iso9001質量管理體系標準要素詳解-預覽頁

　

【正文】 stomer.備注﹕在本國際標準中﹐述語’產品’指的是客戶訂購或客戶需求的產品。s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.組織可以排除的條款僅限于條款7中的要求﹐并且僅可以排除不影響組織提供符合客戶和適用的法律要求的產品的能力和責任的要求。IEC和ISO成員都持有現行有效的國際標準。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整個標準中所使用的朮語’產品’在這里同樣包括’服務’。c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 確定所需標準及方法﹐以確保這些流程可達成有效作業及管制。These processes shall be managed by the organization in accordance with the requirements of this International Standard.組織應對這些流程進行管理使其與本國際標準的要求相一至。b) a quality manual, 質量手冊。()NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.備注1﹕要本國際標準中出現的朮語’文件化程序’﹐是要求建立﹑形成文件﹑實施程序并予以保持。NOTE 3 The documentation can be in any form or type of medium.備注3﹕文件化的程序和文件可存在任何形式的媒體。 Control of documents 文件控制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 .質量管理體系所需的文件應當是受控的﹐記錄是一種特殊的文件﹐。d) to ensure that relevant versions of applicable documents are available at points of use, 在需要使用文件的場合﹐確保得到相應文件的有效版本。 Control of records 質量記錄的控制Records shall be established and maintained to provide evidence of conformity 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.質量記錄應被建立和保持以証明質量管理體系得到有效的運行并符合本國際標準的要求。a) municating to the organization the importance of meeting customer as well as statutory and regulatory requirements, 向組織偉達符合客戶及規章/法令的重要性。 Customer focus 客戶導向Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and ).最高管理階層應確保客戶的需求得已確定﹐并轉化為以實現客戶滿意的要求. () Quality policy 質量方針Top management shall ensure that the quality policy最高管理層應確保質量方針﹕a) is appropriate to the purpose of the organization, 與組織的目的相適應﹔b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, 包括符合標準的要求及持續改進的承諾。質量目標應包含符合產品要求所需之內容。　 Management representative 管理者代表Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes最高管理者應指定一名管理者﹐不受其他職務﹑責任影響﹐應具有以下責任及權力﹕a) ensuring that processes needed for the quality management system are established, implemented and maintained, 確保建立﹑實施和維持質量管理體系所需的程序。 Internal munication 內部溝通Top management shall ensure that appropriate munication processes are established within the organization and that munication takes place regarding the effectiveness of the quality management system.最高管理層應確保在組織間應建立適當的溝通流程﹐確保品質管理系統的有效。Records from management reviews shall be maintained (see ).管理評評審的記錄應被保存。f) changes that could affect the quality management system, and 可能影響質量管理體系的改進。b) to enhance customer satisfaction by meeting customer requirements. 通過符合客戶要求提高客戶滿意度。c) evaluate the effectiveness of the actions taken, 評估所遷擇的行動的效果。b) process equipment (both hardware and software), and 流程設備﹐包括硬體及軟體。產品實現的計劃應與質量管理體系的其它流程的要求相一至。 建立產品所需的流程﹑文件及提供資源。s method of operations.規劃結果應以適合組織運作方法的格式輸出。b) requirements not stated by the customer but necessary for specified or intended use, where known, 并非客戶指定﹐但必須了解明定及已知的預期使用的需求。s mitment to supply a product to the customer (. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that組織 應對與產品相關的要求進行評審﹐該評審應在產品決定或承諾交送客戶前(如接受合約或訂單﹐接受合同或訂單的變更)實施﹐以確保﹕a) product requirements are defined, 產品需求已確定。()。 Customer munication 客戶溝通The organization shall determine and implement effective arrangements for municating with customers in relation to組織應決定與實施與客戶進行有效溝通的安排﹐包括如下內容﹕a) product information, 產品信息b) enquiries, contracts or order handling, including amendments, and 詢問﹑合同和訂單處理﹐包括修訂。c) the responsibilities and authorities for design and development. 設計和開發人員的責任和權力。b) applicable statutory and regulatory requirements, 適用法律法規的要求。 Design and development outputs 設計和開發輸出The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.設計和開發過程的輸出應提供一種格式﹐以驗証設計和開發的輸入及實現的預先設計。d) specify the characteristics of the product that are essential for its safe and proper use. 定議對產品安全及適當用途之必要的特性。Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see ).參與評審的人員包括各職能部門的參與設計和開發各階段評審的代表﹐評審的結果記錄及采取的相關行動應給予保存。變更在執行前應予以評審﹑檢驗﹑確認﹐必要時應進行批準。s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ).組織應根據提供符合組織要求產品的能力來評估和選擇供方。Where the organization or its customer intends to perform verification at the supplier39。 Validation of processes for production and service provision 確認產品及服務準備流程The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or mea