-
4
组织的环境
4.1
理解组织及其环境
见
ISO 9001:2015
的要求。
4
Context of the organization
4.1
Understanding the organization and its context
See ISO 9001:2015 requirements.
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.
The organization shall monitor and review information about
these external and internal issues.
NOTE 1 Issues can include positive and negative factors or
conditions for consideration.
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, knowledge and
performance of the organization.
组织应确定与其目标和战略方向相关 并影响实现其质
量管理体系预期结果的各种外部和内部因素。
组织应对这些内部和外部因素的相关信息进行监视和
评审。
注
1
：这些因素可以包括需要考虑的正面或负面的因素
或条件；
注
2
：可以通过考虑源于国际、国家、地区或本地的各
种法律法规 、技术、竞争、市场、文化、社会和经济因
素的情况，有助于理解外部环境。
注
3
：可以通过考虑组织的价值观、文化、知识和组织
绩效等相关因素状况，有助 于理解内部环境。
4.2
Understanding the needs and expectations of
4.2
理解相关方的需求和期望
见
ISO 9001:2015
的要求。
interested parties
See ISO 9001:2015 requirements.
Due to their effect or potential effect on the o
rganization’s
ability to consistently provide products and services that meet
customer and applicable statutory and regulatory
requirements, the organization shall determine:
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.
由于相关方对组织持续提供满足顾客和适用的法律法
规要求的产 品和服务的能力产生影响或潜在影响，因
此，组织应确定：
a)
与质量管理体系有关的相关方；
b)
这些相关方的要求。
组织应对这些相关方及其要求的相关信息进行监视和
评审。
4.3
确定质量管理体系的范围
见
ISO 9001:2015
的要求。
4.3
Determining the scope of the quality
management system
See ISO 9001:2015 requirements.
The organization shall determine the boundaries and
applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in
组织应确定质量管理体系的边界和适用性，
以确定其范
围。
在确定质量管理体系范围时，组织应考虑：
a)
在
4.1
中涉及的各种外部和内部因素；
b)
在
4.2
中涉及的有关相关方要求；
c)
组织的产品与服务。
4.2;
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.
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 responsibility to ensure the
conformity of its products and services and the enhancement of
customer satisfaction.
对于本标准中适用于组织确定的质量管理体系范围的
全部要求，组织应予以实施。
组织的质量管理体系范围应作为形成文件的信息加以
保持。
该范围应说明质 量管理体系所覆盖的产品和服务
类型，
若组织认为其管理体系范围的应用范围不适用本
标准的某些要求，应说明理由。
那些不适用组织的质量管理体系要求，
不 能影响组织确
保产品和服务合格以及增强顾客满意的能力或责任，
否
则不能声称符合本 标准的要求。
4.3.1
Determining the scope of the quality
management system - supplemental
Supporting functions
，
whether on- site or remote
（
such
as design centres
，
corporate headquarters
，
and
4.3.1
确定质量管理体系的范围
----
补充
distribution centres
），
shall be included in the scope of
the Quality Management System
（
QMS
）
.
支持功能，
无论其在现场或外部场所
（例如：
设计中心、
公司总部和配送中心）
，
应包含在质量管理体系
（
QMS
）
The only permitted exclusion for this Automotive QMS
的范围中。
Standard relates to the product design and
本汽车
QMS
标准唯一允许的删减是
ISO 9001
第
8.3
条
development requirements within ISO 9001
，
Section
中的产品设计和开发要求。删减应以形成文件的信息
8.3. The exclusion shall be justified and maintained as
（见
ISO 9001
第
7.5
条）的形式进行证明和保持。
documented information
（
see ISO 9001
，
Section 7.5
）
.
允许的删减不包括制造过程设计。
Permitted exclusions do not include manufacturing
process design.
4.3.2
Customer-specific requirements
Customer-specific requirements shall be evaluated and
included in the scope of the organization
’
s
quality
4.3.2
顾客特定要求
management system.
应对顾客特定要求进行评价，
并将其包含在组织的质量
管理体系范围内。
4.4
Quality management system and its processes
4.4.1
See ISO 9001:2015 requirements
4.4
质量管理体系及其过程
4.4.1
4.4.1 The organization shall establish, implement, maintain and
continually improve a quality management system, including
the processes needed and their interactions, in accordance with
the requirements of this International Standard.
见
ISO 9001:2015
的要求。
4.4.1
组织应按本标准的要求建立、实施、保持和持续
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 6.1;
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.
改进质量管理体系，
包括质量管理体系所需的过程及其
相互作用。
组织应确定质量管理体系所需的过程及其在整个组织
中的应用，组织应：
a)
确定这些过程所需的输入和期望的输出；
b)
确定这些过程的顺序和相互作用；
c)
确定和应用所需的准则 和方法（包括监视、测量和
相关的绩效指标）
，
以确保这些过程的有效运行和控制；< br>
d)
确定并确保获得这些过程所需的资源；
e)
规定与这些过程相关的责任和权限；
f)
应按照
6.1
的要求确定风险和机遇；
g)
评价这些过程，实施所需的更改，以确保这些过程
实现预期的结果；
h)
改进过程和质量管理体系。
4.4.1.1
产品和过程的符合性
4.4. 1. 1
Conformance of products and processes
The organization shall ensure conformance of all
products and processes
，
including service parts and
those that are outsourced
，
to all applicable customer
，
statutory
，
and regulatory requirements
（
see Section
8.4.2.2
）
.
组织应确保所有的产品和过程，
包括服务件及外包的产
4.4.1.2
Product safety
品和过程，符合一切适用的顾客和法律法规要求（见
The organization shall have documented processes for
8.4.2.2
条）。
the management of product-safety related products
and manufacturing processes
，
which shall include but
not be limited to the following
，
where applicable:
4.4.1.2
产品安全
a
）
identification by the organization of statutory
组织应有形成文件的过程，
用于与产品安全有关的产品
and regulatory product-safety requirements
；
和制造过程管理；
形成文件的过程包括但不限于
（在适
b
）
customer notification of requirements in item
用情况下）：
a
）；
a
）
组织应对产品安全法律法规要求的识别；
c
）
special approvals for design FMEA
；
b
）
向顾客通知
a
）项中的要求；
d
）
identification of product safety- related
c
）
设计
FMEA
的特殊批准；
characteristics
；
d
）
产品安全相关特性的识别；
e
）
identification and controls of safety-related
e
）
产品及制造时安全相关特性的识别和控制；
characteristics of product and at the point of
f
）
控制计划和过程
FMEA
的特殊批准；
manufacture
；
g
）
反应计划（见第
9.1.1.1
条）；
h
）
包括最高管理者在内的，
明确的职责，
升级过
f
）
special approval of control plans and process
程和信息流的定义，以及顾客通知；
FMEAs
；
i
）
组织或顾客为与产品安全有关的产品和相关
g
）
reaction plans
（
see Section 9.1.1.1
）；
h
）
defined responsibilities
，
definition of escalation
j
）
产品或过程的更改在实施之前应获得批准，
包
process and flow of information
，
including top
括对过程和产品更改带给产品安全的潜在影
management
，
and customer notification
；
i
）
training identified by the organization or
customer for personnel involved in product
画
safety
顾客指定的货源（见第
8.4.3.1
条）；
l
）
整个供应链中按制造批次
（至少）
的产品可追
related products and associated manufacturing
溯性（见第
8.5.2.1
条）；
processes
；
m
）
为
新产品导入的经验教训。
j
）
changes of product or process shall be approved
注：
顾客或者组织内部程序可要求与安全相关的要求或
prior to implementation
，
including evaluation of
者文件的特殊批准。
potential effects on product safety from process and
product changes
（
see ISO 9001
，
Section 8.3.6
）；
k
）
transfer of requirements with regard to product
safety throughout the supply chain
，
including
k
）
整个供应链中关于产品安全的要求转移，
包括
响进行评价（见
ISO 9001
第
8.3.6
条）；
制造过程中涉及的人员确定的培训；
customer-designated sources
（
see Section 8.4.3.1
）；
l
）
product traceability by manufactured lot
（
at a
minimum
）
throughout the supply chain
（
see Section
8.5.2.1
）；
m
）
lessons learned for new product introduction.
NOTE: Special approval of safety related requirements
or documents may be required by the customer or the
organization
’
s internal processes.
4.4.2
See ISO 9001:2015 requirements.
4.4.2 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
见
ISO 9001:2015
的要求。
a)
保持形成文件的信息以支持过程运行；
5.1
Leadership and commitment
b)
保留确认其过程是按策划进行的形成文件的信息。
5.1.1
General
See ISO 9001:2015 requirements.
5.1.1 General
总则
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;
4.4.2
在必要的程度上，组织应：
5
领导作用
5.1
领导作用与承诺
5.1.1
总则
见
ISO 9001:2015
的要求。
b) ensuring that the quality policy and quality objectives are
established for the quality management system and are
compatible with the context and strategic direction of the
organization;
c) ensuring the integration of the quality management system
requirements into the organization’s
business processes;
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
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 purpose
s of the organization’s existence, whether the
organization is public, private, for profit or not for profit.
最高管理者应证实其对质量管理体系的领导作用和承
诺，通过：
a)
对质量管理体系的有效性承担责任；
b)
确保制定质量管理体系的质量方针和质量目标，并
与组织环境和战略方向保持一致；
c)
确保将质量管理体系要求融入组织的业务过程；
d)
促进使用过程方法和基于风险的思维；
e)
确保获得质量管理体系所需的资源；
f)
沟通有效的质量管理体系和符合质量管理体系要求
的重要性；
g)
确保实现质量管理体系的预期结果；
h)
促使、指导和支持员工努力提高质量管理体系的有
效性；
i)
推动改进；
j)
支持其他管理者履行其相关领域的职责。
注：
本标准中的
“
业务
”
一词可大致理解为涉及 组织存在
目的的核心价值活动，
组织可以是公有的、
私有的、
盈
利或 非盈利的。
5.1.1.1
公司责任
5.1.1.1
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
”
）
.
5.1.1.2
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
组织应明确并实施公司责任方针，至少包括反贿赂方
input to the management review
（
see Section 9.3.2.1.
）
.
针、员工行为准则以及道德准则升级政策（
“
举报政
策
”
）。
5.1.1.3
Process owners
Top management shall identify process owners who are
responsible for managing the organization's processes
and related outputs. Process owners shall understand
5.1.1.2
过程有效性和效率
their roles and be competent to perform those roles
最高管理者应评审产品实现过程和支持过程，
以评价并
（
see ISO 9001
，
Section 7.2
）
.
改进 过程有效性和效率。
过程评审活动的结果应作为管
理评审的输入（见第
9.3.2.1
条）。
5.1.1.3
过程拥有者
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。
过程拥有者应了解他们的角色，
并
且具备胜任其角色的能力（见< br>ISO 9001
第
7.2
条）
.
5.1.2
Customer focus
See ISO 9001:2015 requirements.
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
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 addressed;
c) the focus on enhancing customer satisfaction is maintained.
5.1.2
以顾客为关注焦点
见
ISO 9001:2015
的要求。
5.2
Policy
5.2.1
Establishing the qualify policy
See ISO 9001:2015 requirements.
Top management shall establish, implement and maintain a
quality policy that:
a) is appropriate to the purpose and context of the 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.
最高管理者应通过以下方面，
证实其对以顾客为关注焦
点的领导作用和承诺：
a)
确定、理解和持续满足顾客要求以及适用的法律和
法规要求；
b)
确定和应对能够影响产品和服务符合性以及增强顾
客满意能力的风险与机遇；
c)
始终致力于增强顾客满意。
5.2.2
Communicating the quality policy
5.2
方针
5.2.1
建立质量方针
见
ISO 9001:2015
的要求。
See ISO 9001:2015 requirements.
The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the
organization;
c) be available to relevant interested parties, as appropriate.
最高管理者应制定、实施和保持质量方针，方针应：
a)
与组织的宗旨和环境相适应，并支持其战略方向；
b)
提供制定质量目标的框架
c)
包括对满足适用要求的承诺；
d)
包括对持续改进质量管理体系的承诺。
5.3
Organizational roles
，
responsibilities and
authorities
See ISO 9001:2015 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 and authority
5.2.2
沟通质量方针
见
ISO 9001:2015
的要求。
for:
a) ensuring that the quality management system conforms to
the requirements of this International Standard;
b) ensuring that the processes are delivering their intended
outputs;
c) reporting on the performance of the quality management
system and on opportunities for improvement (see 10.1), in
particular to top management;
质量方针应：
a)
作为形成文件的信息，可获得并保持；
b)
在组织内得到沟通、理解和应用
c)
适宜时，可向有关相关方提供。
d) ensuring the promotion of customer focus throughout the
5.3
组织的作用、职责和权限
见
ISO 9001:2015
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.
最高管理者应确保相关角色的职责和权限在整个组织
内得到分派、沟通和理解。
最高管理者应分派职责和权限，以：
a)
确保质量管理体系符合本标准的要求；
b)
确保各过程获得其预期的输出；
c)
报告质量管理体系的绩效和改进机会，特别向最高
管理者；
d)
确保在整个组织推动以顾客为关注焦点；
e)
确保在策划和实施质量管理体系的更改时保持其完
整性。
5.3.1
Organizational roles
，
responsibilities
，
and
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
，
setting quality
objectives and related training
，
corrective and
Preventive actions
，
product design and development
，
capacity analysis
，
logistics information
，
customer
scorecards
，
and customer portals.
5.3.2
Responsibility and authority for product
requirements and corrective actions
Top management shall ensure that:
a
）
personnel responsible for conformity to product
requirements have the authority to stop shipment and
5.3.1
组织的作用、职责和权限
----
补充
最高管理者应向人员指派职责和权限，
以确保顾客要求
stop production to correct quality problems
；
得到满足。
这些指派应形成文件。
这包括但不限于：
特
NOTE Due to the process design in some industries
，
it
殊特性的选择，
质量目标和相关培训的设置，
纠正和预
might not always be possible to stop production
防措施，产品设计和开发，产能分析，物流信息，顾客
immediately. In this case
，
the affected batch must be
计分卡以及顾客门户。
contained and shipment to the customer prevented.
b
）
personnel with authority and responsibility for
corrective action are promptly informed of products or
processes that do not conform to requirements to
ensure that nonconforming product is not shipped to
the customer and that all potential nonconforming
5.3.2
产品要求和纠正措施的职责和权限
最高管理者应确保：
a
）
负责产品要求符合性的人员有权停止发运或
生产以纠正质量问题；
注：由于一些行业中的过程设计，
并非总是能
立即停止生产。在这种情况下，
必须对受 影响
批次进行控制，以防将其发运给顾客。
b
）
拥有纠 正措施权限和职责的人员能够及时获
知与要求不符的产品或过程，
以确保避免将不
合格 品发运给顾客，
并确保所有潜在不合格品
product is identified and contained
；
c
）
production operations across all shifts are
staffed with personnel in charge of
，
or delegated
responsibility for
，
ensuring conformity to product
requirements.
6
Planning
6.1
Actions to address risks and opportunities
6.1.1
and 6.1.2
See ISO 9001:2015 requirements.
得到识别与控制；
c
）
所有班次的生产作业都安排有负责确保产品
要求符合性的负责人员或代理职责人员。
6.1.1 When planning for the quality management system, the
organization shall consider the issues referred to in 4.1 and the
requirements referred to in 4.2 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.
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality
management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be
proportionate to the potential impact on the conformity of
products and services.
NOTE 1 Options to address risks can include avoiding risk,
taking risk in order to pursue an opportunity, eliminating the
risk source, changing the likelihood or consequences, sharing
the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to the adoption of new practices,
launching new products, opening new markets, addressing new
customers, building partnerships, using new technology and
other desirable and viable possibilities to address the
orga
nization’s or its customers’ needs.
6
策划
6.1
风险和机遇的应对措施
6.1.1
和
6.1.2
见
ISO 9001:2015
的要求。
6.1.1
策划质量管理体系时，组织应考虑
4.1
所描述的
因素和
4.2
所提及的要求，
并确定需要应对的风险和机
遇以：
a)
确保质量管理体系能够实现其预期的结果；
b)
增强有利影响；
c)
避免或减少不利影响；
d)
实现改进。
6.1.2
组织应策划：
6.1.2.1
Risk analysis
a)
应对这些风险和机遇的措施；
The organization shall include in its risk analysis
，
at a
b)
如何：
1)
在质量管理体系过程中融入整合和实施这些措
minimum
，
lessons learned from product recalls
，
施（见
4.4
）；
product audits
，
field returns and repairs
，
complaints
，
2)
评价这些措施的有效性。
scrap
，
and rework.
所采取的应对风险和机遇的措施应与其对产品和服务
The organization shall retain documented information
符合性的潜在影响相适应。
as evidence of the results of risk analysis.
遇而接受风险、
消除风险源、
改变风险的可能性和结果、
6.1.2.2
Preventive action
The organization shall determine and implement action
分担风险或经过决策而延缓风险。
注
2
： 机遇可以带来新实践的采用、推出新产品、打开
（
s
）
to eliminate the causes of potential
新市场、
获得新客 户、
建立合作关系、
使用新技术以及
nonconformities in order to prevent their occurrence.
能够解决组织或其他顾客需求的其他有利可能性。
Preventive actions shall be appropriate to the severity
of the potential issues.
6.1.2.1
风险分析
The organization shall establish a process to lessen the
注
1
：
应对 风险的选择可以包括：
避免风险、
为获取机
组织应在风险分析中至少包含从产品召回、 产品审核、
impact of negative effects of risk including the
使用现场的退货和修理、
投诉、
报废及返工的经验教训。
组织应保留形成文件的信息，作为风险分析结果的证
据。
6.1.2.2
预防措施
组织应确定并实施措施，
以消除潜在不 合格的原因，
防
止不合格发生。
预防措施应与潜在问题的严重程度相适
应。< br>
组织应建立一个用于减轻风险负面影响的过程，
过程包
括以下方面：
a
）
确定潜在不合格及其原因；
b
）
评价防止不合格发生的措施的需求；
c
）
确定并实施所需的措施；
d
）
所采取措施的成文信息；
e
）
评审所采取的预防措施的有效性；
f
）
利用取得的经验教训预防类似过程中的再次
发生（见
ISO 9001
第
7.1.6
条）。
6.1.2.3
应急计划
组织应：
a
）
对保持生产输出并确保顾客要求得以满足 而
言必不可少的所有制造过程和基础设施设备，
识别并评价相关的内部和外部风险。
b
）
根据风险和对顾客的影响制定应急计划；
c
）
准备应急计划，
以在下列任一情况下保证供应
的持续 性：关键设备故障（另见第
8.5.6.1.1
条）；外部提供的产品、过程和服务中断；常< br>见自然灾害；火灾；公共事业中断；
信息技术
系统受到网络攻击；
劳动力短缺；
或者基础设
施破坏；
d
）
作为应急计划的补充 ，
包含一个通知顾客和其
他相关方的过程，
告知影响顾客作业的任何情
况的程 度和持续时间；
e
）
定期测试应急计划的有效性（如：模拟，视情
况而定）；
f
）
利用包括最高管理者在内的跨部门小组对应
急计划进行评审（ 至少每年一次），并在需要
following:
a
）
determining potential nonconformities and their
causes
；
b
）
evaluating the need for action to prevent
occurrence of nonconformities
；
c
）
determining and implementing action needed
；
d
）
documented information of action taken
；
e
）
reviewing the effectiveness of the preventive
action taken
；
f
）
utilizing lessons learned to prevent recurrence in
similar processes
（
see ISO 9001
，
Section 7.1.6
）
.
6.1.2.3
Contingency plans
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
；
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 8.5.6.1.1
）；
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（
e.g.
，
simulations
，
as appropriate
）；
f
）
conduct contingency plan reviews
（
at a minimum
annually
）
using a multidisciplinary team 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
）
.
The contingency plans shall include provisions to
validate that the manufactured product continues to
meet customer specifications after the re-start of
production following an emergency in which production
g
）
对应急计划形成文件，
并保留描述修订以及更
was stopped and if the regular shutdown processes
改授权人员的形成文件的信息。
were not followed.
应急计划应包含相关规定，
用以在发生生产停止的紧急
6.2
Quality objectives and planning to achieve them
情况后重新开始生产之后，
以及在常规停机过程未得到
6.2.1
and 6.2.2
遵循的情况下，确认制造的产品持续符合顾客规范。
See ISO 9001:2015 requirements.
6.2.1 The organization shall establish quality objectives at
management system.
The quality objectives shall:
a) be consistent with the quality policy;
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;
relevant functions, levels and processes needed for the quality
时进行更新；
6.2
质量目标及其实施的策划
6.2.1
和
6.2.2
见
ISO 9001:2015
的要求。
6.2.1
组织应在质量管理体系所需的相关职能、
层次和
g) be updated as appropriate.
The organization shall maintain documented information on the
quality objectives.
6.2.2 When planning how to achieve its quality objectives, 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.
过程上设定质量目标。
质量目标应：
a)
与质量方针保持一致；
b)
可测量；
c)
考虑到适用的要求；
d)
与提供合格产品和服务以及增强顾客满意有关；
e)
予以监视；
f)
予以沟通；
g)
适时更新。
组织应保持质量目标的形成文件的信息。
6.2.2
策划如何实现其质量目标时，组织应确定：
a)
采取的措施；
b)
需要的资源；
c)
由谁负责；
d)
什么时候完成；
e)
如何评价结果。
6.2.2.1
Quality objectives and planning to achieve
them - supplemental
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.
The results of the organization
’
s review regarding
interested parties and their relevant requirements shall
be considered when the organization establishes its
annual
（
at a minimum
）
quality objectives and related
performance targets
（
internal and external
）
.
6.3
Planning of changes
See ISO 9001:2015 requirements.
When the organization determines the need for changes to the
6.2.2.1
质量目标及其实施的策划
最高管理者应确保为整个组织内的相关职能、
过程 和级
别，明确、建立并保持符合顾客要求的质量目标。
组织在建立其年度
（ 至少每年一次）
质量目标和相关性
能指标
（内部和外部）
时，
应考虑 组织对相关方及其有
关要求的评审结果。
quality management system, the changes shall be carried out in
a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and
authorities.
7
Support
7.1
Resources
7.1.1
General
See ISO 9001:2015 requirements.
6.3
更改的策划
见
ISO 9001:2015
的要求。
7.1.1 General
总则
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;
b) what needs to be obtained from external providers.
当组 织确定需要对质量管理体系进行更改时（见
4.4
），
此种更改应经策划并系统的实施 。
组织应考虑：
a)
更改的目的及其潜在后果；
b)
质量管理体系的完整性；
c)
资源的可获得性；
d)
职责和权限的分配或再分配。
7.1.2
People
See ISO 9001:2015 requirements.
The organization shall determine and provide the persons
necessary for the effective implementation of its quality
7
支持
7.1
资源
7.1.1
总则
见
ISO 9001:2015
的要求。
management system and for the operation and control of its
processes.
7.1.3
Infrastructure
See ISO 9001:2015 requirements.
The organization shall determine, provide and maintain the
infrastructure necessary for the operation of its processes and
to achieve conformity of products and services.
NOTE Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology. < br>组织应确定并提供建立、
实施、
保持和持续改进质量管
理体系所需的资源。
组织应考虑：
a)
现有内部资源的能力和约束；
b)
需要从外部供方获取的资源。
7.1.3.1
Plant
，
facility
，
and equipment planning
见
ISO 9001:2015
的要求。
The organization shall use a multidisciplinary approach
组织应确定并提供所需的人员，
以有效实施质量管理体
including risk identification and risk mitigation methods
系并运行和控制其过程。
for developing and improving plant
，
facility
，
and
equipment plans. In designing plant layouts
，
the
7.1.2
人员
7.1.3
基础设施
见
ISO 9001:2015
的要求。
organization shall:
a
）
optimize material flow
，
material handling
，
and
value-added use of floor space including control of
nonconforming product
，
and
b
）
facilitate synchronous material flow
，
as
applicable.
Methods shall be developed and implemented to
evaluate manufacturing feasibility for new product or
new operations. Manufacturing feasibility assessments
shall include capacity planning.
These methods shall also be applicable for evaluating
proposed changes to existing operations.
组织应确定、
提供并维护过程运行所需的基础设施，
以获得合格的产品和服务。
注：基础设施可包括：
a)
建筑物和相关的设施；
b)
设备，包括硬件和软件；
c)
运输资源；
d)
信息和通讯技术。
7.1.3.1
工厂、设施及设备策划
组织应使用多方论证的方法，
包括风险识别和风险缓解
方法，
来开发并改进工厂、
设施和设备的计划。
在设计
The organization shall maintain process effectiveness
，
工厂布局时，组织应：
including periodic re-evaluation relative to risk
，
to
incorporate any changes made during process
值利用，包括对不合格品的控制，并且
approval
，
control plan maintenance
（
see Section
b
）
在适用时，便于材料的同步流动。
8.5.1.1
），
and verification of job set-ups
（
see Section
应开发并适时对新产品或新操作的制造可行性进行评
8.5.1.3
）
.
价的方法。
制造可行性评估应包括产能策划。
这些方法
还应适用于评价对现有操作的提议更改。
Assessments of manufacturing feasibility and
evaluation of capacity planning shall be inputs to
过程批准、控 制计划维护（见第
8.5.1.1
条）及作业准
management reviews
（
see ISO 9001
，
Section 9.3
）
.
备的验证（见第
8.5.1.3
条）期间做出的任何更改。
NOTE 1 These requirements should include the
制造可行性评估和产能策划的评价应为管理评审的输
application of lean manufacturing principles.
入（见
ISO 9001
第
9.3
条）。
注
1
：这些要求应当包括对精益制造原则的应用。
NOTE 2 These requirements should apply to on-site
注
2
：这些要求应当应用于现场供应商活动，如适用。
supplier activities
，
as applicable.
7.1.4
Environment for the operation of processes
组织应保持过程有效性，
包括定期风险复评，
以纳入在
a
）
优化材料的流动和搬运，
以及对空间场地的增
See ISO 9001:2015 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.
NOTE A suitable environment can be a combination of human
and physical factors, such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention,
emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, airflow,
hygiene, noise).
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.
7.1.4
过程操作的环境
见
ISO 9001:2015
的要求。
7.1.4.1
Environment for the operation of processes -
组织应确定、
提供并维护过程运行所需的环境，
以获得supplemental
合格的产品和服务。
注：
适当的过程运行所需的环境可能是人文因素与物理
The organization shall maintain its premises in a state
of order
，
cleanliness
，
and repair that is consistent with
因素的组合，例如：
a)
社会因素（如无歧视的、和谐稳定、无对抗）；
the product and manufacturing process needs.
b)
心理因素（如舒缓心里压力、预防过度疲劳、
保护
个人情感）
c)
物理因素（如：温度、热量、湿度、照明、空气流
通、卫生、噪音）
由于所提供的产品和服务不同，
这些因素可能有显著的
差异。
注：在
ISO 45001
（或等效标准）第三方认证被认可的
情况下，该认证可以证明组织符合本要求的人员安全方
面。
7.1.4.1
过程操作的环境
----
补充
组织应保持生产现场处于与产品和制造过程相协调的
有序、清洁和整理的状态。
7.1.5
Monitoring and measuring resources
7.1.5.1
General
See ISO 9001:2015 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.
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.
The organization shall retain appropriate documented
information as evidence of fitness for purpose of the monitoring
and measurement resources.
7.1.5
监视和测量资源
7.1.5.1
总则
7.1.5.1.1
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 in the control plan. The analytical methods
and acceptance criteria used shall conform to those in
见
ISO 9001:2015
的要求。
reference manuals on measurement systems analysis.
7.1.5.1
总则
Other analytical methods and acceptance criteria may
当利用监视或测量来验 证产品和服务符合要求时，
组织
应确定并提供所需的资源，以确保结果有效和可靠。
be used if approved by the customer.
组织应确保所提供的资源：
a)
适合特定类型的监视和测量活动；
Records of customer acceptance of alternative methods
b)
得到适当的维护，以确保持续适合其用途。
shall be retained along with results from alternative
组织应保留作为监视和测量资源适合其用途的证据的
measurement systems analysis
（
see Section 9.1.1.1
）
.
形成文件的信息。
NOTE Prioritization of MSA studies should focus on
7.1.5.1.1
测量系统分析
应进行统计研究来分析在控制计划所识 别的每种检验、
测量和试验设备系统的结果中呈现的变异。
所采用的分
析方法及接受准 则，
应与测量系统分析的参考手册相一
致。
如果得到顾客的批准，
其他分析方 法和接收准则也
可以应用。
替代方法的顾客接受记录应与替代测量系统分 析的结
果一起保留（见第
9.1.1.1
条）。
注：
测量系统分析研究的优先级应当着重于关键或特殊
产品或过程特性。
7.1.5.2
测量可追溯性
critical or special product or process characteristics.
7.1.5.2
Measurement traceability
See ISO 9001:2015 requirements.
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is
considered by the organization to be an essential part of
providing confidence in the validity of measurement results,
measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior
to use, against measurement standards traceable to
international or national measurement standards; when no
such standards exist, 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
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.
NOTE A number or another identifier traceable to the
见
ISO 9001:2015
的要求。
当要求测量溯源时，
或组织认为测量溯源是信任测量结
device calibration record meets the intent of the
果有效的基础时，测量设备应：
requirements in ISO 9001:2015.
a)
对照能溯源到国际或国家标准的测量标准，按照规
定的时间间隔或在使用前进行校准 和
（或）
检定
（验证）
，
7.1.5.2.1
Calibration/verification records
当不存在上述标准时，应保留作为校准或检定（验证）
The organization shall have a documented process for
依据的形成文件的信息；
managing calibration/verification records.
b)
予以标识，以确定其状态；
c)
予以保护，防止由于调整、损坏或衰减所导致的准
Records of the calibration/verification activity for all
gauges and measuring and test equipment
（
including
状态和随后的测量结果的失效。
当发现测量设备不符合预期用途时，
组织应确定以往测
employee- owned equipment relevant for measuring
，
量结果 的有效性是否受到不利影响，
必要时应采取适当
customer-owned equipment
，
or on-site supplier-owned
的措施。
equipment
）
needed to provide evidence of conformity
注：一个可追溯到装置校准记录的编号或其他标识符，
满足
ISO 9001
：
2015
要求的意图。
to internal requirements
，
legislative and regulatory
requirements
，
and customer-defined requirements
shall be retained.
The organization shall ensure that
calibration/verification activities and records shall
include the following details:
a
）
revisions following engineering changes that
impact measurement systems
；
b
）
any out-of-specification readings as received for
calibration/verification
；
7.1.5.2.1
校准
/
验证记录
组织应有一个形成 文件的过程，用于管理校准
/
验证记
录。
用以提供符合内部要求、
法 律法规要求及顾客规定
c
）
an assessment of the risk of the intended use of
the product caused by the out-of-specification
condition
；
d
）
when a piece of inspection measurement and
要求证明的所有量具、
测量和试验设备
（包括员工拥有
test equipment is found to be out of calibration or
的测量设备、顾客拥有的设备或现场供应商拥有的设
defective during its planned verification or calibration
备），其校准
/
验证活动的记录应予以保持。
or during its use
，
documented information on the
validity of previous measurement results obtained with
组织应确保校准
/
验证活动和记录应包括以下细节：
this piece of inspection measurement and test
a
）
根据影响测量系统的工程更改进行的修订；
b
）
校准
/
验证时获得的任何偏离规范的读数：
equipment shall be retained
，
including the associated
c
）对偏离规范情况导致的产品预期使用风险的评
standard's last calibration date and the next due date
估；
on the calibration report
；
d
）当在计划验证或校准期间，或在其试用期间，
e
）
notification to the customer if suspect product
检验、
测量和试验设备被查出偏离校准或存在缺陷，
应
保留有关此检验、
测量和试验设备先前测量结果有效性
or material has been shipped
；
的形成文件的信息，
包括校准报告上显示的相关标准的
f
）
statements of conformity to specification after
最后一次校准日期和下一次校准到期日；
calibration/verification
；
g
）
verification that the software version used for
f
）校准
/
验证后，有关符合规范的声明；
product and process control is as specified
；
g
）对用于产品或过程控制的软件版本符合规定的
h
）
records of the calibration and maintenance
验证；
activities for all gaugin
（
including employee-owned
h
） 所有量具（包括员工拥有的设备、顾客拥有的
设备或现场供应商拥有的设备）校准和维护活动的记
equipment
，
customer-owned equipment
，
or on-site
supplier-owned equipment
）；
录；
i
）对用于产品和过程控制的生产相关软件的验证
i
）
production-related software verification used for
（包括安装于员工拥有的设备、
顾客拥有的设备或现场
product and process control
（
including software
供应商拥有的设备的软件）。
installed on employee- owned equipment
，
customer-owned equipment
，
or on-site supplier-owned
equipment
）
.
7.1.5.3
Laboratory requirements
7.1.5.3.1
Internal laboratory
An organization's internal laboratory facility shall have a
defined scope that includes its capability to perform the
e
）
如果可疑产品或材料已被发运，
对顾客的通知；
required inspection
，
test
，
or calibration services. This
laboratory scope shall be included in the quality
management system documentation. The laboratory
shall 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
，
7.1.5.3
实验室要求
7.1.5.3.1
内部实验室
组织的内 部实验室设施应有一个确定的范围，
包括其从
事所要求的检验、
试验或校准服务的额能 力。
该实验室
范围应包括在质量管理体系文件中。
实验室至少应为以
下事项明 确规定并实施要求：
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
）
正确执行这些服务的能力，
可 追溯到相关过程
标准（例如：
ASTM
、
EN
等）；如果没有可用的国家或国际标准，
组织应明确并实施一个
验证测量系统能力的方法；
e
）
顾客要求，如有：
f
）
对有关记录的评审。
注：通过
ISO/IEC 17025
（或等效标准）第三方认可可
以证明组织内部实验室符合这个要求。
7.1.5.3.2
外部实验室
为组织提供检验、试验或校准服务的外部
/
商业
/
独立实
验室应有一个确定的范围，包括其从事所要求的检验 、
试验或校准的能力，并且：
-
实验室应通过
ISO/IEC < br>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、试验或校准服务；
校准证书或试验报告应包含国家认可机构的标
志；或
-
应有证据证明该外部实验室可以被顾客接受。
注：
这些证据可以通过顾客评估来证实，
或由顾客批准
traceable to the relevant process standard
（
such as
ASTM
，
EN
，
etc.
）；
when no 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.
NOTE Third-party accreditation to ISO/IEC 17025
（
or
equivalent
）
may be used to demonstrate the
organization's in-house laboratory conformity to this
requirement.
7.1.5.3.2
External laboratory
External/commercial/independent laboratory facilities
used for inspection
，
test
，
or 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 the relevant
inspection
，
test
，
or calibration service in the scope of
the accreditation
（
certificate
）；
the certificate of
calibration or test report shall include the mark of a
national accreditation body
；
or
- there shall be evidence that the external
laboratory is acceptable to the customer.
NOTE Such evidence may be demonstrated by
customer assessment
，
for example
，
or 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
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 7.1.5.3.1 have been met.
Use of calibration services
，
other than by qualified
（
or
customer accepted
）
laboratories
，
may be subject to
government regulatory confirmation
，
if required.
的第二方机构评估，来证明该实验室满足了
ISO/IEC
17025
或等效国家标准的意图。
第二方机构评估可由评
7.1.6
Organizational knowledge
估实验室的组织，采用顾客批准的评估方法进行。
See ISO 9001:2015 requirements.
当某 一设备没有具备资格的实验室时，
校准服务可以由
设
备
制
造
商
进
行
。
在
这
种
情
况
下
，
组
织
应
确
保
第
7.1.5.3.1
条中 的要求得到满足。
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 made available to
the extent necessary.
When addressing changing needs and trends, the organization
shall consider its current knowledge and determine how to
acquire or access any necessary additional knowledge and
required updates.
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 t
he organization’s objectives.
校准服务的采用，除了由具备资格的（或顾客接受的）
NOTE 2 Organizational knowledge can be based on:
实验室提供的以外，
需要时，
可能需要获得政府监管机
a) internal sources (e.g. intellectual property; knowledge gained
构的确认。
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 (e.g. standards; academia; conferences;
gathering knowledge from customers or external providers).
7.1.6
组织知识
见
ISO 9001:2015
的要求。
组织应确定必要的知识，
以运行过程，
并获得合格产品
和服务。
这些知识应予以保持，并能在所需的范围内得到。
为应对不断 变化的需求和发展趋势，
组织应审视现有的
知识，确定如何获取或接触更多必要的知识和知识更
新。
注
1
：组织的知识是组织特有的知识，通常从其经验中
获得，是以实现组织目标所使用和共享的信息。
注
2
：组织的知识可以基于：
a)
内部资源 （例知识产权；从经验获得的知识；从失
败和成功项目吸取的经验教训；
获取和分享未成文的知
识和经验；过程、产品和服务的改进结果）；
b)
外部资源（例如标准；学术交流；专业会议，从顾
客或外部供方收集的知识）。
7.2
Competence
See ISO 9001:2015 requirements.
The organization shall:
a) determine the necessary competence of person(s) doing
work under its control that affects the performance and
effectiveness of the quality management system;
.
b) ensure that these persons are competent on the basis of
appropriate education, training, or experience;
c) where applicable, take actions to acquire the 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.
7.2.1
Competence - supplemental
7.2
能力
The organization shall establish and maintain a
documented process
（
es
）
for identifying training needs
见
ISO 9001:2015
的要求。
including awareness
（
see Section 7.3.1
）
and achieving
组织应：
competence of all personnel performing activities
a)
确定其控制下工作的人员所需具备的能力，
这些人
affecting conformity to product and process
员从事的工作影响质量管理体系绩效和有效性；
requirements. Personnel performing specific assigned
b)
基于适当的教育、培训或经验，确保这些人员是胜
任的；
c)
适用时，采取措施以获取所需的能力，并评价措施
的有效性；
d)
保留适当的成文信息，作为人员能力的证据。
注：
适当措施可以包括对在职人员进行培训、
辅导或重
新分配工作，或者招聘、外包胜任的人员。
7.2.1
能力
----
补充
组织应建立并保持形成文件的过程，
识 别包括意识
（见
第
7.3.1
条）在内的培训需求，并使所有从事影响产品< br>要求和过程要求符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，
尤其关注对顾客要求
的满足。
7.2.2
能力
----
在职培训
对于承担影响质量要 求、
内部要求、
法规或法律要求符
合性的新的或调整职责的人员，
组织应对其 进行在职培
训
（其中还应包括顾客要求培训）
，
包括合同工或代理
工 。
在职培训的详细程度应与人员的教育程度及其要在
日常工作中执行的任务的复杂程度相称。< br>从事影响质量
的工作人员应被告知不符合顾客要求的后果。
tasks shall be qualified
，
as required
，
with particular
attention to the satisfaction of customer requirements.
7.2.2
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 conformity to quality requirements
，
internal
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 and the complexity of the task
（
s
）
they are required to perform for their daily work.
Persons whose work can affect quality shall be
informed about the consequences of nonconformity to
customer requirements.
7.2.3
Internal auditor competency
The organization shall have a documented process
（
es
）
to verify that internal auditors are competent
，
taking
into account any
requirements defined by the
organization and/or
customer-specific requirements.
For additional guidance on auditor competencies
，
refer
to ISO 19011. The organization shall maintain a list of
qualified internal auditors.
Quality management system auditors shall be able to
demonstrate the following minimum competencies:
a
）
understanding of the automotive process
approach for auditing
，
including risk-based thinking
；
b
）
understanding of applicable customer-specific
requirements
；
c
）
understanding of applicable ISO 9001 and IATF
16949 requirements related to the scope of the audit
；
d
）
understanding of applicable core tool
requirements related to the scope of the audit
；
e
）
understanding how to plan
，
conduct
，
report
，
and close out audit findings.
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.
7.2.3
内部审核员能力
组织应有 形成文件的过程，用于验证内部审核员的能
力，要考虑到
组织规定的要求和
/
或
顾客特定要求。关
于审核员能力的更多参考，参见
ISO
19011
。组织应
保持一份合格内部审核员名单。
质量管理体系审核员应
能够证实最少具备以下能力：
a
）
了解汽车审核过程方法，包括基于风险的思
维；
b
）
了解适用的顾客特定要求；
c
）
了解
ISO 9001
和
IATF 16949
中适用的与审核
范围有关的要求；
d
）
了解与审核范围有关的适用的核心工具要求；
e
）
了解如何计划审核、
实施审核、
报告审核以及
关闭审核发现。
至少
，
制造过程审 核员还应证实对于待审核的相关制造
过程，其具有技术知识，包括过程风险分析（例如
PFME A
）和控制计划。
至少
，
产品审核员还应证 实其了解产品要求，
并能够使
用相关测量和试验设备验证产品符合性。
如果由组织的人员提供培训
来取得人员能力的情况 下，
应保留形成文件的信息，
证实培训师的能力符合上述要
求。
内部审核员能力的维持与改进应通过以下方法进行证
实：
a
）
每年执行组织规定的最小数量的审核，并且
b
）
保持基于内部更改
（如：
过程技术、
产品技 术）
和外部更改（如：
ISO 9001
、
IATF 16949
、核
心工具及顾客特定要求）对相关要求的认知。
7.2.4
第二方审核员能力
组织应证实从事第二方审核的审核员的能力。
第二方审
核员应符合顾客对审核员资质的特定要求，
并证实最少
具备以下核心 能力，包括了解：
a
）
汽车审核过程方法，包括基于风险的思维；
b
）
适用的顾客特定和组织特定要求；
c
）
ISO 9001
和
IATF 16949
中适用的与审核范围有关
At a minimum,
product auditors shall demonstrate
competence in understanding product requirements
and use of relevant measuring and test equipment to
verify product conformity.
If the organization
’
s personnel provide the training to
achieve competency
，
documented information shall be
retained to demonstrate the trainer
’
s competency with
the above requirements.
Maintenance of and improvement in internal auditor
competence shall be demonstrated through:
f
）
executing a minimum number of audits per
year
，
as defined by the organization
；
and
g
）
maintaining knowledge of relevant
requirements based on internal changes
（
e.g.
，
process
technology
，
product technology
）
and external changes
（
e.g.
，
ISO 9001
，
IATF 16949
，
core tools
，
and customer
specific requirements
）
.
7.2.4
Second-party auditor competency
The organization shall demonstrate the competence of
the auditors undertaking the second-party audits.
Second-party auditors shall meet customer specific
requirements for auditor qualification and demonstrate
the minimum following core competencies
，
including
understanding of:
a
）
the automotive process approach to auditing
，
including risk based thinking
；
b
）
applicable customer and organization specific
requirements
；
c
）
applicable ISO 9001 and IATF 16949
requirements related to the scope of the audit
；
d
）
applicable manufacturing process
（
es
）
to be
audited
，
including PFMEA and control plan
；
e
）
applicable core tool requirements related to the
scope of the audit
；
f
）
how to plan
，
conduct
，
prepare audit reports
，
and close out audit findings.
7.3
Awareness
See ISO 9001:2015 requirements.
The organization shall ensure that persons doing work under
the organization’s control are aware of:
a) the quality policy;
的要求；
e
）
与审核范围有关的适用的核心工具要求；
f
）
如何计划审核、实施审核、编制审核报告并关闭审
核发现。
b) relevant quality objectives;
management system, including the benefits of improved
performance;
d) the implications of not conforming with the quality
management system requirements.
d
）
适用的待审核制造过程，
包括
PFMEA
和控制计划；
c) their contribution to the effectiveness of the quality
requirements and the risks involved for the customer
with non- conforming product.
见
ISO 9001
：
2015
的要求。
组织应确保在其控制下工作人员知晓：
a)
质量方针；
7.3.2
Employee motivation and empowerment
b)
相关的质量目标；
The organization shall maintain a documented process
c)
他们对质量管理体系有效性的贡献，包括改进质量
（
es
）
to motivate employees to achieve quality
绩效的益处；
objectives
，
to make continual improvements
，
and to
d)
不符合质量管理体系要求的后果。
create an environment that promotes innovation. The
process shall include the promotion of quality and
technological awareness throughout the whole
organization.
7.3.1
意识
——
补充
组织应保持形成文件的信息，
证实所有员工都认识到其
7.4
Communication
对产品质量的影响，
以及他们所从事的活动在实现、
保
See ISO 9001:2015 requirements.
持并改进质量中的重要性，
还包括顾客要求及不合格品
带给顾客的风险。
The organization shall determine the internal and external
communications relevant to the quality management system,
including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
7.3
意识
7.3.1
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
7.3.2
员工激励和授权
组织应保持形成文件的信息，激励员工实现质量目标，
d) how to communicate;
e) who communicates.
进行持续改进，
并建立一个提倡创新的环境。
该过程应
7.5
Documented information
包括促进整个组织对质量和技术的认知程度。
7.5.1
General
See ISO 9001:2015 requirements.
The organization’s quality management system shall include:
a) documented information required by this International
Standard;
b) documented information determined by the organization as
7.4
沟通
being necessary for the effectiveness of the quality management
system.
见
ISO 9001:2015
的要求。
NOTE The extent of documented information for a quality
management system can differ from one organization to
another due to:
—
the size of organization and its type of activities, processes,
products and services;
—
the complexity of processes and their interactions;
—
the competence of persons.
组织应确定与质量管理体系相关的内部和外部沟通，
包
括：
a)
沟通什么；
b)
何时沟通；
c)
与谁沟通；
d)
如何沟通；
e)
由谁沟通。
7.5
形成文件的信息
7.5.1
总则
见
ISO 9001:2015
的要求。
7.5.1.1
Quality management system documentation
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.
The quality manual shall include
，
at a minimum
，
the
following:
a
）
the scope of the quality management system
，
组织的质量管理体系应包括：
a)
本标准要求的成文信息；
b)
组织确定的为确保质量管理体系有效运行所需的成
文信息。
注：
对于不同组织，
质量管理体系成文信息的多少与详
略程度可不同，取决于：
--
组织的规模，以及活动、过程、产品和服务的类
型；
--
过程及其相互作用的复杂程度；
--
人员的能力。
including details of and justification for any exclusions
；
b
）
documented processes established for the
quality management system
，
or reference to them
；
7.5.1.1
质量管理体系文件
c
）
the organization
’
s processes and their sequence
组织的质量管理体系应形成文件，并包括一份质量手
and interactions
（
inputs and outputs
），
including type
册，可由一系列（电子或硬拷贝形式的）文件构成。
and extent of control of any outsourced processes
；
d
）
a document
（
for example, a table, a list, or a
质量手册的格式和结构由组织自行决定，
将取决于组织
matrix
）< br>indicating where within the organization's
的规模、
文化和复杂性。
如果采用一系列文件，
则应保
quality management system their customer-specific
留一份构成组织质量手册文件的清单。
requirements are addressed.
质量手册应至少包含以下内容：
a
）
质量管理体系的范围，
包括任何删减的细节和
正当的理由；
b
）
为管理体系建立的形成文件的过程或对其引
用；
c
）
组织的过程及其顺序和相互作用（输入和输
出），包括任何外 包过程控制的类型和程度；
d
）
一个显示组织质量管理体系内哪 些地方满足
了顾客特定要求的文件（
如：一张表格，清单
或矩阵）
。
注：可采用一个显示组织过程如何满足本汽车
QMS
标
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
，
7.5.2
Creating and updating
See ISO 9001:2015 requirements.
When creating and updating documented information, the
准要求的矩阵来辅助在组织过程与本汽车
QMS
标准之
间建立联系。
organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or
reference number);
b) format (e.g. language, software version, graphics) and media
(e.g. paper, electronic);
c) review and approval for suitability and adequacy.
7.5.3
Control of documented information
7.5.3.1 and 7.5.3.2
See ISO 9001:2015 requirements.
7.5.3.1 Documented information required by the quality
management system and by this International Standard shall be
controlled to ensure:
a) it is available and suitable for use, where and when it is
needed;
b) it is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the
organization shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
7.5.2
创建和更新
见
ISO 9001:2015
的要求。
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
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.
Documented information retained as evidence of conformity
shall be protected from unintended alterations.
NOTE Access can imply a decision regarding the permission to
view the documented information only, or the
permission and authority to view and change the documented
information.
在创建和更新成文信息时，组织应确保适当的：
a)
标识和说明（如：标题、日期、作者、索引编号）；
b)
形式（如语言、软件版本、图表）和载体（如纸质
的、电子的）；
c)
评审和批准，以确保适宜性和充分性。
7.5.3
成文信息的控制
7.5.3.1
和
7.5.3.2
见
ISO 9001:2015
的要求。
7.5.3.2.1
Record retention
7.5.3.1
应控制质量管理体系和本标准所要求的成文信
The organization shall define
，
document
，
and
息，以确保：
implement a record retention policy. The control of
b)
予以妥善保护（如防止泄密、不当使用或缺失）。
records shall satisfy statutory
，
regulatory
，
organizational
，
and customer requirements.
7.5.3.2
为控制成文信息，适用时，组织应进行下列活
动：
Production part approvals
，
tooling records
（
including
a)
分发、访问、检索和使用；
maintenance and ownership
），
product and process
b)
存储和防护，包括保持可读性；
design records
，
purchase orders
（
if applicable
），
or
c)
变更控制（如版本控制）；
contracts and amendments shall be retained for the
d)
保留和处置。
对于组织确定的策划和运行质量管理体系所需的来自
length of time that the product is active for production
外部的成文信息，组织应进行适当识别，并予以控制。
and service requirements
，
plus one calendar year
，
unless otherwise specified by the customer or
a)
在需求的场合和时机，均可获得并适用；
对所保留的、作为符合性证据的成文信息应予以保护，
regulatory agency.
防止非预期的更改。
注：对成文信息的“访问”可能意味着仅允许查阅，或
NOTE Production part approval documented
意味着允许查阅并授权修改。
7.5.3.2.1
记录保存
组织应有一个确定的、
形成文件的并且被执行的记录保
存 政策。
对记录的控制应满足法律法规、
组织及顾客要
求。
应保存生产件批准文件、工装记录（包括维护和所有
权）、产品和过程设计记录、采购订单（如适用） 或者
合同和修正，
保存时间为产品在现行生产和服务中要求
的有效期，
再加一 个日历年，
除非顾客和监管机构另有
特殊要求。
注：
生产件批准形 成文件的信息可包括已批准产品、
适
用的试验设备记录或已批准试验数据。
7.5.3.2.2
工程规范
组织应有形成文件的过程，
描述基于顾客要求的进度进
行 的所有顾客工程标准
/
规范及相关修订的评审、分发
和实施。
当工程标准
/
规范更改导致产品设计更改时，
请参见
ISO
9001
第
8.3.6
条的要求。
当工程标准
/
规范更改 导致产品
组织应保留每项更改在生产中实施日期的记录。
实施应
包括更新过的文件。< br>
应当在收到工程标准
/
规范更改通知后
10
个工 作日内完
成评审。
注：
当设计记录引用了这些规范，
或 这些规范影响了生
产件批准过程的文件，例如：控制计划、风险分析（如
FMEA
）< br>等时，
这些标准
/
规范的更改需要对顾客的生产
informatio n may include approved product
，
applicable
test equipment records
，
or approved test data.
7.5.3.2.2
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 8.3.6. When an
engineering standard/specification change results in a
product realization process change
，
refer to the
requirements in Section 8.5.6.1. The organization shall
retain a record of the date on which each change is
implemented in production. Implementation shall
include updated documents.
Review should be completed within 10 working days of
receipt of notification of engineering
standards/specifications changes.
NOTE A 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
production part approval process
，
such as control plan
，
risk analysis
（
such as FMEAs
），
etc.
8
Operation
8.1
Operational planning and control
实现过程更改时，
请参见
ISO 9001
第
8.5.6.1
条的要求
.
See ISO 9001:2015 requirements.
The organization shall plan, implement and control the
processes (see 4.4) needed to meet the requirements for the
provision of products and services, and to implement the
actions determined in Clause 6, by:
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
件批准记录进行更新。
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:
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 action to mitigate
any adverse effects, as necessary.
The organization shall ensure that outsourced processes are
controlled (see 8.4).
8
运行
8.1
运行策划和控制
8..1.1
Operational planning and control -
见
ISO 9001:2015
的要求。
supplemental
为满足产品和服务提供的要求，并实施第
6
章确 定的措
施，组织应通过以下措施对所需的过程（见
4.4
）进行
When planning for product realization
，
the following
topics shall be included:
策划、实施和控制：
a
）
customer product requirements and technical
a)
确定产品和服务的要求；
b)
建立下列内容的准则：
specifications
；
1)
过程；
b
）
logistics requirements
；
2)
产品和服务的接收。
c
）
manufacturing feasibility
；
c)
确定所需的资源以使产品和服务符合要求；
d)
按照准则实施过程控制；
d
）
project planning
（
refer to ISO 9001
，
Section
e)
在必要的范围和程度上，
确定并保持、保留成文信
8.3.2
）；
e
）
acceptance criteria.
息，以：
1)
确信过程已按策划进行；
2)
证明产品和服务符合要求。
The resources identified in ISO 9001
，
Section 8.1 c
），
策划的输出应适于组织的运行。
refer to the required verification
，
validation
，
组 织应控制策划的变更，
评审非预期变更的后果，
必要
monitoring
，
measurement
，
inspection
，
and test
时，采取措施减轻不利影响。
activities specific to the product and the criteria for
组织应确保外包过程受控（见
8.4
）。
product acceptance.
8.1.1
运行策划和控制
----
补充
在对产品实现进行策划时，应包含以下主题：
a
）
顾客产品要求和技术规范；
8.1.2
Confidentiality
The organization shall ensure the confidentiality of
customer- contracted products and projects under
development
，
including related product information.
8.2
Requirements for products and services
8.2.1
Customer communication
See ISO 9001:2015 requirements.
Communication with customers shall include:
a) providing information relating to products and services;
b
）
物流要求；
c
）
制造可行性；
d
）
项目策划（参加
ISO 9001
第
8.3.2
条）；
e
）
接受准则。
ISO 9001
第
8.1
条
c< br>）
项中的资源是指所要求的产品特
定的验证、确认、监视、测量、检验和试验活动以及产
品接收准则。
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 actions,
when relevant.
8.2.1.1
Customer communication - supplemental
Written or verbal communication shall be in the
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
（
e.g.
，
computer-aided
design data
，
electronic data interchange
）
.
8.2.2
Determining the requirements for products
8.1.2
保密
and services
组织应确保正在开发中的顾客签约产品和项目及有关
See ISO 9001:2015 requirements.
产品信息的保密。
When determining the requirements for the products and
services to be offered to customers, the organization shall
ensure that:
a) the requirements for the products and services are defined,
including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and
services it offers.
8.2
产品和服务要求
8.2.1
顾客沟通
见
ISO 9001:2015
的要求。
与顾客沟通的内容应包括：
a)
提供有关产品和服务的信息；
b)
处理问询，合同或订单，包括更改；
c)
获取有关产品和服务的顾客反馈，包括顾客抱怨；
d)
处置或控制顾客财产；
e)
关系重大时，制定应急措施的特定要求。
8.2.1.1
顾客沟通
----
补充
应按顾客同意的 语言进行书面或口头沟通。
组织应有能
力按顾客规定的语言和形式来沟通必要的信息，
包括按
顾客规定的计算机语言和格式的数据
（例如：
计算机辅
助设计数据、电 子数据交换等）。
8.2.2.1
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.
Compliance to ISO 9001
，
Section 8.2.2 item a
）
1
），
shall include but not be limited to the following: all
applicable government
，
safety
，
and environmental
regulations related to acquisiti on
，
storage
，
handling
，
recycl ing
，
elimination
，
or disposal of material.
8.2.3
Review of the requirements for products and
services
8.2.3.1
8.2.2
与产品和服务要求的确定
见
ISO 9001:2015
的要求。
在确定向顾客提供的产品和服务的要求时，组织应确
保：
a)
产品和服务的要求得到规定，包括：
1)
适用的法律法规要求；
2)
组织认为的必要要求。
b)
提供的产品和服务能够满足所声明的要求。
8.2.2.1
与产品和服务要求的确定
----
补充
这些要求应包括回收再利用 、
对环境的影响，
以及根据
组织对产品和制造过程的认知所识别的特性。
遵守
ISO 9001
第
8.2.2
条
a
）
1
）
项的要求应包括但不限
于：
所有适用的与材料的获得、存储 、搬运、回收、销毁或
废弃有关的政府。安全和环境法规。
See ISO 9001:2015 requirements.
8.2.3.1 The organization shall ensure that it has the ability to
meet the requirements for products and services to be offered
to customers. The organization shall conduct a review before
committing to supply
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;
c) requirements specified by the organization;
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.
NOTE In some situations, such as internet sales, a formal review
is impractical for each order. Instead, the review can cover
relevant product information, such as catalogues.
8.2.3.1.1
Review of the requirements for products
8.2.3.1
and services
—
supplemental
The organization shall retain documented evidence of a
见
ISO 9001:2015
的要求。
customer-authorized waiver for the requirements
8.2.3.1
组织应确保有能力向顾客提供满足要求的产品
stated in ISO 9001
，
Section 8.2.3.1
，
fora formal review.
和服务。
在承诺向顾客提供产品和服务之前，
组织应对
如下各项要求进行评审：
a)
顾客规定的要求，
包括对交付和交付后活动的要求；
8.2.3.1.2
Customer-designated special characteristics
b)
顾客虽然没有明示，但规定的用途或已知的预期用
The organization shall conform to customer
途所必需的要求；
requirements for designation
，
approval
c)
组织规定的要求；
documentation
，
and control of special characteristics.
d)
适用于产品和服务的法律法规要求；
e)
与以前表述不一致的合同或订单要求。
8.2.3
产品和服务要求的评审
若与先期的的合同或订单的 要求存在差异，
组织应确保
有关事项已经得到解决。
若顾客没有提供成文的要求，
组织在接受顾客要求前应
对顾客要求进行确认。
注：
在某些情况下，
如网上销售，
对每一个订单进行正
式的评审可能 是不实际的。
作为替代方法，
可评审有关
的产品信息，如产品目录。
8.2.3.1.3
Organization manufacturing feasibility
The organization shall utilize a 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 analysis for
any manufacturing or product technology new to the
8.2.3.1.1
产品和服务要求的评审
----
补充
organization and for any changed manufacturing
process or product design.
Additionally
，
the organization should validate through
production runs
，
benchmarking studies
，
or other
appropriate methods
，
their ability to make product to
组织应保留形成文件的证据，
证明对
ISO 9001
第
8.2.3.1
specifications at the required rate.
条中正式评审要求的弃权有顾客授权。
8.2.3.2
See ISO 9001:2015 requirements.
8.2.3.1.2
顾客指定的特殊特性
组织应符合顾客对特殊特性的指定、
批准文件和控制的
要求。
8.2.3.1.3
组织制造可行性
组织应采用多方论证方法 来进行分析，
以确定组织的制
造过程是否是可行的，
能够始终生产出符合顾客规定的< br>全部工程和产能要求的产品。
组织应为任何对其而言新
的制造或产品技术，
以及 任何更改过的制造过程或产品
8.2.3.2 The organization shall retain documented information,
as applicable:
a) on the results of the review;
b) on any new requirements for the products and services.
8.2.4
Changes to requirements for products and
services
See ISO 9001:2015 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.
设计进行可行性分析。
8.3
Design and development of products and
services
此外，
组织应当通过生产运行、
标杆管理研究或其他适
8.3.1
General
当的方法，
确认其能够以所要求的速率生产出符合规范
See ISO 9001:2015 requirements.
的产品。
The organization shall establish, implement and maintain a
design and development process that is appropriate to ensure
the subsequent provision of products and services.
8.3.1.1
Design and development of products and
services
—
supplemental
The requirements of ISO 9001
，
Section 8.3.1
，
shall apply
to product and manufacturing process design and
development and shall focus on error prevention rather
8.2.3.2
than detection.
见
ISO 9001:2015
的要求。
8.2.3.2
适用时，组织应保留与下列方面有关的成文信
The organization shall document the design and
息：
development process.
a)
评审结果；
b)
产品和服务的新要求。
8.3.2
Design and development planning
See ISO 9001:2015 requirements.
8.2.4
产品和服务要求的更改
In determining the stages and controls for design and
development, the organization shall consider:
a) the nature, duration and complexity of the design and
见
ISO 9001:2015
的要求。
development activities;
b) the required process stages, including applicable design and
development reviews;
c) the required design and development verification and
validation activities;
d) the responsibilities and authorities involved in the design
若产品和服务要求发生更 改，
组织应确保相关的成文信
息得到修改，并确保相关人员知道已更改的要求。
8.3
产品和服务的设计和开发
8.3.1
总则
见
ISO 9001:2015
的要求。
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;
g) the need for involvement of customers and users in 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
relevant interested parties;
j) the documented information needed to demonstrate that
design and development requirements have been met.
组织应建立、
实施和保持适当的设计和开发过程，
以便
确保后续的产品和服务的提供。
8.3.1.1
产品和服务的设计和开发
----
补充
ISO
9001
第
8.3.1
条的要求应适用于产品和制造过程
的设计和开发，并且应着重于错误预防，而不是探测。
组织应对设计和开发过程形成文件。
8.3.2.1
Design and development planning
—
supplemental
8.3.2
设计和开发策划
The organization shall ensure that design and
development planning includes all affected
见
ISO 9001:2015
的要求。
stakeholders within the organization and
，
as
在确定设计和开发的各个阶段和控制时，组织应考虑：
appropriate
，
its supply chain. Examples of areas for
a)
设计和开发活动的性质、持续时间和复杂程度；
using such a multidisciplinary approach include but are
b)
所需的过程阶段，包括适用的设计和开发评审；
not limited to the following:
c)
所需的设计和开发的验证及确认活动；
a
）
project management
（
for example
，
APQP or
d)
设计和开发过程涉及的职责和权限；
e)
产品和服务的设计和开发所需的内部和外部资源；
VDA- RGA
）；
b
）
product and manufacturing process design
f)
设计和开发过程参与人员之间接口的控制需求；
activities
（
for example
，
DFM and DFA
），
such as
g)
顾客和使用者参与设计和开发过程的需求；
consideration of the use of alternative designs and
h)
对后续产品和服务提供的要求；
i)
顾客和其他相关方期望的设计和开发过程的控制水
manufacturing processes
；
平；
c
）
development and review of product design risk
j)
证实已经满足设计和开发要求所需的成文信息。
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
，
manufacturin g
，
engineering
，
quality
，
production
，
purchasing
，
supplier
，
maintenance
，
and other appropriate functions.
8.3.2.1
设计和开发策划
----
补充
组织应确保设计和开发策划含该组织内部所有受影响
的利益相关者及其
（适当的）
供应 链。
使用多方论证方
法的方面包括但不限于：
a
）
项目管理（例如：
APQP
或
VDA-RGA
）；
b
）
产品和制造过程设计活动
（如：
DFM
和< br>DFA
）
，
例如：考虑使用替代的设计和制造过程；
c
）
产品设计风险分析（
FMEA
）的开发和评审，包括降低潜在风险的措施；
d
）
制造过程风险分析（如：< br>FMEA
、过程流程、
控制计划和标准的工作指导书）的开发和评
审。
注：多方论证方法通常包括组织的设计、制造、工程、
质量、生产、采购、供应、维护和其它适 当职能。
8.3.2.2
产品设计技能
组织应确 保负有产品设计职责的人员有能力达成设计
要求，
并具备适用的产品设计工具和技术技能。适合的
工具和技术应得到组织的识别。
注：
基于数学的数字化数据的应用便是一种产品设计技
能。
8.3.2.3
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。
组织应按照风险和对顾客潜在影响的
组织应将软件开发纳入其内部审核方案的范围（见第
9.2.2.1
条）。
8.3.2.2
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.
NOTE An example of product design skills is the
application of digitized mathematically based data.
8.3.2.3
Development of products with embedded
software
The organization shall use a process for quality
assurance for their products with internally developed
embedded software
，
A software development
assessment methodology shall be 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.
The organization shall include software development
within the scope of their internal audit programme
（
see
Section 9.2.2.1
）
.
8.3.3
Design and development inputs
See ISO 9001:2015 requirements.
The organization shall determine the requirements essential for
the specific types of products and services to be designed and
developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and
development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has
committed to implement;
e) potential consequences of failure due to the nature of the
products and services.
Inputs shall be adequate for design and development purposes,
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on
design and development inputs.
优先级，为软件开发能力自评估保留形成文件的信息。
complete and unambiguous.
8.3.3.1
Product design input
The organization shall identify
，
document
，
and review
8.3.3
设计和开发输入
见
ISO 9001:2015
的要求。
组织应针对所设计和开发的具体类型的产品和服务，< br>确
定必需的要求，要求应考虑：
a)
功能和性能要求；
b)
来源于以前类似设计和开发活动的信息；
c)
法律法规要求；
d)
组织承诺实施的标准或行业规范；
e)
由产品和服务性质所导致的潜在失效后果。
针对设计和开发的目的，
输入应是充分和适宜的，
且应
完整、清楚。
相互矛盾的设计和开发输入应得到解决。
组织应保留有关设计和开发输入的成文信息。
8.3.3.1
产品设计输入
组织应对作为合同评 审结果的产品设计输入要求进行
识别、
形成文件并进行评审。
产品设计输入要求包括但
不限于：
a
）
产品规范，包括但不限于特殊特性（见第
8.3.3.3
条）；
b
）
边界和对接要求；
c
）
标识、可追溯性和包装；
d
）
对涉及的替代选择的考虑；
e
）
对输入要求风险的评估 ，以及对组织缓解
/
管
理风险
（包括来自可行性分析的风险）
的能力
的评估；
f
）
产品要求符合性的目标，包括防护、可靠 性、
耐久性、可服务性、健康、安全、环境、开发
时程安排和成本等方面；
g
）
顾客确定的目的国
（如有提供）
的使用法律法
规要求；
h
）
嵌入式软件的要求。
组织应有一个过程，
将从以前的设计项目、
竞争产品分
析（标杆）、供应商反馈、 内部输入、使用现场数据和
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 including but not limited
to special characteristics
（
see Section 8.3.3.3
）；
b
）
boundary and interface requirements
；
c
）
identification
，
traceability
，
and packaging
；
d
）
consideration of design alternatives
；
e
）
assessment of risks with the input requirements
and the organization's ability to mitigate/manage the
risks
，
including from the feasibility analysis
；
f
）
targets for conformity to product requirements
including preservation
，
reliability
，
durability
，
servi ceability
，
health
，
safety
，
en vironmental
，
development timing
，
and cost
；
g
）
applicable statutory and regulatory
requirements of the customer-identified country of
destination
，
if provided
；
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.
8.3.3.2
Manufacturing process design input
The organization shall identify
，
document
，
and review
manufacturing process design input requirements
including but not limited to the following:
a
）
product design output data including special
characteristics
；
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
；
g
）
product handling and ergonomic requirements
；
and
h
）
design for manufacturing and design for
assembly.
The manufacturing process design shall include the use
其他相关资源中获取的信息，
推广应用于当前和未来相
似性质的项目。
注：使用权衡曲线是考虑设计的替代选择的一种方法。
8.3.3.2
制造过程设计输入
组织应对制造过 程设计输入要求进行识别、
形成文件并
进行评审，包括但不限于：
a
）
产品设计输出的数据，包括特殊特性；
b
）
生产力、过程能力、时程安排及成本的目标；
c
）
制造技术替代选择；
d
）
顾客要求，如有；
e
）
以往的开发经验；
f
）
新材料；
g
）
产品搬运和人体工学要求；以及
h
）
制造设计和装配设计。
制造过程设计应包括，
针对问题适当的重 要性程度，
和
所遭遇到的风险相称的程度来使用防错方法。
8.3.3.3
特殊特性
组织应采用多方论证方法来建立、
形成文件并实施用于
识别特殊特性的过程，
包括顾客确定的以及组织风险分
析所确定的特殊特性，应包括：
a)
将特殊特性记录进产品和
/
或生产文件（按要
求）、相关风险分析（例如过程FMEA
）、控
制计划和标准的工作
/
操作说明书；特殊特性
用 特定的标记进行标识，
并且记录在创建的生
产文件中，或者对于这些特殊特性要求的控
制；
b)
为产品和生产过程的特殊特性开发控制和监
视策略；
c)
顾客规定的批准，如有要求；
d)
遵循顾客规定的定义和符号或 组织的等效符
号或标记，如符号转换表所示。如有要求，应
向顾客提交符号转换表。
of error-proofing methods to a degree appropriate to
the magnitude of the problem
（
s
）
and commensurate
with the risks encountered.
8.3.3.3
Special characteristics
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:
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
；
b
）
development of control and monitoring
strategies for special characteristics of products and
production processes
；
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.
8.3.4
Design and development controls
See ISO 9001:2015 requirements.
The organization shall apply controls to the design and
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 requirements for the
specified application or intended use;
e) any necessary actions are taken on problems determined
during the reviews, or verification and validation activities;
f) documented information of these activities is retained.
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.
8.3.4
设计和开发控制
见
ISO9001
：
2015
的要求
组织应对设计和开发过程进行控制，以确保：
a)
规定拟获得的结果；
b)
实施评审活动，以评价设计和开发的结果满足要求
的能力；
c)
实施验证活动，以确保设计和开输出满足输入的要
求；
d)
实施确认活动，以确保产品和服务能够满足规定的
使用要求或者预期用途；
e)
针对评审、验证和确认过程中确定的问题采取必要
措施；
f)
保留这些活动的成文信息。
注：设计和开发的评审、验证 和确认具有不同的目的。
根据组织的产品和服务的具体情况，
可单独或以任意组
合的方 式进行。
8.3.4.1
监视
产品和过程的设计和开发期间特定阶段的测量应被确
定、
分析 ，
以汇总结果的形式来报告，
作为对管理评审
的输入（见第
9.2.2.1< br>条）。
在顾客有要求时，
应在顾客规定或同意的阶段向顾客报告对产品和过程开发活动的测量。
注：
在适当的情况下，
这 些测量可包括质量风险、
成本、
前置期、关键路径和其它测量。
8.3.4.2
设计和开发确认
应根据顾客要求，
包括适用的行业和政府机构发布的监
8.3.4.1
Monitoring
Measurements at specified stages during the design
and development of products and processes shall be
defined
，
analysed
，
and reported with summary results
as an input to management review
（
see
Section9.3.2.1
）
.
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.
NOTE When appropriate
，
these measurements may
include quality risks
，
costs
，
lead times
，
critical paths
，
and other measurements.
8.3.4.2
Design and development validation
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 customer-specified timing
，
as
applicable.
Where contractually agreed with the customer
，
this
shall include evaluation of the interaction of the
organization's product
，
including embedded software
，
within the system of the final customer's product.
8.3.4.3
Prototype programme
When required 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 to requirements.
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 8.4
）
.
8.3.4.4
Product approval process
The organization shall establish
，
implement
，
and
maintain a product and manufacturing approval
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