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目的评价管理体系过程及其运行的符合性、适应性和有效性。方法通过分析2004-2010年中心管理体系内审和外审中发现的不符合项,检验管理体系的运行状况。结果在2004-2010年期间体系审核结果共发现102项不符合项。涉及管理要求的有11个要素45项,涉及技术要求的有9个要素57项。结论中心管理体系总体运行良好,但在设备管理和文件记录控制等方面还有薄弱环节,需要加强监督管理,保持持续改进。
Purpose To evaluate the compliance, adaptability and effectiveness of the management system process and its operation. Methods By analyzing the non-conformities found in the internal audit and external audit of the central management system from 2004 to 2010, the operating status of the management system was tested. Results A total of 102 nonconformities were identified during the system audit in 2004-2010. There are 45 eleven elements involved in management requirements and 57 nine elements related to technical requirements. Conclusion The central management system is generally well run, but there are still some weak links in terms of equipment management and document recording control. Supervision and management needs to be strengthened to keep improving.