iso9001質量管理體系標準要素詳解-wenkub.com

　 　

【正文】 Production and service provision 產品和服務的準備 Control of production and service provision 產品和服務的準備控制The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable組織應對生產和服務準備進行計劃和管制﹐包括﹕a) the availability of information that describes the characteristics of the product, 得到規定產品特性的有效信息。c) requirements for qualification of personnel, and 人員資格要求﹔d) quality management system requirements. 質量管理體系要求﹔The organization shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier.組織應確保采購資料所包含的規定要求適當后才發出。控制的類型和程度應取決于其對隨后的實現過程和輸出的作用。驗証結果及隨后的跟進措施應予以記錄() Design and development validation 設計和開發確認Design and development validation shall be performed in accordance with planned arrangements (see ) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be pleted prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see ).應實施設計和開發確認設計和開發出的產品能夠滿足特殊或預期的使用要求﹐無論如何﹐應在交付或實現產品前完成確認。()a) to evaluate the ability of the results of design and development to meet requirements, and 評估設計和開發滿足需求的能力。b) provide appropriate information for purchasing, production and for service provision, 提供適當的采購﹑生產﹑和服務的資訊。d) other requirements essential for design and development. 設計和開發必要的其他任何要求。Planning output shall be updated, as appropriate, as the design and development progresses.隨著設計和開發的進行﹐計劃應進行更新以確保適用性。 Design and development 設計和開發 Design and development planning 設計和開發計劃The organization shall plan and control the design and development of product.組織應計劃和控制產品的設計和開發During the design and development planning, the organization shall determine在設計和開發計劃中組織應確定﹕a) the design and development stages, 設計和開發的進程。Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.當產品需求變更時﹐組織應確保相關文件已被修訂﹐且要確保相關人員已知道變更之要求。c) the organization has the ability to meet the defined requirements. 組織有能力滿足所定議的各項需求。d) any additional requirements determined by the organization. 組織應確定任何額外要求。　NOTE 2 The organization may also apply the requirements given in to the development of product realization processes.。 針對產品及產品允收條件決定所需之各驗証﹑確認﹑監控﹑檢查及測試之活動。 產品的質量目標和需求。 Work environment 工作環境The organization shall determine and manage the work environment needed to achieve conformity to product requirements.組織應確定和管理達到產品合格要求所需的工作環境。e) maintain appropriate records of education, training, skills and experience (see ). 保存有關教育﹑經驗﹑培訓﹑技朮和經驗的記錄。 Competence, awareness and training 培訓意識和能力The organization shall組織應﹕a) determine the necessary petence for personnel performing work affecting product quality, 識別人員在從事影響質量的活動中對能力的需求。b) improvement of product related to customer requirements, and 與客戶需求有關的產品改善。d) status of preventive and corrective actions, 預防及糾正措施的狀態。s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.最高管理應每隔規定時間﹐審核品質管理體系﹐確保質量管理體系的持續適用性﹑正確﹑有效。c) ensuring the promotion of awareness of customer requirements throughout the organization. 確保組織全體人員對客戶需求的充分知悉。b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 當質量管理體系在規劃和執行上有改變時﹐要維持質量管理體系的完整性。d) is municated and understood within the organization, and 在組織內各部門間進行溝通﹐并使各部門都能理解e) is reviewed for continuing suitability. 對質量方針的持續適用性進行評審。d) conducting management reviews, and 執行管理評審。應建立程序文件以標識﹑貯存﹑追溯和保護質量記錄﹐并規定保存期限和處理方法。f) to ensure that documents of external origin are identified and their distribution controlled, and 確保外來文件已作標識﹐并控制其發放。b) to review and update as necessary and reapprove documents, 進行必要的審核和更新﹐并重新獲得批準。b) the documented procedures established for the quality management system, or reference to them, and 質量管理體系建立的文件化程序或其援引。b) the plexity of processes and their interactions, and 流程的復雜程度和相互作用。d)documents needed by the organization to ensure the effective planning, operation and control of its processes, and組織需求的確保流程得到有效的實施和控制的文件。NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.備注﹕在上面所述的質量管理所需的流程包括管理活動﹑資源提供﹑產品實現及測量流程。e) monitor, measure and analyse these processes, and 監控﹑測量及分析這些流程。The organization shall組織應a) identify the processes needed for the quality management system and their application throughout the organization (see ), 認別實施質量管理系統及應用于整個組織所需的流程。The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:在ISO9001﹕2000 描述供應鏈所使用的朮語被改變為組織普遍使用的詞匯﹕ Supplier organization customer 供方 組織 客戶The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. 朮語’組織’取代了ISO9001:1994版使用的朮語’供方’,意思是適用于本國際標準的單位。2 Normative reference 引用標準The following normative docu