【正文】 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) 透過系統(tǒng)的有效運(yùn)用，包括持續(xù)改善系統(tǒng)之過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。 組織應(yīng)遵照本國(guó)際標(biāo)準(zhǔn)的要求管理這些過程。品質(zhì)目標(biāo)應(yīng)可被量測(cè)，且必須與品質(zhì)政策相一致?；A(chǔ)設(shè)施包括可行的下列 a) 建築物、工作空間及附屬的設(shè)施； b) 過程設(shè)備 (包括軟、硬體設(shè)備 )，和 c) 支援服務(wù) (例如運(yùn)輸、通訊 )。 備註： 在某些情況下，例如網(wǎng)路行銷，對(duì)每一張訂單進(jìn)行正式審查並不實(shí)際。 當(dāng)客戶提供非文件化的需求敘述時(shí)，組織在接受客戶需求前應(yīng)加以確認(rèn)。 b) process equipment (both hardware and software), and c) supporting services (such as transport or munication). Work environment The anization shall determine and manage the the work environment needed to achieve conformity to product requirements. b) 提供訓(xùn)練或其他措施以滿足這些需求， c) 評(píng)估所採(cǎi)取措施的有效性， d) 確保員工認(rèn)知本身作業(yè)的 相關(guān)性 與重要性及其對(duì)達(dá)成品質(zhì)目標(biāo)的貢獻(xiàn)，和 e) 維護(hù)適當(dāng)?shù)慕逃?、?xùn)練、技能及經(jīng)驗(yàn)的紀(jì)錄 (見 )。 品質(zhì)政策 高階管理者應(yīng)確保其品質(zhì)政策 a) 適合於組織的目地 ， b) 包括符合品質(zhì)管理系統(tǒng)需求及持續(xù)改善系統(tǒng)有效性之承諾， c) 提供一個(gè)建立及審查品質(zhì)目標(biāo)之體制， d) 於組織中被溝通及瞭解， e) 審查其持續(xù)的適切性。 4 品質(zhì)管理系統(tǒng) 一般要求 組織應(yīng)遵照本國(guó)際標(biāo)準(zhǔn)的要求建立、文件化、執(zhí)行、維持品質(zhì)管理系統(tǒng)並持續(xù)改善其有效性。 備註 在本國(guó)際標(biāo)準(zhǔn)中， ”產(chǎn)品 ”一詞適用於預(yù)期提供 予顧客或其所需要之產(chǎn)品。 當(dāng)組織選擇 將 會(huì)影響產(chǎn)品符合 要求的 部分 過程 委 外 時(shí) ，組織應(yīng)確保 其 管制 亦及於 此等 委 外之過程， 且 在品質(zhì)管理系統(tǒng)中界定 其 管制方式。 品質(zhì)管理系統(tǒng)規(guī)劃 高階管理者應(yīng)確保： a) 規(guī)劃品質(zhì)管理系統(tǒng)以符合條文 及品質(zhì)目標(biāo)之要求，和 b) 當(dāng)品質(zhì)管理系統(tǒng)計(jì)劃將有或已有變化時(shí)，維持品質(zhì)管理系統(tǒng)之完整性。 工作環(huán)境 組織應(yīng)決定和管理為達(dá)到符合產(chǎn)品需求必要的工 作環(huán)境。取代的方式為對(duì)相關(guān)產(chǎn)品資訊，例如型錄、廣告素材等加以審查。 審查結(jié)果及後續(xù)措施的紀(jì)錄必須加以維持 (見 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： Records of the results of the review and actions arising from the review shall be maintained (see ). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the anization before acceptance. Where product requirements are changed, the anization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE: In some situations, such as in inter sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. Customer munication The anization shall determine and implement effective arrangements for municating with customers in relation to: a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer plaints. Design and development Design and development planning The anization shall plan and control design and development of product. During the design and development planning, the anization shall determine a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities