【文章內(nèi)容簡(jiǎn)介】 ement systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 3 Terms and definitions 3 術(shù)語和定義 For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. 為了本國(guó)際標(biāo)準(zhǔn)的目的， ISO9000 中給出了術(shù)語和定義適用。 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，已經(jīng)被更改以及反映當(dāng)前使用的術(shù)語： 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“組織”取代了 ISO9001： 1994中使用的術(shù)語“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“分承包方”。 Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 在本國(guó)際標(biāo)準(zhǔn)中，當(dāng)出現(xiàn)術(shù)語“產(chǎn)品”時(shí)，也能表示“服務(wù)”。 Terms and definitions for automotive industry 汽車行業(yè)的術(shù)語和定義 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)語和定義。 11 11 given in ISO 9000:2020 and the following apply. Control plan 控制計(jì)劃 Documented description of the systems and processes required for controlling product(see annex A) 對(duì)控制產(chǎn)品所要 求的體系和過程的文件化的描述（見附錄 A）。 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。 NOTE This responsibility includes testing and verification of design performance within the customer’s specified application. 注 本職責(zé)包括按顧客指定方法進(jìn)行設(shè)計(jì)性能的試驗(yàn)和驗(yàn)證。 Error proofing 防錯(cuò) Product and manufacturing process design and development to prevent manufacture of nonconforming products. 產(chǎn)品和制造過程設(shè)計(jì)和開發(fā)以防止制造不合格產(chǎn)品。 Laboratory 實(shí)驗(yàn)室 Facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing. 進(jìn)行包括但不限于化學(xué)、冶金、尺寸、物理、電性能或可靠性試驗(yàn)在內(nèi)的檢驗(yàn)、試驗(yàn)和校準(zhǔn)的設(shè)施。 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。 Manufacturing 制造 Process of making of fabricating 制造或裝配以下事項(xiàng)的過程： — production materials, — 生產(chǎn)材料， — production or service parts, — 生產(chǎn)件或服務(wù)件， — assemblies, or — 裝配， 或 — heat treating, welding, paining, plating or other finishing services — 熱處理、焊接、噴漆、電鍍或其它最終服務(wù)。 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. 基于過程數(shù)據(jù)，通過預(yù)知可能的失效模式而避免維護(hù)問題的活動(dòng)。 Preventive maintenance 預(yù)防性維護(hù) Planned action to eliminate cause of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design. 為消除設(shè)備失效和非計(jì)劃的生產(chǎn)中斷而策劃的活動(dòng)，是制造過程設(shè)計(jì) 的輸出。 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。 NOTE This can be caused by method, quality, unscheduled or late deliveries, etc. 注 這可能會(huì)因方法、數(shù)量、非計(jì)劃或延遲交付等而導(dǎo)致。 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)過程發(fā)生的場(chǎng)所。 Site 現(xiàn)場(chǎng) Location at which valueadded manufacturing processes occur 增值制造過程發(fā)生的場(chǎng)所。 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)過程的產(chǎn)品特性或制造過程參數(shù)。 4 Quality management system 4 質(zhì)量管理體系 General requirements 總要求 ISO 9001:2020, Quality management systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 4 Quality management system 4 質(zhì)量管理體系 General requirements 總要求 The anization shall establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The anization shall: 組織必須按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系，形成文件，加以實(shí)施和保持，并持續(xù)改進(jìn)其有效性。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程，及其在組織中的應(yīng)用（見 ）， b)determine the sequence and interaction of these process, b)確定這些過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)確保可以獲得必要的資源和信息，以支持這些過程的運(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)這些過程策劃的結(jié)果和對(duì)這些過程的持續(xù)改進(jìn)。 These processes shall be managed by the anization in accordance with the requirements of this International Standard. 組織必須按本標(biāo)準(zhǔn)的要求管理這些過程。 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程，組織必須確保對(duì)其實(shí)施控制。對(duì)此類外包過程的控制必須在質(zhì)量管理體系中加以識(shí)別。 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