• Proceedings of the KSR Conference
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• 2006.05b
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• pp.844-849
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• 2006

• Journal of Korean Society for Quality Management
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• v.46 no.2
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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.

• Journal of Advanced Navigation Technology
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• v.15 no.6
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• pp.1194-1211
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• 2011

The main research purpose of this paper is developed to Fusion Management System Model that is competition advantage and excellence airport for the airport authorities. Fusion Management System Model is developed to fuse and convert how is consist of creativity management and management quality system. Fusion management system structure is as follow. Firstly, part of foundation configured to philosophy and intention of CEO, company as like university and value-based creative corporate culture. Secondly, part of body is applied that is process by 6sigma, system by ISO9001. Thirdly, part of head is applied that is strategy and evaluation by Malcolm Baldrige National Quality Award of U.S.A. Also, system connected to synergy line that is creativity management, fusion & convergence and trust. Finally, this system has been researched to the practical perspective in order to realize for airport authorities.

• The Journal of the Korea Contents Association
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• v.15 no.10
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• pp.468-480
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• 2015

The FTA between South Korea and China has been concluded in 2014. This means that there is high possibility of the economic integration in Northeast Asia. China's rapid growth has led the global economy, and the Northeast Asia has been attracting attention as the main market. Although the South Korean government cannot help continuing the overseas market-oriented policies, South Korea's construction orders in the Northeast Asia are insignificant, and their profitability is still low. It is time for South Korean construction industry to promote qualitative growth instead of quantitative growth. South Korean construction industry have to focus more on quality management to produce high-quality construction output. In order to support South Korean construction industry, Korean government needs to provide more advanced national quality management system. Therefore, this study compares national quality management systems in South Korea, Japan, and China, and suggests the direction of the South Korean national quality management system reform. In addition, another objective of this study is to confirm the importance of an ISO9001 based quality management system as a basis of the economic integration in Northeast Asia.

• Convergence Security Journal
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• v.17 no.3
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• pp.65-71
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• 2017

"National important facilities" refers to facilities that have a great influence on national security and people's live s if enemy occupation, destruction, or functional paralysis is imposed by the Ministry of Defense Directive. In view of the case of nuclear plant hacking and the attack on the government building "National important facilities" could be the target of anti-social crimes. In the meantime, the "National important facilities" check is limited to the facilit y survey. so The purpose of this study is to develop generalized requirements. Therefore, comparing the requiremen ts of ISO 9001:2015 and ISO 27001:2013. There are only 8 differences(operating) out of 1-10. And the rest are used in common. In addition, we confirmed that the results of comparing the cases of domestic and foreign CPTED are within the "Six Principles". In Chapter 8, the principle of application of CPTED was inserted and the certification re quirements of the "National important facilities" management system were derived.

• Journal of the Korea Safety Management & Science
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• v.16 no.3
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• pp.351-362
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• 2014

A prerequisite for improving the quality of a product is to enhance the quality of its parts supplied from outsourced enterprises. An enterprise certified by ISO 9001 Quality Management System is expected to develop their effective quality assurance system and maintain it through continuous control and improvement, thereby ensuring the good quality of products that they produce. However, it is reported that small and medium-sized enterprises certified by ISO 9001 have difficulty establishing an effective quality assurance system. This study aims to propose a new method of improving a quality assurance system that can be more effective in small and medium-sized enterprises. This study collectively considered requirements specified in several international standards on quality system and the results of expert group brainstorming to identify evaluation areas and items for assessing a quality assurance system. Based on these evaluation areas and items, a set of checklists for diagnosing and improving a quality assurance system was developed. In order to demonstrate the usefulness of the proposed method, this study applied it to ten small and medium-sized enterprises and could identify four approaches for improving their current quality assurance system. The presented improvement method, which consists of establishment of quality goals and quality innovation plan, defective products corrective activities, 4M and design change process, improvement of customer quality information management, is expected to be utilized as a useful tool for the enhancement of the quality assurance system of small and medium-sized enterprises.

• Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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• v.9 no.1
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• pp.815-824
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• 2019

It is not easy to present a generalized operating model because the operating environment of a sport event is composed of a complex matrix structure. In this study, we propose 'standardization' which provides guidance of concept and process of sport event management to solve this sports event management problem. To purpose complete of this study, the frame was developed by the international standard ISO 9001: 2015 is applied. The standards framework for sports event process management system structure proposed in this study consists of scope of application, citing standard, Terms and definitions, organizational situation, leadership, planning, support, operation, performance evaluation, and improvement. This sport event process management system standard can be applied to any organization that wants to host, prepare, and operate sport events regardless of the form or scale of the sport event. In addition, this standard was focused on process management of life-cycle stages of sporting events, therefor it was possible to manage interrelationships and dependencies between processes and processes.

• Proceedings of the Society of Korea Industrial and System Engineering Conference
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• 2002.05a
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• pp.413-419
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• 2002

본 연구의 목적은 품질경영시스템의 ISO 9000:2000/KS A 9000:2001 개정 규격 내용 및 요구사항을 살펴보는 한편, 우리나라 중소기업이 전환규격을 적용하는데 있어서 ERP PACKAGE를 이용하여 효과적인 품질경영시스템 구축 방안을 제시하기 위함이다. 본 연구에서는 업무 PROCESS와 품질 기록을 중심으로 ISO 9000:2000/KS A 9000:2001 개정 규격을 ERP PACKAGE에 접목하는 방법을 도출하였으며, 적용 사례로서 기계 제조업체의 구매업무를 중심으로 품질경영시스템 구축방안을 제시하였다. 본 연구의 결과는 다음과 같다. 첫째, 정형화된 업무 체계를 갖추어 업무 담당자간 혹은 부서간의 업무 마찰을 줄이고 여러부서에서 발생하는 업부 DATA를 중앙집중식으로 공유하여 동일한 DATA의 수집과 작성에 중복성을 최소화하는 등에서 업무의 효과가 있는 것을 볼 수 있다. 둘째, ERP PACKAGE를 이용한 품질경영시스템(ISO 9000:2000/KS A 9000:2001)의 효과적인 추진 방안은 다음과 같다 1) 전환 규격의 충분한 이해가 요구된다. 2) 현재의 업무 프로세스를 파악한 후 ERP PACKAGE에서 제공하는 개선된 업무프로세스를 적용하는 것이 필요하다. 3) 개선된 업무 프로세스의 실행 결과를 ERP PACKAGE 모듈에서 품질기록으로 유지한다. 4) 새로운 품질경영 정보 시스템을 업무 전반에 적용하기 위한 기업인프라 구축과 프로세스에 대한 지속적인 개선이 요구된다. 본 연구에서는 ISO 9000:2000/KS A 9000:2001 개정 규격요구사항을 이해하고 ERP PACKAGE를 이용하여 최초로 개정규격을 적용하거나, 전환규격으로 품질경영시스템을 구축 시 좀더 효과적이고 효율적인 품질경영시스템을 구축하는데 업무지침으로 활용될 수 있을 것이다.의 수와 생존율면에서 볼 때 가장 적합한 것으로 사료되었다./TEX>개월 투여하게 되면 HDL 콜레스테롤 양이 현저히 증가하였으며, 총 콜레스테롤 양, 동맥경화지표, 중성지방, 유리지방산, 과산화지방은 현 저히 감소하였다.- 결론 - 홍삼과 진세노사이드는 사람과 흰쥐에 있어 과지혈증을 호전시켰다. 실험적으로 과지혈증을 유발시킨 흰쥐에서, 혈중 아포단백질, 지방단백질 및 프로스타글란딘 상호성을 개선시켰다.었다.xA_{2}$ synthetase 억제제인 imidazole의 효과와 유사하였다. 4. G-Re는 $1{\times}10^{-5}g/ml$ 이하의 농도에서는 효과가 없으나 $1{\times}10^{-4}g/ml$ 이상의 농도에서 농도의존적으로 유의성 있는 $PGE_{2},\;PGF_{2}{\alpha},\;TXB_{2}$의 생성억제와 함께 6-keto-$PGF_{1}{\alpha}$ 증가를 보였다. 이는 prostacyclin synthetase를 자극하는 serotonin의 효과와 같은 작용으로서 prostacyclin synthetase 억제제인 tranylcypromine에 대하여 길항효과를 보였다. 5. $TxB_{2}$생성억제 작용을 나타내는 ginsenoside들의 효과를 뒷받침하기 위하여 인삼 saponin 성분을 전처치한 patelet rich plasma에서 혈소판 응집시험 결과, ADP로 유도된 혈소판 응집반응에는 모든 인삼 saponin 성분들이 효과가 없었으나 arachidonic acid로 유도된 혈소판 응집반응에는 $G-Rb_{2}$, G-Rc, G-Re의 순으로 농도 의존적인 억제현상을 보였다. 이상의 결과와 같이 인삼 saponin 성분들은

• NEWSLETTER 전기공업
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• no.93-4 s.77
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• pp.1-20
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• 1993

• Proceedings of the Safety Management and Science Conference
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• 2006.04a
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• pp.323-330
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• 2006

This paper is to introduce guidelines for integrated systems auditing. International standards such as ISO 19011, ISO 9001 and ISO 14001 are considered. This study is to discuss guidelines for quality and environmental management systems auditing and requirement with guidance for use.