品质系统稽核查检表.doc

QUALITY SYSTEMS AUDIT CHECKLIST 1: Quality System Requirements 品質系統要求 Avg score(平均分): [ ] Subtotal(得分): [ ] Counts(總分): [ 19 ] Score(得分) Yes=1 No=0 N/A=X 責任單位 (Ref 4.1) 1.1 Has the supplier defined and documented its corporate quality policy, objectives and commitments to quality? 供應商是否有一致的已規定并文件化的品質方針、目標并付諸于品質活動中? 工標品保部 (Ref 4.1) 1.2 Are procedures in place to ensure this quality policy is understood, implemented and maintained at all levels in the organization? 是否有程序确保品質方針為公司各階層了解、實施并維持? 工標品保部 (Ref 4.1) 1.3 Has the supplier defined the responsibility, authority and interrelation of all personnel who manage, perform and verify work that affects the quality of products, materials or services? (i.e. procedures, organization charts, quality manual) 供商是否規定了影響品質(包括產品、物料、服務)之管理、執行及驗証之工作人員的權責和相互關系?(例如:程序、組織架构、品質手冊) 工標品保部 (Ref 4.1) 1.4 Has the supplier provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products? 供應商是否提供充分資源進行驗証活動, 例如: 產品和制程的檢驗、測試、監控和審核? 工標品保部 (Ref 4.1) 1.5 Has the supplier appointed a management representative who has responsibility and authority for ensuring that a quality management system has been implemented and maintained? 供應商是否任命了管理代表, 擔負确保品質管理系統已被執行及維持之權責? 工標品保部 (Ref 4.1) 1.6 Does the supplier conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals? (i.e. does the quality system meet customer requirements?) 供應商是否規定期間內執行管理評審以驗証品質管理系統适切性和有效性?(例如:品質系統是否滿足客戶要求) 工標品保部 (Ref 4.1) 1.7 Are records maintained of these management reviews? 管理評審的記錄是否保存? 工標品保部 (Ref 4.2) 1.8 Has the supplier established and maintained a documented quality system including procedures and work instructions? 供應商是否建立并維持包括程序和工作指導(WI)的文件化的品質系統? 工標品保部 (Ref 4.2) 1.9 Have the procedures and work instructions been effectively implemented? (i.e. available to all personnel who need them) 是否程序文件和WI被有效實施(例: 適合所有需用的人員)