【正文】 總要求 補(bǔ)充）： 15 15 當(dāng)組織外包時(shí)，不允許委托技術(shù)職責(zé)。 NOTE Processes needed for the quality management system referred to above should include 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。 Where an anization choose to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. 針對(duì)組織所選擇的任何影響產(chǎn)品符合要求的外包過(guò)程，組織必須確保對(duì)其實(shí)施控制。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)。 Special characteristic 特殊特性 Product characteristic or manufacturing process parameter which can affect safety or pliance with regulations, fit, function, performance or subsequent processing of product. 可能影響安全性或法規(guī)的符合性、產(chǎn)品的配合、功能、性能，或產(chǎn)品后續(xù)生產(chǎn)過(guò)程的產(chǎn)品特性或制造過(guò)程參數(shù)。 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。 Premium freight 超額運(yùn)費(fèi) Extra costs or charges incurred additional to contracted delivery. 由于產(chǎn)生額外交付而導(dǎo)致的額外的成本或費(fèi)用。 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)。 Laboratory scope 實(shí)驗(yàn)室范圍 Controlled document containing 受控文件包括： — specific tests, evaluations and calibrations that a laboratory is qualified to perform, — 實(shí)驗(yàn)室有資格進(jìn)行的特定試驗(yàn)、評(píng)價(jià)和校準(zhǔn)， 12 12 — list of the equipment which it uses to perform the above, and — 用來(lái)進(jìn)行上述活動(dòng)的設(shè)備清單 ，和 — list of methods and standards to which it performs the above — 進(jìn)行上述活動(dòng)的方法和標(biāo)準(zhǔn)的清單。 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。 Design responsible anization 具有設(shè)計(jì)職責(zé)的組織 Organization with authority to establish a new, or change an existing, product specification 組織有權(quán)限建立新的、或更改現(xiàn)有的產(chǎn)品規(guī)范。 Terms and definitions for automotive industry 汽車行業(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。 The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: 本版 ISO9001標(biāo)準(zhǔn)描述供應(yīng)鏈?zhǔn)褂玫男g(shù)語(yǔ)，已經(jīng)被更改以及反映當(dāng)前使用的術(shù)語(yǔ)： supplier→ anization→ customer 供方 → 組織 → 顧客 The term ”anization” replace the “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies, Also, the term ”supplier” now replaces the term “subcontractor” . 本國(guó)際標(biāo)準(zhǔn)所使用的術(shù)語(yǔ)“組織”取代了 ISO9001： 1994中使用的術(shù)語(yǔ)“供方”，并指代本標(biāo)準(zhǔn)所適用的單位，現(xiàn)在使用的“供方”取代以前使用的術(shù)語(yǔ)“分承包方”。 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。但是，簽署本技術(shù)規(guī)范的各方鼓勵(lì)討論使用下列標(biāo)準(zhǔn)最新版本的可能性。 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。 除以上的說(shuō)明外，質(zhì)量管理體系必須提及 ISO/TS16949： 2020 的所有要求。 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)。 Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions 如果有排除的情形，就不能接受符合這項(xiàng)標(biāo)準(zhǔn)；除非這些排除是在第 7 條中的要求，而且這些排除不會(huì)影響組織提供9 9 are limited to requirements within clause 7, and such exclusions do not affect the anization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 符合顧客和適用的法規(guī) 要求產(chǎn)品的能力或職責(zé) 。 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 。過(guò)程審核方法在體系內(nèi)檢查單個(gè) 過(guò)程間（它們結(jié)合在一起，相互影響滿足技術(shù)規(guī)范的要求） 的連接的現(xiàn)行控制。 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。 Supporting functions, whether onsite or remote(such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support 現(xiàn)場(chǎng)或外部的支持功能（例如設(shè)計(jì)中心、公司總部和配送中心），因其支持現(xiàn)場(chǎng)而 構(gòu)成現(xiàn)場(chǎng)審核的一部分，但不能獨(dú)立獲得關(guān)于本技術(shù)規(guī)范的認(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。 TECHNICAL SPECIFICATION 技術(shù)規(guī)范 Quality management systemsParticular requirements for the application of ISO 9001:2020 for automotive production and relevant part anizations 質(zhì)量管理體系 — 汽車行業(yè)生產(chǎn)件與相關(guān)服務(wù)件的組織實(shí)施 ISO9001：2020 的特殊要求 1