4.1 Understanding of the organization  and its context理解组织及其环境

Has the organization determined  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? 组织是否已确定了与其目标和战略方向相关并影响其实现质量管理体系预期结果的各种外部和内部因素？

4.1 Understanding of the  organization and its context理解组织及其环境

Is information on changes in the  context systematically presented in the Management Review?

Have they been considered as inputs  for scope definition and identification of risks and opportunities? opportunities?

环境变化的信息是否系统化地提交给管理评审？是否在定义范围和确定风险及机遇时被考虑？

How does organization monitor and review the information about external  and internal issues?组织是如何对这些内部和外部因素的相关信息进行监视和评审的？

4.2 Understanding the needs and expectations  of interested parties理解相关方的需求和期望

Has the organization determined the following?组织是否确定了下述内容：

a)The interested parties that are  relevant to the quality management system;与质量管理体系有关的相关方;

b)The requirements of these  interested parties that are relevant to the quality management system.与质量管理体系相关的相关方要求.

Is information on changes in the  context systematically presented in the Management Review?相关方及其要求变化的信息是否系统化地提交给管理评审？

Have they been considered as input  for scope definition and identification of risks and opportunities?是否在定义范围和确定风险及机遇时被考虑？

How does organization monitor and  review the information about the interested parties and the relevant requirements?

组织是如何对相关方及其要求进行监视和评审的？

4.3 Determining the scope of the  quality management system.确定质量管理体系的范围

Is scope of the QMS documented,  and justification for any scope exclusions?质量管理体系范围是否文件化？是否对任何不适用条款要求进行了合理解释？

4.3.1&2 IATF 16949

Is there a statement in QMS for  Customer Specific Requirements evaluation? 在质量管理体系中是否有针对顾客特定要求的评价的声明？

4.4 [Quality management system and its processes]确质量管理体系及其过程

Has the organization determined the processes needed for the QMS and (underlined items  are new):
 组织是否确定了质量管理体系所需的过程和（下划线的是新条款）

a) determined   the inputs required and the outputs expected from these processes;
 确定这些过程所需的输入和期望的输出；

b) determined the sequence and interaction of  these processes;
 确定这些过程的顺序及其接口；

c) determined an applied the criteria and methods  (including monitoring, measurements and related performance indicators)  needed to ensure the effective operation, and control of these processes;
 确定和应用所需的准则和方法（包括监视、测量和相关绩效指标），以确保这些过程的运行和有效控制；

d) determined the resources needed and ensure  their availability;
 确定并确保获得这些过程所需的资源；

e) assigned the responsibilities and  authorities for these processes;
 规定与这些过程相关的责任和权限；

f) addressed the risks and opportunities as  determined in accordance with the requirements of 6.1, 
 应对按照6.1要求所确定的风险和机遇；

g) evaluated these processes and implemented  any changes needed to ensure the processes  achieve their intended results;
 评价这些过程，实施所需的变更，以确保实现这些过程的预期结果；

h) improved the processes and the quality management system.

改进过程和质量管理体系

How does the organization maintain documented information to support operations & retain  documented information; to have confidence that the processes are  carried out as planned?

组织如何在必要的程度上，保持形成文件的信息以支持过程运行，和保留确认其过程按策划进行的形成文件的信息。

4.4.1.1 IATF 16949

How is conformance of all products  & services ensured, including service parts, and regulatory obligations?

组织如何确保所有产品和过程，包括服务件及适用的法律法规要求？

4.4.1.2 IATF 16949

Where is documented process for product  safety and does it include 4.4.1.2 a) - through m) requirements?  是否形成用于与产品安全管理的文件的过程？该文件是否包括了4.4.1.2 a) ~m)全部要求？

5.1.1

[Leadership and  commitment - General]领导作用和承诺-总则

How does top management demonstrate  leadership and commitment to the QMS?

最高管理者如何证实其对质量管理体系的领导作用和承诺？

Do they take a leading role and  understand their duties in promoting and supporting the QMS?

他们是否担当起一个有效的领导角色，清楚他们推动和支持质量管理体系的责任？

·       Taking accountability of the effectiveness of  the QMS对质量管理体系的有效性承担责任；

·      Connection to strategic direction  连接到战略方向

·       Integration of requirements into the  organization’s business processes.把要求融入组织的业务过程

·      Promoting awareness of process approach and risk  based thinking促进过程方法和基于风险的思维的意识

·      Engaging, directing and supporting persons to  contribute to the QMS促使、指导和支持员工对质量管理体系的贡献

5.1.1.1 IATF 16949

Where is corporate responsibilities  / policies including anti bribery, code of conduct, ethics escalation, and  whistle blowing policy been addressed?   在哪里确定了公司的责任/政策，包括了反贿赂方针，行为准则，道德准则升级政策和“举报政策”？

5.1.1.2 IATF 16949

Where is process effectiveness  & efficiency addressed in the QMS?质量管理体系中的过程有效性和效率体现在哪？

5.1.1.3 IATF 16949

Where are Process Owners  responsibilities, roles, and competencies specified? 在哪明确规定了过程所有者的职责、角色和能力？

5.２

[Quality policy]

质量方针

Is the quality policy compatible with strategic  direction and the context of the organization? (5.1.1 b)质量方针是否与组织的战略方向和环境相一致？(5.1.1  b)

5.3.1 IATF 16949

Where are  organizational roles, responsibilities, and authorities specified in the QMS? 

质量管理体系中哪里明确规定了组织岗位，职责和权限？

5.3.2 IATF 16949

Where is  responsibility & authority for product requirements and corrective  actions specified in the QMS? (includes stop work authority)质量管理体系中在哪明确规定了产品要求和纠正措施的职责和权限？（包括停止工作的权力）

6.1 - 6.1.2

[Actions to address risks and  opportunities]应对风险和机遇的措施

Does the organization specify a  systematic approach to identify risks and opportunities and define actions in  their processes / QMS?组织是否能证实有一个系统方法保证他们能够有效地识别风险和机遇及在质量管理体系中确定措施？

6.1.2.1 IATF 16949

Has the organization considered the  external and internal issues and requirements of interested parties when  determining the risks and opportunities?

Where is risk analysis and documented  information specified?组织在确定风险和机会时是否考虑了外部和内部的问题和要求？风险分析和文件化信息在哪里？

6.1.2.2 IATF 16949

Preventive actions and documented  information is specified in the QMS?质量管理体系中是否明确规定了预防措施和成文信息的要求？

6.1.2.3 IATF 16949

Where are contingency plans, and  periodic test specified?在哪明确规定了应急计划及其定期测试的要求？

6.2.1

[(The organization  shall establish quality objectives.)]组织应建立质量目标

Does the organization establish  quality objectives at relevant functions, levels and processes?

组织是否在相关职能、层次和过程设定质量目标？

Are the quality objectives  compatible with the strategic direction and the context of the organization?  (5.1.1 b)

质量目标是否与组织的战略方向和环境相一致？(5.1.1  b)

Are the quality objectives as  below?:

质量目标是否如下：

a)  be consistent with the quality policy,与质量方针保持一致；

b)  be measurable;可测量；

c)   take into account applicable requirements;考虑到适用的要求；

d)  be relevant to conformity of products and services  and the enhancement of customer satisfaction;与提供合格产品和服务以及增强顾客满意相关；

e)  be monitored;予以监视；

f)   be communicated;予以沟通；

g)  be updated as appropriate.适时更新

Do they retain documented  information on the quality objectives?组织是否保留关于质量目标的形成文件的信息？

6.2.2.1 IATF 16949

Where is Quality objectives  supplemental specified?在哪明确规定了质量目标/补充的要求？

6.2.2

[(When planning how to achieve its quality  objectives, the organization shall determine.)]

当策划如何实现质量目标时，组织应确定：

To achieve its quality objectives, does the  organization determine the followings?

为了实现质量目标，组织是否确定下述内容：

a)  what will be done;采取的措施；

b)  what resources will be required;需要的资源；

c)   who will be responsible;由谁负责；

d)  when it will be completed;何时完成；

e)  how the results will be evaluated.如何评价结果。

Can they  demonstrate the whole cycle of objectives setting according to the above?  

是否能证实根据上述要求设定目标的完整循环？

6.3

[Planning of changes]

变更的策划

Where the organization determines the need for  change to the quality management system (see 4.4), is the change carried out  in a planned and systematic manner?

当组织确定需要对质量管理体系进行变更时（参见4.4条款），此种变更是否系统地策划并实施？

Does the organization consider the following:

组织是否考虑到下述内容：

a)  the purpose of the change and their potential  consequences;

变更目的及其潜在后果；

b)  the integrity of the QMS;

质量管理体系的完整性；

c)   the availability of resources;

资源的可获得性；

d)  the allocation or reallocation of responsibilities  and authorities.

职责和权限的分配或再分配。

7.1.3.1 IATF 16949

Where is Plant, facility, and

equipment planning specified?在哪明确规定了工厂，设施和设备策划的要求？

7.1.4.1 IATF 16949

Where is environment /supplemental  specified?在哪明确规定了（过程操作的）环境/补充的要求？

7.1.5.1.1  IATF 16949

Where is MSA and customer  acceptance specified in QMS? 在质量管理体系中是否明确规定了MSA和顾客接受的要求？

7.1.5.2.1/  7.1.5.3.1/   7.1.5.3.2  IATF 16949

Where is the calibration/  verification –documented process, internal  laboratory, and external laboratory specified?在哪明确规定了校准/验证-文件化过程，内部实验室，外部实验室？

7.1.6

[Organizational knowledge]

组织的知识

How does the organization determine and maintain the  knowledge necessary to address changing needs and trends and for the  operation of its processes and to achieve conformity of products and services?组织如何确定和保持为应对不断变化的需求和发展趋势以及运行过程所需的知识，以获得合格产品和服务？

7.2.1/ 7.2.2 / 7.2.3 / 7.2.4  IATF 16949

Where is documented process for competence/  training, and documented process for internal auditor competency  defined in the QMS?在质量管理体系中在哪明确规定了能力/培训的文件化过程要求？内部审核员能力的文件化过程要求？

7.3.1 IATF 16949

Does the QMS specify awareness/  supplemental?  质量管理体系是否明确规定了意识/补充的要求？

7.3.2 IATF 16949

Does the QMS specify documented process for motivation &  empowerment?  质量管理体系是否明确规定了激励和授权的文件化过程要求？

7.4

[Communication]

沟通

How does the organization determine the internal and  external communications relevant to the quality management system including:

组织如何确定与质量管理体系相关的内部和外部沟通，包括：

a)  on what it will communicate;沟通什么；

b)  when to communicate;何时沟通；

c)   with whom to communicate;与谁沟通；

d)  how to communicate;如何沟通；

e)  who communicates由谁负责。

7.5.1.1 IATF 16949

Where is the documented process for QMS documentation specified,  and a document / matrix - indicating where in the QMS that its CSR’s are addressed? 在哪明确规定了文件化质量管理体系的文件化过程要求？是否有—个显示组织质量管理体系内哪些地方满足了顾客特定要求的文件（即：矩阵）？

7.5.3.2.1 IATF 16949

Does the QMS identify record  retention policy & list?质量管理体系是否明确规定了记录保存政策和清单？

7.5.3.2.2 IATF 16949

Does the QMS specify Engineering  specifications and documented process?   质量管理体系是否明确规定了工程规范和文件化过程的要求？

8.1

[Operational planning and control]

运行策划和控制

How does the organization control planned changes  and review the consequences of unintended changes, taking action to mitigate  any adverse effects, as necessary?组织如何控制策划的更改，评审非预期变更的后果，必要时，采取措施消除不利影响？

8.1.1/ 8.1.2  IATF 16949

Does the QMS specify Operational  planning, control, and confidentiality?质量管理体系是否明确规定了运行策划、控制和保密？

8.2.1.1/ 8.2.2.1 IATF 16949

Does the QMS specify customer  communications, and requirements for products & services supplemental?质量管理体系是否明确规定了顾客沟通，产品和服务/补充的要求？

8.2.3.1.1/ 8.2.3.1.2/ 8.3.1.3  IATF 16949

Where is review of  requirements for products & services, customer designated special  characteristics, and manufacturing feasibility specified? 产品和服务的要求，客户指定的特殊特性和制造可行性的评审的要求被规定在哪里？

8.3.1.1/ 8.3.2.1 / 8.3.2.2/  8.3.2.3 IATF 16949

Does the QMS identify product &  manufacturing process design supplemental, planning supplemental, product  design skills, and development / embedded software? 质量管理体系是否识别了产品和制造过程设计/补充，计划/补充，产品设计/技巧，开发/嵌入式软件的要求？

8.3.3.1/ 8.3.3.2/ 8.3.3.3 IATF  16949

Where are product design input,  manufacturing process design input and documented process for special  characteristics specified?产品设计输入、制造过程设计输入和特殊特性的文件化过程的要求在哪里被规定？

8.3.4.1 / 8.3.4.2/ 8.3.4.3 /  8.3.4.4 IATF 16949

Does the QMS specify monitoring,  design & development validation, prototype program, and product approval  process? 质量管理体系是否明确规定了监测、设计和开发验证、原型样件方案和产品批准过程？

8.3.5.1/ 8.3.5.2/ 8.3.6.1 IATF  16949

Where are design  & development outputs, and manufacturing process design output, and  design / development changes identified?

设计和开发输出、制造过程设计输出、设计/开发更改的要求在哪里被识别？

8.4.1 -8.4.2

[Control of externally provided  processes, products and services]

外部提供过程、产品和服务的控制

How does the organization determine the controls to  be applied to externally provided processes, products and services when:在下列情况下，组织如何确定对外部提供的过程、产品和服务实施的控制：

a)products  and services from external providers are intended for incorporation into the  organization’s own  products and services;外部供方的过程、产品和服务构成组织自身的产品和服务的一部分；

b)products  and services are provided directly to the customer(s) by external providers  on behalf of the organization;外部供方替组织直接将产品和服务提供给顾客；

c)a process or part of a process is provided by an  external provider as a result of a decision by the organization 组织决定由外部供方提供过程或部分过程。

Has the organization sufficiently determined needed  controls to be applied to external provisions of processes and  products/services taking into consideration:

组织是否对外部提供的过程、产品和服务实施所需的控制予以充分的考虑？

a)    the potential impact of the  external provisions on the organization’s ability to meet customer and  regulatory requirements外部提供的过程、产品和服务对组织稳定地提供满足顾客要求和适用的法律法规要求的能力的潜在影响；

b)   the effectiveness of the controls applied by the  external provider外部供方自身控制的有效性；

Does the organization establish and apply criteria  for the evaluation, selection, monitoring of performance and re-evaluation of  the external providers based on their ability to provide processes or  products and services in accordance with specified requirements?组织是否基于外部供方提供所要求的过程、产品或服务的能力，建立对外部供方的评价、选择、绩效监视以及再评价的准则，并加以实施。
 Do they retain appropriate documented information of  the results of the evaluations, monitoring of performance and re-evaluations  of external providers?

是否保留适当的对外部供方的评价、绩效监视以及再评价的形成文件的信息？

8.4.1.1/ 8.4.1.2/

8.4.1.3

IATF 16949

Where is documented process for supplier selection, and  customer –directed sources  specified in the QMS?质量管理体系在哪里明确规定了供方选择，顾客指定的货源的要求？

8.4.2.1/ 8.4.2.2/8.4.2.3/  8.4.2.3.1/8.4.2.4 /8.4.2.4.1 /8.4.2.5 IATF 16949

Does the QMS specify a documented process type & extent of control of  outsourcing, documented process for statutory & regulatory,  supplier QMS development, product related software & embedded software, documented process for supplier monitoring , development  , and second party audit ? 质量管理体系是否明确规定了外包过程控制类型和控制范围的文件化过程，法律和法规的文件化过程，供应商质量管理体系的开发，产品相关软件和嵌入式软件，供应商监控、开发和第二方审核的文件化过程的要求？

8.4.3.1 IATF 16949

Does the  QMS identify information for external providers, supplemental?  质量管理体系是否识别了外部供方信息/补充的要求？

8.5.5

[Post-delivery activities]

交付后的活动

When post-delivery activities apply for the  organization: 
 In determining the extent of post-delivery activities that are required, does  the organization consider thefollowing:

当交付后活动适用于组织：

在确定交付后活动的覆盖范围和程度时，组织是否考虑了下述内容：

a)statutory and regulatory requirements.法律法规要求；

b)the  potential undesired consequences associated with the products and services;与产品和服务相关的潜在非预期后果；

c)the nature, use and intended lifetime of the  products and services;产品和服务的性质、用途和预期寿命；

d)customer requirements顾客要求；

e)customer feedback;顾客反馈。

8.5.1.1/ 8.5.1.2/8.5.1.3/  8.5.1.4 / 8.5.1.5/ 8.5.1.6 / 8.5.1.7 IATF 16949

Does the QMS specify production & prelaunch  control plans, standard work, visual standards, verification of job set up  and after shut down, production tooling & equipment management, and  production scheduling?  质量管理体系是否明确规定了量产和试生产控制计划、工作标准、目视标准，作业准备和停机后的验证、生产工装和设备管理、生产排程？

8.5.2.1 / 8.5.4.1 IATF 16949

Where is  identification & traceability, and preservation covered in the QMS?质量管理体系中在哪包含了标识，可追溯性和保存的要求？

8.5.5.1/ 8.5.5.2 IATF 16949

Does the QMS specify feedback of  information from service, and service agreement with customer?质量管理体系是否明确规定了来自服务的反馈信息，以及与顾客的服务协议的要求？   

8.5.6

[Control of changes]

更改控制

Does the organization review and control changes for  production or service provision to the extent necessary to ensure continuing  conformity with specified requirements?

组织是否对生产和服务提供的更改进行必要的评审和控制，以确保持续符合特定要求？

Does the organization retain documented information  describing the results of the review of changes, the personnel authorizing  the change, and any necessary actions.组织是否保留形成文件的信息，包括有关更改评审结果、授权进行更改的人员以及任何必要的措施？

8.5.6.1/ 8.5.6.1.1 IATF 16949

Does the QMS include a documented process for control of changes, and documented process for change control supplemental,  and maintain a list of process controls for primary and backup methods?质量管理体系是否包含了一个文件化的变更控制过程，以及变更控制/补充的文件化过程，并维护一份过程控制初始和备用方法的清单？

8.6.1/ 8.6.2/ 8.6.3 / 8.6.4 /  8.6.5/ 8.6.6 IATF 16949

Does the QMS specify release of  products / services, layout & functional test, appearance items,  verification for externally provided product/ services, regulatory  conformity, and appearance criterion?质量管理体系是否明确规定了产品/服务的放行、全尺寸检验和功能测试、外观项目、外部提供的产品/服务的验证、法规的符合性和外观标准的要求？

8.7.1.1/8.7.1.2/8.7.1.3/  8.7.1.4/ 8.7.1.5/ 8.7.1.6/ 8.7.1.7 IATF 16949

Does the QMS specify customer  authorized concession; customer specified controls for nonconforming product,  control of suspect product, documented process for control of reworked &  repaired product, customer notification, and a documented process for nonconforming  disposition?质量管理体系是否明确规定了顾客的让步授权；顾客规定的不合格品的控制过程，可疑产品的控制，返工和返修产品的文件化处理，顾客通知，以及不合格品处置文件化过程的要求？

9.1.1

[General (Monitoring,  measurement, analysis and evaluation)]

总则（监视、测量、分析和评价）

Are the following items determined?

下述条款是否确定？

a)what needs to be monitored and  measured;需要监视和测量的对象；

b)the methods for monitoring,  measurement, analysis and evaluation needed to ensure valid results;确保有效结果所需要的监视、测量、分析和评价方法；

c)when the monitoring and measuring  shall be performed;实施监视和测量的时机；

d) when the results from monitoring  and measurement shall be analysed and evaluated.分析和评价监视和测量结果的时机。

Does the organization evaluate the performance and the  effectiveness of the QMS?组织是否评价质量管理体系的绩效和有效性？

(see also 9.1.3 “Analysis and evaluation” below) （参见见下面9.1.3“分析与评价”）

Does the organization retain documented information  as evidence of the results?

组织是否保留形成文件的信息，作为结果的证据？

9.1.1.1/9.1.1.2/ 9.1.1.3   IATF 16949

Does the QMS specify monitoring  & measurement of mfg. processes, identification of statistical tools, and  application of statistical concepts? 质量管理体系是否明确规定了制造过程的监视和测量、统计工具的识别和统计概念的应用的要求？

9.1.2.1 IATF 16949

Where does the QMS  specify customer satisfaction supplemental?   质量管理体系在哪里明确规定了顾客满意度/补充的要求？

9.1.3 [Analysis and evaluation]

分析与评价

Does the organization analyze and evaluate  appropriate data and information arising from monitoring and measurements?

组织是否分析和评价了通过监视和测量获得的数据和信息？

Are results of the analysis used to evaluate:

是否利用分析结果评价：

a) conformity of products and services;产品和服务的符合性；

b) the degree of customer satisfaction;顾客满意程度；

c) the performance and effectiveness of the quality management system;质量管理体系的绩效和有效性；

d) if planning has been successfully implemented;策划是否得到有效实施；

e) the effectiveness of actions taken to address risks and opportunities  ;针对风险和机遇所采取措施的有效性；

f) the performance of external provider(s);外部供方的绩效；

g) the need for improvements to the quality management system.质量管理体系改进的需求。

Are the results of analysis and evaluation used to  provide inputs to management review?分析和评价的结果是否用于为管理评审提供输入？

9.1.3.1. IATF 16949

Does the QMS identify  prioritization?质量管理体系识别了优先级？

9.2.2.1 / 9.2.2.2/ 9.2.2.3/  9.3.2.4/ IATF 16949

Where does the QMS specify internal  audit program / documented process, QMS system audit, manufacturing  process audit, and product audit?质量管理体系在哪里明确规定内部审核方案/文件化过程，质量管理体系审核，制造过程审核和产品审核？

9.3

[Management review]

管理评审

Is the management review planned and carried out  taking into consideration of the followings (new items underlined):

策划和实施管理评审时是否考虑了下列内容（下划线的是新条款）：

a) the status of actions from  previous management reviews;以往管理评审所采取措施的实施情况；

b) changes in external and internal  issues that are relevant to the quality management system;与质量管理体系相关的内外部因素的变化；

c) information on the quality  performance, including trends for:有关质量绩效的信息，包括下列趋势性信息：

1) customer satisfaction and feedback from relevant  interested parties; 顾客满意和相关方的反馈；

2)  the extent to which quality objectives have been  met;质量目标的实现程度；

3) process  performance and conformity of products and services; 过程绩效以及产品和服务的符合性；

4) nonconformities and corrective  actions;不合格以及纠正措施；

5) monitoring and measurement results;监视和测量结果；

6)  audit results;审核结果；

7)  the performance of external providers;外部供方的绩效。

d)  the adequacy of resources

资源的充分性；

e)  the effectiveness of actions taken to address risks  and opportunities (see 6.1);应对风险和机遇所采取措施的有效性（见6.1）

f) opportunities for improvement.改进的机会。

9.3.1.1 IATF 16949

Does the QMS specify management  review supplemental criterion?质量管理体系是否明确了管理补充准则？

9.3.2.1/ 9.3.3.1 IATF 16949

Where does the QMS specify  management review inputs and outputs?质量管理体系是否明确了管理输入和输出？

10.1 [improvement]改进

Where does the QMS specify  improvement, and nonconformity corrective action?质量管理体系在哪里明确规定了改进和不符合纠正措施的要求？

10.2.3/ 10.2.4/ 10.2.5 / 10.2.6  IATF 16949

Does the QMS specify documented process for problem solving, documented process for error proofing, warranty  management system, and customer complaint / field test analysis?  质量管理体系是否明确规定了解决问题的文件化过程，防错的文件化过程，保修管理系统，顾客投诉/现场测试分析的要求？

10.3.1 IATF 16949

Where is the documented process for continual improvement in the  QMS?质量管理体系在哪里明确规定了持续改进的文件化过程的要求？