《ISO9001AwarenessTrainingforstaffs精编版》由会员分享，可在线阅读，更多相关《ISO9001AwarenessTrainingforstaffs精编版（116页珍藏版）》请在金锄头文库上搜索。
1、ISO9000:2000 Awareness Training ISO9000:2000 認識培訓 Quality Management System Standard 質量管理系統標準,ISO-国际标准化组织,ISO-International Organization for Standardization 成立于1947年2月23日 总部设于瑞士日内瓦 推动和协调国际标准化工作 推动国际贸易的发展 120多个成员国组成，包括欧共体和欧盟的所有成员国，美国、日本、中国、新加坡等,国际标准制定的过程,TC技术委员会 TC176：质量管理和质量保证技术委员会 成立于1980年 制定质量管理和质
2、量保证标准 ISO9000族标准就是由ISO/TC176制定的所有国际标准,Changes from ISO9000:1994ISO9000:1994更改概要,ISO9001,ISO9002,ISO9003,ISO9001:2000-,QMS requirements 質量管理系統要求,ISO9000:2000-,Fundamentals and be safeguarded from adjustments that would invalidate the measurement result 妥善防護以免因調整不當而使其校正失效 Protected from damage and det
3、erioration during handling, maintenance and storage 在搬運、維護、和儲存時應加以保護以避色損傷和變質,7.6 Control of monitoring and measuring devices 測量和監控裝置控制,Assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements (see 4.2.4). 當發現校正失效時，應評估之前的結果並採取適當的措施 Th
4、e ability of any computer software used in the monitoring and measurement of specified requirements shall be confirmed prior to initial use to satisfy the intended application. This shall be undertaken and reconfirmed as necessary. 為特定要求而使用在量測和監督的軟體在使用前應予以確認. NOTE See ISO 10012-1 and ISO 10012-2 for
5、 guidance. 備註: 參閱ISO 10012指引,8 Measurement, analysis and improvement 測量、分析和改進,8.1 General 總則 8.2 Monitoring and measurement測量和監控 8.3 Control of nonconforming product 不合格控制 8.4 Analysis of data 資料分析 8.5 Improvement 改進,8.1 General 總則,Define, plan and implement measurement and monitoring processes 確定、計
6、劃和實施測量及監控過程 Demonstrate conformity of the product 保證產品的符合性 Ensure the conformity of the QMS 保證質量管理系統的符合性 Continually improve the effectiveness of the QMS 持續改進質量管理系統的有效性 Determine and use applicable methods, include statistical techniques, and the extent of their use 鑒別和使用合適方法，包括統計工具，及其使用的內容,8.2 Moni
7、toring and measurement 測量及監控,8.2.1 Customer satisfaction 顧客滿 8.2.2 Internal audit 內部審核 8.2.3 Monitoring and measurement of processes 測量及監控過程 8.2.4 Monitoring and measurement of product 測量及監控產品,8.2 Monitoring and measurement 測量及監控,Measurement of the performance of the QMS 質量管理系統表現的一個測量Monitor custome
8、r perception whether the organization has fulfilled customer requirements 監控顧客對於組織已否滿足客戶要求的看法 Determine methods for obtaining and using this information 規定收集及應用資訊的方法,8.2 Monitoring and measurement 測量及監控,Conduct internal audits at planned intervals to determine whether the quality management system 組
9、織應執行定期性的內部審核，以判斷質量管理系統： Conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements 符合本國際標準的要求 Effectively implemented and maintained 已有效地運作和維持,8.2 Monitoring and measurement 測量及監控,An audit program shall be plan
10、ned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits 組織應制定審核計劃，該計劃將依活動的狀況和重要性、被審核的範圍和以往審核結果列作考慮The audit criteria, scope, frequency and methods shall be defined 審核範圍、頻率和方法應作界定Auditors shall not audit their own wo
11、rk 審核應由與受審方之工作無直接關係的人員執行 The responsibilities and requirements for planning and conducting audits, and for reporting results shall be defined 審核的策劃、執行及報告等責任及要求應作界定,8.2 Monitoring and measurement 測量及監控,Follow-up activities shall include the verification of the actions taken and the reporting of verif
12、ication results (see 8.5.2) 後續跟催活動應包括驗證糾正措施並記錄驗證結果 The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes 管理階層應確定對審核期間所發現之缺失所採取的糾正措施在在限期前執行 NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3
13、for guidance. 備註: 參閱ISO 10011-1, ISO 10011-2和ISO 10011-3指引,8.2 Monitoring and measurement 測量及監控,8.2.3 Monitoring and measurement of processes 測量及監控過程 Apply suitable methods for monitoring and measurement 組織應採用適當量測和監督方法 Demonstrate the ability of the processes to achieve planned results 方法需展示過程可達致計劃結
14、果的能力 Correction and corrective action shall be taken if not achieve in order to ensure conformity of the product 若不能達致，需採取糾正和糾正措施以確保產品的符合性,8.2 Monitoring and measurement 測量及監控,8.2.4 Monitoring and measurement of product 測量及監控產品 Monitor and measure the characteristics of the product to verify that pr
15、oduct requirements are satisfied 組織應量測和監督產品的特性，以驗證產品符合要求 Carry out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1) 這些監督和量測應架構在產品實現流程的適當階段 Evidence of conformity with the acceptance criteria shall be maintained. 符合允收標準的證據應予以文件化 Records sh
16、all indicate the person(s) authorizing release of product (see4.2.4). 記錄應能顯示負責產品放行的權責人員,8.2 Monitoring and measurement 測量及監控,Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed. Otherwise it should be approved by a relevant authority or the customer. 只有在所有規定的活動都已圓滿完成後，產品才能放行和服務才能交付，不然應取得客戶的核准. No clear regulation on receive, process and final inspection of product 沒有明確規定進貨，過程和最終檢
