【正文】 務(wù)”僅適用于：預(yù)期提供給顧客或顧客所要求的產(chǎn)品和服務(wù)。 NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 注 2：法律法規(guī)要求可稱作為法定要求 Scope – Supplemental 范圍 補(bǔ)充 This Technical Specification defines quality management system requirements in the rail sector(RQMS) 本技術(shù)規(guī)范確定了鐵路工業(yè)的質(zhì)量管理體系要求（ RQMS） ? to be applied throughout the whole supply chain of railway industrial related products for the design development, manufacturing and maintenance activities (excluding operations and services of rail transports) 應(yīng)用于鐵路工業(yè)整個(gè)供應(yīng)鏈相關(guān)產(chǎn)品的設(shè)計(jì)開發(fā)、制造和維護(hù)保養(yǎng)活動(dòng)（不包括鐵路運(yùn)輸?shù)姆?wù)和運(yùn)行） ? that provides continual improvement, emphasizing defect prevention and defect reduction in the supply chain 在整個(gè)供應(yīng)鏈進(jìn)行持續(xù)改進(jìn)、強(qiáng)調(diào)防錯(cuò)和減少浪費(fèi) ? to enhance and sustain product quality, including its safety aspects. 強(qiáng)化和持續(xù)穩(wěn)定的保證產(chǎn)品質(zhì)量，包括產(chǎn)品安全方面。 NOTE This Technical Specification allows anizations to have the same flexibility when determining the boundaries and applicability of the quality management system as described in clause of ISO 9001:2023. 注：在確定 ISO9001： 2023 第 ，本技術(shù)規(guī)范允許組織有相同的彈性。 2 Normative references引用文件 The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 下列文件中的條款，整體或部分通過本標(biāo)準(zhǔn)的引用而成為本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件，只有引用版本適用，凡是不注日期的引用文件，其最新版本適用于本標(biāo)準(zhǔn)（包括任何修訂版）。 ISO 9000:2023, Quality management systems — Fundamentals and vocabulary. ISO 9000:2023 質(zhì)量管理體系 —基礎(chǔ)和術(shù)語 3 Terms and definitions術(shù)語和定義 For the purposes of this document, the terms and definitions given in ISO 9000:2023 apply. 本標(biāo)準(zhǔn)采用 ISO 9000:2023中所確立的術(shù)語和定義。 Terms and definitions for the rail sector 鐵路行業(yè)的術(shù)語和定義 application software 應(yīng)用軟件 Computer programme that performs a set of functions to support the execution of a process. 執(zhí)行一系列功能的計(jì)算機(jī)程序以支持過程的運(yùn)行。 This can be a software programme, database, puterized spreadsheet, electronic file or web tool, bought from the market or developed by the anization. 這可能是一個(gè)市場(chǎng)購買或組織自行開發(fā)的軟件程序、數(shù)據(jù)庫、電子表格、電子文件或網(wǎng)絡(luò)工具。 availability (of an item) 可用性（一個(gè)物品的） Ability to be in a state to perform as required 按照要求執(zhí)行某種狀態(tài)的能力。 Note 1 to entry: Availability depends upon the bined characteristics of the reliability, recoverability, and maintainability of the item, and the maintenance support performance. 本條目注 1：可用性是取決于物品的可靠性、可恢復(fù)性和可維護(hù)性以及維護(hù)支持績(jī)效的綜合參數(shù) [IEC 60050192:2023, 1920123]. missioning 調(diào)試 Phase before handover to a customer, in which a product is final tested under operational conditions to verify it functions according to its specifications. The product is prepared to start operation. 交付給客戶前的階段，在此階段在使用條件下進(jìn)行最終試驗(yàn)根據(jù)其技術(shù)規(guī)范驗(yàn)證其功能。產(chǎn)品準(zhǔn)備開始運(yùn)行。 ponent 部件 Subdevice above the integration level of the smallest replaceable unit of a system in service or maintenance. 應(yīng)用于服務(wù)和維護(hù)保養(yǎng)中的最小維護(hù)單元之上的整合子裝置。 configuration audit 技術(shù)狀態(tài)（配置）審核 Audit performed in accordance with documented procedures to determine whether a product conforms to its requirements and product configuration information. [ISO 10007:2023, 3 ] 根據(jù)文件化程序進(jìn)行審核以確定產(chǎn)品是否符合產(chǎn)品要求和產(chǎn)品技術(shù)狀態(tài)（配置）信息。 configuration baseline 技術(shù)狀態(tài)基線 Approved product configuration information that establishes the characteristics of a product at a point in time that serves as reference for activities throughout the life cycle of the product. 在產(chǎn)品的整個(gè)生命周期中，經(jīng)批準(zhǔn)的以時(shí)間為基準(zhǔn)建立產(chǎn)品特性的產(chǎn)品配置信息。 [ISO 10007:2023, ] configuration status accounting 配置狀態(tài)統(tǒng)計(jì) Formalized recording and reporting of product configuration information, the status of proposed changes and the status of the implementation of approved changes. 產(chǎn)品配置信息的記錄和報(bào)告，計(jì)劃變更的狀態(tài)和已批準(zhǔn)變更的執(zhí)行狀態(tài)。 [ISO 10007:2023, .] consignment stock寄售庫存 Stock owned by an external provider, but held by the anization to ensure availability of parts. 外部供方所有的庫存，但是由組織控制以確保零件供應(yīng)。 critical / criticality危險(xiǎn)的 /危險(xiǎn)度 Objects having the potential of introducing high risks that can threaten quality, safety or business performance, based on a risk assessment. 在風(fēng)險(xiǎn)評(píng)估的基礎(chǔ)上，具有引入高風(fēng)險(xiǎn)可能性的對(duì)象，風(fēng)險(xiǎn)可能影響質(zhì)量、安全或運(yùn)行績(jī)效。 deferred work 延期工作 Activity which is part of a predetermined sequence in a process, that is delayed or postponed. 過程中作為預(yù)訂順序一部分的活動(dòng)，被延期或延遲。 deliverables 可交付物 All types of output for the scope of supply to fulfil set requirements (. user manual, maintenance manual, test reports, test equipment, training, spare and support parts). 供貨范圍內(nèi)滿足設(shè)定要求的所有類型的輸出（例如，用戶手冊(cè)、保養(yǎng)手冊(cè)、試驗(yàn)報(bào)告、試驗(yàn)設(shè)備、培訓(xùn)、備品備件） first article inspection 首件檢驗(yàn) Set of inspection and verification activities in order to validate a production process. 為了確認(rèn)生產(chǎn)過程進(jìn)行的一系列檢驗(yàn)和驗(yàn)證活動(dòng)。 FRACAS Closed loop process used to improve dependability of current and future designs by feedback of testing, modification and use experience. 通過實(shí)驗(yàn)反饋、修改和利用經(jīng)驗(yàn)，用來改進(jìn)當(dāng)前和將來設(shè)計(jì)可靠性的閉環(huán)過程。 [IEC 60050192:2023, 1921204]. functional requirement 功能要求 Dedicated requirement or capability of a function within the functional breakdown structure. 在功能展開結(jié)構(gòu)中，功能的能力和詳細(xì)要求。 gate criteria 門準(zhǔn)則 Acceptance criteria for deliverables at gates in order to support the decisions to be taken, such as accepted, conditionally accepted or rejected. 為了支持所采取的決定（例如接受、條件接受或拒絕），在質(zhì)量門處可交付物的接受準(zhǔn)則。 handover 移交 Passing control authority of the subject item from one anization to another, including transfer of responsibilities to the receiving anization. 將主體項(xiàng)目的控制權(quán)從一個(gè)組織轉(zhuǎn)移到另一個(gè)組織，包括接收組織的責(zé)任轉(zhuǎn)移 installation 安裝 Phase after delivery at customer premises and prior to missioning. 交付到客戶處后和調(diào)試前的階段 NOTE Installation is a typical phase of infrastructure activities. 注：安裝是基礎(chǔ)設(shè)施活動(dòng)的典型階段 integration maturity 集成成熟度 Degree of fulfilment of the integration requirements of a product (. already or never integrated in the anization’s products). 產(chǎn)品集成要求的滿足程度（例如組織的產(chǎn)品已經(jīng)集成或從未集成） integration requirements 集成要求 Requireme