IRIS内审员培训
1. General
2-1. IRIS certification Process
2-2. Questionnaire and assessment
guideline
3. Benifits from IRIS
process and procedure
Standard requirement.
课程内容
Chapter 1
General
基于 ISO 9001：2008的结构
IRIS增加了一些铁路行业的特殊要求，如：
项目管理
RAMS/LCC 等…
IRIS包括:
带 «shall»的即表示为强制要求。
带 «should»的即表示为推荐要求。
个别为 “knockout”要求 (12 questions)。
Introduction
带 «shall»的即表示为强制要求。
带 «should»的即表示为推荐要求，以便于企业达到更高的成熟度。
当使用“such as”时，表示该建议仅供参考。
当使用“NOTE”时，仅是对相关的标准加以说明。
Introduction
什么是IRIS？
IRIS = International Railway Industry Standard
IRIS代表的是国际铁路行业标准；
IRIS旨在针对铁路行业特点，开发和实施一套全球通用系统来评估商业管理系统，包括：
基于ISO9001的关键原理和铁路行业的特殊要求之国际公认标准。
由认可的认证机构执行的一个统一的评估流程。
一个网站发布的信息系统。
备注1:它不包括对财务数据和项目或合同的具体要求的评估。
备注2:IRIS基于相似的行业标准，如：汽车、航空和食品领域。这些行业标准已经展示了其质量改善的作用。
IRIS标准框架
4. 质量管理体系
总要求
文件要求
知识管理
多现场管理
5. 管理职责
管理承诺
以顾客为关注焦点
质量方针
策划
职责、权限和沟通
管理评审
6. 资源管理
资源提供
人力资源
基础设施
工作环境
应急计划
7 . 产品实现
产品实现的策划
与顾客有关的过程
设计和开发
采购
生产和服务的提供
监视和测量设备的控制
项目管理
技术状态管理
首件检验
调试/顾客服务
RAMS/LCC
老化管理
变更控制
8. 测量、分析和改进
总则
监视和测量
不合格品的控制
数据分析
改进
UNIFE – Association of European Railway Industries
欧洲铁路行业联盟
The European rail supply industry was formerly represented by
AICMR (Association Internationale des Constructeurs de Matériel Roulant),
AFEDEF (Association des Fabricants Européens d'Équipements Ferroviaires)
CELTE (Constructeurs Européens des Locomotives Thermiques et Électriques)
The three associations merged into UNIFE in 1991.
在UNIFE内部成立了一个工作组以在ISO9001：2008基础上定义和促进商业管理的铁路特殊标准。
UNIFE
全球性的非盈利机构
确保铁路行业获得高品质的产品和服务
加强跨国界的竞争
提升铁路行业设备和零部件制造商的水
平，使其符合全球认可的水平，提升竞
争力
什么是IRIS？
IRIS Technical
Forum For
Improvement
UNIFE Presiding Board
IRIS Steering Committee
Rules of Procedure
UNIFE
Nomination Agreement
Nomination Agreement
Nomination Agreement
Operators
IRIS Management Centre (UNIFE)
Certification Body 1 *
Certification Body x *
Client n
Request for Certification
Client 3
Client 2
Client 1
Framework Agreement
Approval & Contract
Auditor Validation
Committee (AVC)
Approval, Validation & Follow up
Auditor
Pool
Auditors tied up with CBs
Permanent
or ad hoc
IRIS Working
Groups
System Integrators
Equipment Manufacturers
IRIS Advisory
Board (IAB)
Operators and IRIS
Steering Committee
representatives
组织结构
Responsibilities
IRIS 筹划执行指导委员会
IRIS 管理中心
IRIS标准的发展史
Responsibilities
发展并执行IRIS体系，包括
国际标准–要求
评估过程–审核和评估方
全球认证信息数据库
设立并监督IRIS管理中心
认证机构的批准
委员会成员资格的准入和取消
和其他组织/协会的合作
IRIS工作组的指定
IRIS 筹划执行指导委员会
Responsibilities
IRIS信息的发布
IRIS系统的执行和促进
建立、管理、维持
IRIS网站
IRIS 数据库
IRIS 审核工具
监督认证机构
IRIS培训和信息会议的组织
运作和活动的日常管理
管理标准和培训资料的发行
IRIS 管理中心
IRIS 委员会成员
法维莱
克诺尔
阿尔斯通
庞巴迪
雅迪
赛雪龙
西门子
安萨多伯瑞德
Chapter 2-1
IRIS Certification Process
由IRIS管理中心
进行管理:
Agreements with
Certification
Bodies
Certification
Body
Evaluation
Audit
Training
program for
Auditor
qualification
IRIS
Requirement
Standard
Web-Portal for
information
supplier
要求
全球参与性
ISO 9001和IRIS 批准认证框架协议
在已认可的认证机构之间相互承认IRIS证书
接受见证审核
申请网上数据库和审核工具
IRIS
IRIS Approval
of Certification
Bodies
IRIS认证过程
不同类型的 “审核评估”
第一次审核 -> “Certification audit”
在规定基础上 -> “Surveillance audits”
到期后的审核 -> “Recertification audits”
IRIS管理中心进行管理:
认证机构
审核评估
是否通过?
纠正措施?
结束或
撤销证书
No
否 (失败)
委托人认可
报告/
结果
是
开始
IRIS要求标准
供应商信息的
网络入口
Client request
for IRIS
certification
执行纠正
措施
Invoice to Client
IRIS和
ISO 9001证书
Yes
如果审核失败 “重新审核”必须
在90天内重新开始
IRIS认证过程
审核准备
IRIS-PORTAL 获取相关信息
购买标准和AUDIT-TOOL
自评（. Question）
评估过程
采用计分的方式
采用检查表的方式
认证审核
如通过审核则颁发IRIS和ISO9001证书
如审核未通过，则要求在90天内进行重审
如未通过审核是因为KO Question的问题，那么整个认证流程必须重新开始
认证审核的日期将会登录到IRIS-PORTAL，并作为后续审核的参考
IRIS续评间隔：不超过12个月
IRIS续评的审核范围包括:
所有 “knockout”问题
认证机构针对ISO9001续评审核的特殊要求
实施改进活动的特定过程或区域
认证机构在上次审核过程中发现不符合的场所或区域
客户要求增加分数的过程
IRIS续评的条款的得分会被更新
?
A
B
Multi sites
approach
认证方案-续评
认证方案-续评豁免条件
如果组织的IRIS审核总得分≧75%, 则：
如果IRIS的主条款得分≧80%的话，那么该主条款在续评中将不再审核 ，但在复评中要审核
如果IRIS的主条款得分≧75-80%的话，那么该主条款在续评中将被部分抽样审核
注1：IRIS的主条款指标准
条款4：质量管理体系
条款5：管理职责
条款6：资源管理
条款7：产品实现
条款8：测量、分析和改进
注2：豁免不包括认证机构对于和ISO9001相关的强制审核要求
认证方案-复评
证书到期之前，必须进行复评，换发新的证书
整个认证流程重新开始
Chapter 2-2
Questionnaire and assessment
guideline
建议初访要在组织的现场进行，以准确评估组织的审核准备工作的完整性。初访的主要内容包括：
IRIS的16个程序和25个过程
KO问题
现场的状况
IRIS审核范围的澄清
审核所需资源的确定
确定审核计划
Readiness review 初访
审核计划
审核计划应覆盖审核的产品范围和反映审核的复杂程度
审核计划主要包括：
审核范围（确定查检表的适用条款）
标明要审核的部门和过程
审核时间和地点
审核组成员
受审核方的代表
开始和结束会议的安排
开始和结束会议
开始会议的目的：
审核和受审核方互相介绍
说明和确认审核计划
介绍审核的过程和方法
澄清双方的疑问
结束会议的目的：报告
审核发现
审核结果
提出CAR和IMR
组织的强处
组织需改进的地方
受审核方和审核方
受审核方职责:
审核方职责:
. 问题。
2.开放性问题的评估将通过采用一组分为5个阶段的
方法来评估过程的成熟阶段以及实施的等级情况。
3.封闭式 (Yes/No) 则没有成熟阶段性这类问题。
注：问题中像 ‘不适用’ (‘NA’)之类的问题将不会
对其进行评估，相关的理由将在报告中加以说明。
Management representative:
Has Top Management appointed a member of Management?
How ?, Who ? ...
查检表内容
Knock out questions (.)
在每次审核前KO问题应该被确定
KO问题的完成与否应作为IRIS首要条件
.问题是不计分的
当一个KO需求没有达到时，整个审核就失效
认证将重新开始
Failed on twelve . questions!
Knock Out questions
质量管理系统-总要求
设计开发的输入
设计开发的确认
调试/客户服务
设计开发（信号）
生产和服务提供过程的确认
不合格过程的控制
变更管理
1
2
3
4
设计批准（信号）
9
5
7
6
8
10
项目管理
项目管理-质量管理
首件检验
11
12
12 . questions
Open Questions
根据组织每项要求完成情况，评定成熟度水平分数等级
应针对认证范围和公司特点客观地描述等级评定和打分
当组织在某处评为 “defined”时，审核员应提出改进要求并就改善计划和方案和组织达成一致
当组织在某处评为 “qualified”时，审核员可以提出改进建议
Maturity Level
Requirement is
Point
“optimized”
Exceeded and continuously improved
4
“qualified”
Exceeded
3
“defined”
Met in full
2
“poor”
Partially met
1
“insufficient”
Not met
0
Open questions
Closed Questions 封闭式问题
Two possible scores:
Answer to question is
Requirement is
Point
YES
Met
2
NO
Not met
0
Closed questions
问题
序号
IRIS
应
ISO 9001
应
ISO 9001 和 IRIS 要求
的问题
IRIS检查表
问题类型
成熟水平
IRIS检查表
Qualified =
超越
(打3)
Optimized=
超越要求和
持续改进 (打 4)
Defined= 满足
(打2)
Poor= 部分满足
(打1)
IRIS检查表
.-问题在现场
评审前进行评审
开放性问题
(打0 ,1,2,3,4)
关闭性问题
(打0 或2)
IRIS检查表
包括每个问题的答案，提供正确的或能有所提高的行为方案，以下方案可以用：
Corrective or Improvement Action
符合度
级别
分数
提供行为方案
开放问题
封闭问题
符合
优
4
无特定措施要求
良好
3
建议改进措施
基本合格
2
建议采取改进措施
无特定措施要求
不符合
一般
1
要求采取纠正措施，在90天内关闭
不及格
0
要求采取纠正措施，在90天内重新审核
要求采取纠正措施，在90天内重新审核
Calculation of the threshold
The threshold is the product of two factors. Factor 1 is the number of applicable questions (except the . questions, which are not scored). Factor 2 is fixed by the minimum required score (2 points).
Threshold [points] = (# applicable questions - # applicable . questions) x 2 points
The maximum achievable score varies depending from the composite of "open" (max. 4 points) and "closed" (max. 2 points) questions
The IRIS Audit-Tool supports this calculation of the threshold.
The Threshold 及格线
Award of the IRIS Certification is based on the fulfilment of all the following criteria:
所有和KO问题相关的要求均符合
所有IRIS CARS全部关闭
组织的最终得分达到及格线的要求
IRIS Certification Award
审核人天表
26
>10700
25
8500-10700
24
6801-8500
23
5451-5800
22
4351-5450
21
3451-4350
20
2676-3450
19
2026-2675
18
1551-2025
17
1176-1550
16
1001-1175
15
876-1000
14
626-875
13
426-625
12
276-425
11
176-275
10
126-175
9
101-125
86-100
66-85
46-65
26-45
11-25
1-10
IRIS复评审核
IRIS续评审核
IRIS正评审核
员工人数
Upgrading from other Standards
Upgrading of current certification by one of the IRIS approved certification bodies will be taken into account prior to the initial assessment to IRIS, as follows:
审核人天表
最少和复评人天相同
X
X
X
最少和复评人天相同
X
X
最少和复评人天相同
X
最少和复评人天相同
X
X
最多30%
X
X
最多30%
X
最多20%
X
按正评审核人天的折扣率（见前表）
IRIS“00”
AS9100或/和ISO/TS16949：2002
ISO9001：2000
IRIS“01”认证升级
现有的验证体系
1、车体
11、通讯系统
2、车体配件
12、电缆和电柜
3、转向架
13、门系统
4、动力系统
14、HVAC加热通风空调系统
5、牵引系统
15、倾摆系统
6、辅助系统
16、照明
7、制动系统
17、联接器
8、内部构件
18、整车
9、控制系统
19、信号系统
10、乘客信息系统
20、单件部件
认证范围
证书会使用IRIS的标记
IRIS的证书有效期为3年
ISO9001证书独立于IRIS证书
一旦证书到期，组织将进行复评或撤销证书。
证书
资料的保密性
会员：IRIS Group，系统集成商，客户，认证机构，等
一级数据库的信息（仅会员可以查看）：
一般信息：名称、地址、联系方式，…….
企业被核可的状态
证书的有效期及认证范围
二级数据库的信息（需经组织授权方可查看）：
审核报告
纠正措施的实施计划及其整改状态
组织的分数
证书
Chapter 3
Benefits from IRIS
IRIS认证的益处,能给企业带来什么:
1\和9001定性验证不一样,IRIS为定量的验证和评估.
2\供应链管理,
3\RAMS,RAMS对于我国铁路行业发展有着至关重要的意义.
4\风险管理,合同,投标.
为什么用IRIS？
5\KPI的要求
6\项目管理
7\知识管理
8\未来趋势:进入铁路行业的门槛
为什么用IRIS？
Chapter 4
Mandatory process and procedure
See the difference !
Process Definition
Set of interrelated or interacting activities which transform inputs into outputs (ISO 9000 # and IRIS Annex 6).
IRIS Interpretation
Whenever this standard refers to “a process”, this process shall be documented and should be controlled by appropriate key performance indicators. (IRIS #).
input
process
outputs (products)
Definitions
See the difference !
“Shall” 强制要求通常会出现在IRIS questionnaire的成熟度ML-1 (poor) and ML-2 (defined)。
“Should” 可选要求通常会出现在IRIS questionnaire的成熟度ML-3 (qualified) and ML-4 (optimized)。
Text with “shall” and “should”
Control of changes
12
Purchasing Process
8
Procedure
Clause
Processes/activities to be documented in procedures
1
Transfer of contract activities
2
Control of documents
3
Control of records
4
Provision of resources
5
Training
6
Design and development validation (test procedure)
7
Design approval
9
Control of equipment and tools
10
First article inspection (FAI)
11
RAMS / LCC
13
Internal audit
14
Control of nonconforming product
15
Corrective action
16
Preventive action
Processes/activities to be documented in procedures
Project Management – Cost management
14
Control of Production and service provision
9
Control of design and development changes
7
Review of requirements related to the product
4
Business plan
2
Process
Clause
Processes required by IRIS
1
Control of customer documents
3
Planning of product realization
5
Tender management
6
Design and development
8
Purchasing process
10
Control of production process changes
11
Validation of processes for production and service provision
12
Control of monitoring and measurement equipment
13
Project management or new product development
15
Project management - Quality management
Processes/activities to be documented
Customer Satisfaction
24
Control of changes
22
First Article Inspection (FAI)
18
Process
Clause
Processes required by IRIS
16
Project management - Risk and opportunity management
17
Configuration management
19
Commissioning / Customer Service
20
RAMS / LCC
21
Obsolescence management
23
Monitoring, measurement, analysis and improvement
25
Control of nonconforming processes
Processes/activities to be documented
Chapter 5
IRIS Standard requirements
CLAUSES 4
Quality Management System
质量管理体系
总要求General requirements
In case of transfer of process or parts thereof, that affect product
conformity to requirement within the execution of a contract, a
documented procedure including: feasibility study, risk analysis,
planning, communication to customer and first article inspections to the
appropriate level shall exist.
在执行合同过程中如有转包(过程或产品)的情况发生，且影响到产品的
符合性时,组织必须有一个文件化的转包程序，其内容适当地包括：可行
性研究、风险分析、计划、顾客沟通和首件检验。
. Question-01
No: KO (总是适用)
质量管理体系——总要求
如果合同履行过程中发生会影响产品符合要求的转包或外协的情况，是否存在以下达到了一个适当的水平的形成文件的程序，例如可行性研究、风险分析、策划、顾客沟通和首件检验等？
总述 General
In addition to the ISO9001:2008, the business management system documentation shall
include:除ISO 9001:2008要求外,企业系统文件应包括
e) documented statements of a technical safety policy and safety
objectives.形成文件的技术安全方针和安全目标
f) Management system requirements imposed by the applicable regulatory authorities.
管理系统要求应包括适用的法规要求。
The organization shall (3)ensure that personnel have access to business management system documentation and are aware of relevant documents. Customer and /or regulatory authorities’ representatives shall (4) have access to the business
management system documentation.
组织必须保证职员能获得企业管理系统文件，并且了解相关的文件，顾客和/或法规监管代表必须能获得企业管理系统文件。
质量手册 Quality Manual
When referencing the documented procedures, the relationship
between the requirements of this document and the documented
procedures should (1)be clearly shown.
当参考文件化程序时，本标准中的要求和文件化程序要求之间的关系
应该清楚描述。
文件控制 Control of Documents
The organization shall demonstrate effective management and control
of all documents pertinent to the products it supplies. Names of
personnel who authorize and carry out reviews of the necessary
documentation shall be identified.
组织必须证实对与它供应的产品有关的所有文件进行有效管理和控制。
必须识别批准和执行必要的文件评审的人员的名字。
Effective systems shall be in place to review impact of documents of external origin.
必须建立有效的体系来评审外来文件的影响。
文件控制 Control of Documents
The organization shall have a process to ensure the traceability of customer documents throughout the entire supply chain, . specifications, requirements.
组织必须有一个过程来确保客户文件在整个供应链内的可追溯性，如:规范、
要求。
Note1: Document of external origin can be: standard, customer
requirements specification, specific customer document, regulatory
requirements, etc.
注1: 外来文件可以包括：标准、顾客的要求说明书、顾客的特殊文件、法
律法规要求等。
文件控制Control of Documents
Note2: Customer requirements can be for example RAMS/LCC,
obsolescence, special process, spare parts, weight, acoustic
注２：顾客要求可能以多种形式出现：如RAMS/LCC、老化、特殊过程、
备品备件、重量和音效等。
Note 3: This process may be included as part of the organization’s change
management process.
注３：此过程可以作为组织变更管理过程一个部分。
记录控制 Control of Records
This documented procedure shall(7) also include approval of results
recorded before official release.
文件化的记录控制程序(2/14)也必须规定：在记录正式发布前对记录结果的批准。
Records shall(9) be available for review by /release to customers and
regulatory authorities in accordance with contract or regulatory
requirements.
记录必须能够根据合同或法规要求供顾客和法规机构评审或提供给
他们。
知识管理Knowledge management
Best practices shall be identified, documented , implemented and regularly updated to improve the organization’s process efficiency and product in quality, costs and delivery performance.
最佳作法必须被识别,形成文件,被执行并且定期更新，以便改进组织过程效率和改善产品的质量、成本和交货绩效。
知识管理Knowledge management
Note 1：Note 1 This can include but is not limited to:
此项可以包括（但不仅限于）：
－ Design rules (engineering standards) 设计原则、工程标准；
－ Manufacturing practices 制造实践；
－ Procedures 程序；
The organization should define and implement a Process to identify, obtain, protect, use and evaluate information, knowledge and technology
组织应当定义和实施一个过程来识别、获得、保护、使用和评估信息、知识和技术
多现场项目的管理
Management of multi sites projects
In cases where a project involves multiple sites, an appropriate business management system (. project quality plan) shall (11) be properly documented and implemented, and shall cover as a minimum:
当项目涉及多现场时，必须适当地形成文件并执行适当的企业管理系统（如：项目质量计划），并且必须至少包括：
－ work split and operational interfaces, including alignment of customer
requirements
操作接口和运作协调，包括整理顾客要求 ；
－ authorities and responsibilities and communication channels (internal
and with the customer) including feedback on the results for each
Sites’ scope of responsibility
职责和权限及沟通渠道（内部和与顾客之间的）包括每个现场的职责范围
的反馈；
多现场项目管理
Management of multi sites projects
－ Applicable process, procedures documents and records on each site.
各现场适用的过程、程序、文件和记录；
－ Assurance of IRIS compliance.
确保符合IRIS要求；
Efficiency of Multi- site project activities should(12) regularly be
assessed to the appropriate level (. throughout audits, management
reviews, process reviews, customer complaint etc…) and improved
where necessary.
在合适的层面上，定期评估跨现场项目的效率（包括：系统审核、管理
评审、过程评审、顾客抱怨处理等），并且必要时加以改进。
CLAUSE 5
Management Responsibility
管理职责
管理承诺 Management commitment
IRIS无特殊要求
以顾客为中心 Customer focus
Company policy shall also reflect the organization’s willingness to satisfy customer needs.
组织方针同时必须表达出在对满足顾客要求的组织意愿。
质量方针Quality Policy
The organization should define and implement a structured Process for
strategy and policy formulation, which includes an analysis of the needs
and expectations of customers along with an analysis of statutory and
regulatory requirements.
组织应当制定并执行一个战略和政策制定的结构化过程，其中包括对顾客的需要和期望的分析及对法律法规要求的分析。
企业计划Business plan
The organization shall establish and review at least annually a
business plan for the scope of their rail sector activities,
covering as a minimum the following topics:
组织必须制定针对其铁路部分活动的范围的企业计划，并且至少
每年对企业计划进行一次评审，企业计划至少应当包括以下主题：
－ Company mission and vision
公司使命和愿景；
－ Plan to reduce identified risks,
降低已识别风险的计划；
－ Market and product strategy, including development plans of new
products / Processes and phase out strategies,
市场和产品策略，包括新产品/新过程的开发计划和淘汰策略；
－ Impact of changes in technologies and in statutory and regulatory
requirements,
技术和法律法规要求变化的影响；
－ Make or buy strategy,
自制或外购的战略；
－ Company capacity (current and future) and Business objectives.
公司能力（当前和未来）及企业目标。
企业计划Business plan
企业计划Business plan
This business plan should be effectively and appropriately communicated throughout the organization and supported by mid and long term action plans in accordance with the business plan vision.
企业计划应该在整个组织得到有效的和适当的沟通，并根据企业计划的设想被中长期行动计划所支持。
A cost management process shall be in place in order to manage the finances of the organizations, including rules for accounting and controlling.
为了管理组织的财务包括会计规则和控制规则，成本管理过程必须确定。
The organization should define and implement a process for predicting, monitoring and controlling financial resources.
组织应当制定和实施一个预测、监视和控制财政资源的过程。
策划-质量目标
Planning-Quality objectives
Business objectives should be cascaded and broken down
consistently in the organization and reviews should be organized on a regular basis at each level of the organization.
业务目标应当在组织内逐层分解展开，并且应当定期在组织的每一层进行评审。
策划-质量目标
Planning-Quality objectives
Business objectives should address customer expectations and
be achievable within defined timescales.
业务目标应阐述顾客的期望并在规定的时间内是可以实现的。
The organization should define and implement a planning Process,
which includes consideration of changing external trends and
interested parties needs.
组织应制定和实施策划过程，这个过程包括对不断变化的外部趋势
和相关方需要的考虑。
质量管理体系策划
Quality management system planning
IRIS无特殊要求
职责和职权
Responsibility and authority
Ownership, authorities and responsibilities for all Processes shall be defined.
所有过程的责任人、职责和权限必须确定。
Interfaces with the customer shall be identified and communication channels described and communicated.
应当识别组织与顾客的接口，并且应当描述和交流其沟通渠道。
Each employee shall have the responsibility to raise any issue / deviation from the requirement to his / her manager for appropriate action.
组织中的每个员工都有责任向他/她的管理人员提出与要求偏离的事项和
任何变异，便于采取适当的行动。
管理者代表
Management representative
In addition to the ISO9001:2008 requirements the management representative shall have:除ISO 9001:2008要求外,管理代表还应有以下职责:
d) The organization freedom to resolve matters pertaining to quality or stop development/production/delivery/field support activities if critical requirements are not met.
在组织中解决质量相关问题的自主权，或者在关键要求未满足时，停止开发、生产、交付和现场支持活动的权利。
内部沟通 Internal communication
The organization shall establish a communication system from the management to its personnel and vice versa, giving consideration to, as a minimum:
组织必须建立一个在管理层和员工之间的双向沟通系统，至少考虑到以下
几点:
－ Policy 方针
－ Mission and vision 使命和远景
－ Company performance, and Customer related issues
组织绩效，和顾客相关的事宜
The organization should define and implement a Process for external communication
组织应当制定和实施一个外部沟通的过程。
顾客关系管理
Customer relation management
Top management shall appoint a member of management who,
irrespective of other responsibilities, shall have responsibility and authority
that includes:
最高管理者必须指定一名管理者，不管其他职责，该管理者必须拥有如下
职责和职权：
a) ensuring that processes needed to satisfy customer satisfaction and
requirements are established, implemented and maintained,
确保建立、实施和保持满足顾客满意的过程和要求；
b) reporting to top management on the performance of these processes
and any need for improvement, and
向最高管理者报告这些过程绩效和任何改进需求；
c) Ensuring the promotion of awareness of customer satisfaction
throughout the organization and related training.
确保在组织内部提升顾客满意的意识，并做相关的培训。
管理评审—总则 Management review
General
Planned intervals shall not exceed 12 months.
策划的管理评审间隔时间必须不超过12个月。
Process reviews prior to the management review (or included therein) should be carried out and formal records maintained.
管理评审之前（或之中），应当执行过程评审，并且保留过程评审的正式记录。
管理评审的输入Review input
In addition to the ISO9001:2008 requirements, the input to management
review shall include:
除ISO9001：2008要求之外，管理评审的输入内容必须包括：
h) key issues from previous project reviews, and
先前项目评审的关键事项；和
i) results of previous Process reviews and
以前过程评审的结果，及
k) Analysis of actual and potential field-failures (including during
commissioning and warranty) and their impact on quality, safety or the
environment.
实际和潜在的现场失效分析（包括调试和保质期间），和它们对质量、
安全或环境的影响。
管理评审的输入Review input
As a minimum the following KPI’s shall be reviewed:
至少必须评审如下关键绩效指标（KPI）：
－ All mandatory KPI’s (see annex 3)
所有强制的KPI(见附件3)
－ Customer on time delivery performance, and
顾客按期交货绩效，和
－ non conformities raised by the customers throughout the entire product life cycle.
在整个产品生命周期中，顾客提出的不符合项；
管理评审的输入Review input
During the management review the following KPI’s should be reviewed:
在管理评审中，以下的KPI应当评审：
－all recommended KPI’s listed in annex 3,
列于附件3的所有被提到的推荐性KPI,
and in addition KPI’s which state information about
和以下状态信息有关的KPI ：
－ internal and supplier non conformities throughout the entire product life cycle,
在整个产品生命周期中，组织内部和供方的不符合项；
－ supplier on time delivery performance,
供方按期交货绩效；
－ customer NCR response time, and quality deficiency costs.
对顾客不符合项的反应时间，和质量缺陷成本 。
管理评审的输出 Review output
In addition to the ISO 9001:2008, the output from management
review shall include any decisions and actions related to
除ISO9001：2008要求之外，管理评审的输出内容必须包括任
相关的决定和措施：
－ integration of business Processes,
经营过程的整合，
－ business objectives achievement and
经营目标的实现，及
－ customer satisfaction
顾客满意度。
CLAUSE 6
Resource Management 资源管理
资源提供 Provision of Resources
NOTE 1 The requirements described in this clause may be deployed at
Project team level.
注1这章中所描述的要求可能被部署在项目小组的水平。
The organization should define and implement a Process for the
planning of resources, including their identification, provision and
monitoring.
组织应当制定和实施一个过程，以便策划资源，包括他们的识别、提供
和监视。
A documented procedure shall be in place to ensure the appropriate
capacity regarding personnel, equipment, etc. taking into consideration the
current order book and the forecast orders on a mid-and long-term basis.
考虑现有的订单量和中长期预测订单量，组织必须制定文件化的程序来确
保如人员、设备等相适应的生产能力。
资源提供 Provision of Resources
总要求General
The organization should define, implement, measure and review human resource management processes within the management.
组织应当定义,执行,测量和评审在管理系统内的人力资源管理各个过程.
能力、意识和培训
Competences, awareness and training
In addition to the ISO9001:2008 requirements the organization shall
除了ISO9001：2008要求之外，组织必须 ：
f) Ensure that its personnel is aware of the relevance and importance of
their activities and how they contribute to the achievement of the
safety objectives.
确保员工认识到所从事活动的相关性和重要性，以及如何为实现安全
目标作出贡献。
The organization should define and implement an appraisal Process for
systematically identifying training needs.
组织应当制定和实施一个系统的识别培训需求的评估过程。
产品设计能力
Product Design Skills
The organization shall ensure that personnel with responsibility for
product design have the necessary competence to achieve design
requirements and are skilled in applicable tools and techniques.
组织必须确保产品设计责任人拥有必须的能力来达成设计要求，并且能
熟练的运用相应的工具和技术。
Applicable tools and techniques shall be identified by the organization.
组织必须识别适用的工具和技术。
员工的激励和授权
Employee motivation and empowerment
The organization shall motivate employees to achieve business, quality
and safety objectives, to make continual improvements, and to create an
environment to promote innovation.
为了达成组织的企业目标、质量目标和安全目标，为了持续改进和营造和提升创新环境氛围，组织必须激励员工。
Note 1: This could include a suggestion of a scheme system deployed
throughout the entire organization.
注1：这可以包括在整个组织内推行建议提案系统。
培训 Training
The organization shall establish and maintain documented
procedures for identifying and planning training needs in order to
achieve the necessary competence of personnel performing activities
affecting product quality and safety at all levels of the organization.
组织必须建立和保持文件化的培训程序，用以识别和策划培训需求，
以便达到在组织的所有层面上从事影响产品质量和安全的人员能够具
备必要的能力，与本地的法规要求一致,
Output of knowledge management activities (see section ) shall be
taken into consideration as an input to training planning.
知识管理活动的输出（见），必须作为培训策划的输入加以考虑 。
培训 Training
Personnel performing specific assigned tasks (. special processes)
shall be qualified, as required, with particular attention to the
satisfactions of customer requirements
执行特定任务的人员（如特殊过程，工程变更活动）必须按要求鉴定合
格，要特别关注与顾客要求、本地的要求和法规的要求的满足.
A system shall be in place to maintain and upgrade the qualifications of such personnel.
必须有一个系统用以保持和提升这些人员的资格。
培训 Training
Appropriate rules shall apply for temporary workers and new comers to the organization and induction training shall be performed including as a minimum product quality and environment and occupational health and safety.
组织必须识别影响产品质量和安全的关键活动，同时保留和定期更新执
行这些关键活动的熟练员工的记录。
Personnel whose work can affect quality and safety shall be informed about the consequences to the customer of nonconformity to quality and safety requirements.
必须告知从事影响质量和安全活动的员工有关质量和安全要求的不符合对顾客的影响后果。
Appropriate induction shall be performed for temporary workers and
newcomers, covering as a minimum Product quality and Safety.
对于临时员工和新员工必须进行适当的入职培训，最少要涵盖产品质量和安
全方面。
绩效管理策划
Performance management plan
An appraisal system shall (11) be established to regularly set
individual objectives linked with business objectives and review the
individual performance.
组织必须制定一套评价体系，用以定期设定与企业目标相关联的个人目
标，并且评估个人绩效。
Note1: The appraisal system can also address the needs for training
and development of individual people. On Shop floor level, team
objectives can be seen as sufficient individual objectives.
注1：此评价体系也可以阐述培训需求和个人发展需求。在车间层
级，团队目标可以视为个人目标。
基础设施 Infrastructure
In addition to the requirements, the infrastructure includes, as applicable:
除ISO9001：2008要求之外，基础设施包括，适当时：
d) planned maintenance activities:
计划的维护活动；
e) packaging and preservation condition checks of equipment/tooling
and measurement equipment;
设备/工装和测量设备的包装、防护/条件检查；
f) availability of (spare and consumables) parts replacement parts for
key manufacturing equipment;
关键制造设备的替换件(备品和耗材)的可获得性；
基础设施 Infrastructure
g) Documenting, evaluating and improving maintenance objectives.
文件化、评估和改进维护目标。
The organization should utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment.
组织应当运用预见性维护维修方法以持续改进生产设备的有效性和效率。
工作环境 Work Environment
The organization should define and implement Processes to ensure that the
work environment complies with all applicable statutory or regulatory
requirements.
组织应当制定和实施过程，以确保工作环境符合适用的法律法规要求。
Note 1： Factors that might affect the conformity of the product include
temperature, humidity, lighting, cleanliness, protection from electrostatic
discharge.
注1：可能影响产品符合性因素包括：温度、湿度、亮度、洁净度、
静电防护。
工作环境 Work Environment
Product safety and means to minimize potential risks to employees
shall be addressed by the organization, especially in the design and
development process and in the production process activities.
组织必须阐述产品安全和将员工对于产品的潜在风险降到最小的方法，尤其在设计开发过程及生产过程中的活动。
The organization shall maintain its premises in a state of order,
cleanliness and repair consistent with the product and production
process needs.
组织必须维持其厂房设施处于整洁完好状态，以满足产品和生产过程
的需要。
应急计划 Contingency Plan
The organization shall prepare contingency plans to mitigate the event of
an emergency such as utility interruptions, interruptions in the supply chain,
labor shortage, key equipment failure and field returns, taking into account
the output of the resources analysis and including a succession plan.
组织必须考虑到资源分析的输出并包括接替计划，准备应急计划用于减
缓紧急情况，如：公共设施中断、供应链中断、劳动力短缺、关键设备
故障和现场退货。应急计划应考虑资源分析的输出，并包括相应后续计划。
CLAUSE 7
Product Realization 产品实现
产品实现的策划
Planning of Product realization
The organization should define, implement and manage Key Processes, such as those related to Product realization and customer satisfaction.
组织应当确定、实施和管理关键过程，如产品实现和客户满意有关的过程。
与产品有关要求的确定
Determination of requirements related to the product
A detailed internal total cost breakdown based on the requirements shall be determined. The cost breakdown should be supported by return of experience from operation and supplier offers.
组织必须确定符合要求的详细内部总成本分解工作。运行和供方报价过程中积累和反馈的经验应该支持成本分解工作。
产品相关要求的评审
Review of requirements related to the product
The organization should define and implement a change Process, which includes a change control board. A multi disciplinary approach (including suppliers when appropriate) shall be used. Project Management and design / development shall be appropriately represented in all requirements’ reviews.
组织应当确定并执行变更过程，其中包括变更控制委员会。必须使用多功能小组方法（适当时包括供方）。项目管理和设计/开发内容应适当地出现在所有要求的评审中。
产品相关要求的评审
Review of requirements related to the product
The organization shall have a process to ensure that requirements identified are:
组织必须有一个过程来确保已识别的要求是：
a) individually compliant (. Clause by clause)
逐个符合（如：逐条款满足）；
b) negotiated and updated with impact on the offer identified,
商议和更新后对已有报价的影响；
c) evaluated and taken into account, and Properly transferred,
understood, acknowledged and committed to by everybody
involved.
评估和考虑，并且被每个相关人员适当地转换，理解，承认和允诺。
e) Complete, clear, precise, unequivocal, verification, testable,
maintainable, and feasible.
完整的、清晰的、准确的、非含糊不清的、可验证的、可测试的、
可维护的和可行的。
产品相关要求的评审
Review of requirements related to the product
The performance of this Process should be measured by a KPI (see annex 3).
本过程应当通过关键绩效指标（见附件3）来测量其绩效。
This Process shall also control contract variation including liaison with
customers.
本过程还应控制合约的变更，包括与顾客的联系。
The Process shall be applied for all the phases: submission of tenders,
acceptance of contracts or orders, acceptance of changes to contracts or
orders.
此过程必须适用于所有的阶段：标书的递交、合同或订单的接受、合同或订单
变更的认可。
Deficiencies identified during the Process shall be managed and corrected by
the organization.
组织必须管理和改善过程中识别出的不足之处。
产品相关要求的评审
Review of requirements related to the product
In order to avoid risks and to allow a smooth project/product
realization reviews shall cover as a minimum the aspects (see also ):
critical product characteristics, customer& regulatory requirements,
scope, time, cost, quality, resources, communication, risk, changes.
为了避免风险，使项目／产品实现过程顺利，评审必须至少涵盖以下方
面（可以参考条款）：关键产品特性、顾客和法规要求、范围、时间、
成本、质量、资源、沟通、风险和变更。
产品相关要求的评审
Review of requirements related to the product
Reports should be issued to senior management and regular reviews
should be held with them (allowing proactive activities) covering:
应当向高级管理层发布报告，并定期和管理层一起（允许主动的活动）评审报告，其中包括：
－ actual situation vs. planned situation in terms of time；
时间方面，实际情况与计划的对比；
－ forecast (time to complete),
预测（完成时间），
－ contingency activities, mitigation plans,
应急活动，规避计划，
－ actualization of risk assessment and
风险评估的实现
－ follow-up of open issue list.
开放性问题清单的跟进。
产品相关要求的评审
Review of requirements related to the product
Risks shall be identified, monitored and mitigated when applicable.
适用时，必须识别、监控和规避风险。
Risks shall be communicated internally and to the customer, if applicable.
适用时，必须进行内部地风险沟通并告知顾客。
NOTE 1: These requirements are also applicable to after sales activities
described in .
注1：这些要求同样适用于条款中描述的售后服务活动。
顾客沟通 Customer communication
The organization shall define and implement effective
arrangements for communicating any and all information
related to the delivery of the customers‘ contractual
requirements in the value chain.
在价值链中，组织必须定义和实施有效的沟通系统，确保任何
按顾客合同要求交付的相关信息得到有效安排。
顾客沟通 Customer communication
NOTE 1 This requirement may be included as part of the organization’s
supply chain management.
注1：本要求可以是组织供应链管理的一部分。
NOTE 2 Proactive communications on specific supplier management within a
Project may be established.
注2：通过积极主动地沟通，建立具体的供应商管理项目。
The organization should define and implement a Process for external communication (see clause ).
组织应确定并实施与外部沟通过程（见）。
投标管理Tender management
In addition to the requirements related to the Product (see clause ), the
organization shall have a Process and should have a documented Procedure to
ensure that requirements identified during the tender phase are:
除了有关产品的要求外（见 ），组织必须有一过程，且应当有形成文件的程序，以确保在投标过程中识别出的要求是：
a) individually checked for compliance (. clause by clause),
检查逐项符合（例如，逐条符合）；
b) negotiated and updated with impact on the offer identified,
通过谈判，并且更新受到影响的报价；
c) evaluated and taken into account,
经过评估和考虑的；
投标管理Tender management
d) properly transferred, understood, acknowledged and committed to by
everybody involved and
适当地传达到每个相关人员，并被其理解、领会和承诺；
e) complete, clear, precise, unequivocal, verifiable, testable, maintainable
and feasible.
完整的、清晰的、准确的、非含糊不清的的、可验证的、可测试的、可维护的和可行的。
The performance of this Process shall be measured by a KPI (see annex 3).
本过程的绩效必须通过关键绩效指标（见附件3）来测量。
投标管理Tender management
Prior to committing to the quotation process the organization shall use
a multidisciplinary approach (including suppliers when appropriate) to
investigate customer and regulatory requirement. Also the organization shall
confirm and document the feasibility of the proposed products in the tender.
在报价之前，组织必须使用多功能小组方法（适当时包括供方）来了解顾客和
法律法规的要求。在投标中，组织也必须确认所提供产品的可行性，并形成文
件。
During the tender review the organization shall approve the offer, including
planning, resource and budget.
在投标评审中，组织必须批准报价，包括策划和资源和预算。
As a minimum, Project / Product requirements as well as risks and
opportunities shall be identified, controlled and validated.
作为最低要求，组织必须识别、控制和确认项目/产品要求，及风险和机会。
设计和开发 Design and Development
The organization shall establish and maintain a Process for design and development and should document it in a Procedure.
组织必须建立和维持设计和开发的过程，并应当形成文件化的程序。
The performance of this Process shall be measured by a KPI (see annex 3).
本过程的绩效必须通过关键绩效指标（见附件3）来测量。
The organization should define and implement an innovation Process for new Products and Processes, which is able to identify changes in the organization’s business environment, and to plan innovations.
组织应确定和实施新产品和新工艺的创新过程，以识别组织环境的变更，并策划创新过程。
设计和开发 Design and Development
Every new technology / new Product shall fulfil the design and development requirements described in clause .
每个新技术/新产品必须满足条款所描述的设计和开发要求。
The principles applied in developing high integrity systems shall be in line with the IEC (CENELEC) standards or other agreed equivalent models.
在发展高度整合系统的过程中适用的原则应符合国际电工委员会（ CENELEC ）标准或其他等效议定的模式。
The software design Process shall explicitly implement the appropriate requirements (. IEC 62279 (EN 50128)) related to the Safety Integrity Level of the intended IRIS scope of certification.
软件设计过程中应明确执行适当的要求（如IEC 62279 (EN 50128)）中与IRIS证书中的范围相关的安全完善性等级。
设计和开发 Design and Development
Documentation and training related to the application of the Product shall be considered as integral part of the system to be designed and developed, especially in a Safety critical environment.
与适用产品相关的文件和培训是所设计和开发的系统不可分割的一部分，特别是在安全关键的环境中。
The organization shall have the capability to provide this where required for safe use.
当有安全使用要求的地方,组织必须有能力提供它。
NOTE 1 The focus is on error prevention rather than detection.
注1：重点是错误的预防，而不是错误的检测。
. Question-02
No: KO (也可不适用)
产品的设计和开发
组织应用于开发高集成系统的原则是否与IEC(CENELEC) 标准或其它等同标准相一致？软件设计过程是否明确执行了与IRIS 证书中的预期认证范围中的安全整体等级相关的适当要求（例如IEC 62279（EN 50128））?
设计和开发策划
Design and Development Planning
The organization should define and implement a collaboration Process and
indicators to measure its efficiency.
组织应当确定并执行一项合作过程，并通过指标以测量其有效性。
The organization shall determine task sequence, mandatory steps,
significant stages and method of configuration control.
组织必须确定任务顺序、强制性步骤、重要阶段和技术状态控制方法。
Where appropriate, due to complexity, the organization shall give
consideration to the following activities:
适当时，根据项目的复杂程度，组织必须考虑以下活动：
－ Structuring the design effort into significant elements, and
将设计的重点放在重要要素上，
－ For each element, analyzing the tasks and the necessary resources for
their design and development.
并且对每一项要素，分析任务情况，并为它们的设计和开发配备必要的资
源。
设计和开发策划
Design and Development Planning
This analysis should consider an identified responsible person, design
content, input data, planning constraints, and performance conditions.
这种分析应当考虑已明确的责任人、设计内容、输入数据、计划限制因
素和运作条件。
Design concepts, for example, design for safety, design for
maintainability, and design for environment, should be investigated and
applied where appropriate.
应当研究安全性设计、可维护性设计和环境友好性设计等设计理念，并
在适合时加以应用。
设计和开发输入
Design and Development Inputs
The organization shall ensure new technologies/new products (designed to meet market needs) are validated before introduction into a customer project.
（为满足市场需求）在新技术/新产品导入顾客项目之前，组织必须确保
新技术/新产品已经确认。(3/10)
This new technology/new product development shall apply the design and development requirements described in this clause.
此新技术/新产品开发必须适用于此条款中的设计和开发要求。
RAMS/LCC shall be considered as design inputs.
设计输入必须考虑RAMS/LCC。
设计和开发输入
Design and Development Inputs
NOTE 1 In particular, customers are expected to collect by the end users
all the information needed and demanded by the supplier in order
to enable the supplier to have complete and reliable design inputs.
注1：特别是, 期望顾客可以收集由最终用户所有必要的信息和供方需求，以便使供应商有完整可靠的设计输入。
. Question-03
No: KO (也可不适用)
产品的设计和开发
设计和开发输入组织是否能够确保其为满足市场需求而设计的新技术／新产品在引入顾客项目之前得到了确认？
设计和开发输出
Design and Development Outputs
The organization should define and implement a Process, which ensures that approval is carried out by sufficient competent staff (. gate reviews Process).
组织应当确定并实施一个过程，以确保只有充足能力的员工能执行批准过程（如项目评审过程）。
The design and development output shall be expressed in terms that can be verified against Production Process input requirements.
设计和开发输出必须通过生产过程输入要求的形式表现。
NOTE 1 The production process input (design output) shall include:
注1 生产流程输入（设计输出）必须包括：
－Specifications and draws 规范和图纸
－information on materials 材料信息
－Production process flow chart/layout 生产流程图/布局图
设计和开发输出
Design and Development Outputs
－ Control Plan 控制计划
－ Work Instructions 工作指导书
－ Process and Product acceptance criteria 产品和流程的接受准则
－ Data for quality, measurement, reliability, maintainability,
与质量、测量、可靠性和可维护性相关的数据
－ Results of error-proofing activities, as appropriate, and
适当时，防错活动的结果， 和
－ Methods of rapid detection and feedback of product/production
process nonconformities
产品/生产过程不符合的快速检测和反馈的方法
设计和开发评审
Design and development review
In addition to the ISO9001:2008 requirements, systematic reviews of
design and development shall be performed：
除了满足ISO9001：2008要求之外，组织必须执行系统化的设计和开发
评审,以:
c) to authorize progression to the next stage.
授权进行下一步
Note1 These design/development reviews are the part or input for the
phase review (see ).
注 1：这些设计/开发评审是阶段性评审输入或其组成部分（)。
Measurements at specified stages of design and development should be
defined, analysed and reported as an input to management / Project review.在特定的设计开发阶段,测量应当被定义\分析\报告,并作为管理/项目评审的输入.
设计和开发评审
Design and development review
NOTE 2 These measurements include quality, risks, costs, lead times,
critical paths and others, as appropriate.
注2：适当时，这些测量包括质量、风险、成本、交期、关键途径和其他。
NOTE 3 Design and development reviews are conducted on each level of
detail (. architecture design, modular design).
注3：在每个细节层次模型上执行设计和开发评审（如 体系结构设计、 模
块化设计等）。
Reviews shall also involve other functions as appropriate to review the
Product characteristics (. costs, RAMS and serviceability).
在适当时，评审也必须包括其他相关职能部门，以评审产品特性（如成本、
RAMS和适用性）。
设计和开发验证
Design and development verification
Note 1 Design and development verification are conducted on each level of detail (for example architecture design, modular design…)
注1：在每个细分层级上执行设计和开发验证（如：体系结构设计、模块化设计等）。
设计和开发确认
Design and development validation
Design and development validation shall be demonstrated for all identified operational conditions.
设计和开发确认必须证明所有已识别的操作条件。
The organization shall apply the validation concepts, organization and methods as mandated by applicable standards (. IEC 62278 (EN 50126), IEC 62279 (EN 50128), IEC 62425 (EN 50129)).
组织必须运用确认的概念、组织结构和方法作为规定的适用的标准（如IEC 62278 (EN 50126), IEC 62279 (EN 50128), IEC 62425 (EN 50129))。
设计和开发确认
Design and development validation
A documented Procedure shall be in place in the event that tests are
necessary for validation. These tests shall be planned, controlled, reviewed
and documented to ensure and prove the following:
在需要用试验去进行确认的情况下，必须制定文件化的程序。这些试验必须策划、控制、评审和形成文件，以确保并证明以下内容：
a) test plans or specifications identify the product being tested and the
resources being used, define test objectives and conditions, parameters
to be recorded, and relevant acceptance criteria, test conditions and
environment reproducible.
试验计划或规范明确所需试验的产品和所需使用的资源，规定测试目标和条
件、记录参数和相关验收准则、测试条件和可再生环境；
设计和开发确认
Design and development validation
b) test procedures describe the method of operation, the performance of the test, and the recording of the results.
测试程序描述操作方法、测试的要求和结果记录；
c) the correct configuration of the product is submitted for test.
递交正确的产品技术状态用于试验；
d) the requirements of the test plan and the test procedures are
observed, and
遵守试验计划和试验程序的要求；
e) The acceptance criteria are met.
满足验收准则。
. Question-04
No: KO
设计和开发确认
组织是否能够确保设计和开发确认（例如报告、计算和测试结果等）能够展示在所有相关的工作条件下，产品均能满足规定的特殊要求？组织用于确认和验证的概念和方法以及组织的设定是否完全符合相关标准的相关要求(例如IEC 62278(EN50126) 、IEC 62279(EN50128) 、IEC 62425(EN50129))？
设计和开发更改的控制
Control of Design and development changes
The organization should define and implement a design and development change Process.
组织应当确定并执行设计和开发变更过程。
The organization shall have a Process to control deferred and Abnormal Work in design and development.
在设计和开发过程中，组织必须制定用以控制延期的和异常的工作状况的过程。
NOTE 1 The control of design and development changes may be part of
Configuration Management.
注1：设计和开发更改的控制是技术状态管理的一部分。
设计和批准 Design approval
In the case that IEC 62279 (EN 50128) in conjunction with a Safety
Integrity Level is required, the organization shall provide a documented
Procedure defining the Safety Case and approval in line with IEC 62425(EN 50129)
如果要求IEC 62279 （EN 50128 ）结合安全完善性等级，组织必须规
定一个文件化的程序，以确定安全状况和符合IEC 62425(EN 50129)的认可。
. Question-05
No: KO (也可不适用)
设计批准
如果要求本标准必须结合安全整体等级，组织是否根据IEC62279（EN50128）建立了形成文件的程序来定义安全情况和批准要求？
采购过程 Purchasing process
In addition to ISO 9001:2008, the organization shall ensure that a Process for purchasing of Products is in place.
除了ISO 9001:2008的要求，组织必须确保制定产品采购过程。
The performance of this Process shall be measured by a KPI (see annex 3).
本过程应通过关键绩效指标（见附件3）来测量其绩效。
The organization should define and implement a Process to select, evaluate, re-evaluate and rank suppliers.
组织应当确定并执行用以选择、评估、重新评估和排序供应商的过程。
The organization shall provide a documented Procedure covering purchasing Process activities that affect Product conformity to requirements.
应提供文件化程序，覆盖影响产品符合性的要求的采购过程活动。
采购过程 Purchasing process
The organization shall implement a system to ensure the quality of all
组织必须执行一个系统去确保以下质量：
— Products purchased from suppliers,
从供方采购的产品；
— Products purchased from customer designated suppliers.
从顾客指定的供方采购的产品。
The organization shall:
组织必须：
a) maintain and use a register of approved suppliers which includes the
scope of their approval,
维护和使用核准供应商（包括他们核准的范围）的名录；
采购过程 Purchasing process
b) ensure that customer requirements are cascaded down through the Supply
Chain and especially that both, the organization and its suppliers, use
customer approved Special Processes, where required,
确保顾客要求在供应链中逐层展开,特别是客户有要求时,组织和他的供应商要使用客户批准的特殊过程
c) ensure that the function having responsibility for approving supplier quality
systems has the authority to reject the use of sources and
确保批准供方质量体系的职能部门有权拒绝供货来源的使用；以及
d) assess and manage the risks for supply of Critical Products throughout the
Supply Chain.
在整个供应链中，评估和管理关键性产品的供给风险。
采购过程 Purchasing process
The organization should:
组织应当：
a) periodically review supplier performance throughout the entire
supply chain; the results of these reviews should be used as a
basis for establishing the level of controls to be implemented, and
周期性地评审整个供应链的供方绩效；这些评审结果应当作为建立和
执行供方控制级别的基础；
b) Define the necessary action to be taken when dealing with
suppliers that do not meet technical and/or performance
requirements.
当处理供方不符合技术和/或绩效要求时，应规定所采取必要的措施。
The organization should define and implement a relationship Process to develop key suppliers.
组织应确定并执行用以发展关键供方相关的过程。
采购过程 Purchasing process
Unless otherwise specified by the customer, suppliers to the organization should be certified according to ISO 9001:2008 by an accredited third party certification body.
除非顾客特别要求，组织的供方应当通过获得认可的第三方认证机构ISO 9001:2008认证。
The organization shall develop suppliers with the goal of improving supplier operational performance.
组织必须旨在改进供应商营运绩效来发展供应商。
NOTE 1 Conformity with ISO9001:2008 is the first step in achieving this goal.
The prioritization of suppliers for development depends upon, . the
supplier’s quality performance and the importance of the Product supplied.
注1：符合ISO 9001:2008的要求时达成此目标的第一步。供方发展的优先次序取
决于 供方的质量绩效和所采购产品的重要程度等因素。
采购信息Purchasing information
In addition to the ISO9001:2008 requirements purchasing information
shall include:
除ISO9001：2008要求之外，采购信息必须包括：
d) the name or other identification, and applicable issues of specifications,
drawings, process requirements (including special ones), inspection
instructions and other relevant technical data,
名称或其它标识，适用版本的规范、图纸、过程要求（包括特殊过程）、检验指导、来自组织质量计划的适当详细资料和其他相关的技术数据；
e) Requirements for design, test, examination, inspection and related
instructions for acceptance by the organization.
设计要求、测试、检查、检验的要求和相关的组织接受准则；
采购信息 Purchasing information
f) requirements for test specimens ( . production method, number,
storage conditions) for design approval, inspection, investigation or auditing
用于设计批准、检验、调查或审核的测试样本要求（如：生产方法、数量、储存条件）；
g) requirements relative to
相关联要求：
－ supplier notification to organization of nonconforming product, and
供方向组织提供的不合格产品通知；
－ Arrangements for organization approval of supplier nonconforming
material.
对供方不合格产品批准的安排；
采购信息 Purchasing information
h) requirements for the supplier to notify the organization of changes in
product and/or process definition and, where required, obtain
organization approval,
供方告知组织关于产品和/或过程定义的变更，有要求时，并获得组织
批准的要求；
i) right of access by the organization, their customer, and regulatory
authorities to all facilities involved in the order and to all applicable
records.
组织、顾客和相关的执法权威机构有权查阅与定单相关的所有设施和
所有适用的记录；
采购信息 Purchasing information
j) requirements for the supplier to cascade to its suppliers, the applicable requirements in the purchasing documents, where required, and
对于有要求的地方,适用的要求体现在采购文件上.对供方的要求应逐层向其分供方传递；
k) requirements for Supply Chain logistics and
供应链物流管理的要求；和
l) requirements for all Deliverables associated to the Product.
所有可交付的相关产品的要求。
采购信息 Purchasing information
The organization shall ensure that the supplier’s offer is selected only after thorough analysis prior to negotiation.
组织必须确保在先前谈判分析后，选定供方报价。
The negotiation shall take into account:
谈判必须考虑：
— the level of compliance with the purchasing information,
符合采购信息的水平；
— the total cost requirements (including LCC) and
总的成本要求（包括LCC）；以及
— previous Product quality, costs and delivery performances.
先前的产品质量、成本和交付绩效。
采购产品的验证
Verification of purchased product
The organization should define and implement a Process for verification activities, like inspection or audit at supplier’s premises, which is supported by checklists and templates.
组织应确定并实施用以验证活动的过程，如通过检查表和模板，在供方现场检验或审核。
采购产品的验证
Verification of purchased product
Verification activities shall include:
验证活动必须包括：
a) Obtaining objective evidence of the quality of the product from suppliers
(. accompanying documentation, certificate of conformity, test
reports, statistical records, process control),
获得所采购产品质量的客观证据（如：附属文件、合格证书、测试报
告、统计记录、过程控制证据）；
b）review of the required documentation,
评审所需的文件；
c） inspection of products upon receipt.
产品的进货检查。
Verification activities of the organization should also include inspection and audit
at supplier’s premises.
组织的验证活动也应当包括对供方现场检验和审核。
采购产品的验证
Verification of purchased product
The purchased Product shall not be used or Processed until it has been verified as conforming to specified requirements or unless it is released under authorized customer Concession (see clause ).
直到验证符合规定的要求，或得到顾客授权放行（见），才能使用和加工采购的产品。
Where the organization utilizes test reports to verify purchased Product, the data in those reports shall be acceptable per applicable specifications.
当组织使用检测报告来验证采购产品时，那些报告中的数据必须逐条符合所适用的规范。
The organization shall periodically verify test reports for raw material.
组织必须周期性地验证原材料的测试报告。
采购产品的验证
Verification of purchased product
The organization shall define activities accordingly in case of delegation of
verification to the supplier or supplier certification.
当授权供方验证或供方资质认证时，组织必须确定相应地活动。
Where the organization delegates verification activities to the supplier, the
requirements for delegation shall be defined and a register of delegations
maintained.
当组织授权供方进行验证时，授权的要求必须明确并保留授权记录。
NOTE 1 In the case of change of the Product design or Production Process,
these requirements for delegation may be reviewed accordingly.
注1：当产品设计或生产过程变更时，这些授权的要求相应地会被评审。
供应链管理 supply chain management
Supplier deliveries shall be scheduled in order to meet the purchase requirements.
必须安排供方的交付活动，以满足采购要求。
Ordering shall be supported by an information system which:
必须有个信息系统来支持订单处理。此系统：
— covers the supply,
覆盖整个供应链；
— permits access to customer, supplier and Production information at key
stages of the purchasing Process and
在采购过程的关键步骤能够获得顾客、供方和产品信息；以及
— is order driven.
是订单驱动型的信息系统。
供应链管理 supply chain management
The organization shall communicate regularly a forecast to its supplier so that they can manage their capacity accordingly.
组织必须定期与供方沟通预测的情况，以便供方据此管理他们的产能。
Supplier shortages shall be identified, communicated to the organization, controlled and actions shall be established to recover the delivery schedule.
必须识别供方的短缺，与组织进行沟通、控制并采取措施来赶上交付进度。
NOTE 1 Identification of potential supplier shortages is part of risk
management, according to clause .
注1：根据条款，潜在供方短缺的识别是风险管理的一部分。
NOTE 2 Identified supplier shortages are dealt within the contingency plan,
according to clause .
注2：根据条款，制定应变计划来解决已识别的供方短缺。
生产和服务提供 Production and service provision
Note 1: Production in the spirit of this clause can also apply within the
engineering process (commissioning, installation).
注 1：本条款中有关生产的要求也可以适用于工程过程 （如：调试、安
装）。
The organization shall ensure that the Production Process inputs are expressed
in terms that can be verified against design and development output requirements,
including:
组织必须确保生产过程输入表现为设计和开发输出要求的形式，包括：
生产和服务提供
Control of production and service provision
specifications and drawings,
规范和图纸；
information on materials,
材料信息；
Production Process flow chart / layout,
生产过程流程图/布局；
control plan
控制计划；
work instructions,
作业指导书；
生产和服务提供
Control of production and service provision
Process and Product approval acceptance criteria,
过程和产品批准验收准则；
data for quality, measurement, reliability, maintainability,
质量、测量、可靠性和可维护性数据；
results of error prevention activities (. FMEA), as appropriate and
适当时，错误预防措施的结果（如FMEA潜在失效模式与后果分析）；
methods of rapid detection and feedback of Product / Production Process nonconformities.
产品/生产过程不符合的快速检测和反馈的方法。
生产和服务提供的控制
Control of production and service provision
In addition to the ISO 9001:2008, controlled conditions shall include for all shifts:
除了ISO 9001:2008的要求外，对于所有班次，受控条条件必须包括：
g) accountability for all Products during manufacturing (. parts quantities, split orders, nonconforming Product),
所有产品在制造过程中的可计量性（如部件数量、分批订单、不合格产品数量）；
h) Evidence that all manufacturing and inspection operations have been
completed as planned, or as otherwise documented and authorized.
所有制造和检验活动已按照计划全部完成的证据，否则需要文件化支
持和授权。
The organization shall have a process to control deferred and abnormal work in production.
组织必须有一个过程去控制生产过程中的延迟或其他反常的工作.
生产计划 Production Scheduling
Production (including test equipment) shall be:
生产（包括测试设备）必须：
— scheduled (short-, mid- (MPS = Master Production Schedule) and
long-term (SOP = Sales and Operation Plan)) in order to meet the
customer purchase requirements,
有计划（短期、中期（主生产计划）和长期（销售运营计划），以
满足顾客购买需求；
— supported by an information system that permits access to
Production information at key stages of the Process and
有信息系统支持，该系统允许在过程的关键阶段获得生产信息。
— order driven.
有订单驱动。
生产计划 Production Scheduling
The organization shall use customer forecasts and orders
to plan, measure capacity and adjust regularly, their
resources according to workload taking into account risks
(. extra order at the last minute, supplier failure, etc..)
组织必须依据顾客的预测和定单做计划，测量产能和根据生产量及风险的考量定期调整资源（如：额外的紧急插单，供货失败等）。
Bottlenecks in production shall be identified and
improvement action plan established.
必须识别生产瓶颈和制订改进措施计划。
生产文件 Production Documentation
Production operations shall be carried out in accordance with approved data.
生产运行必须按照批准的资料进行。
This data shall contain as necessary:
必要时，这资料必须包括：
a) drawings, parts lists, process flow charts, including inspection operations,
production documentation (. manufacturing plans, traveler, router,
work order, process cards) and inspection documents (see ), and
图纸、零件清单、过程流程图、生产文件（如：制造计划、工作指令、流
程卡）；检验文件（见)，和
b) A list of tools and numerical control (NC) machine programs required and any specific instructions associated with their use.
工装清单、数控机器程序和任何与其使用有关的具体指导文件 。
生产流程变更控制
Control of production process changes
The organization shall establish, document and maintain a process to
control production process changes.
组织必须建立、文件化、和维护一个过程 (13/19)，以便于控制生产流程变
更。
Persons authorized to approve changes to production processes shall
be identified.
授权批准生产流程的变更的人员必须被明确。
The organization shall identify and obtain acceptance of changes that
require customer and/or regulatory authority approval in accordance with
contract or regulatory requirements.
当根据合同或法规要求变更时，要获得顾客或法规机构批准；组织必须对
此加以识别，并获得变更的许可。
生产流程变更控制
Control of production process changes
Changes affecting processes, production equipment, tools and
programs shall be documented.
影响过程、生产设备、工具和程序的变更必须形成文件。
The results of changes to production processes should be reviewed to
confirm that the desired effect has been achieved without adverse
effects to product quality.
应当评审生产过程变更的结果，以确认在没有对产品质量产生不良反应的前
提下，已到达预期的效果。
生产流程变更控制
Control of production process changes
The organization shall maintain a Record of the date and/or serial
number of each change which is implemented in Production.
在生产过程中，组织必须保持每个变更执行的日期和/或序号的记录。
NOTE 1 Clause refers to the change management Process
which is described in clause of this document.
注1：条款涉及的变更管理过程在此标准条款中有描述。
设备和工装的控制
Control of equipment and tools
The organization shall have a documented Procedure for providing adequate
manufacturing equipment and tools to produce Products according to the design
output.
根据设计输出的要求，组织必须形成文件化程序，提供适当的生产设备和工具
以生产产品。
The organization should apply the design and development Process (see clause
) for manufacturing equipment (. tools, jigs, fixtures).
组织应当运用设计和开发过程（见条款）来制造设备（如工具、夹具、固定装
置）。
NOTE 1 The validation of the manufacturing equipment is including in clause .
注1：制造设备的验证包括条款。
生产和服务提供的确认 Validation of
processes for production and service provision
The organization should define and implement a Process for validation of Processes for Production and service provision.
组织应确定并实施某一过程，用以生产和服务提供过程的确认。
Special Processes shall be managed according to the contractual and/or internal requirements.
特殊过程必须根据合同和/或内部的要求进行管理。
The organization shall establish a Process for the control of Special Processes, including qualification and approval of the Special Processes prior to use and in accordance with documented specifications and any subsequent changes thereto.
组织必须建立某一过程，以控制这些特殊过程，包括执行特殊过程之前，
按照文件化过程规范对这些过程，以及其任何后续变更后进行认可和批准。
All personnel performing Special Processes shall be identified, trained and authorized.
组织必须对执行特殊过程的所有人员进行确定、培训和授权。
. Question-06
No: KO (也可不适用)
生产和服务提供过程的确认
是否根据合同和/或内部要求，对特殊过程进行管理？
标识和可追溯性 Identification and traceability
IRIS无特殊要求
顾客财产 Customer Property
IRIS无特殊要求
产品防护 Preservation of Product
Preservation of product should also include, where applicable in accordance with product specifications and/or applicable regulations, provision for:
可行时， 根据产品规范和/或适用的法规，产品防护也应当包括如下要求：
a) cleaning,
清洁；
b) special handling for sensitive products,
敏感产品的特殊处理；
产品防护 Preservation of Product
c) marking and labeling,
标记和标签；
d) shelf life control and stock rotation
保存期限控制和存货周转；
e) special handling for hazardous materials.
有害材料的特殊处理。
The organization shall ensure that product documentation required by the
contract/order is present at delivery and is protected against loss and
deterioration.
交付时，组织必须确保备齐合同/订单所要求的产品文件，并防止文件遗失和
损坏。
Note 1 This also applies to products supplied to the organization including
spare parts.
注1：这也适用于提供给组织的产品，包括备件。
监视和测量设备的控制
Control of monitoring and measuring equipments
In addition to the ISO 9001:2008, measurement equipment shall
除了ISO 9001:2008的要求外，测量设备必须:
f) be recalled in accordance with a defined method when requiring calibration.
当需要校准时，按照规定的方法召回。
The organization shall maintain a register of these monitoring and
measuring devices, and define the process employed for their
calibrating including details of equipment type, unique identification,
location, frequency of checks, check method and acceptance criteria.
组织必须保留这些监视和测量设施清单，并规定对这些监视和测量设
施校验的过程，包括：设备的具体类型、唯一性标识、地点、检查频
次、检查方法和接受准则。
监视和测量设施的控制
Control of monitoring and measuring devices
NOTE1 : Monitoring and measuring devices include, but are not limited to:
test hardware, test software, Automated Test Equipment and plotters used
to produce inspection data. This also includes devices that are personally
owned, developed in house, and supplied by the customer to provide
evidence of product conformity.
注１：监视和测量装置包括，但不仅限于：
测试硬件、测试软件、自动化测试设备（ATE）和用于绘制产品检验数据的
绘图仪。这也包括那些个人拥有的、内部开发的和顾客提供的用于为产品符
合性提供证据的装置。
The organization shall ensure that ambient conditions are suitable for
the carrying out of the calibration, inspection, measurement and testing
组织必须确保其周围环境是适合进行校验、检查、测量和测试。
项目管理 Project management
The organization shall implement a project management or new
product development process addressing the applicable areas of
project management, describing roles and responsibilities,
integrating all relevant functions of the organization into a
multidisciplinary team.
组织必须执行项目管理方法或系统，或新产品开发过程(10/19)阐述
项目管理的适用领域，描述作用和责任，并整合组织内所有相关职
能部门形成多功能小组。
项目管理 Project management
The performance of this Process shall be measured by a KPI (see annex 3).
此过程的绩效必须通过关键绩效指标（见附件3）来衡量。
NOTE 1 The Scope of Project Management Process is from tender
phase until the end of warranty period (Project Life Cycle).
注1：项目管理过程的范围是从投标阶段到质保期结束（项目生命周
期）。
NOTE 2 If applicable in the Project, the required SIL level has to be taken into consideration.
注2：适用时，在项目中必须考虑SIL水平的要求。
. Question-07
No: KO (总是适用)
项目管理组织
是否实施了项目管理方法或系统，或新产品开发过程中阐述了项
目管理的适用领域，描述职责和任务，整合组织内所有相关职能部门形成多功
能小组？该过程的实施通过KPI来测量了？
整合管理 Integration management
An integrated project plan shall be developed, reflecting the specific
rules to follow whilst executing a project (. multi site project,
consortium) throughout the entire project life cycle, including project
plan change control.
必须制定一个整合的项目计划，在此计划中体现在整个项目生命周期中执
行项目所必须遵守的规则（如多现场项目、联营企业），包括项目计划变
更控制。
整合管理 Integration management
NOTE 1 A multidisciplinary team typically includes the organization’s design,
manufacturing, quality, Production, field support and other appropriate
personnel including supplier and customer when appropriate.
注1：典型的多职能小组包括组织的设计、制造、质量、生产、现场支持和其他相关人员。适当时，包括供方和顾客。
NOTE 2 It is to be understood that Project Management as well as new Product
development Process can be part of an overall Product realization Process.
注2：项目管理和新产品开发过程可以理解为整个产品实现过程的一部分。
范围管理 Scope management
The organization shall ensure the entire scope of work is identified,
subdivided in work packages, controlled and verified.
组织必须确保识别完整的工作范围，细化工作包，控制和验证整个工
作范围。
Scope changes shall be controlled and consistency guaranteed
throughout the project and reflected in the project plan.
组织必须控制项目范围的变更，并且在整个项目过程中保证其一致
性，同时，反映在项目计划中。
NOTE 1 Scope management is detailed in clause design and
development.
备注1：范围管理具体内容见条款“设计和开发”。
时间管理 Time management
The organization shall ensure timely completion of the project through
the identification of :
组织必须通过识别以下事项，确保按时完成项目：
－ Specific activities that must be performed to produce the project
deliverables.
为产生项目可交付成果所必须执行的具体活动。
－ interactivity dependencies between the work package ( including those
at suppliers)
工作包之间的相互依赖性（包括在供方的作业）
－ activity sequences, resource requirements and duration,
活动顺序、资源要求和期限，
－ the critical path.
关键路径。
时间管理 Time management
These integrated activities (. project schedule) shall be regularly reviewed, controlled and recorded.
组织必须定期评审、控制和记录这些综合活动（如：项目日程计划）。
In any case of an imminent deviation, the organization shall identify and implement appropriate counter measures to avoid any impact on customers.
针对即将发生的偏差，组织必须识别和实施相应的措施来避免对顾客的影响。
The organization shall not change the delivery schedule unless authorized by the customer.
如果没有顾客的许可，组织不得改变交货进度表。
Project schedules shall be regularly updated with regard to:
项目进度计划必须定期更新，包括：
－ development activities with suppliers (major milestones with suppliers) and
与供方的开发活动（供方的关键里程碑）和
－ the identification and management of long lead time items.
识别和管理长期投产项目。
成本管理 Cost management
A cost management Process shall be in place:
必须制定成本管理过程：
－ to plan all Project related costs during the whole Project Life Cycle,
在整个项目生命周期，以计划所有项目有关的成本；
－ to regularly follow the cost progress on each work package and on each
item of the total cost breakdown, including the identification of the estimate
to completion.
以定期追踪每个工作包和总成本分解出的每一项目的成本进度，包括明确尚
未完成的成本估算。
The performance of this Process shall be measured by a KPI (see annex 3).
此过程的绩效通过关键绩效指标（见附件3）来衡量。
Cost savings should be identified in order to recover the budget in
case of deviation.
应当识别能节省的成本，以便出现偏差时，可以恢复预算
质量管理 Quality Management
The organization shall ensure that a Process is in place to manage Project Deliverables.
组织必须确保制定用以管理项目可交付成果的过程。
As a minimum, the Project Deliverables shall be managed with regard to:
必须管理项目可交付成果，至少包括以下任务：
－ Identification, clarification, fulfillment and control,
识别、澄清、实行和控制；
－ Validation and delivery on time,
确认并按时交付；
－ Approval by the customer (. customer Product acceptance points), where required and
必要时，得到顾客批准（如顾客产品接受点）；
质量管理 Quality Management
－ management of the suppliers within the Project (. listing, Criticality,
innovation, actions, Sites).
在项目中供方的管理（如名录、关键度、创新、措施、场所）。
Open issues shall be controlled and the appropriate resources put in place to manage the associated activities.
必须控制未解决的问题，配备适当的资源以管理相关的活动。
Documented Project reviews shall take place at regular intervals throughout the entire Project life
在整个项目管理周期中，必须定期执行文件化项目评审。
质量管理 Quality Management
Phase reviews shall take place at predefined Project phases / milestones to assess the Project compliance, the availability of work package Deliverables and to authorize the start of the next phase.
在预先确定的项目阶段/里程碑，必须进行阶段评审，以评估项目的符合性、工作包可交付成果的有效性，以及授权启动下一阶段。
The organization’s risk and opportunity management Process shall be employed to rectify any issue / deviation arising from these reviews in order to maintain the Project plan and schedule.
为了保持项目计划和进度，组织必须运用风险和机会管理过程来纠正评审中出现的任何问题/偏差。
Assessment of the Project performance shall be established to monitor the Project progress and efficiency through performance indicators.
必须建立项目绩效的评估，通过绩效指标以监控项目进程和效率。
. Question-08
No: KO (总是适用)
质量管理组织
是否能够确保建立过程来管理项目的可交付成果？
人力资源管理
Human Resources Management
Requirement described in clause of this standard with regard to competence, awareness and training, motivation and empowerment and performance management shall be deployed at Project team level.
本标准条款所描述的有关能力、意识和培训，员工激励和授权、绩效管理的要求,必须在项目团队层面上展开。
－ Identification, documentation and assignment of project roles,
responsibilities and reporting relationships,
识别、文件化和委派项目任务、职责和汇报关系，
－ Acquisition of appropriate resources assigned to and working until
project completion,
确保项目竣工之前，获得适当的资源和工作方法
－ and Development of individual and team competencies to enhance
project performance.
为了提高项目绩效，发展个人和团队能力。
沟通管理Communication Management
The organization shall ensure that the project team determines and
communications needs of the stakeholders (. communication plan).
组织必须确保项目小组确定和沟通利益相关方的需要 （如：沟通计划）。
This information, including performance information, shall be made
available to project stakeholders in a timely manner.
利益相关方必须能及时获得信息，包括绩效信息、产品的特殊要求、缺陷
报告和铁路工业风险 。
Note 1 This is in addition to the basic ISO9001:2008 clause
requirements.
注1：它是ISO9001:2008标准条款要求的附加要求。
风险和机会管理
Risk and Opportunity Management
The organization shall ensure a process is in place to identify, analyze
(quantitatively and qualitatively) and when necessary decide upon the
risk response (. acceptance, mitigation, transfer, avoidance). The
process should include methods like documented risk assessment,
FMEA, control of counter measures.
组织必须制定某一过程来识别、分析风险对策（定性或定量地），并且必
要时决定风险对策（如：接受、减轻、转移、避免）。该过程应当包括如： 风险评估形成文件、FMEA、及相关对策的控制。
The risk response or opportunity enhancement shall be recorded and
reported to all stakeholders as appropriate.
必须记录风险对策或机会强化，并在适当时向所有利益相关方报告。
风险和机会管理
Risk and Opportunity Management
The effectiveness of the response plan shall be assessed on a regular basis (. during the Project reviews). The output of the risk assessment shall be regularly reviewed and updated throughout the Project Life Cycle and should be extracted and communicated for the purpose of lessons to be learnt throughout the organization.
必须定期评估风险对策计划的有效性（如在项目评审期间）。必须在整个项目生命周期中执行定期评审和更新风险评估的输出，并为了在整个组织中学习经验，应当摘录和沟通风险评估的输出。
风险和机会管理
Risk and Opportunity Management
The organization shall demonstrate
组织必须证明
－ appropriate awareness of the Criticality of the Product and the function and risks of a Product within the system / vehicle of which it forms a part,
适当的意识到产品和产品功能的关键性,和作为系统/整车内的其中一部分的产品的风险,；
－ assurance of appropriate Production control Procedures to implement risk mitigation.
适当的产品控制流程保证以减轻风险。
技术状态管理 Configuration management
The organization shall establish, document and maintain a configuration management Process appropriate to the Product.
组织必须建立、形成文件化和保持与产品相适宜的技术状态管理过程。
The organization should have a documented Procedure for configuration management.
组织应当有用以技术状态管理的文件化程序。
The organization shall: 组织必须：
a) at the beginning of the contract, define a list of products (safety critical
products as a minimum) including their component parts, the configuration
of which must be managed. This list shall be approved by the customer,
在合同的初始期，确定一个产品清单（至少包括安全关键产品），包括：它
们的零部件和必须管理的技术状态。此清单必须经顾客批准;
技术状态管理 Configuration management
b) address change management process within the configuration management (see ),
在技术状态管理中指出变更管理流程（见)，
c) maintain traceability during production and operations,
在生产和运行期间，保持可追溯性，
For software development and Production a configuration
management for applied tools has to be available.
对于软件开发和生产，必须对所使用的工具进行技术状态管理。
NOTE 1 Guidance on configuration management is given in ISO10007.
注1：技术状态管理的指南见ISO10007。
NOTE 2 In cases where a change impacts a Product which is subject to
configuration management, the principles described in clause apply.
注2：万一某一变更影响到产品技术状态管理时，应用条款中描述的原则。
首件检验 First Article Inspection (FAI)
The organization shall provide a documented Procedure covering the inspection, verification, documentation and update of Records with results of a representative item from the first series Production run of a new Product or major upgrade of an existing Product, following:
新产品首次批量生产或现有产品重大升级时，组织必须制定文件化的程序，以规定第一批产品中代表性项目的检验、验证、形成文件化和记录更新的结果:
－ the verification of the Production Process or
生产过程的验证或
－ a change that invalidates the previous First Article Inspection result.
先前的首件检验结果失效的更改。
首件检验 First Article Inspection (FAI)
The organization shall ensure that a Process is in place to plan, initiate and
conduct a First Article Inspection. The performance of this Process should be
measured by a KPI (see annex 3).
组织必须确保制定某一过程，用以计划、启动和控制首件检验。此过程的绩效
可通过关键绩效指标来衡量（见附件3）。
This FAI Procedure and Process shall be applied to suppliers according to
defined and agreed criteria.
此首件检验程序和过程应适用于供方,且供方必须根据规定的和协定的准则应用。
首件检验 First Article Inspection (FAI)
NOTE 1 If the Product is a one-off, FAI is meant as validation.
注1：如果产品是一次性的，FAI是指确认。
NOTE 2 FAI is not applicable for organizations having activities in design only.
注2：FAI不适用于只有设计活动的组织。
NOTE 3 If the Product is a software only, FAI is meant as validation according to applicable IEC Standards.
注3：如果产品只是软件，根据合适的IEC标准，FAI是指验证过程。
NOTE 4 FAI is a key milestone of the organization’s Production Process.
注4：FAI是组织生产过程的关键里程碑。
. Question-09
No: KO (也可不适用)
首件检验（FAI）
组织是否提供形成文件的程序，用以规定在新产品零件（或现有零件的重大升
级）首次批量生产时代表性产品的检验、验证和通过记录结果来形成文件和更
新记录？
以：1.验证产品过程
2.进行变更以使先前的首件检验结果有效。
注1：如果产品是一次性产品，FAI 是指确认过程。
注2：首件检验不适用于只有设计活动的组织。
注3：如果产品只是软件，根据适用的IEC标准，FAI是指确认过程。
产品调试/顾客服务
Commissioning/ Customer service
For customer service and commissioning (when commissioning is a contractual requirement)， a Process shall be in place. This Process shall include
对于顾客服务和调试（当调试是合同要求情况下），组织必须制定某一过程。此过程必须包括：
a) actions to be taken where problems are identified after delivery,
including investigation, reporting activities, and actions on service
information.
在交付后，一旦发现问题所应采取的措施，包括：调查、报告活动和
根据服务信息所做的措施。
b) the control and updating of technical documentation.
技术文件的控制和更新。
c) the approval, control, and use of repair schemes.
维修计划的批准、控制和执行。
产品调试/顾客服务
Commissioning/ Customer service
d) the management of Consignment Stock.
寄售库存的管理。
The organization shall demonstrate that adequate customer support is
provided
组织必须证明能提供适当的顾客支持；
－ during commissioning,
在调试期间；
－ until Product validation is complete,
直到完成产品验证；
－ during warranty,
在保质期间；
－ until final customer acceptance.
直到最终顾客认可。
产品调试/顾客服务
Commissioning/ Customer service
Suitable resources shall be available to provide customer support in accordance with the agreed requirements, for all the after sales activities including supply of spare parts.
组织必须确保按协定的要求，为顾客提供支持活动及所有的售后服务活动提供合适的资源，包括备品备件的供应。
Maintenance contracts shall be managed in accordance with the requirements defined in clause 7 “Product realization”.
维护合同必须按照第七章“产品实现”的规定进行管理。
. Question-10
No: KO (也可不适用)
调试／客户服务
如果现场服务过程是合同要求，组织是否提供了一个过程包括：a）产品交付
后，当出现问题时需采取的措施，包括问题调研、报告提交，及针对该服务信
息所采取的行动？
RAMS/LCC
Maintainability of the Product shall be an integrated part of the design and
development Process. Standardized routines for the Maintenance of
software shall be established and recorded according to IEC 62278
(EN50126), IEC 62279 (EN 50128), IEC 62425 (EN 50129) or other
agreed equivalent models in accordance with the design and development
Process.
产品的可维护性必须整合成设计和开发过程的一部分。依据IEC 62278
(EN50126)、 IEC 62279 (EN 50128)、 IEC 62425 (EN 50129) 标准或设
计和开发过程，协定的其他相关等同模型，必须建立并记录软件维护的例
行性的作业标准。
RAMS/LCC
The organization shall have a documented Procedure in place to cover all the aspects of RAMS activities, including:
组织必须制定文件化的程序，以覆盖RAMS活动的所有方面要求，包括：
－ calculation and documentation,
计算和记录；
－ data collection, analysis and improvement action plan set up,
数据收集、分析和建立改进措施计划；
－ implementation of defined tasks of the action plan.
执行措施计划的规定工作。
RAMS/LCC
The organization shall have a Process in place to manage LCC and should document it in a Procedure.
组织必须制定用以管理LCC的过程，并应当形成文件化程序。
Resources shall be in place to address the RAMS / LCC requirements.
必须配备资源，以实施RAMS / LCC要求。
RAMS / LCC data collection and analysis shall be supported by past experience from operation, during and after warranty period and continually improved (see clause ).
RAMS / LCC数据收集和分析工作必须得到在质保期内和质保期后过去所积累的营运经验的支持，并不断改进（见）。
RAMS/LCC
NOTE 1 It is expected that the organization demands and collects all data
needed for the Product.
注1：预期组织需要和收集所有产品必需的数据。
NOTE 2 LCC Process is part of cost management Process (see clause
).
注2：LCC过程是成本管理过程的一部分（见）。
NOTE 3 It is recommended that RAMS / LCC are in line with applicable
standards (. IEC 62278 (EN 50126)).
注3：建议RAMS / LCC过程符合适当的标准要求（如IEC 62278 (EN 50126))。
老化过程管理 Obsolescence Management
The organization shall establish a process to ensure, for the defined and
agreed product life cycle, the availability of the supplied products and
spare parts.
在规定的和协定的产品生命周期，组织必须建立某一过程以确保所提供的产品
和备品备件的有效性。
NOTE 1 This Process may be part of the change management or
configuration management Process.
注1：此过程可以是变更管理或技术状态管理过程的一部分。
NOTE 2 Spare parts may be of the same Product configuration or coming
from alternative solutions which have been developed, validated and
qualified according to the original requirements.
注2：备品备件可以是相同的产品技术状态，或是来自于根据原来的要求开发、
确认和认可的其他可替代方案。
变更控制 control of changes
The organization shall establish a Process and a documented Procedure to implement, execute, control and react to changes that impact Product realization, including the definition of which changes need to be referred back to the customer for authorization in line with local and customer requirements.
组织必须建立某一过程并形成文件化程序，以执行、实现、控制和响应影响产品实现的变更。包括变更的详细情况应反馈给客户，得到顾客的授权，同时要符合地方规定和顾客的要求
The effects of any change, including those changes caused by any supplier (. changes of subcontractor, location, Production Process, standard) and by customers (. for new Product introduction) shall be assessed and verified. Validation and approval activities shall be defined to ensure compliance with customer requirements before implementation. Changes should be analyzed regarding the impact of testing and side effects.
必须评估和验证任何变更所产生的影响，包括由任何供方引起（如转包商、场所、生产过程、标准的变更）和顾客引起（如新产品介绍）的变更。在变更实施前，必须规定变更的确认和批准活动，以确保变更与顾客要求相一致。
变更控制 control of changes
The organization shall have controls in place which prevent changes from external origin being implemented without prior authorization from all appropriate stakeholders.
组织必须进行适当的控制,以防止在未经所有合适的利益相关方事先授权的情况下，实施变更过程。
The impact of change on form, fit and function of proprietary designs (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
对于独有的设计，必须与顾客一起评审其对结构、装配和功能变更（包括性能和/或耐用性）的影响，以确保所有影响都得到适当的评估。
变更控制 control of changes
NOTE 1 Any Product realization changes and their possible constraints
affecting customer requirements require notification to and agreement
from, the customer.
注1：影响到顾客需求的任何产品实现的变更和可能的限制，必须通知顾客并
得到其同意。
NOTE 2 The above requirement applies to design and development changes
(see clause ) as well as Production Process changes (see clause
).
注2：以上要求适用于设计和开发的变更（见），也适用于生产过程的变
更（见）。
NOTE 3 This is in addition to ISO 9001:2008 clause requirements.
注3：此项要求是在ISO 9001:2008（条款）的要求上附加的。
. Question-11
No: KO (总是适用)
变更管理
在变更实施前，是否规定了验证、确认和批准活动，以确保与顾客要求一致？
CLAUSE 8
Measurement, analysis and Improvement
量测、分析和改进
总则 General
In addition to ISO 9001:2008, the organization shall ensure that a Process for measurement, analysis and improvement is in place.
除ISO 9001:2008的要求外，组织必须确保制定用以测量、分析和改进的过程。
顾客满意Customer satisfaction
The organization should define and implement a monitoring Process, which is performed in a systematic and planned way, and includes cross checks with external data sources.
组织应系统地、有计划地确定并实施一项监视过程，其中包括与外部数据源交叉检查
The organization should define and implement Processes for tracking statutory and regulatory requirements.
组织应当规定并执行实施过程进行法律法规要求的跟踪。
顾客满意Customer satisfaction
The organization shall implement a Process for obtaining and evaluating customer satisfaction data. The performance of this Process should be measured by a KPI (see annex 3).
组织必须实施获得和评价顾客满意度数据的过程。这一过程应当通过关键绩效指标（见附件3）加以衡量。
Root cause analysis of the main issues should be done with special emphasis on customer related issues.
组织应对主要问题的根本原因进行分析，特别是与顾客有关的问题。
NOTE 1 Also refer to clause e)
注1 也适用于 e)
内部审核 Internal audit
The organization should define and implement a Process for data gathering (see clause ).
组织应当确定并实施数据收集过程（见）
Internal auditors of relevant functions shall be qualified to ensure that rules of auditor behaviour are applied and IRIS requirements of relevant chapters are understood.
相关职能部门的内审员应具有充分的能力和资格，以确保应用审核员行为准则，及理解IRIS相关章节的要求。
The organization shall audit all Processes of its management system to verify compliance with all requirements (including any external requirements). The audit program shall cover all Production shifts, if applicable.
组织必须审核经营管理体系的所有过程，以验证所有的要求（包括所有外部要求）的符合性。在适用情况下，审核方案必须覆盖所有生产班次。
过程的监视和测量
Monitoring and measurement of process
Mandatory and recommended KPI’s shall be established as listed in
annex 3 to measure and monitor Processes.
强制性和建议性的关键绩效指标应按附件3制定，以衡量和监控过程。
产品的监视和测量
Monitoring and measurement of Product
Measurement requirements for product or service acceptance shall be documented
产品或服务接收的测量要求必须形成文件。
This documentation may be part of the product documentation, but shall include: 该文件可以是产品文件的一部分，但必须包括：
a) criteria for acceptance and /or rejection,
接收和／或拒收的准则；
产品的监视和测量
Monitoring and measurement of Product
b) where in the sequence measurement and testing operations are performed,
按照操作要求进行测量和试验；
c) a record of the measurement results, and
测试结果记录；和
d) type of measurement instruments required and any specific instructions associated with their use.
要求的测量仪器的型号和任何与其使用有关的特定的使用说明书。
Test records shall show actual test results data when required by specification or acceptance test plan.
根据规范和接收试验计划的要求，试验记录必须展现真实的试验结果。
不符合品的控制
Control of nonconforming products
NOTE1 Any deviation within the execution of a Project / contract is considered as non conformity, . logistics aspects, documentation.
注1：在执行项目 / 合同中的任何偏差，例如物流方面、文件化的偏差，都被视为不合格。
不符合过程控制
Control of nonconforming processes
The organization shall establish, document and maintain a Process to manage business management Process variation, which includes:
当经营管理过程发生偏离时，组织必须制定、形成文件及维护以下过程，用以：
identification, Recording and analysing of the root causes of the variation and if the business management Process is non conform, taking appropriate action to correct the nonconforming Process,
识别、记录和分析偏离的根本原因，并且如果过程不符合时，应采取适当措施，纠正不符合过程；
evaluation whether the business management Process variation has resulted has resulted in Product nonconformity and
评估管理过程偏离是否导致产品不合格；并且
identification and control of the nonconforming Product in accordance with clause .
按照条款，识别并控制不合格的产品。
. Question - 12
No: KO （总是适用）
不合格过程的控制
组织是否建立、形成文件和保持一个过程来管理企业管理过程的偏离，包括：
识别、记录和分析偏离的根本原因，及如果企业管理过程不符合，采取适当
行动，纠正不符合过程？
b) 评估过程偏离是否会导致产品不合格？
c)识别并控制不合格产品？
客户让步放行Customer Concession
The organization shall obtain a customer Concession or Deviation Permit prior to further Processing, whenever the Product or Production differs from what has been approved.
当发现产品或生产过程与目前批准的要求有偏差时，组织必须得到顾客让步认可或偏差许可后才能进行后续作业。
Penalties due to Concessions and Deviation Permits should be collected, analyzed and assigned to causers.
让步放行和偏差许可应收缴罚款，分析原因并确定引起者。
NOTE1 Penalties due to Concessions and Deviation Permits may be considered as part of Quality Deficiency Cost.
注1：由于让步放行和偏差许可产生的罚款则可视为质量缺陷成本的一部分。
The organization shall maintain a record of the expiration date of such a concession and /or quantity authorized.
组织必须保持这样的让步放行的期限和／或批准放行的数量的记录。
客户让步放行Customer Concession
The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires.
当顾客让步放行的授权到期后，组织必须确保与初始的或代替的规范相符合。
Material shipped, which is subject to such a concession, shall be clearly and appropriately identified. This applies equally to purchased products.
所装运的材料涉及让步放行时，必须适当清楚地标识。这同样适用于采购的产品。
The organization should define and implement a customer Concession Process.
组织应该确定并实施顾客让步放行过程。
The organization shall reach agreement with such a request from suppliers before submission to the customer.
在向顾客交付前，组织必须确保供方让步放行请求已得到批准。
数据分析Analysis of Data
In addition to ISO 9001:2008, the organization should ensure that a Process for the analysis of data is in place (see clause ) and the performance of this Process should be measured by a KPI (see annex 3).
除ISO 9001:2008的要求外 ，组织应确保制定数据分析的过程（见），且此过程的绩效应通过关键绩效指标来测量（见附件3 ）。
In addition to the ISO 9001:2008, the analysis of data shall provide information relating to:
除ISO9001:2008的要求外，数据分析应提供以下有关方面的信息：
e) external incident reports associated with the organization’s Products and
外部事件报告，涉及组织产品和
f) Product Safety.
产品安全
持续改进 Continual Improvement
The organization should define and implement improvement Processes, based on corrective and preventive actions (see clause and ).
组织应确定并实施基于纠正和预防措施的改进过程，（见第和 ） 。
纠正措施 Corrective Action
In addition to the ISO9001: 2000 requirements, the documented procedure shall define requirements to:
除ISO9001:2008 的要求外，文件化程序必须明确要求：
g) document the effectiveness and close out of corrective action.
纠正措施的有效性和关闭情况形成文件。
The organization should define and implement a corrective action Process, which is regularly reviewed in a multidisciplinary assessment (see clause ).
组织应确定并执行纠正措施过程，利用多元化的评估进行定期评审（见）。
预防措施 Preventive action
The organization should define and implement a preventive action Process, which is regularly reviewed in a multidisciplinary assessment (see clause ).
组织应确定并执行预防措施过程，利用多元化的评估进行定期评审（见）。
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TUTOR NOTE:
During the presentation of the . questions the trainer should ask the delegates for typical relevant evidences (documents (procedures, plans), records …) which shall be investigated in the readiness review.
He should write down these issues on the flip chart.
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