IRIS内审员培训

1、 Founded in 1926 成立于1926年 IRISIRIS内审员培训内审员培训 2 1. General 2-1. IRIS certification Process 2-2. Questionnaire and assessment guideline 3. Benifits from IRIS 4.Mandatory process and procedure 5.IRIS Standard requirement. 课程内容课程内容 3 Chapter 1 General 4 基于基于 ISO

2、 9001：2008的结构的结构 IRIS增加了一些铁路行业的特殊要求，如：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。 个别为个别为 “knockout”要求要求 (12 questions)。 Introduction 5 带带 shallshall的即表示为强制要求。的即表示为强制要求。 带带 shouldshould的即表示为推荐要求，以便于企业达到的即表示为推荐要求，以便于企业达到 更高的成熟度。更高的成熟度。 当使用当使用“such ass

3、uch as”时，表示该建议仅供参考。时，表示该建议仅供参考。 当使用当使用“NOTENOTE”时，仅是对相关的标准加以说明。时，仅是对相关的标准加以说明。 Introduction 6 什么是什么是IRIS？ 7 IRIS标准框架标准框架 4. 质量管理体系质量管理体系 4.1 总要求 4.2 文件要求 4.3 知识管理 4.4 多现场管理 5. 管理职责管理职责 5.1 管理承诺 5.2 以顾客为关注焦点 5.3 质量方针 5.4 策划 5.5 职责、权限和沟通 5.6 管理评审 6. 资源管理资源管理 6.1 资源提供 6.2 人力

4、资源 6.3 基础设施 6.4 工作环境 6.5 应急计划 7 . 产品实现产品实现 7.1 产品实现的策划 7.2 与顾客有关的过程 7.3 设计和开发 7.4 采购 7.5 生产和服务的提供 7.6 监视和测量设备的控制 7.7 项目管理 7.8 技术状态管理 7.9 首件检验 7.10 调试/顾客服务 7.11 RAMS/LCC 7.12 老化管理 7.13 变更控制 8. 测量、分析和改进测量、分析和改进 8.1 总则 8.2 监视和测量 8.3 不合格品的控制 8.4 数据分析 8.5 改进 8 UNIFE Association of European

5、Railway Industries 欧洲铁路行业联盟欧洲铁路行业联盟 The European rail supply industry was formerly represented by AICMR (Association Internationale des Constructeurs de Matriel Roulant), AFEDEF (Association des Fabricants Europens dquipements Ferroviaires) CELTE (Constructeurs Europens des Locomotives Thermiques et

6、 lectriques) 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 9 全球性的非盈利机构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 什么是什么是IRIS？ 10 IRIS Technical Forum For Improvement UNIF

7、E Presiding Board Rules of Procedure UNIFE Nomination Agreement Nomination Agreement Nomination Agreement Operators Certification Body 1 * Certification Body x * Client n Request for Certification Client 3Client 2 Client 1 Framework Agreement Approval 设备/工装和测量设备的包装、防护/条件检查； f) availability of (spare

8、 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； 100 6.3 基础设施基础设施 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 continual

9、ly 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。 101 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

10、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。 6.4 工作环境工作环境 Work Environment 102 6.4 工作环境工作环境 Work Environment Product safe

11、ty 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 orde

12、r, 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。 103 6.5 应急计划应急计划 Contingency Plan The organization shall prepare contingency plans to mitigate the event of an emergency such as utility interruptions, interruptions

13、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。 104 CLAUSE 7 Product

14、 Realization 产品实现产品实现 105 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。 7.1 产品实现的策划产品实现的策划 Planning of Product realization 106 7.2.1与产品有关要求的确定与产

15、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

16、作。 107 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 require

17、ments 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。 7.2.2 产品相关要求的评审产品相关要求的评审 Review of requirements related to the product 108 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

18、 compliant (e.g. 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,

19、 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。 7.2.2 产品相关要求的评审产品相关要求的评审 Review of requirements related to the product 109 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（

20、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

21、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。 7.2.2 产品相关要求的评审产品相关要求的评审 Review of requirements related to the product 110 In order to avoid risks and to allow a smooth project/product realization revi

22、ews shall cover as a minimum the aspects (see also 7.4): critical product characteristics, customer 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 ta

23、ken 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。 143 7.4.1 采购过程采购过程 Purchasing process Unless

24、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 p

25、erformance. 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, e.g. the suppliers 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

26、 决于 供方的质量绩效和所采购产品的重要程度等因素。 144 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), inspectio

27、n 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； 7.4.2 采购信息采购信息Purchasing information 1

28、45 7.4.2 采购信息采购信息 Purchasing information f) requirements for test specimens ( e.g. 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

29、 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； 146 7.4.2 采购信息采购信息 Purchasing information h) requirements for the supplier to notify the organization of changes in product and/or p

30、rocess 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

31、； 147 7.4.2 采购信息采购信息 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

32、) requirements for all Deliverables associated to the Product. 所有可交付的相关产品的要求。 148 The organization shall ensure that the suppliers 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 c

33、ompliance 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。 7.4.2 采购信息采购信息 Purchasing information 149 7.4.3 采购产品的验证采购产品的验证 Verification of purchased pr

34、oduct The organization should define and implement a Process for verification activities, like inspection or audit at suppliers 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。 150 7.4.3 采购产品的验证采购产品的验证 Verification of purchased product

35、Verification activities shall include: 验证活动必须包括： a) Obtaining objective evidence of the quality of the product from suppliers (e.g. 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 t

36、he 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 suppliers premises. 组织的验证活动也应当包括对供方现场检验和审核。 151 7.4.3 采购产品的验证采购产品的验证 Verification of purchased product The purcha

37、sed 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 8.3.2). 直到验证符合规定的要求，或得到顾客授权放行（见8.3.2），才能使用和 加工采购的产品。 Where the organization utilizes test reports to verify purchase

38、d 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。 152 7.4.3 采购产品的验证采购产品的验证 Verification of purchased product The

39、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

40、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。 153 7.4.4 供应链管理供应链管理 supply chain management Supplier deliver

41、ies 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

42、 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。 154 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 org

43、anization, 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 7.7.8. 注1：根据7.7.8条款，潜在供方短缺的识别是风险管理的一部分。 NOTE 2 Identified supplier shortage

44、s are dealt within the contingency plan, according to clause 6.5. 注2：根据6.5条款，制定应变计划来解决已识别的供方短缺。 7.4.4 供应链管理供应链管理 supply chain management 155 7.5 生产和服务提供生产和服务提供 Production and service provision Note 1: Production in the spirit of this clause can also apply within the engineering process

45、 (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： 156 specific

46、ations 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； 7.5 7.5 生产和服务提供生产和服务提供 Control of production and service provision 157 Process and Product approval acceptance criteria, 过程和产品批准验

47、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 (e.g. 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。

48、7.5 7.5 生产和服务提供生产和服务提供 Control of production and service provision 158 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 (e.g. parts quantities, split order

49、s, 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 a

50、bnormal 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. 7.5.1 7.5.1 生产和服务提供的控制生产和服务提供的控制 Control of production and service provision 159 生产计划生产计划 Production Scheduling Production (including test equipment) shall be: 生产（包括测试设备）必须： scheduled (short-, mid- (MPS = Master Productio

51、n 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

52、 driven. 有订单驱动。 160 The organization shall use customer forecasts and orders to plan, measure capacity and adjust regularly, their resources according to workload taking into account risks (e.g. 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

53、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。 生产计划生产计划 Production Scheduling 161 生产文件生产文件 Production Documentation Production operations shall be carried out in accordance with approved

54、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 (e.g. manufacturing plans, traveler, router, work order, process cards) and inspection documents (see 8.2.4), and 图纸、零件清单

55、、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8.2.4)，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 。 162 生产流程变更控制生产流程变更控制 Control of production process changes The organizatio

56、n 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

57、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。 163 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。 T

58、he 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。 生产流程变更控制生产流程变更控制 Control of production process changes 164 The organi

59、zation 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 7.13 of this document. 注1：条款涉及的变更管理过程在此标准条款7.13中有描述。 生产流程变更控制生产流程变更控制 Control of production process changes 165 设备和工装的控制设备和工装的控制 Control of equipment and tools The organization shall have a documented Procedure for providing adequate manufacturing equipment and tools to produce Pr