[构思并实施ISO 9001:2000质量管理体系：阿曼苏丹卡布斯大学眼科三年来的质量改进与效率提升]

[Conceiving and implementing an ISO 9001:2000 quality management system: quality improvement and efficiency increase over 3 years at the Dept. of Ophthalmology, Sultan Qaboos University in Oman].

作者信息

Bialasiewicz A A, Breidenbach K, Ganesh A, Al-Saeidi R, Ganguly S S

机构信息

Department of Ophthalmology and School of Ophthalmic Technicians, College of Medicine and Health Sciences of the Sultan Qaboos University, 123 Al Khod, Muscat, Oman.

出版信息

Ophthalmologe. 2006 Oct;103(10):877-87. doi: 10.1007/s00347-006-1375-y.

DOI:10.1007/s00347-006-1375-y

PMID:16821074

Abstract

BACKGROUND

Oman is a developing country of the Middle East with a University Hospital in a national health system. Problems related to documentation, structure, and procedure prevailing in a multicultural environment result in a lack of productivity. The aim of this study was to test the feasibility of introducing a quality management system according to ISO 9001:2000 into a university department of ophthalmology with special reference to quality and efficiency data over 3 years.

MATERIALS AND METHODS

Standardized types of documentation (35 documents, 183 forms and formats, and 453 registers) under a formal roof (booklets for work instructions, quality management, procedures) were conceived in 2001 and implemented, and were evaluated by descriptive statistics over the years 2002-2005 with respect to quality and efficiency. In 2005, the departmental QMS was merged into the QMS of the whole hospital.

RESULTS

Establishment of "responsibility clusters" with structured surveillance tasks, procedural improvements, and continuous audits resulted in a significant quality improvement already during the implementation until ISO 9001:2000 certification in 2002, and over the following 3 years. The data were assessed by non-conformities documented monthly (total inpatients: -50%, outpatients: -20%, operating theater: -100%, teaching: -10%; p <0.05) and increased efficiency assessed by the most important performance indicators (before QMS vs a median of 3 years with QMS): major surgery: +459%, inpatient stay: -49.7%, occupancy rate: +63.9%, technical diagnostics: +292.9%, postgraduate teaching total: +740%, research output total: +330% (p <0.05).

CONCLUSIONS

It is feasible to introduce the quality management system according to ISO 9001:2000 into a developing country in the Middle East. It has an immediate effect on the increase of efficiency (measured by performance indicators) and quality in all systems providing the possibility for regional benchmarking.

摘要

背景

阿曼是中东地区的一个发展中国家，其国家卫生系统中有一家大学医院。在多元文化环境中，与文件记录、结构和程序相关的问题导致了生产力低下。本研究的目的是测试将符合ISO 9001:2000的质量管理体系引入大学眼科部门的可行性，并特别参考3年期间的质量和效率数据。

材料与方法

2001年构思并实施了在正式框架下（工作指导手册、质量管理手册、程序手册）的标准化文件类型（35份文件、183种表格和格式以及453本登记簿），并在2002年至2005年期间通过描述性统计对其质量和效率进行评估。2005年，该部门的质量管理体系并入了整个医院的质量管理体系。

结果

建立具有结构化监督任务、程序改进和持续审核的“责任群组”，在实施过程中直至2002年获得ISO 9001:2000认证期间以及随后的3年中，均带来了显著的质量提升。通过每月记录的不符合项（住院患者总数：-50%，门诊患者：-20%，手术室：-100%，教学：-10%；p<0.05）评估数据，并通过最重要的绩效指标评估效率提升情况（质量管理体系实施前与实施3年的中位数相比）：大手术：+459%，住院时间：-49.7%，占用率：+63.9%，技术诊断：+292.9%，研究生教学总数：+740%，研究产出总数：+330%（p<0.05）。