• 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.

• Management & Information Systems Review
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• v.29 no.4
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• pp.225-244
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• 2010

In the information society, characterized by knowledge and network economy, standards and standardization became a very important factor in determining the competitiveness of nations and firms. This paper defines the concept of standards and standardization and reconstructs the theory on the relationship between standards and technological innovation. The findings and policy implications are as follows. First, the effect of standards on technological innovation differs according to its function(compatibility, minimum quality, information, and variety reduction) and types(product-related and non-product). On the other hand, standards can impede technological innovation. Second, in terms of national innovation system(NIS), standards are an infra-technology, which is a public good. Therefore, government should decide the optimal level of investment on standards and standardization. Third, since standards foster firms' innovation over the all stages of business activities company, industry, and government should connect standardization activities with R&D, manufacturing, marketing, supply chain, and technology transfer, Fourth, standards play an important role in product innovation as well as process innovation. Based on these theoretical background and hypotheses, the empirical study of the Korean firms is needed.

• Architectural research
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• v.18 no.1
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• pp.21-29
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• 2016

Importance of FM has rapidly increased because of its growing business. However, due to lack of clarity and identity of FM in professional areas, standardization of FM became to be imperative in such a rapidly changing global business environment. Facility services are defined as the provision of support the primary activities of an organization, delivered by an internal or external provider. Majority of FM activities are services related to 'space and infrastructure' and 'people and organization' (CEN, 2011). The purpose of this study is to investigate definitions and characteristics of FM from both globally and domestic environment, by comparison with international or national standards, to identify quality management in FM and service characteristics of FM, to investigate the differences in service level elaboration in FM, and to suggest standard issues of quality management in FM service quality. This study examines contents of the European Standards in FM, Part 3 'Guidance on quality in Facility Management, especially for the process of QM standardized by CEN (2011) and explores undefined issues such as service level, measurement metrics according to service characteristics of FM. The European FM Standard guides the common process of QM in terms of requirements specification, service level elaboration, measurement metrics development although it does not specifically address various service levels, specific performance metrics and indicators.

• Journal of Korean Society of Archives and Records Management
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• v.12 no.2
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• pp.117-142
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• 2012

This study analyzes the relevance of retention period assigned for each unit task based on the table of records management standards that has been used in schools around the country since January 2011. Retention period, which used to be appropriated on the basis of a record file in the classification scheme, has been re-appropriated on the basis of unit tasks after the table of records management standards have been introduced. However, the new retention period of school records directly apply the 7 retention periods defined for public institutions according to Public Records Management Act. Therefore, this study attempts to analyze the relevance of retention period for school records appropriated for unit task from various angles regarding laws, indexes, survey results, overseas cases.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.45 no.2
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• pp.1-11
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• 2022

In this paper, we investigate the requirements of QPA(Quality Process Audit), which is a process quality audit system for secondary defense contractors, compared with those of DQMS(Defense Quality Management System). And evaluate whether the deployment of QPA meets the DQMS certification requirements through the case example of Company H. The evaluation items of QPA are composed of five categories such as Material Management, Incoming Inspection, Manufacturing Process, Product Evaluation, and Packaging Management. The QPA requirements are mainly related to the chapter 7(support) and chapter 8(operation) of DQMS standards. In this view point, QPA can be expected as an effective audit for suppliers preparing for DQMS certification. In the case example, we evaluate the results and effects of improvement due to QPA and compare it with the case of DQMS. QPA can be used as appropriate quality management standards of secondary and tertiary defense contractors and can provide the basis guidelines for the preparation of implementation steps in DQMS certification.

• Journal of Environmental Science International
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• v.24 no.1
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• pp.97-115
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• 2015

For the purpose of protecting the health of citizens and creating a delightful environment, the Government shall establish the environmental standards, and make such standards keep their propriety according to any changes in environmental conditions. The Special Metropolitan City, Metropolitan City or Do may, in case where deemed necessary in view of the speciality of regional environments, set forth the separate environmental standards which are more expanded and strengthened than the environmental standards by the Municipal Ordinance of the relevant City/Do. The purpose of this study was for the management of stream waters of Jeju Island and proposed the appropriate Jeju local river environmental standards. Jeju-Do and Daejeon-si applies the Local River Environmental Standards in Korea. While each nation? circumstances and environment are different, for the most part, environmental standards and purposes of use are similar to those in Korea. Proposed Jeju River Local Environment Standards followed The River Environment Standards of Nation(Korea) for Living Environment Standards. Newly Strengthened Value is Cd, Carbon tetrachloride, 1,2-dichloroethene, Tetrachloroethylene(PCE) and add Items is Fluorine, Selenium, Phenol and Toluene for Human Health Protection.

• 한국경영정보학회:학술대회논문집
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• 2008.06a
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• pp.23-28
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• 2008

The growth of the number of places where technology standardization takes place, and the complex relationships among them, pose challenges for participating actors such as companies and governments. Additionally, it takes considerable resources and capabilities to participate in all Standards Development Organizations (SDOs). Some SDOs have been more effective and efficient in standardizing technologies than others. For this reason, actors need to evaluate and analyze different SDOs to select the appropriate SDO(s) for them and to strategically position themselves in standardizing technologies, so that they can gain more competitive positions in the ubiquitous market. However, it is surprising that there have been relatively few studies analyzing different SDOs. Thus, this study aims to gain insight into the differences and similarities between the methods used at four important international SDOs - IEEE, IETF, OMA, and ETSI - and how these methods are judged by participants. These insights can help governments and companies to develop policies and strategies for SDOs in this changing environment.

• Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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• v.25 no.9
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• pp.86-93
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• 2011

The necessity of Power Quality(PQ) Management grow bigger because the disturbance strength in power system is increasing, on the other hand, the tolerance of electrical components is reducing with widely use of the IT and digital equipments. The domestic management standards on power quality are enacted based on the IEC standards in recent. Since the IEC standards defines the measurement and evaluation point on PQ as PCC(Point of Common Coupling) which is normally the point of penetration between customer and power company, the PQ monitoring system(PQMS) should be made to measure and manage the PQ of custom effectively. In this paper, therefore, the economical construction plan on PQMS using the wireless communication channel in distribution automation system is suggested, and the usefulness of the PQMS are shown by analyzing the PQM data with IEC standards.

• Journal of the Korea Safety Management & Science
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• v.16 no.4
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• pp.53-62
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• 2014

According to the statistics of occupational injuries in 2013, the work platforms were main objects causing fall injuries in construction sites. But many scaffold and platform workers use and install the work platforms and the fixed and mobile scaffolding without considering about safety and health standards. We had done a nationwide survey about how the platform workers obey safety and health standards. As the result of this survey, in order to ensure the safety of the work platforms, we founded that the platform workers must obey the safety and health standards when using and installing the work platforms. To improve the safety and health conscious of the workers, it needs to educate a worker on safety and health standards for work platforms. Also, to effectively prevent constructin injuries for the work platforms, it is rextricted for workers to use only safety certified work platforms. And, before installing and using work platforms, it needs to make a work plan for work platforms and obey it.

• Journal of the Korea Safety Management & Science
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• v.17 no.2
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• pp.27-34
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• 2015

If examining utilization by completion of National Competency Standards development, efforts are made so as to organize curriculum matched to education or training and perform subjects based on competence unit educationally in specialized high schools, colleges and university. However, National Competency Standards is insignificantly utilized in enterprises and on the spot due to characteristics of occupation type and diversity of process. This thesis intended to measures of safety efficiency improvement of final enterprise through the human resources assessment system of National Competency Standards based enterprise. Therefore, various methodologies were introduced and results of analysis by Balanced ScoreCard method were suggested for policy measures improving final safety efficiency. The results of this analysis are expected to make contribution to improving the effectiveness of the government's industrial safety and health policies through the establishment of systematic safety and health systems according to the risk level of individual business.