【正文】 e ability to meet the defined requirements. 組織有能力滿足所定議的各項需求。 Design and development 設計和開發(fā) Design and development planning 設計和開發(fā)計劃The organization shall plan and control the design and development of product.組織應計劃和控制產(chǎn)品的設計和開發(fā)During the design and development planning, the organization shall determine在設計和開發(fā)計劃中組織應確定﹕a) the design and development stages, 設計和開發(fā)的進程。d) other requirements essential for design and development. 設計和開發(fā)必要的其他任何要求。()a) to evaluate the ability of the results of design and development to meet requirements, and 評估設計和開發(fā)滿足需求的能力?？刂频念愋秃统潭葢Q于其對隨后的實現(xiàn)過程和輸出的作用。 Production and service provision 產(chǎn)品和服務的準備 Control of production and service provision 產(chǎn)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(chǎn)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(guī)定產(chǎn)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(zhì)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(guī)定要求適當后才發(fā)出。驗証結(jié)果及隨后的跟進措施應予以記錄() Design and development validation 設計和開發(fā)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(fā)確認設計和開發(fā)出的產(chǎn)品能夠滿足特殊或預期的使用要求﹐無論如何﹐應在交付或?qū)崿F(xiàn)產(chǎn)品前完成確認。b) provide appropriate information for purchasing, production and for service provision, 提供適當?shù)牟少彥p生產(chǎn)﹑和服務的資訊。Planning output shall be updated, as appropriate, as the design and development progresses.隨著設計和開發(fā)的進行﹐計劃應進行更新以確保適用性。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(chǎn)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。d) any additional requirements determined by the organization. 組織應確定任何額外要求。 針對產(chǎn)品及產(chǎn)品允收條件決定所需之各驗証﹑確認﹑監(jiān)控﹑檢查及測試之活動。 Work environment 工作環(huán)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(chǎn)品合格要求所需的工作環(huán)境。 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(zhì)量的活動中對能力的需求。d) status of preventive and corrective actions, 預防及糾正措施的狀態(tài)。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。d) is municated and understood within the organization, and 在組織內(nèi)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(zhì)量方針的持續(xù)適用性進行評審。應建立程序文件以標識﹑貯存﹑追溯和保護質(zhì)量記錄﹐并規(guī)定保存期限和處理方法。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 plexity of processes and their interactions, and 流程的復雜程度和相互作用。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(zhì)量管理所需的流程包括管理活動﹑資源提供﹑產(chǎn)品實現(xiàn)及測量流程。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(zhì)量管理系統(tǒng)及應用于整個組織所需的流程。2 Normative reference 引用標準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.下列相關國際標準所包含條文﹐通過在本標準中引用而構(gòu)成為本標準的條文﹐由于引用的條文會逐漸過時﹑陸續(xù)修正或改版﹐造成引用的國際標準不再適用。s policies.Do: implement the processes.Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.Act: take actions to continually improve process performance. Figure 1 — Model of a processbased quality management systemQuality management systems — Requirements1 Scope 范圍 General 總則This International Standard specifies requirements for a quality management system where an organization本國際標準規(guī)定的質(zhì)量管理體系要求組織﹕a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 需証實其持續(xù)提供符合客戶需求及適用法規(guī)要求產(chǎn)品的能力。4. ISO19011質(zhì)量和環(huán)境審核指南取代了現(xiàn)行的ISO10011 (包括3個分標準) 和ISO14010﹑ISO14011﹑ISO14012 標準。5. ISO10012測量控制系統(tǒng)﹐取代現(xiàn)行的ISO100121, 2標瘁 94版的ISO9001有20個要素﹐現(xiàn)改為4個部份﹐相互新聞系如下圖﹕ISO 9001:2000ISO 9001:19941 Application應用23 概述＋ 品質(zhì)手冊 文件的管制++ 品質(zhì)記錄的管制+++、職權(quán)、溝通6資源管理+++7 產(chǎn)品實現(xiàn) 產(chǎn)品實現(xiàn)的規(guī)劃++ 客戶相關流程 產(chǎn)品有關需求的決定+ 產(chǎn)品有關需求的審查++ 客戶溝通++++++++++++++++++8量測、分析及改善+++++++++++二﹑詞語的使用更加準確或符合組織的習慣 “質(zhì)量管理體系”取代了 “質(zhì)量保証體系”﹔ “文件控制” 取代了 “