ISO 9001(2008年版)國際品質管理系統在醫院的運用

The Operation of ISO 9001:2008 International Quality Management System in Hospital

張興聰(HSING-TSUNG CHANG)

指導教授 ： 李亞欣

中山醫學大學/健康管理學院/醫療產業科技管理學系碩士班/碩士(2016年)

摘要

目的：「ISO風潮」起始於1987年，國際標準組織(ISO)發布了第一份針對品質管理制度規範之一系列標準－ISO 9000，統一各國既有的相關標準，也可避免造成國際上通商之障礙，而1992年因為歐洲經濟統合，使用本標準做為企業品質管理能力的驗證之故，促成全球各國熱烈地推展ISO 9000標準，也奠定了國際標準組織所發行標準之權威地位。國內醫院也藉由推行一些品質活動，來提高服務品質，而ISO品質保證活動則為其中之一。國內醫療產業導入ISO 9001品質管理系統起步甚晚，因此本研究主要探討醫院對ISO品質管理系統的導入，探討個人特性、醫院特性及職位層級對品質管理系統中系統規劃、管理責任、資源管理、服務實現及持續改善的認知與看法。方法與資料：本研究分三部分進行討論：個人特性、醫院特性與職位層級，討論其是否會影響系統規劃、管理責任、資源管理、服務實現與持續改善之滿意度。並使用自構式結構問卷，採樣條件為使用SGS標準之醫療院所，排除加入三年以下之體系、中途並未退出ISO 品質管理系統，進而分北、中、南三區進行抽樣調查。結果：本研究共回收49份問卷，其中男性占10.2%(N =5)，女性占89.8%(N=44)。系統規劃為本研究中滿意度最低(76.70%)之分類，而資源管理為本研究中滿意度最高(84.42%)之分類。整體而言性別與年齡並不影響其滿意度；年齡與五類之滿意度並無統計上顯著相關；所屬醫院層級越高，其系統規劃之滿意度越低、所屬醫院層級越高，服務實現與持續改善的滿意度也越高；導入年數越久，其系統規劃、管理責任、服務實現與持續改善之滿意度越高；職位在資源管理(0.039)及持續改善(0.031)之滿意度在統計上有顯著差異。

關鍵字

ISO 9001 ； 醫院執行ISO滿意度

並列摘要

Objective: The so called "ISO wave" started in 1987, when the International Organization for Standardization (ISO) published the first of a series of standards for quality management systems – the ISO 9000, which served to harmonize the different national standards in order to avoid the international trade barriers. In 1992, because of the integration of European economy, the application of this standard as a corporate quality management and as its verification has become a popular trend around the world, which further gave the ISO 9000 its authority worldwide. Although not the first to introduce this system and its application started rather late, many hospitals in Taiwan nowadays use the ISO 900 to improve their service qualities. In this study, we aimed to investigate whether different personal characteristics, different hospital types, and the work hierarchy would have different satisfaction level in system planning, in placing their management responsibility, to relay the resource management, to conduct the hospital services, and to lead to a continual improvement.
Methods and materials: This study is consisted of three different parts: personal characteristics, hospital types, and work hierarchy. To discuss whether people of different personality characteristics, hospital of different operating characters, and the work hierarchy would have different satisfaction level of the system planning, placing management responsibility, relay resource management, conducting service and continual improvement (the five categories), this investigation was carried out by using a self-configuring structured questionnaire, interviewing hospital management personnel who work in hospitals using SGS standards. Hospitals that have not been using the system more then three years were excluded, and the participating hospitals must not quit halfway in using ISO quality management system while this study was ongoing. The sampled hospitals were chosen from the northern, central and southern Taiwan.
Results: Forty nine questionnaires were completed. Men accounted for 10.2% (N = 5), and women for 89.8% (N = 44). In average, they had the lowest satisfaction in system planning (76.70%) and had the highest satisfaction in the resource management (84.42%). Gender and age did not show any significant statistical impact on the satisfaction levels in the five categories. Hospitals of higher operating level had lower satisfaction with their systems planning, but had higher satisfaction in the service conduction as well as in leading to the continuous improvement. The longer the hospital’s using the system, the higher the satisfaction level would be in the system planning, management responsibility, service conduction and continual improvement. Work hierarchy showed a statistic significant difference in satisfaction level of the resource management (0.039) and continual improvement (0.031).

並列關鍵字

ISO 9001 ； ISO satisfaction with the implementation of the hospital

參考文獻

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