【文章內容簡介】 d 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 下圖為公司的質量管理體系文件文件結構，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)工作指導書、產(chǎn)品說明書、圖紙、檢查指導書、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 質量手冊 Quality Manual 質量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 10 of 66 202010 manual , etc.。 Level 4 –記錄： 用于證實操作效果和符合性的客觀證 據(jù)。 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，并且了解相關的程序。 Company ensures that personnel have access to business management system documentation and are aware of relevant documents. 公司保證顧客和 /或法規(guī)監(jiān)管機構的代表能夠獲得企業(yè)管理體系 文件。 Company ensures that customer and/or regulatory authorities’ representatives have access to the business management system documentation. 質量手冊 Quality Manual 質量部建立并保持質量手冊以描述： QA establish and maintain a Quality Manual is to describe: a. 質量管理體系的 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. 質量管理體系的程序及對其引用應得到清楚地說明 (見附件 文件清單 )； ISO9001:2020IRIS:REV02(2020)顧客支持參考文件Custome r sup po rti ng 1. 項目管理 P ro j ect m anag em ent 2. 控制計劃 Contro l P l an 3. 工具和技術 To ol s/ techn i cal顧客特殊要求Custome r speci fi c requ i rem ents國際鐵路行業(yè)標準要求I ntern ati on al Ra i l way I nd ustry S tand ard Re qu i rem ents國際質量管理體系要求I ntern ati on al Qu al i ty M anag em ent S ystem Re qu i rem ents質量手冊QM S M anu al標準操作程序S tand ard op erati ng pr oced ur es作業(yè)指導文件wo rk i nstru cti on s相關記錄Re cord sLevel 1: 規(guī)定體系要求 / ， 、方法和職責 包括顧客要求 法律法規(guī)需求的保證 R e g u la t e s y s t e m r e q u ir e me n t s /me t h o d s a n d r e s p o n s ib ilit ie s , in c lu d in g c o mm it me n t o n s a t is f y in g c u s t o me r /r e g u la t o r y r e q u ir e me n t s .Level 2: 規(guī)定何人 / 何事 / 何時 R e g u la t e w h o /w h a t /w h e nLevel 3: 規(guī)定如何做 R e g u la t e h o wLevel 4: ，結果 體系運作的證據(jù) R e s u lt s , e v id e n c e o f s y s t e m o p e r a t io n 質量手冊 Quality Manual 質量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 11 of 66 202010 The QMS procedures and their cross reference (refer to document list) c. 質量管理體系所有過程之間的相互作用的表述 Quality management system processes and their interaction. 文件控制 Document control 質量部建立并保持文件控制程序（），技術部建立技術文件管理程序 ()以管理文件的建立、修改、評審、批準、分發(fā)、回收、歸檔及處置等活動，保證： 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. 質量體系文件在簽發(fā)之前應得到授權人員的審核和批準； All system documents are reviewed and approved by authorized person before release。 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。 c. 文件變更應記錄于文件修訂記錄 ,并以適當?shù)臉俗R識別現(xiàn)行修訂狀態(tài)； Changes of document are recorded in revision log, and the current revision status of documents are identified。 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。 e. 文件保持清晰并易于識別； Documents remain legible and readily identifiable。 f. 對外來文件進行評審；，并控制分發(fā)；外來文件對公司內部體系的影響須加以評估和落實 External documents are reviewed, identified and their distribution controlled。 the influence of external origin document shall be evaluated and actions shall be taken where necessary g. 失效文件應由文件發(fā)放人負責收回； Obsolete document retrieved by the distribution function. SKE 對所有適用產(chǎn)品有關的文件進行有效控制，明確授權并執(zhí)行審查文件的人員的姓名。 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 /要求在整個供應鏈內的可追溯性。外來文件包括：行業(yè)規(guī)范、標準、顧客的特殊文件、法律法規(guī)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 requirements 記錄控制 Control of records 質量部建立并保持記錄控制程序，用來規(guī)定質量管理體系中記錄的標識、儲存、保護索引、保存和處置的要求。 A Documented procedure on record control () is established to define the requirements to 質量手冊 Quality Manual 質量管理體系要求 Quality management system requirements Section: QM Rev. draft Page 12 of 66 202010 identification, storage, protection, retrieval, retention an