• 산업경영시스템학회지
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• 제44권2호
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• pp.124-131
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• 2021

In the recent business environment, risks related to product safety problems are increasing. These are arising from various factors such as increasing product and production complexity, supply chain diversification, enhanced PL (product liability) law and strengthening regulations of the government. Accordingly, ISO (international organization for standardization) published standards of PSMS (product safety management system) for suppliers such as ISO 10377 and ISO 10393. Meanwhile, the ISO 9001 QMS (quality management system) was revised in 2015, and it has established itself as an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction. This study aims to suggest an integration framework of QMS and PSMS based on the recent ISO international standards. To this end, firstly, the relationship between QMS and PSMS is studied based on the quality and product safety definitions, PDCA (plan-do-check-act) cycle and risk-based thinking. Secondly, the requirements of ISO 10377 and ISO 9001 are compared and classified as the common and ISO 10377 specific requirements. Finally, integration steps of two systems are suggested and guidelines that can systemize the integrated requirements are presented in the aspect of processes and documentation. This study is expected to be used as a guideline that helps companies those have already acquired QMS certification to build an international-level product safety management system early.

• 대한인간공학회지
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• 제31권2호
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• pp.363-370
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• 2012

Objective: The objective of this study is to analyze standards of ISO 9001, ISO 14001, KOSHA 18001, GAP and ISO 22000 to make an integrated system and check whether an integrated system can be used at small size companies. Background: There are many certification criteria for quality, safety and health such as ISO 9001, ISO 14001, KOSHA 18001, GAP and ISO 22000. However, these criteria are difficult and complicated to be used at a small size company. Thus. it is not easy for small size companies to obtain certifications using these criteria. But customers and workers of small size companies want the key points of these systems to be implemented. Method: ISO 9001, ISO 14001, KOSHA 18001, GAP and ISO 22000 were analyzed to find the commonality and duplications as well as the importance of the items in these standards. And a survey was conducted to check whether certain aspects of the anticipated integrated system can be implemented at small size companies. Results: Items were classified into categories based upon the importance to food safety, quality, safety, environment, and health. Items which are common among standards were also identified and thus give ideas to make the new standards simpler than the currently available standards. Items which were important but may not be easily implemented at the small size companies were also identified. Conclusion: By considering the fact that the currently used accreditation standards have many similar aspects, these systems can be integrated into one new system which small size companies can use relatively easily.

• 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.126-140
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• 2004

The AS 9100 aerospace standard has become the aerospace quality management system standard agreed to, instead of ISO 9001 and MIL-Q-9858A by international aerospace manufacturing companies. In this paper correlative requirements of each of the standards are compared and analyzed. Then the evolutionary concept and its direction is proposed as a guide to participate in the preparation and establishment of current aerospace quality management systems. This study is applicable to the future as well as present aerospace manufacturing activities throughout the world.

• 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.

• 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.

• 국제학술발표논문집
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• The 6th International Conference on Construction Engineering and Project Management
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• pp.481-485
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• 2015

Indonesian construction companies are currently facing high competition both among themselves and with global construction companies. In order to address this issue, the Government of Indonesia has enacted specific regulations and policies relating to the development and implementation of quality management systems (QMSs) ISO 9001 based in construction, acknowledging that the consistency of construction project quality requires a formal quality system as a guarantee to raise quality standards at all project stages. The research has been undertaken to examine the effectiveness of the regulations and policies against several key performance indicators (KPIs) of the ISO 9001 Indonesian construction companies. A comprehensive review of the relevant regulations and policies together with interviews with the Government and National Construction Services Development Board recommend possible additional guidelines and supporting quality system, which intends to measure contractors' project output against defined standards as well as to assess their performance among other similar service providers. The outcomes of the research contribute to the development of the Indonesian own construction industry quality measurement and assessment system.

• 품질경영학회지
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• 제35권3호
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• pp.75-87
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• 2007

This paper deals with an integration model of three major quality management systems. The well known global standards such as ISO 9001 quality system, Malcolm Baldrige model, and EFQM model are integrated as a prototype quality system. The proposed model is then applied to help a power generation company to select improvement tasks for enhancing quality management. Here, we discuss three quality management systems, an integration process of the three systems, the integrated model, and a real world application case.

• 산업경영시스템학회지
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• 제23권54호
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• pp.97-110
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• 2000

As more and more companies pursue ISO 9000 certification, one of the most misconceptions about ISO 9000 is that registration is necessary only for business. ISO 9000 is being driven by commercial requirements, not legal fiat. This registration can be used as evidence of compliance to the ISO 9000 to satisfy specific customer requirements. The primary objective of this research is to provide the efficient implementation process of ISO 9000 certification on the basis of total quality management concerning with ISO/CDl 9001:2000, ISO/CDl 9004:2000 and ISO/CD2 9001:2000. Based on the result of first paper in May 1999, this study has been conducted using the data collected from 312 manufacturing companies which registered ISO 9000 certification. This analysis can be applied to Korean small and medium industrial companies in establishing and maintaining the development of qualify systems. The companies should be able to benefit if they make continuous effort to improve the quality activities based on the factors suggested in this paper.

• 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.