iso9001質量管理體系標準要素詳解(文件)

　

【正文】 plement and maintain the quality management system and continually improve its effectiveness, and 執行與維持品質管理體系并持續改進其有效性。b) provide training or take other actions to satisfy these needs, 提供培訓或其他方式以滿足這些需求。 Infrastructure 資源結構The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable組織應確認﹑提供﹑保持達成產品合格所需的資源結構﹐資源結構包括﹕a) buildings, workspace and associated utilities, 建筑﹑工作場地和相關設施。7 Product realization 產品的實現 Planning of product realization 產品實現的規劃The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ).組織應建立和實施產品實現所需的計劃和發展程序。b) the need to establish processes, documents, and provide resources specific to the product。d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). 提供証明程序執行和產品符合要求的記錄The output of this planning shall be in a form suitable for the organization39。 Customerrelated processes 客戶相關流程 Determination of requirements related to the product 決定有關產品的各項要求The organization shall determine組織應決定a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, 客戶指定之要求﹐包括運送及郵寄之要求。 Review of requirements related to the product 與產品相關要求的評審The organization shall review the requirements related to the product. This review shall be conducted prior to the organization39。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 organization before acceptance.評審結果和由于評審引起的活動應被記錄。NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.備注﹕在特殊情況下如網絡銷售等每一訂單都進行正式的評審是不現實的﹐可以審查相關的產品的信息如﹕型號﹑廣告材料等。b) the review, verification and validation that are appropriate to each design and development stage, and 設計和開發的每個階段的評審﹑驗証和確認的活動。 Design and development inputs 設計和開發的輸入Inputs relating to product requirements shall be determined and records maintained (see ). These inputs shall include與產品各項需求相關之輸入應予定議和記錄()﹐其包括﹕a) functional and performance requirements, 功能與執行的需求。These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other.應對這些輸入的適用性進行評審﹐所有的需求都應滿足﹐表述清楚且各部分間接口清楚。c) contain or reference product acceptance criteria, and 包括或引用設計或開發產品接受的標準。b) to identify any problems and propose necessary actions. 識別問題并建議解決方案。確認驗証結果及隨后的跟進措施應予以記錄() Control of design and development changes 設計和開發變更的控制Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.應識別設計和開發變更并記錄其修訂。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。 Verification of purchased product 采購產品的驗証The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.組織應識別并實施對采購進行驗証或其他必須的活動﹐確保采購的產品符合采購需求。b) the availability of work instructions, as necessary, 必要時編制工作指導文件﹔c) the use of suitable equipment, 使用相應設備﹔d) the availability and use of monitoring and measuring devices, 提供并使用測量和監控設備﹔e) the implementation of monitoring and measurement, and 執行監控活動﹔f) the implementation of release, delivery and postdelivery activities. 實施規定的放行﹑交付和相應的音樂會活動。s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.當組織或其客戶提出在供方貨源處進行驗証活動時﹐組織應在采購資料中規定驗証安排和產品放行方法。選擇標準對供方進行定期的評估﹐評估結果和隨后的躍進措施應予以記錄. Purchasing information 采購資料Purchasing information shall describe the product to be purchased, including where appropriate采購資料應包含對所采購產品的適當描述﹐包括﹕a) requirements for approval of product, procedures, processes and equipment, 產品﹑程序﹑流程﹑設備的認可條件。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評審結果的記錄及隨后的跟進措施應予以保存() Purchasing 采購 Purchasing process 采購流程The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.組織應確保采購的產品符合采購需求。 Design and development verification 設計和開發驗証Verification shall be performed in accordance with planned arrangements (see ) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see ).應實施設計和開發驗証以確保輸出符合設計和開發輸入要求。 Design and development review 設計和開發評審At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see )在適當階段﹐組織應對設計和開發進行系統的評審以確保與計劃安排的相一至。Design and development outputs shall設計和開發輸出應﹕a) meet the input requirements for design and development, 符合設計和開發輸入的要求。c) where applicable, information derived from previous similar des