xx电气有限公司质量手册IRIS手册.doc

质量手册 Quality Manual 江苏经纬斯柯达电气有限公司质量手册SKE Quality Manual 质量管理体系指南A guide to IRIS姓名/职务NAME/FUNCTION 签字SIGNATURE 编制Prepared by质量经理/QA manager审核Reviewed by质量总监/QA Director管理者代表/MR批准Approved by副总经理/Deputy General Manager总经理/General Manager管理Process OwnerSKEQASKE 质量部文件号Document ID:SKE-QMS-40-10-00-001版本：ISSUE: Draft本手册为江苏经纬斯柯达电器有限公司所有。无事先授权，任何人不得对此手册的全部或部分内容进行复制和外传。This manual is the property of Jiangsu Skoda-Kingway electronic Co., Ltd.(SKE). The reproduction, distribution, utilization or the communication of this document or any part thereof, without prior authorization is strictly prohibited.发布日期：Issue Date:2012-10各部门评审Cross functional review部门Dept.签字Signature日期Date Technical Project Operation QA Purchase S&M IT&Finance HRRevision Log修订版本Revision日期Date版本修订记录Revision History影响的页码Affected PagesQM Rev. draftPage 65 of 662012-10质量手册目录Table of contents1.0引言Introduction2.0适用范围及引用文件 Applicable scope, Reference documents3.0 质量手册介绍 Introduction to the quality manual4.0 质量管理体系要求 Quality management system requirements5.0 管理职责 Management responsibility6.0 资源管理 Resources management7.0 产品实现Product realization 8.0 测量、分析和改进 Measurement, analysis and improvement 附录 质量手册 Quality Manual 引言IntroductionSection: 1.01.1公司简介 Company introduction江苏经纬斯柯达电气有限公司（以下称SKE）是由江苏经纬轨道交通设备有限公司与斯柯达电气有限公司共同出资在中华人民共和国江苏省苏州市组建的中外合资企业。合资双方于二零一零年九月签订了合资合同。Jiangsu Skoda-Kingway electronic Co., Ltd. (SKE) is established in Suzhou, Jiangsu, P. R. China. SKE is a joint venture between Jiangsu Kingway Railway communication equipment Co., Ltd. and Skoda Electronic. The Joint Venture Contract was signed by both parties in September 2010.SKE的经营范围：轨道运输牵引与控制设备的研发、设计、制造、销售、相关的技术支持、协助及售后服务。 The business scope of SKE is development, design, manufacturing, sales, related technical support, assistant and services of the Rail transportation traction and control equipment.我们将致力于向国内外客户按时提供高度可靠、质量优良、低运营成本的产品。Here at SKE we are dedicated to deliver highly reliable, top quality products to the market, domestic and aboard, on time and at the lowest cost of ownership.公司标识 SKE Logo：公司联系方式：电话/传真：+86 512 6768 5222 / +86 512 6768 7222Tel/Fax: +86 512 6768 5222 / +86 512 6768 7222Website: www. skoda. cz地址 Address：中国 江苏省 苏州市 吴中大道1368号No. 1368 Wuzhong Road, Suzhou, Jiangsu Province, P. R. China邮编 Zip code：215104质量手册 Quality Manual 适用范围及引用文件 Applicable scope, Reference documentsSection: 2.02.1适用范围Applicable scope本质量手册适用于SKE。This Quality Manual is applicable to SKE.公司的质量管理手册覆盖IRIS标准除信号以外的所有要求，信号的设计由客户自行负责，软件公司无设计，但对供应商提供产品有验证/确认活动，所以公司的IRIS管理体系删减并排除了7.3.8设计批准中的信号要求。SKE quality management system covers all elements except signal related requirements, the design responsibility of signal is customer, the design responsibility of software is supplier, SKE has responsibility to verify/validate supplied software product. So SKE IRIS management excluded signal related clause 7.3.8.公司IRIS体系认证范围：轨道运输牵引与控制设备的研发、设计、制造、销售、相关的技术支持、协助及售后服务The certification scope of this IRIS management system: Development, design, manufacturing, sales, related technical support, assistant and services of the Rail transportation traction and control equipment.2.2本手册引用了下列文件中的条款以说明质量管理体系的原则和程序：The clauses in following standards are quoted to define the policy and procedure of quality management system. ISO 9001:2008质量管理体系要求ISO 9001:2008 Quality Management System-RequirementsISO9000: 2005 质量管理体系基础和术语ISO9000: 2005 Quality Management SystemFundamentals and Vocabulary国际铁路行业标准02版International Railway Industry Standard version 02ISO 14001:2004环境管理体系要求及使用指南ISO 14001:2004 Environmental Management Systems - RequirementsISO 18001:2007职业健康和安全管理体系 要求ISO 18001:2007Occupational Health & Safety Mgmt. System RequirementsEN 50126 The specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS)质量手册 Quality Manual 质量手册介绍 Introduction to this Quality ManualSection: 3.03.1 概述 General introduction本手册根据国际铁路行业标准02版要求结合本公司实际情况编制，并符合客户和有关法律、法规和各项政策规定。This manual is established according to the International Railway Industry Standard Version 2, and meets our customer requirements and all related legal requirements. 手册中陈述了组织结构、质量方针和质量管理体系的要素，对质量管理体系的过程顺序和相互作用进行了描述。同时，明确了与质量相关的人员的职责和权限及质量管理体系的执行要求。The manual describes SKE organization structure, quality policy, standard elements, the sequence and interaction of quality related processes, as well as the responsibilities and authorities of staffs that having impact on product quality.本手册是SKE质量管理体系的基本准则，公司全体员工须严格执行本管理手册和其它质量管理体系文件规定，确保质量管理体系、产品和过程的持续改进。定期评审手册并在必要时进行修订。This manual is the basic criteria to the operation of QMS in SKE. It is the responsibility for all employees in SKE to comply with this manual and all management system document requirements. This system is constantly under review and further developments are incorporated as required.3.2 质量手册的控制Control of the Quality Manual3.2.1 总则 General本质量手册依据程序文件控制的要求来管理；This quality manual is controlled according to the Procedure “Control of Document”;手册以电子文件的形式在公司内部办公网络上发布，网络上的文件始终为最新版本。电子文件的纸介质输出不做受控文件管理。The manual will be released via SKE OA system; and keep the latest version in the network; the printout is uncontrolled document. 有需求时，经管理者代表批准，手册的非受控拷贝可以发放给任意顾客或其他组织；发放给供应商的手册应受控。With the Management Representative (MR) permission, when needed, uncontrolled copy can be issued to any customer or other organization, controlled copy issued to any supplier. 文控中心负责保存手册的批准文本，并保持一份发放记录；DCC keep the approved paper copy, maintains a record to register and control the distribution of the manual;3.2.2审核和批准 Review and Approval本手册由管理者代表和各部门部长联合评审，由总经理/副总经理批准。This manual is reviewed by management representative and all departments manager, and approved by GM / DGM.3.2.4更改控制 Control of Changes 质量手册的任何更改由管理者代表评审，总经理批准；Any change to the quality manual is reviewed by management representative and approved by General Manager;3.3术语和定义 Terms and definitionsSkoda斯柯达运输 Bombardier TransportationKWT江苏经纬轨道交通设备有限公司 Jiangsu Kingway railway communication equipment Co., Ltd.SKE江苏经纬斯柯达电气有限公司 Jiangsu Skoda-Kingway Electronic Co., Ltd.GM/DGM总经理/副总经理 General Manager / Deputy General ManagerQMS质量管理体系 Quality Management SystemIRIS国际铁路行业标准 International Railway Industry StandardMR管理者代表 Management RepresentativeDCC文件控制中心 Document Control CenterEU欧洲 EuropeanSPC统计过程控制 Statistical Process ControlQA质量部 Quality DepartmentPRO采购部 Procurement DepartmentOP生产制造部 Operation DepartmentIT&F&C信息和财务控制部 Information Technology Financial & Control DepartmentHR人力资源部 Human Resource Department EN技术部 Engineering DepartmentPM项目管理部 Project ManagementS&M市场部 Sales & Market Department本手册中的其它术语和定义引用ISO 9001:2008质量管理体系要求、ISO 9000:2005 质量管理体系基础和术语和国际铁路行业标准02版中的术语。Others terms and definitions in this manual comply with ISO 9001:2008 “Quality Management SystemRequirement”, ISO9000: 2005 “Quality Management SystemFundamental and Vocabulary” and International Railway Industry Standard version 02.质量手册 Quality Manual 质量管理体系要求Quality management system requirementsSection: 4.04.1总要求 General Requirements本手册概述了公司为确保产品质量符合顾客的要求，根据国际铁路行业标准02版要求，建立、文件化、实施和持续改进质量管理体系。This manual describes the established the quality management system in SKE according to the IRIS requirements and customer requirements, to implement and continuous improve the management system, the company has:4.1.1公司把质量管理体系所需要的过程识别为三大类：顾客导向过程（COP）、支持过程（SP）和管理过程(MP)，共有 22 个过程，包括其在整个组织中的应用。SKE identify the processes required by the quality management system as three types and 22 processes: Customer Oriented Process (COP), Supporting Process (SP) and Management Process (MP), which including the application in SKE.顾客导向过程：对顾客直接产生影响，通过输入和输出直接和外部顾客进行联系的过程，会为公司直接带来经济效益。公司的顾客导向过程识别为6个。Customer Oriented Process: process directly related to customer through input/output, it is a value-add process by fulfilling customer requirements, 6 COPs are identified.支持过程：为支持顾客导向过程的功能过程，公司的支持过程识别为11个。Supporting Process: functional processes to support customer oriented process. 11 SPs is identified.管理过程：指由最高管理者对组织或质量体系进行管理的过程。公司的管理过程识别为5个。Management Process: processes leaded by management level to manage the company and its quality management system, 5 MPs are identified.编码Item过 程 名 称Process description编码Item过 程 名 称Process description编码Item过 程 名 称Process descriptionC1合同/订单评审contract/order reviewS1文件管理/知识管理Document/knowledge management.M1经营管理Business managementC2项目管理Project ManagementS2 资源提供管理resources provisionM2管理评审Management reviewC3设计和开发Design/developmentS3人力资源管理Human resource management.M3内部审核 Internal auditC4产品生产product realizationS4采购管理Purchasing management.M4数据分析和沟通 Data analysis and communicationC5产品交付/服务Product delivery/serviceS5标识和可追溯性管理Identification/traceability management.M5改进管理improvement managementC6 顾客反馈/投诉Customer feedback/complaintS6产品防护管理Product preservationS7监测和测量设备管理Monitoring &Measurement equipment management.S8技术状态管理Configuration management.S9产品/过程监测和测量Monitoring &measurement of product/processS10成本管理Cost managementS11不合格品控制管理 Control of nonconforming product备注Note“C1C6”为顾客导向过程（COP），“S1S11”为支持过程（SP），“M1M5”为管理过程（MP）。b. 明确了过程间的次序和相互作用(见附件1：过程关系图)；Determined the sequence and interaction of the processes; （refer to appendix 1: processes matrix）c. 为保证过程的有效运作，对过程制定了过程运行的准则和方法；determined criteria and methods needed to ensure that both the operation and control of these processes are effective,d. 通过资源提供、人力资源管理,设施设备管理和工作环境管理确保必要的资源和信息,以支持这些过程的操作和监视；Ensured the availability of resources and information needed to support the operation and monitoring of these processes through resource provision, human resource, infrastructure management;e. 通过内部审核、过程监控、产品监视和测量、数据分析过程对过程实施测量、监控和分析； Monitored, measured, and analyzed these processes through internal audit, process control, product monitoring and measurement, data analysis, etcf. 实施措施以实现过程策划的结果，并通过质量方针、质量目标、管理评审、纠正与预防措施等对过程实现结果进行改进；Implemented actions needed to achieve the planned results and continual improve these processes through quality policy and objectives, management review and corrective/preventive action.g. 公司测量器具检定校准、轮对组装等部分产品制造过程存在外包，按照计量工具和测量设备的鉴定/校准、外包控制程序、采购管理程序和供应商管理相关程序进行控制。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。Measurement instruments verification and some production processes such as wheel set installation are outsourced, the control of outsourcing process is according to Production Tools/ Measuring Equipment Certification/Calibration procedure, outsourcing procedure, supply management procedure, and other supplier management procedures, including feasibility study, risk analysis, planning, communication of customer and first article inspection, etc.4.2文件要求 Document Requirements 4.2.1总则 General 下图为公司的质量管理体系文件文件结构，文件分为如下四级：The following diagram outlines the structure of SKE QMS. The levels of documentation and instructions include:Level 1:质量手册：描述如何按照IRIS 02要求建立、执行并保持公司的质量管理体系；QMS manual Description of SKE establishing, implementing and maintaining a Quality Management System that meets requirements of IRIS 02.Level 2 标准操作程序：描述质量管理手册中主要要素具体操作的程序文件；Standard Operating Procedures (SOP) Procedures which describe the overall activities corresponding to the major sections of this QMS Manual.Level 3 作业指导书类文件：是详细说明工作的第三级文件，例如生产工作指导书、产品说明书、图纸、检查指导书、检验计划、项目管理程序、保养说明书等； Work Instructions: Supporting documents which specify the works to be done, such as production work instruction, product specification, drawing, inspection sheet, inspection plan, Project Management Procedure, maintenance manual , etc.;Level 4 记录：用于证实操作效果和符合性的客观证据。Records Objective evidences to prove the performance and conformance operations. 以及：And:管理体系要求适用的法规要求；Management system requirements for imposed by the applicable regulatory authorities.技术安全方针和安全目标的文件化声明(参见附件9 )Documented statements of a technical safety policy and safety objectives(refer to appendix 9).公司保证员工能获得企业管理系统文件，并且了解相关的程序。Company ensures that personnel have access to business management system documentation and are aware of relevant documents.公司保证顾客和/或法规监管机构的代表能够获得企业管理体系文件。Company ensures that customer and/or regulatory authorities representatives have access to the business management system documentation.4.2.2 质量手册Quality Manual质量部建立并保持质量手册以描述： QA establish and maintain a Quality Manual is to describe:a.质量管理体系的范围，包括删减的细节和理由 (见2.1) ；The scope of the QMS (including the justification of exclusion, refer to clause 2.1);b. 质量管理体系的程序及对其引用应得到清楚地说明(见附件-文件清单)；The QMS procedures and their cross reference (refer to document list)c.质量管理体系所有过程之间的相互作用的表述Quality management system processes and their interaction.4.2.3 文件控制 Document control质量部建立并保持文件控制程序（），技术部建立技术文件管理程序()以管理文件的建立、修改、评审、批准、分发、回收、归档及处置等活动，保证：QA establish and maintain document control procedure () and technical document management procedure () to manage the establishment, change, review, approval, distribution, retrieval, archive and destroy of document to ensure:a. 质量体系文件在签发之前应得到授权人员的审核和批准；All system documents are reviewed and approved by authorized person before release;b. 对文件评审和修改时,文件必须经过重新批准；Documents are re-approved after review and revision;c. 文件变更应记录于文件修订记录,并以适当的标识识别现行修订状态；Changes of document are recorded in revision log, and the current revision status of documents are identified;d. 各使用现场能够得到文件有效版本；Relevant versions of applicable documents are available at points of use;e. 文件保持清晰并易于识别；Documents remain legible and readily identifiable;f. 对外来文件进行评审；，并控制分发；外来文件对公司内部体系的影响须加以评估和落实External documents are reviewed, identified and their distribution controlled; the influence of external origin document shall be evaluated and actions shall be taken where necessaryg. 失效文件应由文件发放人负责收回；Obsolete document retrieved by the distribution function. SKE对所有适用产品有关的文件进行有效控制，明确授权并执行审查文件的人员的姓名。SKE control all applicable product related document, identify staff that have the authorization to review the documents. 项目部建立并保持顾客文件管理程序()，对外来文件进行评审、分发等受控管理，以确保顾客规范/要求在整个供应链内的可追溯性。外来文件包括：行业规范、标准、顾客的特殊文件、法律法规要求等。 PM establish and maintain customer document management procedure(SKE SOP 40 10 05 114) to ensure the traceability of customer documents throughout the entire supply chain, SKE review and control the external document according to document control procedure. External documents can be: industry rules, standards, customer document, statutory and regulatory requirements4.2.4记录控制Control of records质量部建立并保持记录控制程序，用来规定质量管理体系中记录的标识、储存、保护索引、保存和处置的要求。 A Documented procedure on record control () is established to define the requirements to identification, storage, protection, retrieval, retention and disposition of records.程序文件和作业指导书等要求建立的表单记录（格式），与相应质量管理体系文件一起由相关部门负责人批准。Records attached to procedures and work instructions shall be approved with the related documents.所有与活动、产品或服务相关的记录应是清晰、易于识别和利用。各部门确定专/兼职人员负责按照记录控制程序要求，标识、编码、收集、归档、检索、借阅、复制、贮存、保护、保存和处置质量记录，以确保：All records are legible and identifiable to the activities, products or services involved. Each department shall nominate personnel to control the records (including identification, coding, collection, archive, sorting, borrowing, copy, storage, protection and disposition) to ensure: a. 质量记录都得到正确处理，包括来自供应商的质量记录；Correct disposition of all quality records, including records from supplier;b. 能方便地找到有关质量体系运行有效性的证据；Easy to get the evidences to demonstrate the efficiency of quality management system;c. 当需要将记录作为资源加以利用时，不致失实；The records is right when it is use as resources;d. 符合法律法规的要求；Appliance to legislation requirements;e. 记录正式发布之前，对记录的结果予以批准；见记录授权清单Approve record results before official release. Refer to record authorization listf. 各项记录的保存期限得到规定。 Retain time is regulated for all records;g. 记录必须是可用的，能够提供给顾客和法规监管机构用于评审或授权放行。Records shall be available for review and/or release by customers and regulatory authorities 4.3 知识管理 Knowledge Management项目部建立并保持知识管理过程和知识管理程序()，以识别、获取、维护、应用和评价信息、知识和技术，并且定期更新，以改进公司过程效率和改善产品质量、成本和交货绩效。知识管理内容包括（但不限于）： PM establish and maintain a knowledge management procedure () to identify, obtain, protect, use and evaluate information, knowledge and technology, and regularly update the improved the company process efficiency and product in quality, costs and delivery performance. Knowledge management includes but not limited to:a. 设计标准、设计规则,design rules, engineering standards,b. 项目完成后的经验,lessons learn after a project;c. 制造实践manufacturing practicesd. 程序；procedurese. 客户反馈、内部异常处理状况等。Customer feedback, internal知识信息可作为新项目/产品、人员培训提供输入。The knowledge can serve as inputs for new project/product, and internal training.4.4 多现场项目管理 项目部建立并保持项目管理程序()，以管理当项目涉及多现场时，确保项目满足要求并且至少包括： PM establishes and maintains a project management procedure () to ensure the project requirements are met in case where a project involves multiple sites, covers:a. 工作分工和工作接口（包括内外部）；work split and operational interfaces, (including internal and external) b. 职责、权限和公司内部沟通渠道和与顾客的沟通渠道（包括每个现场职责范围内的结果反馈）；Roles, responsibilities and communication channels internal and with the customer including feedback on the results for each sites scope of responsibility.c. 每个现场适用的过程、程序、文件和记录； applicable processes, procedures, documents and records on e