【正文】 ‖或 ―安全目標(biāo) ‖。 The content include ISO 9001:2023 text and supplements has been originated by the UNIFE, IRIS Certification? working group. ? Whenever the ISO 9001:2023 text in this Technical Specification refers to ―quality management system‖, this term shall be considered as ―business management system‖, not limited to quality, so that it enpasses all business processes of the anization. Therefore, in the supplemental rail sector specific requirements, the term ―business management system‖ is used outside the boxed text. 本文內(nèi)容包括 ISO9001： 2023的內(nèi)容以及由 UNIFE IRIS 認(rèn)證工作組開(kāi)發(fā)的補(bǔ)充要求。 The potential benefits to an anization of implementing a quality management system based on this International Standard are: 基于本國(guó)際標(biāo)準(zhǔn)實(shí)施一個(gè)質(zhì)量管理體系對(duì)組織的潛在益處是： a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements。 The quality management system requirements specified in this International Standard are plementary to requirements for products and services. 在本國(guó)際標(biāo)準(zhǔn)中規(guī)定的質(zhì)量管理體系要求是產(chǎn)品和服務(wù)要求的補(bǔ)充。 “應(yīng)” 表明一種要求 “should” indicates a remendation。 過(guò)程方法 — improvement。 The application of the process approach in a quality management system enables: 在質(zhì)量管理體系中應(yīng)用過(guò)程方法能夠： a) understanding and consistency in meeting requirements。 P—策劃：根據(jù)顧客的要求和組織的方針，以及識(shí)別和確定的風(fēng)險(xiǎn)和機(jī)遇，建立體系及其過(guò)程的目標(biāo)，以及為了達(dá)成結(jié)果所需的資源； — Do: implement what was planned。同時(shí)應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇為增強(qiáng)質(zhì)量管理體系的有效性，達(dá)成改進(jìn)的結(jié)果和預(yù)防負(fù)面影響建立了基礎(chǔ)。 —ISO 9000 質(zhì)量管理體系 —基礎(chǔ)和術(shù)語(yǔ) 為合適的理解和實(shí)施本標(biāo)準(zhǔn)提供了重要的背景。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）。 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。 [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(kāi)結(jié)構(gòu)中，功能的能力和詳細(xì)要求。 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。 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 In this International Standard, the terms “ product” or “ service” only apply to products and services intended for, or required by, a customer. 注 1：在本標(biāo)準(zhǔn)中，術(shù)語(yǔ)“產(chǎn)品”或“服務(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)。由風(fēng)險(xiǎn)引起的正面的偏離可以提供機(jī)遇，但并不是所有的風(fēng)險(xiǎn)的正面影響都會(huì)產(chǎn)生機(jī)遇。 ? 過(guò)程方法 ：組織內(nèi)諸過(guò)程的系統(tǒng)的應(yīng)用，連同這些過(guò)程的識(shí)別和相互作用及管理。 Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks. ? 圖 1 給出了任意一個(gè)過(guò)程的圖示，展示了各要素間的相互作用。 Understanding and managing interrelated processes as a system contributes to the anization’s effectiveness and efficiency in achieving its intended results. This approach enables the anization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the anization can be enhanced. 將相互關(guān)聯(lián)過(guò)程的作為系統(tǒng)進(jìn)行理解并加以管理，有助于組織實(shí)現(xiàn)預(yù)期結(jié)果的有效性和效率。 The quality management principles are: 質(zhì)量管理原則有： — customer focus。 Riskbased thinking enables an anization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise. 基于風(fēng)險(xiǎn)的思維使組織能夠確定那些可能導(dǎo)致它的過(guò)程和質(zhì)量管理體系偏離策劃的結(jié)果的因素，通過(guò)預(yù)防控制來(lái)減少負(fù)面的影響，而且最大化的利用它們產(chǎn)生的機(jī)遇。 This International Standard can be used by internal and external parties. 本標(biāo)準(zhǔn)可以用于于內(nèi)部和外部。當(dāng)本技術(shù)規(guī)范提及 ―安全 ‖ 時(shí)，這個(gè)術(shù)語(yǔ)應(yīng)理解為 ―產(chǎn)品安全 ‖ ， 不要與 ―職業(yè)安全 ‖ 混淆。當(dāng)本技術(shù)規(guī)范中 ISO9001： 2023中提及 ―質(zhì)量管理體系 ‖ 時(shí)，這個(gè)術(shù)語(yǔ)應(yīng)該理解為 ―運(yùn)營(yíng)管理體系 ‖ ，不限于質(zhì)量管理體系，因此其覆蓋組織全部運(yùn)營(yíng)過(guò)程。 有能力持續(xù)提供滿足顧客以及適用的法律法規(guī)要求的產(chǎn)品和服務(wù)； b) facilitating opportunities to enhance customer satisfaction。 This International Standard employs the process approach, which incorporates the PlanDo CheckAct (PDCA) cycle and riskbased thinking. 本標(biāo)準(zhǔn)采用過(guò)程方法，結(jié)合 PDCA循環(huán)和基于風(fēng)險(xiǎn)的思維。 “應(yīng)該” 表明一種建議 “may” indicates a permission。 改進(jìn) — evidencebased decision making。 理解并持續(xù)滿足要求； b) the consideration of processes in terms of added value。 D—實(shí)施：策劃的實(shí)施； — Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results。 Opportunities can arise as a result of a situation favorable to achieving an intended result, for example, a set of circumstances that allow the anization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. 機(jī)遇可以因一種有利情況的出現(xiàn)來(lái)達(dá)成預(yù)期的結(jié)果，例如：一些允許組織吸引顧客，開(kāi)發(fā)新產(chǎn)品和服務(wù)，減少浪費(fèi)或提高生產(chǎn)效率的情形。 — ISO 9004 Managing for the sustained success of an anization — A quality management approach provides guidance for anizations that choose to progress beyond the requirements of this International Standard. —ISO 9004 組織持續(xù)成功的管理 — 一種質(zhì)量管理方法為組織超越本標(biāo)準(zhǔn)要求追求進(jìn)步提供了指南。 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(yǔ) 3 Terms and definitions術(shù)語(yǔ)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(yǔ)和定義。 configuration baseline 技術(shù)狀態(tài)基線 Approved product configuration information that establishes