iso90012000isreoninternationalcertification(编辑修改稿)

iso90012000isreoninternationalcertification(编辑修改稿)内容摘要：

The anization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (.), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in . A documented procedure shall be established to define the controls needed d) 組織為確保其過程有效規劃、運作及管制所需要的文件，及 e)本國際標準要求之紀錄 (見 ) 備註 1 本國際標準中出現 ”文件化程序 ”之處，係要求該程序須被建立、文件化、實施及維持。 備註 2 各組織其品質管理系統文件化的程度或有差別，端賴下列而定 a) 組織的規模及活動的型態， b) 過程的複雜性及相互關係， c) 員工的能力。 備註 3 文件可能為任何形式或種類的媒體。 品質手冊 組織應建立與維護品質手冊，其內容包含 a) 品質管理系統的範圍，包括對排除部份的細 節與理由 (見 )， b) 品質管理系統所建立的文件化程序，或參考該 等程序，及 c) 描述品質管理系統各過程的順序及其彼此間之相互關係。 文件管制 品質管理系統運作所要求之文件應加以管制，紀錄為一特殊型態之文件應依據條文 之要求加以管制。 應建立文件化之程序用以管制 a) 文件發行前，核准其正確性， 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯絡處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： a) to approve documents for adequacy prior to issue, b) to review and update as necessary and reapprove documents, c) to ensure that changes and the current version status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Control of records Records shall be established and maintained to provid e e vid e nce of co nformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5 Management responsibility Management mitment Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by a) municating to the anization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and b) 審查、必要的更新與再次核准文件， c) 確保文件的改變及目前版次狀態被標明， d) 確保使用文件各場所，持有相應版次的適當文件， e) 確保維持文件易於閱讀及容易識別， f) 確保外來原始文件被識別及管制其分發，和 g) 防止作廢文件被誤用，如因任何目的而留存時，應被適當的識別。 記錄管制 品質管理系統所須之記錄應被建立與維護，以證明符合品質管理系統的要求及有效運作。 品質紀錄應易於閱讀、識別及取用。 應建立文件化程序以定義記錄的識別、儲存、取用、保護、保存期限與處置方式。 5 管理責任 管理承諾 高階管理者應透過下列方式，以證明對其品質管理系統的發展、實施與持續改善系統有效性之承諾： a) 對組織內部溝通 符合客戶及法令、法規要求的重 要性， b) 建立品質政策， c) 確保品質目標被建立， d) 執行管理審查，和 e) 確保提供必要的資源。 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯絡處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： e) ensuring the availability of resources. Customer focus Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see and ). Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the anization, b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is municated and understood within the anization, and e) is reviewed for continuing suitability. Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see a)], are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality policy. Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned 顧客為重 高階管理者應確保顧客之需求已被決定且滿足，以達到增進客戶滿意為目的 (見 及)。 品質政策 高階管理者應確保其品質政策 a) 適合於組織的目地 ， b) 包括符合品質管理系統需求及持續改善系統有效性之承諾， c) 提供一個建立及審查品質目標之體制， d) 於組織中被溝通及瞭解， e) 審查其持續的適切性。 規劃 品質目標 高階管理者應確保 組織內各相關機能及各層級之品質目標被建立，品質目標包含符合產品要求之各項需求 (見 )。 品質目標應可被量測，且必須與品質政策相一致。 品質管理系統規劃 高階管理者應確保： a) 規劃品質管理系統以符合條文 及品質目標之要求，和 b) 當品質管理系統計劃將有或已有變化時，維持品質管理系統之完整性。 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯絡處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： c) and implemented. Responsibility, authority and munication Responsibility and authority Top management shall ensure that the responsibilities, authorities are defined and m。