【正文】 系統(tǒng)所需要的流程參照上述，包含管理、資源、產(chǎn)品實(shí)現(xiàn)和量 測(cè)。 Where an anization chooses 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. 當(dāng)一個(gè)組織選擇用外部來源之任何影響產(chǎn)品符合要求之流程時(shí)，組織應(yīng)確保能完全 管制這樣的流程。 The anization shall 組織應(yīng) a) identify the processes needed for the quality management system and their application throughout the anization (see ), 鑒定品質(zhì)管理系統(tǒng)所需之流程 b) determine the sequence and interaction of these processes, 決定這些流程之順序與其交互之關(guān)系 c) Determine criteria and methods needed to ensure that both the operation and control of these processes 企業(yè) ()大量管理資料下載 3 are effective, 決定準(zhǔn)則與方法以確保這些流程可有效運(yùn)作與管制 d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes, 確保有效的資源與信息的取得以支持作業(yè)和監(jiān)督這些流程 e) Monitor, measure and analyze these processes, and 監(jiān)督、量測(cè)及分析這些流程及 f) Implement actions necessary to achieve planned results and continual improvement of these processes. 實(shí)施措施，以達(dá)成所規(guī)畫結(jié)果和持續(xù)性改善這些流程之所需。現(xiàn)在的用詞「供貨商」，即是以前的用詞「分包商」，這些改變是因?yàn)榕c組織所使用字匯相對(duì)應(yīng)。 ISO 9000:2020, Quality management systems – Fundamentals and vocabulary. ISO 9000： 2020，品質(zhì)管理系統(tǒng) —原則與詞匯 3 Terms and definitions 用詞 與定義 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)之目的， ISO 9000： 2020內(nèi)所賦予的用詞和定義適用。然而，使用本國(guó)際標(biāo)準(zhǔn)之各方被鼓勵(lì)探討應(yīng)用下列各項(xiàng)標(biāo)準(zhǔn)最新版次的可能性。企業(yè) ()大量管理資料下載 1 INTERNATIONAL STANDARD Quality management systemsRequirements 1. Scope 范圍 General 概述 This International Standard specifies requirements for a quality management where an anization 本國(guó)際標(biāo)準(zhǔn)所訂之品質(zhì)管理系統(tǒng)要求，當(dāng)一個(gè)組織 a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 必須展現(xiàn)其提供符合顧客要求及符合適用法規(guī)要求一致的產(chǎn)品能力，及 b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 透過對(duì)系統(tǒng)有效應(yīng)用以增進(jìn)顧客滿意之目標(biāo)，包含對(duì)系統(tǒng)的持續(xù)改善各流程和對(duì)顧客要求及適用法規(guī)要求之符合的保證 NOTE In this International Standard, the term ―product‖ applies only to the product intended for, or required by, a customer. 注：本國(guó)際標(biāo)準(zhǔn)內(nèi)之『產(chǎn)品』一詞是指只適用于預(yù)期的或顧客要求的產(chǎn)品 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. 本國(guó)際標(biāo)準(zhǔn)的所有要求是通用的，并期望適用于不論型式 、規(guī)模大小與所提供產(chǎn)品的所有組織 Where any requirement(s) of this International Standard cannot be applied due to the nature of an anization and its product, this can be considered for exclusion. 當(dāng)本國(guó)際標(biāo)準(zhǔn)的任何要求因組織及其產(chǎn)品之性質(zhì)而無法適用，可以考慮加以排除 Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions 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. 當(dāng)排除進(jìn)行時(shí)，除非這些排除被限制在條文 7內(nèi)之要求，且這些排除不能影響組織能力或責(zé)任，及提供實(shí)現(xiàn)符合顧客與適用法規(guī)要求的產(chǎn)品，否則無法主張符合本國(guó)際標(biāo)準(zhǔn) 2 Normative reference 引用標(biāo)準(zhǔn) The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard 企業(yè) ()大量管理資料下載 2 are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standard. 本國(guó)際標(biāo)準(zhǔn)各項(xiàng)規(guī)定系由下列標(biāo)準(zhǔn)之規(guī)定所組成，并于全文中引述參考。由于所引用的標(biāo)準(zhǔn)會(huì)逐漸過時(shí)而陸續(xù)修正或改版，造成引用的國(guó)際標(biāo)準(zhǔn)不再適用。 IEC 和 ISO會(huì)員則維持最新有效國(guó)際標(biāo)準(zhǔn)之登錄。 The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: 下列用詞 在本版國(guó)際標(biāo)準(zhǔn)中使用，用以描述供應(yīng)煉，已改為反應(yīng)現(xiàn)有使用之字匯： Supplier → anization → customer 供貨商 → 組織 → 顧客 The term ―anization‖ replaces the term ―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‖. 用詞「組織」取代了以前使用的用詞「供貨商」，意思是使用本國(guó)際標(biāo)準(zhǔn)的單位。 Throughout the text of this International Standard, wherever the term ―product‖ occurs, it can also mean ―service‖. 本國(guó)際標(biāo)準(zhǔn)全文上下，無論何處使用到用詞「產(chǎn)品」，亦能夠同義于「服務(wù)」 4 Quality management system品質(zhì)管理系統(tǒng) General requirements 一般要求 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. 組織應(yīng)建立、文件化、執(zhí)行、維持一個(gè)品質(zhì)管理系統(tǒng)及持續(xù)不斷改善其功能以符合本國(guó)際標(biāo)準(zhǔn)之要求。 These processes shall be managed by the anization in accordance with the requirements of this International Standard. 組織應(yīng)管理這些流程，以與本國(guó)際標(biāo)準(zhǔn)要求一致。這樣的外部資源流程的管制應(yīng)在品質(zhì)管理系統(tǒng)內(nèi)加以鑒別。 Documentation requirements 文件要求 General 概述 The quality management system documentation shall include 品質(zhì)管理系統(tǒng)文件應(yīng)包含： a) documented statements of a quality policy and quality objectives, 品質(zhì)政策和品質(zhì)目標(biāo)； b) a quality manual, 品質(zhì)手冊(cè)； c) documented procedures required by this International Standard, 本國(guó)際標(biāo)準(zhǔn)所要求的書面程序； d) documents needed by the anization to ensure the effective planning, operation and control of its processes, and 組織用以確保其流程有效的規(guī)劃、作業(yè)和管制所要求的文件； e) records required by this International Standard (see ). 本國(guó) 際標(biāo)準(zhǔn)要求的品質(zhì)記錄。 企業(yè) ()大量管理資料下載 4 NOTE 2 The extent of the quality management system documentation can differ from one anization to another due to 注 2：每個(gè)組織的品質(zhì)管理系統(tǒng)文件的程度可能有別于另一個(gè)組織，可歸因于： a) the size of aniza