【正文】 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、保養(yǎng)手冊、試驗(yàn)報告、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。產(chǎn)品準(zhǔn)備開始運(yùn)行。 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。（見條款 ) This International Standard enables an anization to use the process approach, coupled with the PDCA cycle and riskbased thinking, to align or integrate its quality management system with the requirements of other management system standards. 本標(biāo)準(zhǔn)使組織采用過程方法，并與 PDCA循環(huán)和基于風(fēng)險的考慮相結(jié)合，從而使組織的質(zhì)量管理體系與其他管理體系標(biāo)準(zhǔn)的要求一致或整合。 The concept of riskbased thinking has been implicit in previous editions of this International Standard including, for example基于風(fēng)險的考慮這一概念也已經(jīng)隱含在本標(biāo)準(zhǔn)之前的版本，包括如 Carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. 實(shí)施預(yù)防措施來消除潛在的不符合，分析發(fā)生的任何不符合，并采取同不符合的影響相適應(yīng)的措施避免再次發(fā)生。 Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle. 圖 2 闡述了條款 4至 10如何通過 PDCA循環(huán)集合在一起。 The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the anization. 過程方法包含了過程的系統(tǒng)的定義和管理以及過程間的相互作用，以達(dá)到與組織質(zhì)量方針和戰(zhàn)略方向一致的預(yù)期的結(jié)果。 領(lǐng)導(dǎo)作用 — engagement of people。為了達(dá)成這個目標(biāo)，組織可能發(fā)現(xiàn)除了糾正和持續(xù)改進(jìn)還有必要采用不同形式的改進(jìn)，例如突破性改變，創(chuàng)新和重組。 不同質(zhì)量管理體系結(jié)構(gòu)的統(tǒng)一； alignment of documentation to the clause structure of this International Standard。 ? Whenever this Technical Specification requires documented processes (. calibration and production), these processes can be defined within a single documented process (. both defined within a ―production management‖ process). 當(dāng)技術(shù)規(guī)范要求文件化過程時（例如：校準(zhǔn)和生產(chǎn)），這些過程可以在一個文件中描述（例如：都描述中 ―生產(chǎn)管理 ‖過程中。Quality management system – Business management system requirements for rail anizations: ISO 9001:2023 and particular requirements for application in the rail sector ISO/TS22163:2023 ? The aim of this Technical Specification which has been prepared by UNIFE, the European Rail Industry Association, is the development and continual improvement of a business management system to ensure product quality and safety in the global rail sector. 由 UNIFE（歐洲鐵路工業(yè)協(xié)會）開發(fā)的本技術(shù)規(guī)范的目的是開發(fā)并持續(xù)改進(jìn)運(yùn)營管理體系以確保在全球鐵路領(lǐng)域的產(chǎn)品質(zhì)量和安全。 Table of contents目錄 Foreword 前言 0 Introduction 引言 General 總則 Quality management principles 質(zhì)量管理原則 Process approach 過程方法 General 總則 PlanDoCheckAct cycle PDCA循環(huán) Riskbased thinking基于風(fēng)險的思維 Relationship with other management system standards 與其他管理體系的關(guān)系 Scope – Supplemental 范圍 補(bǔ)充 2 Normative references引用標(biāo)準(zhǔn) 3 Terms and definitions 術(shù)語和定義 Terms and definitions for the rail sector鐵路行業(yè)術(shù)語和定義 Abbreviations 縮寫 4 Context of the anization 組織的背景環(huán)境 Understanding the anization and its context 理解組織及其背景環(huán)境 Understanding the needs and expectations of interested parties理解相關(guān)方的需求和期望 Determining the scope of the quality management system確定質(zhì)量管理體系的范圍 Quality management system and its processes 質(zhì)量管理體系及其過程 Quality management system and its processes Supplemental 質(zhì)量管理體系及其過程 補(bǔ)充 5 Leadership領(lǐng)導(dǎo)作用 Leadership and mitment 領(lǐng)導(dǎo)作用和承諾 General 總則 Customer focus 以顧客為關(guān)注焦點(diǎn) Policy 方針 Establishing the quality policy建立質(zhì)量方針 Communicating the quality policy 溝通質(zhì)量方針 Quality policy – Supplemental 質(zhì)量方針補(bǔ)充 Safety policy 安全方針 Organizational roles, responsibilities and authorities 組織作用、職責(zé)和權(quán)限 Organizational roles, responsibilities and authorities – Supplemental組織作用、職責(zé)和權(quán)限 補(bǔ)充 Responsibilities and authorities of process owners過程所有者的職責(zé)和權(quán)限 6 Planning策劃 Actions to address risks and opportunities 風(fēng)險和機(jī)遇的應(yīng)對措施 Actions to address risks and opportunities Supplemental 風(fēng)險和機(jī)遇的應(yīng)對措施 補(bǔ)充 Contingency planning 應(yīng)急計(jì)劃 Quality objectives and planning to achieve them 質(zhì)量目標(biāo)及其實(shí)施的策劃 Safety objectives 安全目標(biāo) Planning of changes 變更的策劃 Business planning 經(jīng)營計(jì)劃 7 Support 支持 Resources 資源 General 總則 General Supplemental 總則 補(bǔ)充 People 人員 Infrastructure 基礎(chǔ)設(shè)施 Environment for the operation of processes 過程操作的環(huán)境 Monitoring and measuring resources監(jiān)視和測量資源 General 總則 Measurement traceability 測量的可追溯性 Monitoring and measuring resources Supplemental 監(jiān)視和測量資源 補(bǔ)充 Organizational knowledge 組織的知識 Organizational knowledge Supplemental 組織的知識 補(bǔ)充 Competence 能力 Competence Supplemental 能力 補(bǔ)充 Awareness 意識 Awareness Supplemental 意識 補(bǔ)充 Communication 溝通 Documented information 形成文件的信息 General 總則 Creating and updating 編制和更新 Control of documented information文件化信息的控制 Control of documented information Supplemental 文件化信息的控制 補(bǔ)充 8 Operation 運(yùn)行 Operational planning and control運(yùn)行的策劃和控制 Planning for the outsourcing or transfer of processes過程外包和轉(zhuǎn)包的策劃 Tender management 投標(biāo)管理 Project management 項(xiàng)目管理 Project integration management項(xiàng)目整合管理 Project scope management 項(xiàng)目范圍管理 Project time management項(xiàng)目時間管理 Project cost management項(xiàng)目成本管理 Project quality management 項(xiàng)目質(zhì)量管理 Project human resource management項(xiàng)目人力資源管理 Project munications management項(xiàng)目溝通管理 Project risk and opportunity management 項(xiàng)目風(fēng)險和機(jī)遇管理 Project procurement management 項(xiàng)目采購管理 Configuration management 技術(shù)狀態(tài)管理 Change management 變更管理 Requirements for products and service