【正文】 of product Control of monitoring and measuring devices 8 Measurement, analysis and improvement General Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Improvement Continual improvement Corrective action Preventive action Quality management systems – Requirements 1 Scope General This International Standard specifies requirements for a 設(shè)計(jì)與開(kāi)發(fā)的輸出 設(shè)計(jì)與開(kāi)發(fā)的審查 設(shè)計(jì)與開(kāi)發(fā)的驗(yàn)證 設(shè)計(jì)與開(kāi)發(fā)的確認(rèn) 設(shè)計(jì)與開(kāi)發(fā)變更的管制 採(cǎi)購(gòu) 採(cǎi)購(gòu)過(guò)程 採(cǎi)購(gòu)資訊 採(cǎi)購(gòu)品驗(yàn)證 生產(chǎn)及服務(wù)提供 生產(chǎn)及服務(wù)提供之管制 生產(chǎn)與服務(wù)提供過(guò)程的確認(rèn) 鑑別與追溯 客戶財(cái)產(chǎn) 產(chǎn)品保存 量測(cè)與監(jiān)控設(shè)備的管制 、分析與改善 通則 監(jiān)控與量測(cè) 客戶滿意 內(nèi)部稽核 過(guò)程的監(jiān)控與量測(cè) 產(chǎn)品的監(jiān)控與量測(cè) 不合格品管制 資料分析 改善 持續(xù)改善 矯正措施 預(yù)防措施 品質(zhì)管理系統(tǒng) 要求 1 範(fàn)圍 通則 當(dāng)組織有下列要求時(shí)，本國(guó)際標(biāo)準(zhǔn)界定其品質(zhì)管理系統(tǒng) 桃園市中 正路 1249 號(hào) 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安錦廈村小康街 2 號(hào) 2F TEL： 07695325815 FAX： 07695325817 Email： quality management system where an anization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 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. NOTE In this International Standard, the term “product” applies to the product intended for, or required by, a customer. Application All requirements of this International Standard are generic and are intended to be applicable to all anizations, regardless of type, size and product provided. Were 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. 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. 2 Normative reference 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 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 Standards. ISO 9000:20xx, Quality management systems – Fundamentals and vocabulary. 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. 的需求： a) 須要展現(xiàn)其能力足以穩(wěn)定地提供符合客戶及適用法規(guī)要求之產(chǎn)品，和 b) 透過(guò)系統(tǒng)的有效運(yùn)用，包括持續(xù)改善系統(tǒng)之過(guò)程與保證符合客戶及適當(dāng)法規(guī)要求，以增進(jìn)客戶滿意。然而依據(jù)本國(guó)際標(biāo)準(zhǔn)達(dá)成共識(shí)之各團(tuán)體仍應(yīng)探求使用下列引用標(biāo)準(zhǔn)最新版次的可能。 組織應(yīng)： a) 鑑別品質(zhì)管理系統(tǒng)所需的過(guò)程及其在組織 桃園市中 正路 1249 號(hào) 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安錦廈村小康街 2 號(hào) 2F TEL： 07695325815 FAX： 07695325817 Email： a) identify the processes needed for the quality management system and their application throughout the anization (see ), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the anization in accordance with the requirements of this International Standard. 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. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. Documentation requirements General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, 中之運(yùn)用 (見(jiàn) )， b) 決定這些過(guò)程的順序及相互關(guān)係， c) 決定確保這些過(guò)程有效運(yùn)作及管制的必要的準(zhǔn)則及方法， d) 確保提供支援這些過(guò)程的運(yùn)作及監(jiān) 督必要的資源與資訊 ， e) 監(jiān)控、量測(cè)及分析這些過(guò)程，和 f) 採(cǎi)取必要行動(dòng)以達(dá)成這些過(guò)程的預(yù)期結(jié)果及持續(xù)改善。 文件管制 品質(zhì)管理系統(tǒng)運(yùn)作所要求之文件應(yīng)加以管制，紀(jì)錄為一特殊型態(tài)之文件應(yīng)依據(jù)條文 之要求加以管制。 規(guī)劃 品質(zhì)目標(biāo) 高階管理者應(yīng)確保 組織內(nèi)各相關(guān)機(jī)能及各層級(jí)之品質(zhì)目標(biāo)被建立，品質(zhì)目標(biāo)包含符合產(chǎn)品要求之各項(xiàng)需求 (見(jiàn) )。管理審查應(yīng)包括評(píng)估改善的機(jī)會(huì)與品質(zhì)管理系統(tǒng)修正的必要性，包括品質(zhì)政策與目標(biāo)。 基礎(chǔ)設(shè)施 組織應(yīng)決定、提供及維護(hù)為達(dá)成符合產(chǎn)品需求必要的基礎(chǔ)設(shè)施。 此項(xiàng)規(guī)劃產(chǎn)出的結(jié)果，其格式應(yīng)適合其組織的作業(yè)方法。 當(dāng)產(chǎn)品需求被改變時(shí)，組織應(yīng)確保相關(guān)文件被修正，及相關(guān)人員都知道改 變後的需求