IRIS体系审核时的评分方法

1、IRIS体系审核时的评分方法 Total questions:255，including 12 K.O.questions。 总共255个问题，其中包括12个K.O.问题 1.Knock-out（K.O.）questions关键性问题 2.Open questions which are assessed through a four level approach for assessing the level of maturity ofprocesses and the grade/extension of implementation（Optimized，Qualified，Define

2、d，Poor） 开放式问题：通过在审核时评分过程的成熟程度和实施的程度，设定了四种不同级别（优秀，合格。可以。差）。 3.Closed questions（Yes/No）without progressive maturity levels。 封闭式问题：只有满足/不满足，没有递进的成熟度级别。 Note：Questions indicated as Non applicable（'NA'）are not assessed and relevant justification shall bedocumented。 注：如果问题被指明为“不适用”（即NA），这些问题将不会被审核

3、，但要说明“不适用”的原因，并被形成文件。 knock out questions（K.O.）关键性问题（K.O.问题）： A detailed pre assessment of the Knock Out（K.O.）questions shall be carried out to ascertain the readiness toundertake the audit。 对K.O.问题应逐条进行预审核，以确定能否开始正式的审核。 Fulfilment is considered as a prerequisite for IRIS certification。 满足K.O.问题的要求是

4、开始IRIS认证的前提条件。 K.O. questions are not scored。 K.O.问题不打分。 When a K.O.requirement is not met，the whole audit fails。The Certification process has to start with a newrequest（covering the full audit process again）。 一旦K.O.问题没有满足，将不能通过审核。组织需要重新递交认证申请（审核过程将重新覆盖所有要素）。 K.O.问题一共12个，其中2个只适用于信号系统的公司。 Quality Man

5、agement System - General requirements 质量管理体系-通用要求 In case of transfer or outsourcing of activity with the execution of a contract does a transfer procedureincluding：feasibility study，nsk analysis，planning，communication to customer and FALs to the appropriate levelexist？ 当合同执行过程中有转让或者外包的情况发生，是否有转让的程序

6、？其内容包括：可行性研究，风险分析，策划，客户沟通和首件检验，这些内容有在适当的水平上吗？ Design and development（For Signalling only）设计和开发（仅适用于信号系统） Does the organization apply the principles in developing high integrity System in line with the CENELEC standardor other agreed equivalent models？The software design process must explicitly imple

7、ment the requirements of EN50128 related to safety integrity of the intended scope of the IRIS certificate。 组织在开发高集成系统时是否应用在CENELEC标准或其它协议的等效标准？软件开发过程必须实施EN50128的要求（与IRIS证书范围的安全集成有关时）。 CENELEC-European committee for electro-technical standardization 欧洲电工技术标准委员会 Design and development inputs 设计和开发输入

8、Does the organization ensure new technologies / new products are validated before being introduced in a customerproject？ 组织是否确保新技术/新产品在引入顾客项目前得到确认？ Design and development validation 设计和开发确认 Does the organization ensure that reports，calculation，test results，etc，demonstrate that the productdefinition

9、meets the specification requirements for all the relevant operational conditions？ 组织是否确保报告、计算、测试结果等能够展示产品定义满足所有相关的运行条件的规范要求？ Design approval（For Signalling only）设计批准（仅仅适用于信号系统） Does the organization provide a documented procedure defining the safety case and approval in line with thisstandard？组织是否准备

10、了文件化的程序，用于按照这个标准要求明确安全情况和批准？ Validation of processes for production and service provision 生产和服务提供过程的确认 Are special processed managed according to the contractual requirements？特殊过程是否按照合同要求进行管理? Project Management 项目管理 Does the organization implement a documented project management（PM）approach or Syst

11、em，or new productdevelopment process addressing the applicable areas of PM，describing roles and responsibilities，integrating thewhole functions of the organization in a multidisciplinary team？ 组织是否实施项目管理方法或体系，或新产品开发过程，涉及项目管理的使用领域，描述职责和任务，整合组织内所有相关职能形成多功能小组？ Quality management 质量管理 Does the organizat

12、ion ensure that the process is in place to manage project deliverables？ 组织是否确保有过程来管理项目是可以交付的？ Change management 变更管理 Are verification，validation AND APPROVAL，activities defined，to ensure compliance with customer requirements BEFORE IMPLEMENTATION？ 在实施前，是否定义了验证、确认和批准活动，以确保符合顾客要求？ First article inspec

13、tion（FAI）首件检验 Does the organizations System provide a documented procedure defining inspection，verification and documentationof a representative item from the first serial production run of a new part or following any subsequent change thatinvalidates the previous first article inspection result？ No

14、te：if the product is a one-off or a software，FAI is meant as validation 组织的体系是否有文件化的程序，规定在新零件首次批量生产时（或任何随后的会导致先前的首件检验结果失效的变更引入时）代表性零件的检验、验证和文件化？ 注：如果产品仅是一个或是软件,FAI就是指得是确认。 Commissioning / Customer service 测试/客户服务 Does the organization provide a process for field services/Do field processes provide：a

15、ctions to be taken whereproblems are identified after delivery，including investigation，reporting activities and actions or service Information。 组织是否有现场服务的过程？现场服务过程是否提供，在交付后，当发现问题时，要采取相应的措施，包括调查，报告活动和服务信息的措施？ Control of nonconforming processes 不合格过程的控制 In the event of business management process vari

16、ation，does the organization have a process in place to； a）Identify and record the variation，and if the business management process is non-conform to take appropriateaction tot correct the nonconforming process？ b）Evaluate whether the business management process variation has resulted in product nonc

17、onformity？ c) Identify and control the non-conforming product？ 当发生过程偏差时，组织是否有过程来：a）识别，记录偏差并采取适当行动，纠正不合格的过程，b）评估是否过程偏差已经导致产品不合格，并且c）识别并控制不合格的产品？ Quality management/质量管理 Does the organization ensure that a process is in place to manage project deliverables？ 组织是否确保有过程来管理项目是可以交付的？ The organization has a

18、 structured，appropriate project related quality system in place with manuals，proceduresand quality plans to manage project deliverables 组织有结构化的、合适的与项目有关的质量体系，包括手册、程序和质量计划来管理项目是可以交付的。 Change management/变更管理 Are verification，validation AND APPROVAL activities defined，to ensure compliance with customer

19、 requirements BEFORE IMLEMENTATION？ 在变更实施前，是否定义了验证，确认和批准活动，以确保符合顾客要求？ Verification，validation and approval activities are defined，to ensure compliance with customer requirementsBEFORE IMPLENMTSTION。Process implemented and records are available 在变更实施前。定义了验证、确认和批准活动，以确保符合顾客要求。过程得到了实施并有记录。 Open Questio

20、ns 开放式问题项 Each individual requirement（question）shall be scored progressively using maturity levels。 每项要求（每个问题）将按照成熟度级别被评分。 Maturity levels and relevant expected evidences shall be interpreted consistently with audit scope and companycharacteristics。 等级的评定依据和相关的审核发现必须是一致的。Maturity Level成熟度级别Is the requirement met？是否满足要求？Point分数“Optimized”优秀Exceeded and continuously improved4“qualified”合格Exceeded超过要求3“defined”满足Met in full达到要求2“poor”差Partially met部分满足要求1“insufficient”不满Not met不满足要求