 shall be increased based on risk to compliance
with customer requirements resulting from internal or external changes
统计看法的应用
impacting the quality management system and performance-related issues.
从事统计数据收集、解析和管理的员工应认识和使
用统计看法，比方：变差、控制〔牢固性〕 、过程能力和过分调整结果。
Management review inputs
See ISO 9001:2021 requirements.
The management review shall taking into consideration:
be planned and carried out
顾客满意
a) the status of actions from previous management
见 ISO 9001 ： 2021 的要求。
reviews;
b) changes in external and internal issues that are
组织应监察顾客对其需求和希望已获取满足的程度
iatf16949中英文比较版1013新版
的感觉。组织应确定获取、监察和评审该信息的方 法。
relevant to the quality management system;
c) information on the performance and effectivenessof
注：监察顾客感觉的例子可包括顾客检查、顾客对
the quality management system, including trends in:
交付产品或效劳的反响、顾客会商、市场据有率分 析、顾客赞美、担保索赔和经销商报告。
1) customer satisfaction interested parties; 2) the extent met;
and feedback from relevant
to which quality objectives have been
3) process performance and conformity of products and services;
顾客满意 ---- 补充
4) nonconformities and corrective actions; 5) monitoring and measurement results; 6) audit results;
7) the performance of external providers;
应经过对内部和外面绩效指标的连续议论来监察顾客对组织的满意度，以保证吻合产品和过程标准及其他顾客要求。
绩效指标应基于客观凭据，包括但不限于：
d) the adequacy of resources;
a〕 已交付部件的质量绩效； b〕 对顾客造成的搅乱；
c〕 使用现场退货、召回和保修〔在适用情
况下〕；
e) the effectiveness
of actions taken to address risks
and opportunities (see ;
f) opportunities for improvement.
d〕 交付时间安排的绩效〔包括超额运费的
情况〕；
Management review inputs – supplemental
Input to management review shall include:
e〕 与质量或交付问题相关的顾客通知， 包括特别
状态。
a〕cost of poor quality 〔cost of internal and external nonconformance 〕；
b〕measures of process effectiveness c〕measures of process efficiency d〕product conformance ；
；
；
组织应监察制造过程的绩效以证明吻合顾客对产质量量和过程效率的要求。监察应包括顾客绩效数据的评审，其中包括所供给的在线顾客门户和顾客计分卡。
e〕assessments of manufacturing feasibility
made for changes to existing operations
and for new facilities or new product 〔see Section 〕；
f 〕customer satisfaction 〔 see ISO 9001 ， Section 〕；
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g〕review of performance against maintenance objectives ；
h〕warranty performance 〔 where applicable
〕；
解析和议论
i 〕review of customer scorecards 〔 where applicable 〕；
见 ISO 9001 ： 2021 的要求。
j 〕identification of potential field failures
组织应解析和议论经过监察和测量获取的适合的数据和信息。
identified through risk analysis 〔such as FMEA〕；
and their impact
on
k〕actual field failures
应利用解析结果议论：
safety or the environment.
a) 产品和效劳的吻合性；
b) 顾客满意程度；
c) 质量管理系统的绩效和有效性；
d) 筹办可否获取有效推行；
e) 对付风险和时机所采用措施的有效性；
f) 外面供方的绩效；
g) 质量管理系统改良的需求。
注：数据解析的方法可包括统计技术。
Management review outputs
See ISO 9001:2021 requirements.
The outputs of the management review shall include decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs.
The organization shall retain documented information as evidence of the results of management reviews.
优先级
Management review outputs – supplemental
Top management shall document and implement an action plan when customer performance targets are not met.
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良措施的优先级。
10 Improvement
内部审察
General
和见 ISO 9001 ： 2021 的要求。
See ISO 9001:2021 requirements.
组织应按筹办的时间间隔进行内部审察，以供给有
The organization shall determine and select
iatf16949中英文比较版1013新版
关质量管理系统的以下信息：
a) 可否吻合：
1) 组织自己的质量管理系统要求；
2) 本标准的要求；
b) 可否获取有效的推行和保持。
opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
组织应：
a) 依照相关过程的重要性、对组织产生影响的变化和过去的审察结果，筹办、拟定、推行和保持审察方案，审察方案包括频次、方法、职责、筹办要求和报告；
b) 规定每次审察的审赞成那么和范围；
c) 选择审察员并推行审察，以保证审察过程客观公正；
d) 保证将审察结果报告给相关管理者；
e) 及时采用适合的纠正和纠正措施；
f) 保存成文信息，作为推行审察方案以及审察结果的凭据。
c) improving the performance and effectiveness of the quality management system.
NOTE Examples of improvement can include correction,
corrective action, continual improvement, breakthrough
change, innovation and re-organization.
Nonconformity and corrective action and ISO 9001:2021 requirements.
When a nonconformity occurs, including any arising
from complaints, the organization shall:
注：见 ISO 19011 管理系统审察指南。
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 the nonconformity,
in order that it does not
recur or occur elsewhere, by:
1) reviewing and analysing the nonconformity; 2) determining the causes of the nonconformity; 3) determining
if similar
nonconformities
exist,
or
内部审察方案
could potentially occur;
组织应有一个形成文件的内部审察过程。该过程应包括拟定并推行一个涵盖整个质量管理系统的内部审察方案，其中包括质量管理系统审察、制造过程审察和产品审察。
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during
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planning, if necessary;
f) make changes to the quality management system, if necessary.
应依照风险、内部和外面绩效趋势和过程的重点程度确定审察方案的优先级。
Corrective
actions shall be appropriate to the effects
of the nonconformities encountered.
在负责软件开发的情况下，组织应在其内部审察方案中包括软件开发能力评估。
The organization as evidence of:
shall retain documented information
a) the nature
of the nonconformities and any subsequent
actions taken;
对付审察频次进行评审，并在合合时，依照发生的
b) the results of any corrective action.
过程改正、内部和外面不吻合及 / 或顾客投诉进行调整。对付审察方案有效性进行评审，作为管理评审的一局部。
Problem solving
The organization shall have a documented process(es 〕 for problem solving including:
a〕defined approaches for various types and
scale of problems 〔. ，new product development, current manufacturing
issues ， field failures ，audit findings
〕；
质量管理系统审察
b〕containment ，interim actions ，and related
activities necessary for control of
nonconforming outputs 〔see ISO 9001 ， Section 〕；
组织应依照年度方案，每三个日历年采用过程方法审察一次所有的质量管理系统过程，已考据与本汽
c〕root cause analysis ，methodology used ， analysis ，and results ；
车 QMS标准的吻合性。结合这些审察，组织对付顾客特定的质量管理系统要求进行抽样，检查可否获取有效推行。
d〕implementation of systemic corrective
actions ，including consideration of the
impact on similar processes and products ；
e〕verification of the effectiveness of implemented corrective actions ；
f 〕reviewing and ，where necessary ，updating
the appropriate documented information 〔. ，PFMEA， control plan 〕 .
制造过程审察
Where the customer has specific prescribed
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组织应采用顾客特定要求的过程审察方法，每三个日历年审察一次所有制造过程，以确定其有效性和效率。若是顾客未指定，组织应确定要采用的审察方法。
processes ，tools ，or systems for problem solving ，
the organization shall use those processes ， tools ，or systems unless otherwise approved by the customer.
Error-proofing
在每个审察方案内，每个制造过程的审察应涵盖所有发生的班次，包括适合的交抽样。
The organization shall have a documented process to determine the use of appropriate
error-proofing methodologies. Details of the method used shall be documented in the
process risk analysis 〔such as PFMEA〕 and test frequencies shall be documented in the control plan.
制造过程审察应包括对过程风险解析〔如 PFMEA〕、控制方案和相关文件有效履行的审察。
The process shall include the testing of error-proofing devices for failure or simulated failure. Records shall be maintained. Challenge parts ，when used，shall be identified ，controlled ， verified ，and calibrated where feasible. Error-proofing device failures shall have a reaction plan.
产品审察
Warranty management systems
组织应采用顾客特定要求的方法，在生产及交付的适合阶段对产品进行审察，已考据对所规定要求的吻合性。若是顾客未指定，组织应确定要采用的审察方法。
When the organization is required to provide
warranty for their product(s 〕，the organization
shall implement a warranty management process.
The organization shall include in the process a
method for warranty part analysis ，including NTF 〔no trouble found 〕 . When specified by the
customer ，the organization shall implement the
required warranty management process.
管理评审
Customer complaints and field failure test
总那么
analysis
见 ISO 9001 ： 2021 的要求。
最高管理者应按筹办的时间间隔对组织的质量管理
系统进行评审，以保证其连续的适合性、充分性和
有效性，并与组织的战略方向一致。
The organization shall perform analysis on
， customer complaints and field failures
including any returned parts ，and shall initiate problem solving and corrective action to prevent recurrence.
Where requested by the customer ，this shall
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管理评审 ---- 补充
include analysis of the interaction of embedded software of the organization's product within
the system of the final customer ’ s product.
管理评审应最少每年进行一次。应基于由影响质量管理系统和绩效相关问题的内部或外面改正造成的顾客要求吻合性的风险，提高管理评审的频次。
The organization shall communicate the results of testing/analysis to the customer and also within the organization.
管理评审输入
Continual improvement
见 ISO 9001 ： 2021 的要求。
See ISO 9001:2021 requirements.
The organization shall continually improve the
suitability, adequacy and effectiveness of the quality management system.
筹办和推行管理评审时应试虑以下内容：
a) 过去管理评审所采用措施的情况；
b) 与质量管理系统相关的内外面因素的变化；
c) 以下相关质量管理系统绩效和有效性的信息，包括其趋势：
1) 顾客满意和相关相关方的反响；
2) 质量目标的实现程度；
3) 过程绩效及产品和效劳的合格情况；
The organization
shall consider the results and the outputs
of analysis
and evaluation,
from management review,
to determine if there are needs or opportunities that shall be addressed as part of continual improvement.
.
Continual improvement – supplemental
4) 不合格和纠正措施； 5) 监察和测量结果； 6) 审察结果； 7) 外面供方的绩效；
The organization shall have a documented process
for continual improvement. The organization shall include in this process the following:
d) 资源的充分性；
e) 对付风险和时机所采用的措施的有效性〔见 〕；
f) 改良的机会。
a〕identification of the methodology used ，
objectives ，measurement，effectiveness ， and documented information ；
b〕a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste ；
c〕risk analysis 〔such as FMEA〕.
NOTEContinual improvement is implemented once manufacturing processes are statistically capable and stable or when product
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characteristics are predictable and meet
customer requirements.
管理评审输入 ---- 补充
管理评审的输入应包括：
a〕 不良质量本钱〔内部和外面不吻合本钱〕 b〕 过程有效性的权衡； c〕 过程效率的权衡； d〕 产品吻合性；
e〕 对现有操作改正和新设施或新产品进行的
；
制造可行性评估〔见第条〕 ；
f 〕 顾客满意〔见 ISO 9001 第条〕； g〕 比较保护目标的绩效评审； h〕 保修绩效〔在适用情况下〕 ； i 〕 顾客计分卡评审〔在适用情况下〕
；
j 〕 经过风险解析 〔如 FMEA〕识其他潜藏使用现
场无效表记；
k〕 实质使用现场无效及其对安全或环境的影
响。
管理评审输出
见 ISO 9001 ： 2021 的要求。
管理评审的输出应包括与以下事项相关的决定和措
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施：
a〕改良的机会；
b) 质量管理系统所需的改正；
c) 资源需求。
组织应保存成文信息，作为管理评审的结果的凭据。
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
文件化的措施方案并推行。
10 改良
总那么
见 ISO 9001 ： 2021 的要求。
组织应确定和选择改良机会，并采用必要措施，以
满足顾客要求和增强顾客满意。
这应包括：
a) 改良产品和效劳，以满足要求并对付未来的需求和希望；
b) 纠正、预防或减少不利影响；
c) 改良质量管理系统的绩效和有效性。
注：改良的例子可包括纠正、纠正措施、连续改良、
打破性改革、创新和重组。
不吻合和纠正措施
和见 ISO 9001 ： 2021 的要求。
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当发生不合格时，包括来自投诉的不合格， ，组织
应：
a) 对不合格做出对付，并在适用时：
1) 采用措施以控制和纠正不合格；
2) 办理结果；
b) 经过以下活动，议论可否需要采用措施，以除掉产生不合格的原因，防范其再次发生或在其他场合发生：
1) 评审和解析不合格；
2) 确定不合格的原因；
3) 确定可否存在或可能发生近似的不合格；
c) 推行所需的措施；
d) 评审所采用的纠正措施的有效性；
e) 需要时，更新筹办时期确定的风险和时机；
f) 需要时，改正质量管理系统。
纠正措施应与不合格所产生的影响相适应。
组织应保存成文信息，作为以下事项的凭据：
a) 不合格的性质以及随后所采用的措施；
b) 纠正措施的结果。
问题解决
组织应有形成文件的问题解决过程，包括：
a〕 用于各种种类和规模的问题〔如：新产品开
发、当前制造问题、适用现场无效、审察发
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现〕的明确方法；
b〕 控制不吻合输出所必要的截止、
临时措施及
相关活动〔见 ISO 9001 第条〕；
c〕 根本源因解析、采用的方法、解析及结果； d〕 系统性纠正措施的推行， 包括考虑对相似过
程和产品的影响；
e〕 对已推行纠正措施有效性的考据； f 〕 对适合形成文件的信息〔如：
PFMEA、控制
方案〕的评审，必要时进行更新。
假设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
赞成。
防错
组织应有一个形成文件的过程，用于确定适合防错
方法的使用。所采用方法的详细信息应在过程风险
解析中〔如 PFMEA〕形成文件，试验频次应记录在控 制方案中。
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过程应包括防错装置无效或模拟无效的试验。应保
持记录。假设使用挑战件，那么应在可行时对挑战件进
行表记、控制、考据和校准。防错装置无效应有一
个反响方案。
保修管理系统
当组织被要求为其产品供给保修时，组织应推行一
个保修管理过程。组织应在该过程中包括一个保修
件解析法，包括
NTF〔未发现故障〕 。当顾客指准时，
组织应推行所要求的保修管理过程。
顾客投诉和使用现场无效实验解析
组织对付顾客投诉和使用现场无效，包括退货部件，
进行解析，并且应采用问题解决和纠正措施以预防
再次发生。向顾客并且在组织内部传达。
在顾客要求的情况下，这应包括最后顾客产品系统
内，组织产品嵌入式软件相互作用的解析。
组织应向顾客并且在组织内部传达试验
/ 解析的结
果。
连续改良
见 ISO 9001 ： 2021 的要求。
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组织应连续改良质量管理系统的适合性、充分性和
有效性。
组织应试虑解析和议论的结果以及管理评审的输
出，以确定可否存在需求和时机，这些需求应作为
连续改良的一局部加以对付。
连续改良——补充
组织应有一个形成文件的连续改良过程。组织在本
过程中包括以下内容：
a) 对所采用方法、目标、测量、有效性和形
成文件的信息的鉴别；
b) 一个制造过程改良行动方案，重点放在减
少过程变差和浪费。 c) 风险解析〔比方 FMEA〕。
注：连续改良是当过程有统计能力且牢固，或
者产品特色为可展望且满足顾客要求时推行
的。
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