Development of an Integrated Quality Management System Combining ISO9001 and Hospital Evaluation

本研究旨在开发整合ISO9001与日本品质保健委员会(JCQHC)评估项目之整合品质管理体系，以提升医疗品质，并将整合品质管理体系应用于医院，以验证整合品质管理体系的有效性。2004财年，对水户总医院的医疗岗位、医疗事故等医疗质量状况进行了调查。调查了JCQHC和ISO9001的活动，制定了医疗工作和集成质量管理体系的草案模型。2005财年，该模式草案在三藤总医院得到应用，并澄清了应用中的问题。在其他几家医院，明确了有待建立的质量管理体系的形式。2006财年，在前两年研究成果的基础上完成了集成质量管理体系模型的构建，提出了质量管理体系模型，并对模型的有效性进行了验证。在日本，9300家医院中有2300家获得了JCQHC认证。该模型对医院具有一定的参考价值。本研究的结果解决了医疗行业质量管理体系的缺陷，为减少医疗事故，提高医疗质量提供了可能。因此，日本国民享受到了安全医疗服务的好处。医院也可以利用JCQHC检查的机会建立质量管理体系。在对质量管理体系进行验证的过程中，发现质量管理体系在医院引入和推广过程中出现了种种困难。因此，未来的主要工作是开发一种有效和高效的方法来将质量管理体系引入和推广到医院。

The purposes of this study are development of integrated quality management system which combines ISO9001 and evaluation items of Japan Council for Quality Health Care (JCQHC) in order to improve quality of healthcare, and verifying effectiveness of the integrated system by applying it to hospitals. In 2004 fiscal year, status of healthcare quality such as medical jobs, medical accidents etc. are investigated at Mito General Hospital. Activities about JCQHC and ISO9001 are investigated and medical jobs and draft model of integrated quality management system is developed. In 2005 fiscal year, the draft model is applied to Mito General Hospital and issues in application are clarified. At other several hospitals, form of quality management system to be developed is clarified. In 2006 fiscal year, based on the results of last two years the integrated quality management system model is completed.In this study, quality management system model is proposed and effectiveness of the model is verified. In Japan 2300 hospitals out of 9300 hospitals are certified by JCQHC. The proposed model is useful for the hospitals. The results of this study solve defectiveness of quality management system in healthcare sector and make it possible to improve quality of healthcare by decreasing medical accidents. Thus Japanese nation receive benefits of safety healthcare service. Also hospitals can develop quality management system using opportunity for JCQHC examination. It makes it possible to avoid superficial or unnecessary activities and to make medical jobs effective and efficient.In the process of verifying quality management system it is found that various difficulties happen when quality management system is introduced and promoted to hospitals. Thus main future work is development of an effective and efficient method for introducing and promoting quality management system to hospitals.