xx电气有限公司质量手册iris手册

xx电气有限公司质量手册iris手册内容摘要：

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 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 质量手册 Quality Manual 质量管理体系要求 Quality management system requirements Section: QM Rev. draft Page 10 of 66 202010 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. 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 ) ； The scope of the QMS (including the justification of exclusion, refer to clause )。 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 )； ISO9001:2020IRIS:REV02(2020)顾客支持参考文件Custome r sup po rti ng 1. 项目管理 P ro j ect m anag em ent 2. 控制计划 Contro l P l an 3. 工具和技术 To ol s/ techn i cal顾客特殊要求Custome r speci fi c requ i rem ents国际铁路行业标准要求I ntern ati on al Ra i l way I nd ustry S tand ard Re qu i rem ents国际质量管理体系要求I ntern ati on al Qu al i ty M anag em ent S ystem Re qu i rem ents质量手册QM S M anu al标准操作程序S tand ard op erati ng pr oced ur es作业指导文件wo rk i nstru cti on s相关记录Re cord sLevel 1: 规定体系要求 / ， 、方法和职责 包括顾客要求 法律法规需求的保证 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: 规定何人 / 何事 / 何时 R e g u la t e w h o /w h a t /w h e nLevel 3: 规定如何做 R e g u la t e h o wLevel 4: ，结果 体系运作的证据 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 质量手册 Quality Manual 质量管理体系要求 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. 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. 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 reapproved 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 necessary g. 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 requirements 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 质量手册 Quality Manual 质量管理体系要求 Quality management system requirements Section: QM Rev. draft Page 12 of 66 202010 identification, storage, protection, retrieval, retention an。