• 산업경영시스템학회지
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• 제38권4호
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• pp.1-10
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• 2015

ISO 9001, quality management system, is widely known as advancing internal efficiency and productivity in various industry. As a result, the number of companies that have adopted ISO 9001's certification have been increasing continuously year by year since ISO 9000' family standard was published in 1987s. This fact shows that a lot of businesses are trying to get the accreditation for improving the competitiveness of quality. The purpose of this study is to present that ISO 9001's certification motives affect to the requirement's implementation and show that the execution of requirements influences on management performance in the small manufacturer. In order to carry out this research, we obtained 96 survey sheets and inspected twenty assumptions based on the reliability, validity of the questionnaires. The results of regression analysis are summarized as follows; First, the factors of certification motive influence on the requirement's implementation except resources management. Second, the two elements of ISO 9001 requirement, resources management and product realization, have an important effect on the operational performance and financial performance considerably in the companies that choose the internal motive. Finally, the two requisites of ISO 9001 requirement, resources management and measurement, analysis and improvement, affect to the operational performance and financial performance significantly in the businesses that select the external motive. Based on the results, the companies that choose the internal motive have a good performance to execute the ISO 9001 requirements. Also, to implement the requirements of ISO 9001 is helpful for the companies to produce the operational and financial performance.

• 대한안전경영과학회:학술대회논문집
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• 대한안전경영과학회 2006년도 춘계공동학술대회
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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.

• 품질경영학회지
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• 제25권1호
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• pp.17-30
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• 1997

Three big U.S. automakers have developed the QS-9000 quality system for their su, pp.iers. These automakers are requiring their su, pp.iers to implement the QS-9000 based quality system. This QS-9000 system is based upon the ISO 9000 series quality systems. This paper describes the differences between the ISO 9000 series requirements and the QS-9000 requirements. It also suggests the way to implement the QS-9000 quality systems for Korean su, pp.iers.

• 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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• 제44권3호
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• pp.541-552
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• 2016

Purpose: In this study, we propose that how to approach a effective system engineering and optimize system engineering management process for the mass production weapon system parts localization development process and success in DTaQ. Methods: To approach a effective system engineering for the mass production weapon system parts localization, we analyze a weapon system acquisition process and system engineering process of Republic of Korea and DTaQ parts localization business regulations in advance. after results of analysis of them, we implement a optimized parts localization development system engineering based on ISO/IEC/IEEE 15288. Results: In order to apply International Standard ISO/IEC/IEEE 15288 to the mass production weapon system parts localization development process, we compare the mass production weapon system parts localization acquisition environment with ISO/IEC/IEEE 15288 and analyze them. therefore, It is possible to implement a part of concept stage and development stage of ISO/IEC/IEEE total life cycle stage for the mass production weapon system parts localization development process. To achieve the technical review milestones of DTaQ parts localization business regulations in the selected stages of ISO/IEC/IEEE, the development and management agency perform 2 high rank process and 19 low rank process specified in ISO/IEC/IEEE. Conclusion: When the development and management agency perform the mass production weapon system parts localization development using the proposed system engineering approach, they should easily meet milestone through the clarified requirement and simplified System Engineering output documents in limited development period.

• 대한안전경영과학회:학술대회논문집
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• 대한안전경영과학회 2006년도 춘계공동학술대회
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• pp.355-362
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• 2006

This paper is to introduce guidelines for automotive and food quality management system. International standards such as ISO/TS 16949 and ISO 15161 are considered. This study is to discuss particular requirements for the application of ISO 9001 : 2000 for automotive production and relevant service part organization , and guidelines on the application of ISO 9001 : 2000 for the food and drink industry.

• 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.

• 산업융합연구
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• 제13권3호
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• pp.27-39
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• 2015

This Study aims to analyze the management performances of the rubber products from the perspectives of ISO9001 Quality Management System, which is a new management technique for management innovation, in order to secure the competitiveness of the small and medium manufacturers of rubber products for automobile as automobile application components. The results of the analysis can be summarized as follows: First, as the results of the analysis of effect of the (1) responsibility of the management, (2) resources management, (3) realization of the products, and (4) measurement, analysis and improvement, which are the 4 core requirements of the ISO9001 Quality Management System, on the management performances of the small and medium sized manufacturers of the rubber components for automobile, it was found that only the responsibility of the management and resources management affect the management performance. The above research findings imply that the company must absolutely rely on the upper ranked groups rather than the lower ranked groups, and on the responsibilities of the management rather than the upper ranked groups in order to elevate the management performance of the small and medium sized manufacturers of the rubber components for automobile.

• 품질경영학회지
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• 제32권2호
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• pp.1-14
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• 2004

As environmental issues have been become critical concerns of business, many domestic small and medium enterprises(SME's) are rapidly accepting environmental management systems(EMS) that confirm ISO 14001 guidelines. The purpose of this paper is to present the results of an empirical study carried out on a sample of certified SME's with the aim of identifying obstacles encountered in adopting ISO 14001 standards and the impact of environmental systems on corporate performance after implementation of the ISO 14001 registration process. Data from this study show that the vast majority of respondents reported environmental improvements related to the implementation of an ISO 14001 EMS, especially in the area of employees' participation of the environmental management and responsibilities for reducing negative impacts, energy and resource conservation, materials reuse, and raising top management commitment. The greatest obstacles for implementing the ISO 14001 standard are lack of cooperation and a scarcity of resources such as personnel, money, and time. Results of this study serve as a reference point understanding the problems in the implementation of ISO 14001 in other small and medium firms.

• 디지털융복합연구
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• 제14권11호
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• pp.181-191
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• 2016

본 연구의 목적은 융 복합 시대에 자동차 전장부품인 자동차 고무 자바라를 생산하는 중소제조업체의 기업 경쟁력을 확보하기 위한 경영혁신에 대한 새로운 경영기법인 ISO9001품질경영시스템 요구사항 관점에서 고무자바라제품 생산기업의 경영성과를 분석하는데 있다. 이를 위해서, 자동차 부품 생산업체중, 고무 자바라 제품을 생산하는 업체를 대상으로 방문조사를 실시하였다. 연구결과, 첫째, 중소자동차 고무 자비라 부품업체에서 ISO 9001 품질경영 시스템의 4가지 핵심 요구사항 중, 경영자 책임과 자원관리가 경영성과에 긍정적 영향을 미치는 것으로 나타났다. 또한, 직급별로 차이를 조사한 결과, 상위 직급 집단은 경영자 책임이, 하위 직급 집단은 ISO 9001에 따른 품질경영에 대한 인식도가 저조한 것으로 나타났다. 이는 중소 자동차 전장부품인 자동차 고무 자바라 생산에 대한 개선 방향 컨설팅 지칭과 생산성 향상 전략 방안을 수립하는데 기여하게 될 것이다.