【文章內(nèi)容簡(jiǎn)介】 draft Page 8 of 66 202010 亮粽蛞 備注 Note 亮粽蛞 “C1－ C6”為顧客導(dǎo)向過程（ COP）， “S1－ S11”為支持過程（ SP）， “M1－ M5”為管理過程（ MP）。 亮粽蛞 亮粽蛞 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 )； 亮粽蛞 Determined the sequence and interaction of the processes。 （ refer to appendix 1: processes matrix） 亮粽蛞 c. 為保證過程的有效運(yùn)作，對(duì)過程制定了過程運(yùn)行的準(zhǔn)則和方法； determined criteria and methods needed to ensure that both the operation and control of these processes are effective,亮粽蛞 d. 通過資源提供、人力資源管理 ,設(shè)施設(shè)備管理和工作環(huán)境管理確保必要的資源和信息 ,以支持這些過程的操作和監(jiān)視； Ensured the availability of resources and information needed to support the operation and monitoring of these processes through resource provision, human resource, infrastructure management。亮粽蛞 e. 通過內(nèi)部審核、過程監(jiān)控、產(chǎn)品監(jiān)視和測(cè)量、數(shù)據(jù)分析過程對(duì)過程實(shí)施測(cè)量、監(jiān)控和分析 ； 亮粽蛞 Monitored, measured, and analyzed these processes through internal audit, process control, product monitoring and measurement, data analysis, etc 亮粽蛞 f. 實(shí)施措施以實(shí)現(xiàn)過程策劃的結(jié)果，并通過質(zhì)量方針、質(zhì)量目標(biāo)、管理評(píng)審、糾正與預(yù)防措施等對(duì)過程實(shí)現(xiàn)結(jié)果進(jìn)行改進(jìn)； Implemented actions needed to achieve the planned results and continual improve these processes through quality policy and objectives, management review and corrective/preventive g. 公司測(cè)量器具 檢 定校準(zhǔn) 、輪對(duì)組裝等部分產(chǎn)品制造過程存在外包，按照《計(jì)量工具和測(cè)量設(shè)備的鑒定 /校準(zhǔn)》、《外包控制程序》、《采購(gòu)管理程序》和供應(yīng)商管理相關(guān)程序進(jìn)行控制。其內(nèi)容適當(dāng)?shù)匕ǎ嚎尚行匝芯?、風(fēng)險(xiǎn)分析、計(jì)劃、顧客溝通和首件檢驗(yàn)。 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, 文件要求 Document Requirements 亮粽蛞 總則 General 亮粽蛞 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(jí)： 亮粽蛞 The following diagram outlines the structure of SKE QMS. The levels of documentation and instructions include:亮粽蛞 Level 1:質(zhì)量手冊(cè)： 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； 亮粽蛞 QMS manual – Description of SKE establishing, implementing and maintaining a Quality Management System that meets requirements of IRIS Level 2 –標(biāo)準(zhǔn)操作程序： 描述質(zhì)量管理手冊(cè)中主要要素具體操作的程序文件； 亮粽蛞 Standard Operating Procedures (SOP) – Procedures which describe the overall activities corresponding to the major sections of this QMS 質(zhì)量手冊(cè) 亮粽蛞 Quality Manual 亮粽蛞 質(zhì)量管理體系要求 亮粽蛞 Quality management system requirements 亮粽蛞 Section: 亮粽蛞 亮粽蛞 QM Rev. draft Page 9 of 66 202010 亮粽蛞 Level 3 –作業(yè)指導(dǎo)書類文件： 是詳細(xì)說明工作的第三級(jí)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(yàn)計(jì)劃、項(xiàng)目管理程序、保養(yǎng)說明書等； 亮粽蛞 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.。亮粽蛞 Level 4 –記錄： 用于證實(shí)操作效果和符合性的客觀證據(jù)。 亮粽蛞 Records Objective evidences to prove the performance and conformance operations. 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 亮粽蛞 以及： And:亮粽蛞 管理體系要求適用的法規(guī)要求； Management system requirements for imposed by the applicable regulatory 技術(shù)安全方針和安全目標(biāo)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).亮粽蛞 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 personnel have access to business management system documentation and are aware of relevant 公司保證顧客和 /或法規(guī) 監(jiān)管機(jī)構(gòu)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 質(zhì)量手冊(cè) Quality Manual 亮粽蛞 ISO9001:2020IRIS:REV02(2020)顧客支持參考文件Cus tom er supporti ng 1. 項(xiàng)目管理 P roj ec t m ana gem ent 2. 控制計(jì)劃 Contr ol P l an 3. 工具和技術(shù) Tools / te chni ca l顧客特殊要求Cus tom er spe ci fi c requi rem ent s國(guó)際鐵路行業(yè)標(biāo)準(zhǔn)要求I nte rnat i onal Ra i l way I ndustry S ta ndard Re qui rem ent s國(guó)際質(zhì)量管理體系要求I nte rnat i onal Qual i ty M ana gem ent S ys te m Re qui rem ent s質(zhì)量手冊(cè)QM S M anual標(biāo)準(zhǔn)操作程序S ta ndard opera ti ng proce dures作業(yè)指導(dǎo)文件work i nst ruct i ons相關(guān)記錄Re cordsLev el 1: 規(guī)定體系要求 / ， 、方法和職責(zé) 包括顧客要求 法律法規(guī)需求的保證 Re g u lat e s ys te m r eq u ir eme n ts /met h o d s a n d r es p o n sib ilitie s, in clu d in g co mmit men t o n sa tis fy in g cu st o mer /r eg u lat o r y r eq u ir eme n ts .Lev el 2: 規(guī)定何人 / 何事 / 何時(shí) Re g u lat e w h o /w h at /w h enLev el 3: 規(guī)定如何做 Re g u lat e h o wLev el 4: ，結(jié)果 體系運(yùn)作的證據(jù) Re su lts , ev id en ce o f s ys te m o p er at io n 質(zhì)量手冊(cè) 亮粽蛞 Quality Manual 亮粽蛞 質(zhì)量管理體系要求 亮粽蛞 Quality management system requirements 亮粽蛞 Section: 亮粽蛞 亮粽蛞 QM Rev. draft Page 10 of 66 202010 亮粽蛞 質(zhì)量部建立并保持質(zhì)量手冊(cè)以描述： 亮粽蛞 QA establish and maintain a Quality Manual is to describe:亮粽蛞 a. 質(zhì)量管理體系的范圍，包括刪減的細(xì)節(jié)和理由 (見 ) ； The scope of the QMS (including the justification of exclusion, refer to clause )。 亮粽蛞 b. 質(zhì)量管理體系的程序及對(duì)其引用應(yīng)得到清楚地說明 (見附件 文件清單 )； The QMS procedures and their cross reference (refer to document list)亮粽蛞 c. 質(zhì)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 文件控制 Document control 亮粽蛞 質(zhì)量部建立并保持文件控制程序（），技術(shù)部建立技術(shù)文件管理程序 ()以管理文件的建立、修改、評(píng)審、批準(zhǔn)、分發(fā)、回收、歸檔及處置等活動(dòng)，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:亮粽蛞 a. 質(zhì)量體系文件在簽發(fā)之前應(yīng)得到授權(quán)人員的審核和批準(zhǔn)； All system documents are reviewed and approved by authorized person before release。亮粽蛞 b. 對(duì)文件評(píng)審和修改時(shí) ,文件必須經(jīng)過重新批準(zhǔn)； Documents are reapproved after review and revision。亮粽蛞 c. 文件變更應(yīng)記錄于文件修訂記錄 ,并以適當(dāng)?shù)臉?biāo)識(shí)識(shí)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。亮粽蛞 d. 各使用現(xiàn)場(chǎng)能夠得到文件有效版本 ； Relevant versions of applicable d