【正文】 QM Rev. draft Page 6 of 66 202010 概述 General introduction 本手冊根據(jù)《國際鐵路行業(yè)標準》 02 版要求結(jié)合本公司實際情況編制，并符合客戶和有關(guān)法律、法規(guī)和各項政策規(guī)定。同時，明確了與質(zhì)量相關(guān)的人員的職責(zé)和權(quán)限及質(zhì)量管理體系的執(zhí)行要求。定期評審手冊并在必要時進行修訂。 手冊 以電子文件的形式在公司內(nèi)部辦公網(wǎng)絡(luò)上發(fā)布，網(wǎng)絡(luò)上的文件始終為最新版本。 The manual will be released via SKE OA system。 the printout is uncontrolled document. 有需求時， 經(jīng)管理者代表批準， 手冊的 非受控拷貝可以發(fā)放給任意顧客或其他組織；發(fā)放給供應(yīng)商的手冊應(yīng)受控。 審核和批準 Review and Approval 本手冊由管理者代表和各部門部長聯(lián)合評審，由總經(jīng)理 /副總經(jīng)理批準。 術(shù)語和定義 Terms and definitions Skoda— 斯柯達運輸 Bombardier Transportation KWT— 江蘇經(jīng)緯軌道交通設(shè)備有限公司 Jiangsu Kingway railway munication equipment Co., Ltd. SKE— 江蘇經(jīng)緯斯柯達電氣有限公司 Jiangsu SkodaKingway Electronic Co., Ltd. GM/DGM— 總經(jīng)理 /副總經(jīng)理 General Manager / Deputy General Manager QMS— 質(zhì)量管理體系 Quality Management System IRIS－國際鐵路行業(yè)標準 International Railway Industry Standard MR— 管理者代表 Management Representative DCC— 文件控制中心 Document Control Center EU— 歐洲 European SPC— 統(tǒng)計過程控制 Statistical Process Control QA— 質(zhì)量部 Quality Department PRO— 采購 部 Procurement Department OP— 生產(chǎn)制造部 Operation Department ITamp。C— 信息和財務(wù)控制部 Information Technology Financial amp。M— 市場部 Sales amp。 Others terms and definitions in this manual ply with ISO 9001:2020 “Quality Management System— Requirement”, ISO9000: 2020 “Quality Management System—Fundamental and Vocabulary” and International Railway Industry Standard version 02. 質(zhì)量手冊 Quality Manual 質(zhì)量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 8 of 66 202010 總要求 General Requirements 本手冊概述了公司為確保產(chǎn)品質(zhì)量符合顧客 的要求， 根據(jù)《國際鐵路行業(yè)標準》 02 版要求，建立、文件化、實施和持續(xù)改進質(zhì)量管理體系。 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. 顧客導(dǎo)向過程：對顧客直接產(chǎn)生影響，通過輸入和輸出直接和外部顧客進行聯(lián)系的過程，會為公司直接帶來經(jīng)濟效益。 Customer Oriented Process: process directly related to customer through input/output, it is a valueadd process by fulfilling customer requirements, 6 COPs are identified. 支持過程：為支持顧客導(dǎo)向過程的功能過程，公司的支持過程識別為 11 個。公司的管理過程識別為 5 個。Measurement equipment management. S8 技術(shù)狀態(tài)管理 Configuration management. S9 產(chǎn)品 /過程監(jiān)測和測量 Monitoring amp。 質(zhì)量手冊 Quality Manual 質(zhì)量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 9 of 66 202010 b. 明確了過程間的次序和相互作用 (見附件 1：過程關(guān)系圖 )； Determined the sequence and interaction of the processes。 e. 通過內(nèi)部審核、過程監(jiān)控、產(chǎn)品監(jiān)視和測量、數(shù)據(jù)分析過程對過程實施測量、監(jiān)控和分析 ； Monitored, measured, and analyzed these processes through internal audit, process control, product monitoring and measurement, data analysis, etc f. 實施措施以實現(xiàn)過程策劃的結(jié)果，并通過質(zhì)量方針、質(zhì)量目標、管理評審、糾正與預(yù)防措施等對過程實現(xiàn)結(jié)果進行改進； 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. 公司測量器具 檢定校準 、輪對組裝等部分產(chǎn)品制造過程存在外包，按照《計量工具和測量設(shè)備的鑒定 /校準》、《外包控制程序》、《采購管理程序》和供應(yīng)商管理相關(guān)程序進行控制。 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, munication of customer and first article inspection, etc. 文件要求 Document Requirements 總則 General 下圖為公司的質(zhì)量管理體系文件文件結(jié)構(gòu)，文件分為如下四級： The following diagram outlines the structure of SKE QMS. The levels of documentation and instructions include: Level 1:質(zhì)量手冊： 描述如何按照 IRIS 02 要求建立、執(zhí)行并保持公司的質(zhì)量管理體系； QMS manual – Description of SKE establishing, implementing and maintaining a Quality Management System that meets requirements of IRIS 02. Level 2 –標準操作程序 ： 描述質(zhì)量管理手冊中主要要素具體操作的程序文件； Standard Operating Procedures (SOP) – Procedures which describe the overall activities corresponding to the major sections of this QMS Manual. Level 3 –作業(yè)指導(dǎo)書類文件： 是詳細說明工作的第三級文件，例如生產(chǎn)工作指導(dǎo)書、產(chǎn)品說明書、圖紙、檢查指導(dǎo)書、檢驗計劃、項目管理程序、保養(yǎng)說明書等； 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 質(zhì)量手冊 Quality Manual 質(zhì)量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 10 of 66 202010 manual , etc.。 Records Objective evidences to prove the performance and conformance operations. 以及： And: 管理體系要求適用的法規(guī)要求； Management system requirements for imposed by the applicable regulatory authorities. 技術(shù)安全方針和安全目標的文件化聲明 (參見附件 9 ) Documented statements of a technical safety policy and safety objectives(refer to appendix 9). 公司保證員工能獲得企業(yè)管理系統(tǒng)文件，并且了解相關(guān)的程序。 Company ensures that customer and/or regulatory authorities’ representatives have access to the business management system documentation. 質(zhì)量手冊 Quality Manual 質(zhì)量部建立并保持質(zhì)量手冊以描述： QA establish and maintain a Quality Manual is to describe: a. 質(zhì)量管理體系的 范圍，包括刪減的細節(jié)和理由 (見 ) ； The scope of the QMS (including the justification of exclusion, refer to clause )。 b. 對文件評審和修改時 ,文件必須經(jīng)過重新批準； Documents are reapproved after review and revision。 d. 各使用現(xiàn)場能夠得到文件有效版本； Relevant versions of applicable documents are available at points of use。 f. 對外來文件進行評審；，并控制分發(fā)；外來文件對公司內(nèi)部體系的影響須加以評估和落實 External documents are reviewed, identified and their distribution controlled。 SKE control all applicable product related document, identify staff that have the authorization to review the documents. 項目部建立并保持顧客文件管理程序 ()，對外來文件進行評審、分發(fā)等受控管理，以確保顧客規(guī)范 /要求在整個供應(yīng)鏈內(nèi)的可追溯性。 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 c