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[ISO 10007:2023, ] configuration status accounting 配置狀態(tài)統(tǒng)計 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告,計劃變更的狀態(tài)和已批準(zhǔn)變更的執(zhí)行狀態(tài)。 Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176. 附件 B提供了 ISO/TC 176已經(jīng)開發(fā)的關(guān)于質(zhì)量管理和質(zhì)量管理體系的其他國際標(biāo)準(zhǔn)的細(xì)節(jié) This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. 本標(biāo)準(zhǔn)不包括其他管理體系的特定要求,例如環(huán)境管理,職業(yè)健康安全管理或財務(wù)管理。 C—檢查:根據(jù)方針、目標(biāo)、要求和策劃的活動,對過程及其產(chǎn)生的產(chǎn)品和服務(wù)進(jìn)行監(jiān)視和(適用時)測量,并報告結(jié)果; — Act: take actions to improve performance, as necessary. A—改進(jìn):必要時,采取措施,以改進(jìn)績效。 基于證據(jù)的決策 — relationship management. 關(guān)系管理 Process approach過程方法 General總則 This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in . 本標(biāo)準(zhǔn)鼓勵在建立、實施質(zhì)量管理體系以及改進(jìn)其有效性時采用過程方法,通過滿足顧客要求,增強顧客滿意。 The process approach enables an anization to plan its processes and their interactions. 過程方法使組織能夠策劃它的過程和過程之間的相互作用。因此,在鐵路行業(yè)補充特定要求時,在方框外使用術(shù)語 ―運營管理體系 ‖ 。 應(yīng)對與組織的背景和目標(biāo)相關(guān)的風(fēng)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。 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(biāo)準(zhǔn)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(jìn)組織績效的典型的實例。 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(jìn)過程。風(fēng)險是一種不確定性和這些可以有正面或負(fù)面影響的不確定性的結(jié)果。 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。 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。 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。 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. 機遇可以因一種有利情況的出現(xiàn)來達(dá)成預(yù)期的結(jié)果,例如:一些允許組織吸引顧客,開發(fā)新產(chǎn)品和服務(wù),減少浪費或提高生產(chǎn)效率的情形。 理解并持續(xù)滿足要求; b) the consideration of processes in terms of added value。 “應(yīng)該” 表明一種建議 “may” indicates a permission。 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。當(dāng)本技術(shù)規(guī)范提及 ―安全 ‖ 時,這個術(shù)語應(yīng)理解為 ―產(chǎn)品安全 ‖ , 不要與 ―職業(yè)安全 ‖ 混淆。 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)險的思維使組織能夠確定那些可能導(dǎo)致它的過程和質(zhì)量管理體系偏離策劃的結(jié)果的因素,通過預(yù)防控制來減少負(fù)面的影響,而且最大化的利用它們產(chǎn)生的機遇。 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)過程的作為系統(tǒng)進(jìn)行理解并加以管理,有助于組織實現(xiàn)預(yù)期結(jié)果的有效性和效率。 ? 過程方法 :組織內(nèi)諸過程的系統(tǒng)的應(yīng)用,連同這些過程的識別和相互作用及管理。 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“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)。 critical / criticality危險的 /危險度 Objects having the potential of introducing high risks that can threaten quality, safety or business performance, based on a risk assessment. 在風(fēng)險評估的基礎(chǔ)上,具有引入高風(fēng)險可能性的對象,風(fēng)險可能影響質(zhì)量、安全或運行績效。 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。 —ISO 9000 質(zhì)量管理體系 —基礎(chǔ)和術(shù)語 為合適的理解和實施本標(biāo)準(zhǔn)提供了重要的背景。 P—策劃:根據(jù)顧客的要求和組織的方針,以及識別和確定的風(fēng)險和機遇,建立體系及其過程的目標(biāo),以及為了達(dá)成結(jié)果所需的資源; — Do: implement what was planned。 過程方法 — improvement。 The quality management system requirements specified in this International Standard are plementary to requirements for products and services. 在本國際標(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)要求的補充。 The content include ISO 9001:2023 text and supplements has been originated by the UNIFE, IRIS Certification? working group. ? Whenever the ISO 9001:2023 t