• Title/Summary/Keyword: Standards Management

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General Requirements Pertaining to Radiation Protection in Diagnostic X-ray Equipment -KFDA DRS 1-1-3 : 2008 base on IEC 60601-1-3:2008- (진단용 엑스선 장치에 있어서 방사선 방어에 대한 일반 요구사항 -IEC 60601-1-3:2008에 근거한 KFDA DRS 1-1-3:2008-)

  • Kang, Hee-Doo;Dong, Kyung-Rae;Kweon, Dae-Cheol;Choi, Jun-Gu;Jeong, Jae-Ho;Jung, Jae-Eun;Ryu, Young-Hwan
    • Korean Journal of Digital Imaging in Medicine
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    • v.11 no.2
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    • pp.69-77
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    • 2009
  • This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

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The Relationship between Industrial Standards Acquisition and the Technological Development of Korean Enterprises (우리나라 기업의 산업표준 획득과 기술개발과의 관계)

  • 이달환;허현회
    • Journal of Korea Technology Innovation Society
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    • v.2 no.1
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    • pp.74-89
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    • 1999
  • The purpose of this study is to identify in two aspects the relationship between standardization activities and technological development at the firm level. The first aspect is to analyze the relationship between the current Korean industrial standards system and the firm's technological development vis-a-vis quality standards. The analysis reveals that even if Korean firms recognize the importance of standards, the level of product quality of the KS mark is still lower compared to the average world level. The survey also reveals that the reasons for acquiring ISO and KS marks are mainly aimed at enforcing company image and increasing quality management mind, rather than to foster technological innovation. The second aspect explores how much Korean industrial standards (KS marks) affect the firm's technological development in the Process of standards acquisition activities. The survey results show that standardization activities have a less positive impact on technological innovation than on the maintenance of consistent production works.

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An Empirical Study on the Effect of International Standards Management System Integration on Business Performance - Focused on Quality, Environment and Health & safety management system- (국제표준 경영시스템 통합이 경영성과에 미치는 영향에 대한 실증적 연구 - 품질, 환경 및 안전·보건 경영시스템 중심으로 -)

  • Kim, Yeun Sung;Suk, Ho Sam;Sung, Do Kyong
    • Journal of Korean Society for Quality Management
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    • v.45 no.4
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    • pp.781-810
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    • 2017
  • Purpose: This paper studied about the integration for management system of representative international standard related to sustainable development. The well-known International standards such as ISO 9001, ISO 14001 and OHSAS 18001 (ISO 45001) can be operated in accordance with the organizational situation individually, or in a variety of ways of integration. It can be applied to help organizations utilizing the newly established "ISO IEC Directive Part1 Annex SL", when integrating quality, environmental and safety & health management systems based on international standards. Methods: We conducted an empirical survey of management executives and experts to study how three factors (management systems, organizational capabilities and integration methods) could affect business performance. Results: The questionnaire was analyzed using AMOS structural equation model. Quality, environmental and safety and health management systems affected management performance, and integration methods of management system affected business efficiency, risk performance and financial performance. Integration method is also important because organizational competence affects various aspects of integrated management. However, factors that affect integration should also be considered in terms of organizational capabilities. This is because organizational capacity influences the integration plan. Conclusion: To integrate the document system at the strategic level, management should actively participate in integrated operations to integrate organizations, eliminate duplicate tasks, and foster document integration experts to reflect the characteristics of individual standard. In the case of document integration, quality management is focusing, but once ISO 45001 is issued, the use of Annex SL is increasing, and Quality, environment and safety & health integration will also be expanded. It is possible to increase the effect of integration by strategically approaching and establishing organization document system rather than simple integration according to management system standard arrangement.

Current Status and Future Directions on the Management of the Korean Standards (KS): Woods, Pulp and Papers (목재 및 펄프·제지 분야 한국산업표준(KS)의 운영현황과 방향)

  • Shin, Hyun-Kyeong;Choi, Yong-Seok;Kim, Keon-Ho;Eom, Chang-Deuk;Park, Joo-Saeng;Shim, Kug-Bo
    • Journal of Korean Society of Forest Science
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    • v.107 no.2
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    • pp.205-217
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    • 2018
  • This study aims to review the standard operation status on wood, pulp and paper industry in Korea according to the industry standardization law which has been revised for strengthening expertise of relevant department and to propose a management strategy of Korean Standards (KS) in figure. Korea Forest Service (KFS) is the responsible department of managing KS on the wood, pulp and paper industry from 2015, and currently opertates three expert committees (wood and wooden construction, wood-based materials, pulp and paper) and wood and paper industry council to review 426 standards. To support an improvement of technical competency and securement of marketability of Korean wood industry, it is about time to review the standards and to develop practical standards since it is managed by specialized department. For this purpose, it is necessary to establish a systematic approach on the management of KS, based on thorough analysis of current KS. To remove possible technical barrier on trade due to the differences of standards between countries, the conformity with international standards is necessary. Also, for sustainability of standard management system, training specialists and building their capability is essential.

The Optimal Solid Print Density Setting Method for Sheetfed Offset Printing (오프셋 매엽 인쇄의 최적 민인쇄 농도 설정 방법)

  • Seo, Suck-Jin;Kang, Sang-Hoon
    • Journal of the Korean Graphic Arts Communication Society
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    • v.27 no.1
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    • pp.15-27
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    • 2009
  • Since domestic offset print quality control depends on the experience of persons in charge rather than objective data, the standards from the data are needed for the well-organized quality management of high-quality prints. Based on the ISO standards, now the standard specifications, such as GRACoL 7, SWOP 11, SNAP, G7 in America, and EURO Color, ECI, BVDM in Europe, and Japan Color 2001, Japan Color 2004 in Japan, are employed. There exists KS for domestic standards. However, since it has been directly imported from ISO Standards, there are discrepancies in printing materials and media. Although the quality management of commercial prints has been focused and studied. For this circumstance, standards are needed for the production of prints to meet international standards. This paper aims to find out suitable ways to approach domestic printing standards using densitometric method and colorimetric method. Printing experiments on this study were performed with domestic process color inks(Cyan, Magenta, Yellow, Black) and domestic coated papers, under the same conditions as the actual commercial printing processes. In densitometric method, how to set up the optimal solid print density was studied through three tests such as the ways to match solid print density and print contrast to GRACoL standards respectively, and the way to get the highest contrast. In colorimetric method, how to get solid print density with the minimum color difference between the $CIEL^*a^*b^*$ color specification values in GRACoL standards and the measured color specification values in prints, was studied.

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RAMS management system for railway signaling with RAM and Safety activities (RAM과 Safety 활동을 통한 열차제어시스템 RAMS 체계)

  • Hwang, Jong-Gyu;Jo, Hyun-Jeong
    • Proceedings of the IEEK Conference
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    • 2008.06a
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    • pp.1133-1134
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    • 2008
  • There are several international standards, established by IEC, for RAMS management of railway system. Those int'l standards are described only total RAMS management, but RAM and safety activities have dissimilar characteristics. In this paper, we suggest the separated RAMS architecture with RAM and safety activity for railway signaling system.

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Industry's Response to the Green Movement

  • Little, Barry F.P.
    • Analytical Science and Technology
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    • v.8 no.4
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    • pp.1075-1078
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    • 1995
  • This paper describes how industry has responded to the environmental challenge. Benefits include compliance with environmental legislation; genuine reductions to environmental impact; sustainable improvements to profitability in the face of increased competitive pressure. National and international Standards for environmental management offer security and direction for a company wishing to improve environmental performance and coupled with a waste minimisation strategy many financial and environmental benefits can be achieved. Introduction of new technical skills, techniques and worker understanding to aid motivation is an essential component of such a strategy. Monitoring and targeting has a key role to play in the establishment of improved environmental performance.

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A Study of Improvements in the Standards of Cost Estimate for the New Excellent Technology in Construction (건설 신기술의 원가산정기준 개선방안에 대한 연구)

  • Lee, Ju-hyun;Tae, Yong-Ho;Baek, Seung-Ho;Kim, Kyoungmin
    • Korean Journal of Construction Engineering and Management
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    • v.23 no.5
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    • pp.65-76
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    • 2022
  • The New Excellent Technology (NET) designation system, introduced in 1989 for the purpose of promoting the development of domestic construction technology and enhancing national competitiveness, reviews the statement of construction cost of new technologies. And the cost reduction effect such as design, construction, and maintenance cost and the effect of reducing the construction duration are evaluated as an evaluation criteria of economic feasibility. However, in this evaluation process, differences of opinion between the institution of construction cost estimating standard management and the new technology developer about unique technologies frequently occur. In addition it is difficult to objectively compare the construction duration with existing similar technologies because there is no information on productivity as the current cost estimating standards for new technologies only present the required amount per unit quantity. In this study, the current state of cost estimating criteria review procedure, evaluation criteria, and cost estimating standards establishment method were analyzed when screening for the designation of a new construction technologies, and compared with overseas cost estimating standards, measures to improve the cost estimating standards of current construction new technologies were suggested. Through the improved cost estimating standards of this study, it is expected that cost information on new technologies will be provided to clients in more detail than the current ones, and the availability and applicability of new construction technologies would be improved by simplifying the construction cost calculation process more.

A Proposal for a Classification System and Evaluation Standards for Ensuring the Safety of Transport Ventilator in Korea (국내 운반형인공호흡기 안전성 확보를 위한 분류체계 및 평가기준 제안)

  • Kim, Ji-Hyun;Cho, Sung-Ku
    • The Korean Journal of Health Service Management
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    • v.11 no.4
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    • pp.189-202
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    • 2017
  • Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.

Considerations on Standardization in Smart Hospitals

  • Sun-Ju Ahn;Sungin Lee;Chi Hye Park;Da Yeon Kwon;Sooyeon Jeon;Han Byeol Lee;Sang Rok Oh
    • Health Policy and Management
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    • v.34 no.1
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    • pp.4-16
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    • 2024
  • Smart hospitals involve the use of recent ICT (information and communications technology) technologies to improve healthcare access, efficiency, and effectiveness. Standardization in smart hospital technologies is crucial for interoperability, scalability, policy formulation, quality control, and maintenance. This study reviewed relevant international standards for smart hospitals and the organizations that develop them. Specific attention was paid to robotics in smart hospitals and the potential for standardization in this area. The study used online resources and existing standards to analyze technologies, standards, and practices in smart hospitals. Key technologies of smart hospitals were identified. Relevant standards from ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) were mapped to each core technology. Korea's leadership in smart hospital technology were highlighted. Approaches for standardizing smart hospitals were proposed. Finally, potential new international standard items for robotics in smart hospitals were identified and categorized by function: sampling, remote operation, delivery, disinfection, and movement tracking/contact tracing. Standardization in smart hospital technologies is crucial for ensuring interoperability, scalability, ethical use of artificial intelligence, and quality control. Implementing international standards in smart hospitals is expected to benefit individuals, healthcare institutions, nations, and industry by improving healthcare access, quality, and competitiveness.