【正文】 urrent and future designs by feedback of testing, modification and use experience. 通過實驗反饋、修改和利用經(jīng)驗，用來改進當前和將來設(shè)計可靠性的閉環(huán)過程。 [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)。 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)和維護保養(yǎng)中的最小維護單元之上的整合子裝置。 This can be a software programme, database, puterized spreadsheet, electronic file or web tool, bought from the market or developed by the anization. 這可能是一個市場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。 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準的引用而成為本標準的條款。 Quality management systemrequirements質(zhì)量管理體系 要求 1 scope范圍 This International Standard specifies requirements for a quality management system when an anization: 本標準為有下列需求的組織規(guī)定了質(zhì)量管理體系要求 a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and需要證實其具有穩(wěn)定地提供滿足顧客要求和適用法律法規(guī)要求的產(chǎn)品和服務(wù)的能力； b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 通過體系的有效應(yīng)用，包括體系持續(xù)改進的過程，以及保證符合顧客和 適用的法律法規(guī)要求，旨在增強顧客滿意 All the requirements of this International Standard are generic and are intended to be applicable to any anization, regardless of its type or size, or the products and services it provides. 本標準規(guī)定的要求是通用的，意在適用于各種類型、不同規(guī)模和提供不同產(chǎn)品和服務(wù)的組織。 This International Standard relates to ISO 9000 and ISO 9004 as follows: 本標準與 ISO 9000 和 ISO 9004 的關(guān)聯(lián)如下： — ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard。風險是一種不確定性和這些可以有正面或負面影響的不確定性的結(jié)果。 To conform to the requirements of this International Standard, an anization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. 為符合本標準的要求，組織需策劃和實施應(yīng)對風險和機遇的措施。 過程方法 – 鼓勵采用 過程方法 ? 過程 ：通過使用資源和管理 ,將輸入轉(zhuǎn)化為輸出的活動。 The PDCA cycle can be briefly described as follows: PDCA循環(huán)可簡述如下 — Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the anization’ s policies, and identify and address risks and opportunities。 有效過程績效的實現(xiàn)； d) improvement of processes based on evaluation of data and information. 在數(shù)據(jù)和信息評價的基礎(chǔ)上改進過程。 Management of the processes and the system as a whole can be achieved using the PDCA cycle with an overall focus on riskbased thinking aimed at taking advantage of opportunities and preventing undesirable results. 可以在全面關(guān)注旨在預(yù)防不良結(jié)果并利用機會的“基于風險的考慮”的基礎(chǔ)上，應(yīng)用“策劃 —實施 —檢查 —改進”（ PDCA循環(huán)）的方法學實現(xiàn)對過程及系統(tǒng)作為一個整體進行管理。本標準 包含了著重考慮采用過程方法的特定要求。 全員參與 — process approach。 Quality management principles 質(zhì)量管理原則 This International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the anization, some examples of benefits associated with the principle and examples of typical actions to improve the anization’ s performance when applying the principle. 本標準是建立在 ISO 9000中所闡述的質(zhì)量管理原則，闡述包括每項原則的概述，管理原則對組織的重要性的基本原理，和原則相關(guān)利益的一些例子，以及應(yīng)用這些原則改進組織績效的典型的實例。 In this International Standard, the following verbal forms are used: 在本標準中，使用下列非謂語動詞： “shall” indicates a requirement。 The PDCA cycle enables an anization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. PDCA循環(huán)使組織確保它的過程能夠獲得充分的資源并且得到充分管理，確定改進的機會并實施。 統(tǒng)一文件以對應(yīng)本國際標準的條款結(jié)構(gòu) the use of the specific terminology of this International Standard within the anization. 在組織內(nèi)使用本國際標準中的特定術(shù)語。 應(yīng)對與組織的背景和目標相關(guān)的風險和機遇； d) the ability to demonstrate conformity to specified quality management system requirements. 有能力證實對規(guī)定的質(zhì)量管理體系要求符合性。 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 補充 2 Normative references引用標準 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 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)量方針補充 Safety policy 安全方針 Organizational roles, responsibilities and authorities 組織作用、職責和權(quán)限 Organizational roles, responsibilities and authorities – Supplemental組織作用、職責和權(quán)限 補充 Responsib