IRIS简介

作者：法国 贝尔国际验证机构（AFAQ/BestCERT, Ltd.）

中文版 关于IRIS

由欧洲铁路行业协会（UNIFE）发起， IRIS-International Railway Industry Standard (国际铁路行业标准)和国际上所认知的ISO9001质量标准是相辅相成的。IRIS标准是将铁路行业中的特殊要求融入到ISO 9001标准中，简言之，IRIS标准是针对铁路行业的ISO9001标准的延伸。该标准已于2006年6月开始正式实施。

本标准在拟定和推进中得到系统整合商和设备制造商的大力支持，如阿尔斯通交通（Alstom Transportation）, 庞巴迪交通（Bombadier Transportation）, 西门子交通（Siemens Transportation）等。

由于ISO9001标准并没有阐述针对铁路行业的特殊需求，欧洲铁路行业协会决定模仿已经存在于航天（AS9100），汽车（ISO/TS16949）以及食品工业（ISO22000）中相似的标准，试图发展和成立一个国际认可的标准。此标准包括真实的评估过程以及审核和计分原则。

为了确保，设备制造商可以自行选择发证机构申请IRIS证书。IRIS证书将取代四个主要指导委员会成员（阿尔斯通交通，AnsldoBreda, 西门子交通以及庞巴迪交通）各自的评估方法。

背景

对于铁路行业，欧洲铁路运输的自由化使其面对特殊的挑战。由于不断增加的竞争压力，特别是在欧盟的货物市场，铁路最需要的就是拥有随时能运行的运输系统，此系统要求符合主要国际线路沿线国家的不同的要求并且要符合严格的法律法规。铁路运营商对铁路供应行业所期望的是车辆、设施以及运营设备的竞争力并且这些设备能够符合高质量的标准。

IRIS的益处

成功的执行IRIS会给系统整合商以及设备制造商带来一个双赢的局面。此证书带来的益处主要体现在以下几方面：

 整个供应链的质量会得到提升

 设备制造商的评估和核可会更有效

 制造商和供应商的成本会降低

 综合的数据以及其可获得性将得到改进

AFAQ AFNOR 能为您做什么

作为ISO国际标准化组织创始委员和常任理事国，AFAQ AFNOR在验证领域一直处于全球领先地位，在全球已有超过40，000家认证客户。另外，作为同行业的领军者，AFAQ AFNOR于今年9月份颁发了全球第一张IRIS证书。

法国?贝尔国际验证机构作为AFAQ AFNOR在中国的分支机构，为广大客户提供全方位的认证和培训服务。其服务范围包括所有的行业，并能够适应每个行业的特别需要。

EN

About IRIS

Promoted by UNIFE and supported by system integrators and equipment manufacturers, IRIS (International Railway Industry Standard) intends to complement the internationally recognized ISO 9001 quality standard. IRIS is unique to the railway industry and to be an extension of ISO 9001.

The UNIFE initiative is modelled on similar quality standards already in place in the aerospace, automotive and the food industries.

IRIS intends to develop and establish an internationally recognized standard that encompass the actual evaluation process as well as an audit and scoring methodology.

To ensure independency, equipment manufacturers will be able to apply for the IRIS certificate from the certification body of their choice. All equipment manufacturers are thus able to seek certification based on the new standard. This certificate will replace individual evaluation by at least the four founders of this initiative (Alstom Transport, AnsaldoBreda, Siemens Transportation and Bombardier Transportation).

Background

For the railway industry, the liberalization of European rail transport poses a particular challenge. Due to the increasing competitive pressure, especially in the EU's goods market, what the railway needs most are \"ready to run\" transportation systems that meet the different requirements of the individual countries along the main

intercontinental routes as well as comply with the restrictive regulatory requirements. What the railways operators expect of the railway supply industry is competitiveness, proved solution for cars, facilities and operating equipment that meet the high quality of standards required for every day use.

Benefits

  

Quality will increase across the entire supply chain

Evaluation and approval of equipment manufacturers will become more efficient Cost for manufacturers and suppliers will decrease

 Comprehensive data and its accessibility will improve

Why choose AFAQ AFNOR

AFAQ AFNOR is leading certification body in the world. It is the Administration Organization of Standardization in France and is the initiate member of CEN. AFAQ AFNOR also is an active and influential membership of international standards committee. There are more than 40,000 companies already certified by AFAQ AFNOR in 60 countries.

AFAQ/Bestcert, Ltd as the branch of AFAQ AFNOR in China, it can provide a large range of services, including certification and training.Our services aim to all kinds of industries and can meet the specific requirements of every industry.

执行IRIS审核应做的准备 The preparation required to implement IRIS  应建立文件化程序的流程或是活动 IRIS所要求的13个应建立文件化程序1的流程或是活动说明如下，在右方的字段标示ISO 9001:2000所要求的文件化程序。 编号 1 2 3 4 5 6 7 8 9 10 11 12 13 条文 4.1 4.2.3 4.2.4 6.1 6.2.2.2 7.5.6 7.5.8 7.8.2.3 7.10 8.2.2 8.3 8.6.2 8.6.3 需建立文件化程序的流程或活动 转移/外包的合约活动 文件管制 纪录管制 资源供应 训练 设计与开发的确认 初版文件审查 (FAI) 设备及工具的维护 RAMS 内部稽核 不符合产品管制 矫正措施 预防措施 ISO 9001 ISO 9001 ISO 9001 ISO 9001 ISO 9001 ISO 9001 注1 为了顾及客户业务上的需求，上表中应建立文件化程序的流程或活动，其文件化程序的标题，可与上述标题不同。  Processes/Activities to be documented in procedures The thirteen (13) mandatory required documented procedures 1by IRISare listed below. The right column identifies the mandatory ones required by ISO9001:2000. Procedure 1 Clause 4.1 Processes/Activities to be documented in procedures Transfer/outsourcing of contract activities 2 3 4 5 6 7 8 9 10 11 12 13 4.2.3 4.2.4 6.1 6.2.2.2 7.5.6 7.5.8 7.8.2.3 7.10 8.2.2 8.3 8.6.2 8.6.3 Control of documents Control of records Provision of resources Training Design and development validation First article inspection (FAI) Maintenance for equipment and tools RAMS Internal audit Control of nonconforming product Corrective actions Preventive actions ISO 9001 ISO 9001 ISO 9001 ISO 9001 ISO 9001 ISO 9001 1 In respect of the business needs of a client, please note that the coverage of the processes mentioned above could differ from the titles in the table. IRIS要求的程序 下述程序1应建立相关的文件并有主要的绩效性指标来量测、分析及改善其表现。 编号 1 2 3 4 5 6 7 8 9 条文 4.1 4.2.3 7.1 7.3 7.4 7.4.5 7.4.8 7.4.9.1 7.4.9.2 IRIS所要求的程序 成本管理 客户文件管制 产品实现的规划 竞标管理 项目管理或新产品开发 项目管理 – 品质管理 项目管理 – 风险及机会管理 项目管理 – 修正管理 项目管理 – 报废管理 ISO 9001 10 11 12 13 14 15 16 17 18 19 7.5 7.6 7.7.1 7.8.2.2 7.8.3 7.9 7.10 7.11 8.1 8.4 设计与开发 结构管理 采购管理 制程改变管理 产品及服务供应程序确认 委托/客户服务 LCC 监测与量测设备管理 监测、量测、分析及改善 不符合程序管理 ISO 9001 ISO 9001 注1 为了顾及客户业务上的需求，上表中应建立文件化程序的流程或活动，其文件化程序的标题，可与上述标题不同。  Processes required by IRIS The processes 1 listed below require mandatory an appropriate documentation and should have key performance indicators to measure, analyze and to improve their performance. The right column identifies those processes mentioned in ISO9001:2000. Process 1 2 3 4 5 6 7 8 9 10 Clause 4.1 4.2.3 7.1 7.3 7.4 7.4.5 7.4.8 7.4.9.1 7.4.9.2 7.5 Processes required by IRIS Cost management Control of customer documents Planning of product realization Tender management Project management or new product development Project management-Quality management Project management-Risk and opportunity management Project management-Change management Project management-Obsolescence management Design and development ISO 9001 11 12 13 14 15 16 17 18 19 7.6 7.7.1 7.8.2.2 7.8.3 7.9 7.10 7.11 8.1 8.4 Configuration management Purchasing management Control of production process changes Validation of processes for production and service provision Commissioning/Customer service LCC Control of monitoring and measurement devices Monitoring, measurement, analysis and improvement Control of nonconforming processes ISO 9001 ISO 9001 1 In respect of the business needs of a client, please note that the coverage of the processes mentioned above could differ from the titles in the table.