• 한국컴퓨터정보학회논문지
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• 제1권1호
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• pp.65-82
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• 1996

소프트웨어의 개발과 관련하여 품질보증의 문제는 그 특성상 다른 제품의 품질문제와 달리 매우 복잡하다. 소프트웨어의 품질시스템 구축을 위해서는 객관적 개밭표준 혹을 지침의 활용과 사용자 요구사항과의 일치의 확인 등이 중요시 된다 또한 품질표준의 올바른 이해와 품질감사에 대비한 점검사항의 계속적인 활용이 요구 된다 ISO 9000 시리즈는 품질보증을 위한 국제적 표준으로서 탄생되었다. 이 가운데 ISO 9000-3은 소프트웨어 품질경영 및 보증 표준으로 소프트웨어의 설계. 개발，공급. 설치 및 유지보수를 위한 지침이다. 최근 개정된 ISO/CD 9000-3:1995는 일반 제품의 품질표준인 ISO 9001의 늘 속에서 내용상 많은 강화된 변경사항들을 담고 있다 본 연구에서는 새로이 개정된 ISO 9000-3을 ISO 9001과 비교하여 내용을 분석하였고. 품질감사의 중요 점검사항을 도출하여 향후 품질감사에 대비하고 활용할 수 있도록 하였다.

• 한국품질경영학회:학술대회논문집
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• 한국품질경영학회 2006년도 추계 학술대회
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• pp.360-365
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• 2006

Most organizations adopt a process-based approach to manage their operations and now business process management(BPM) is a well-established concept. Because ISO 9001:2000 emphasizes process based, Korea Institute of Science and Technology Information has taken ISO 9001:2000 certificate in November 11, 2003 and now implements quality management systems based on BPMS further applies Hypertext. We call it Online KQMS (KISTI Quality Management System). And Online KQMS is implemented under a platform independent framework based on the web environment. Online KQMS based on BPMS and Hypertext is a new example in field of ISO quality management and is expected to support process management well.

• 품질경영학회지
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• 제31권4호
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• pp.184-193
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• 2003

PL has been developed centering around England and America. Recently many countries are introducing PL system changing the world a single economic bloc based on the rapid development of Technology and Economy. This paper is studied with related literatures and theses, organizational consulting cases within the framework of the firm as the central operating bodies of PL system. In the past, Some papers about System Integration which was operated as a same Certificate System and enacted in a single organization, was studied and presented. But most of papers was a theoretical study related model and conception. In this situation Government supports PSMS of a single system at government expense to 100­200 companies for improving organizational confrontation ability of PL this year. This paper proposed a design and effect of Integration system model based on the analysis of ISO 9001：2000, KS, PSMS and ISO 14001. The integrated system has the following three distinctions. Firstly, KS is a national establishment, national leading certification and forcing standard. Secondly, ISO 9001：2000 and ISO 14001 are an international organization's establishment, non­official certification and optional standard. Finally, PSMS isn't a national law and forcing matter. And it isn't the concept of certification but the operational system by itself. Also if a lawsuit by defect is happened, it is very dangerous. This paper, which is integrated by four management systems and has many consulting cases, is the first in this department and is different from others. Also If people has the basic knowledge about management system, they can directly connect it to the organizational system according to this paper's guidance. It is very good result in this study because the law of PL is executed now.

• 품질경영학회지
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• 제46권2호
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• 품질경영학회지
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• 제39권1호
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• pp.120-130
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• 2011

The purpose of this study is to offer the integrated model of the product safety management system, ISO 9001 Quality Management System, ISO 14001 environmental management system and OHSAS 18001 Occupational Health and Safety Management System and to present its management plan. In order to cope with effectuation of the Product Liability, studies were conducted to construct an integrated system and to find strategies of companies.

• 품질경영학회지
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• 제33권3호
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• pp.41-46
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• 2005

The production, processing, sale and service of food materials are not subject to attainment via a single country. In accordance with internationalization of the world, issues related to food safety have emerged as critical international concerns and they are closely associated with the health and interest of domestic consumers, producers, manufacturers, and distributors. As a third party certification standards, ISO 22000 is in progress International Organization for Standardization(ISO) and the Draft International Standard(DIS) has already been presented on December 2004. The purpose of this study is to analyze the international standards, guidelines and legislation in regard of Food Safety Management System(FSMS) including ISO 9001, Hazard Analysis Critical Control Point(HACCP) and Product Liability(PL) so as to present Korean-model Food Safety Management System requirements and system establishment model.

• 한국산업경영시스템학회:학술대회논문집
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• 한국산업경영시스템학회 2002년도 춘계학술대회
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• pp.433-438
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• 2002

A construction model of quality management system in manufacturing industry focuses on process approach and continual improvement amongst the quality management 8 principles which are elements of quality management system of ISO 9000:2000 family standards, and proposes the model that can construct quality management system throughout the process approach as more simple and effective way in developing and applying a quality management system for characteristics of the manufacturing industry.

• 품질경영학회지
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• 제38권1호
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• pp.101-107
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• 2010

In 2008, a review was made to analyze the effect of the certification of ISO 9001 quality management system in the almost same methods used for a similar review in 2001. Based on the two reviews, this research is to compare and contrast the changes made in between. The results show that the overall satisfaction for the certification has increased over 7 years, along with other beneficial changes, such as decreased cost and increased productivity. However, there has been no significant change in the establishment of the quality management system and in the level of customer satisfaction. ISO 9001 quality management system construction appears which effects variously on the all enterprises management, therefore this is very important strategy for preparing the keen enterprises competition.

• Clinical and Experimental Reproductive Medicine
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• 제34권2호
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• pp.107-115
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• 2007

목 적: ISO 9001:2000 품질경영시스템은 국제적인 인중 기준에 의해 제품 및 서비스의 품질을 적절하게 판정하고 이를 향상시키기 위해 시행되고 있다. 본 연구에서는 이러한 품질경영시스템을 보조생식술 센터에 성공적으로 도입하고 적용하는 과정에서 확인된 효용성에 대해 기술하고자 한다. 연구방법: 제일병원 아이소망센터는 2004년 1월부터 ISO 9001:2000 인증을 위한 활동을 시작하였으며, 고객만족도조사와 주기적인 내부심사와 사후심사를 실시하였다. 심사과정에서 확인된 부적합 사항에 대한 시정 및 예방 조치와 이에 따른 효과성을 검증하였으며, 고객불만사항에 대한 지속적인 관리와 개선을 위한 프로젝트를 진행하였다. 결 과: 본 센터는 초일류 불임센터로 성장하고 최적의 품질경영시스템을 확립하기 위한 품질방침을 설정하여, 2004년 6월에 한국품질재단 (Korean Foundation for Quality)으로부터 "체외수정 및 배아이식 시술에 관련된 연구"에 대하여 ISO 9001:2000 인증을 받았다. 이러한 품질방침을 실현하기 위해 품질경영시스템에 적합한 품질매뉴얼, 프로세스, 절차서, 지침서 등에 대한 문서화를 완료하였다. 삼 년 동안의 내부심사와 사후심사에서 각각 140건과 7건의 부적합이 확인되었으며, 이에 대한 시정조치를 실시하였다. 결 론: 본 센터에서는 ISO 품질경영시스템의 도입과 운영을 통해 고객만족도의 향상, 체계적인 문서화를 통해 업무의 투명화와 효율화가 가능하였다. 보조생식술 센터에서의 ISO 품질경영시스템은 보조생식술에 대한 국가적인 관리시스템을 효율적으로 운영하기 위한 기본적인 기관별 경영시스템으로서 활용이 가능할 것으로 생각된다.

• 품질경영학회지
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• 제32권3호
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• pp.166-181
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• 2004

The aircraft production quality management system in Korea has been implemented to support the developmental phase of Korean aircraft industries, from overhaul of the aircraft and engines to development of military trainer aircraft. After the deletion of the Mil-Q-9858A standard in 1996, Korean aerospace companies established ISO 9001 and AS 9100 as their basic aerospace quality management system specifications. These quality standards were adopted in the same period of time by other leading international aircraft manufacturing companies. This paper presents a future direction on the improvement of quality management systems for Korean aircraft production company by considering (1) Korean governments strategy for the development of Korean aircraft Production industries, (2) short and long term business plan of Korean aerospace industries, and (3) benchmarking leading international company's quality management systems.