【正文】 ude processes for management activities, provision of resources, product realization and measurement. 注 上述質(zhì)量管理體系所需的過(guò)程應(yīng)該包括與管理活動(dòng)、資源提供、產(chǎn)品實(shí)現(xiàn)和測(cè)量有關(guān)的過(guò)程。組織必須： a)identify the process needed for the quality management system and their application through the anization(), a)識(shí)別質(zhì)量管理體系所需的過(guò)程，及其在組織中的應(yīng)用（見(jiàn) ）， b)determine the sequence and interaction of these process, b)確定這些過(guò)程的順序和相互作用， c)determine criteria and methods needed to ensure that both the operation and c)確定為確保這些過(guò)程的有效運(yùn)作和控制所需的準(zhǔn)則和方法， 14 14 control of these processes are effective, d)ensure the availability of resources and information necessary to support the operation and monitoring of these processes, d)確?？梢垣@得必要的資源和信息，以支持這些過(guò)程的運(yùn)作和監(jiān)測(cè)， e)monitor, measure and analyse these processes, and e)監(jiān)測(cè)、測(cè)量和分析這些過(guò)程，和 f)implement actions necessary to achieve planned results and continual improvement of these processes, f)實(shí)施必要的措施，以實(shí)現(xiàn)這些過(guò)程策劃的結(jié)果和對(duì)這些過(guò)程的持續(xù)改進(jìn)。 Remote location 外部場(chǎng)所 13 13 Location that supports sites and at which nonproduction processes occur 支持現(xiàn)場(chǎng)及非生產(chǎn)過(guò)程發(fā)生的場(chǎng)所。 Predictive maintenance 預(yù)知性維護(hù) Activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes. 基于過(guò)程數(shù)據(jù)，通過(guò)預(yù)知可能的失效模式而避免維護(hù)問(wèn)題的活動(dòng)。 Error proofing 防錯(cuò) Product and manufacturing process design and development to prevent manufacture of nonconforming products. 產(chǎn)品和制造過(guò)程設(shè)計(jì)和開(kāi)發(fā)以防止制造不合格產(chǎn)品。 Terms and definitions for automotive industry 汽車(chē)行業(yè)的術(shù)語(yǔ)和定義 For the purposes of this Technical Specification, the terms and definitions 針對(duì)本技術(shù)規(guī)范的目的，適用 ISO9000：2020 和以下給出的術(shù)語(yǔ)和定義。 ISO 及 IEC 成員保持現(xiàn)有有效的國(guó)際標(biāo)準(zhǔn)的注冊(cè)地位。 2 Normative reference 2 引用標(biāo)準(zhǔn) The following normative document contain provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated reference, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to 通過(guò)在本技術(shù)規(guī)范中的引用，下列標(biāo)準(zhǔn)包含了構(gòu)成本技術(shù)規(guī)范規(guī)定的內(nèi)容。 Permitted exclusions do not include manufacturing process design. 允許的排除不包括制造過(guò)程的設(shè)計(jì)。 Application 應(yīng)用 ISO 9001:2020, Quality management systemsRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 Application 應(yīng)用 All requirements of this International Standard are generic and are intended to be applicable to all anizations, regardless of type, size and product provided. 本標(biāo)準(zhǔn)規(guī)定的要求是通用的，適用于不同其類型、規(guī)模和所提供的產(chǎn)品的所有組織 。 IATF 的 ISO/TS16949： 2020 指南 （ 1 范圍 總則）： 支持“現(xiàn)場(chǎng)”的外部場(chǎng)所不能獲得ISO/TS16949： 2020 的獨(dú)立認(rèn)證。 This Technical Specification, in conjunction with ISO9001:2020 , defines the quality management system requirement for the design and development , production and, When relevant, installation and service of automotiverelated products. 本技術(shù)規(guī)范與 ISO9001： 2020 相結(jié)合 ，規(guī)定了用于 與汽車(chē)相關(guān)產(chǎn)品的設(shè)計(jì)與開(kāi)發(fā)、生產(chǎn)，安裝和服務(wù)（若有關(guān)時(shí)）的質(zhì)量管理體系要求。 This Technical Specification, couples with applicable customerspecific requirements, defines the fundamental quality management system requirements for those subscribing to this document. 本技術(shù)規(guī)范與適當(dāng)?shù)念櫩吞厥庖笙嗯浜希x了簽署這項(xiàng)文件的組織的基本質(zhì)量管理體系要求。 This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this 本標(biāo)準(zhǔn)不包括針對(duì)其他管理體系的要求，例如環(huán)境管理、職業(yè)健康與安全管理，財(cái)務(wù)管理或風(fēng)險(xiǎn)管理。 NOTE The knowledge and use of the 注 ISO9000： 2020 和 ISO9004： 20205 5 eight quality management principles referred to in ISO9000:2020 and ISO9004:2020 should be demonstrated and through the anization by top management. 涉及的八項(xiàng)質(zhì)量管理原則的知識(shí)及其應(yīng)用，應(yīng)該由最高管理者在組織內(nèi)展現(xiàn)和傳遞。 ISO9004 gives guidance on a wide range of objective of a quality management system than does ISO9001, particularly for the continual improvement of an anization overall performance and efficiency, as well as its effectiveness. ISO9004 is remended as a guide for anizations whose top management wishes to move beyond the requirements of ISO9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes. 與 ISO9001 相比， ISO9004 對(duì)質(zhì)量管理體 系更寬范圍的目標(biāo)提供了指南。 Input Continual improvement of the quality management system Customer Management responsibility Resource management Measurement, analysis and improvement Product realization Requirements Product Customer Satisfaction Output Valueadding activities Information flow Key Figure 1Model of processbased quality management system 4 4 Relationship with ISO 9004 與 ISO9004 的關(guān)系 ISO9001:2020, Quality management systemsRequirements ISO9001： 2020,質(zhì)量管理體系 — 要求 Relationship with ISO 9004 與 ISO9004 的關(guān)系 The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to plement each other, but can be also be used independently. ISO9001 和 ISO9004 已制定為一對(duì)協(xié)調(diào)一致的質(zhì)量管理體系標(biāo)準(zhǔn)，這兩項(xiàng)標(biāo)準(zhǔn)相互補(bǔ)充，但也可單獨(dú)使用。 計(jì)劃：根據(jù)顧客的要求和組織的方針，為提供結(jié)果建立必要的目標(biāo)和過(guò)程。對(duì)顧客滿意的監(jiān)測(cè)，要求對(duì)顧客有關(guān)組織是否已滿足其要求的感受的信息進(jìn)行評(píng)價(jià)。 過(guò)程方法的優(yōu)點(diǎn)是對(duì)諸過(guò)程的系統(tǒng)中單個(gè)過(guò)程之間的聯(lián)系，以及過(guò)程的組合和相互作用進(jìn)行連續(xù)的控制。 為使組織有效運(yùn) 作，必須識(shí)別和管理眾多相互關(guān)聯(lián)的活動(dòng)?！白ⅰ笔抢斫夂驼f(shuō)明有關(guān)要求的指南。 2 2 引言 總則 ISO9001： 2020，質(zhì)量管理體系 — 要求 引言 總則 采用質(zhì)量管理體系應(yīng)該是一個(gè)組織的一項(xiàng)戰(zhàn)略性決策。 “必須”：表示要求。 楷體文字 ： ISO9001： 2020 原文。 2020 版的 ISO/TS 16949 從2020 年 3 月 1 日起即開(kāi)始生效， ISO/TS 16949： 1999 同時(shí) 廢止。在 ISO/TC 176 支持下，由 IATF 和日本汽車(chē)工業(yè)協(xié)會(huì)共同起草，ISO/TS 16949： 2020 于 2020 年 3 月 1 日正式發(fā) 布。 IATF：國(guó)際汽車(chē)推動(dòng)小組。 未注 《 IATF 的 ISO/TS16949： 2020 指南 》 的條款 ， 說(shuō)明 對(duì)此條文沒(méi)有進(jìn)一步的 IATF 指南。 “例如”：引出的建議只具有指導(dǎo)性作用。 本國(guó)際標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充。 過(guò)程方法 ISO9001： 2020，質(zhì)量管理體系 — 要求 過(guò)程方法 本標(biāo)準(zhǔn)鼓勵(lì)在制定、實(shí)施質(zhì)量管理體系以及改進(jìn)其有效性時(shí)，采用過(guò)程方法，通過(guò)滿足顧客要求，增強(qiáng)