• Title/Summary/Keyword: Global standards

Search Result 671, Processing Time 0.024 seconds

Comparative Study of ISO Standards for an Effective Implementation of the Domestic Medical Device GMP System (ISO 국제표준의 비교 연구를 통한 국내 의료기기 GMP 제도의 효과적인 운영 방안)

  • Jung, Young A;Kim, Young Jin
    • Journal of Korean Society for Quality Management
    • /
    • v.46 no.2
    • /
    • pp.211-224
    • /
    • 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.

Globalization of Korean Electrical Installations Standards and Codes Based on Comparison of IEC 60364 with NFPA 70(NEC)

  • Ki, Chung-Young;Ro, Kwak-Hee;Seop, Shin-Hyo;Joo, Nam-Taik
    • Proceedings of the Korea Institute of Fire Science and Engineering Conference
    • /
    • 2002.11a
    • /
    • pp.280-287
    • /
    • 2002
  • Most Technological laws of Korea are almost identical to those of Japan. Electricity was not introduced to Korea until lighting ceremony in Kyong-Bok palace observed in 1887. Since Korea was annexed to Japan in 1910, Korea have applied Japanese law and regulations made by Chosun government-general. And public works were under Japan control. Korea accepted adopted the power plants of America, codes of NESC, ASME / ANSI, MEMA while Japan accepted or adopted only IEC. Our generation distribution system takes American style while our consumer side takes Japanese style. As global trade system was transferred GATT into WTO, the technological standards, certification, construction and testing are in harmony internationally. The WTO / TBT agreement came in effect after 12th, April, 1979. The sections in the agreement require the members to exchange their own standards and codes for the harmonized ones by degree. The Korean distribution system has a strong resemblance to American system so that the internal engineers are confused in application of the relevant standards. IEC60364 and NEC are technologically similar but practically unconvertible because both have their different originality, that is to say Europe and USA. This paper deals with the fundamental elements of electrical safety system on review of IEC 60364 and NEC. This paper considers how engineers should apply IEC60364 and NFPA 70(NEC) based on all-the-way review of them.

  • PDF

Research on Web standards compliance and professional level of domestic Web Developer (국내 웹 개발자의 웹표준 준수 및 전문성 수준에 대한 연구)

  • Shin, Moon-sun;Jeong, Kyeong-ja;Kim, Byung-chul
    • Journal of Digital Convergence
    • /
    • v.14 no.4
    • /
    • pp.201-208
    • /
    • 2016
  • Recently, non-standard techniques of web like Active-X caused not only user inconvenience but also barriers to the business of Internet. The government recognized that the serious environmental situation of using Internet is needed to be improved. Especially, HTML5 convergence technology is meant to be a specific platform over the devices, users, and systems. It also means web standards to support more creative business service model and emerging market. In this paper, we performed a survey on Web standards compliance and web development professional level of domestic web developers. In addition, we present the basic direction of government policy of software and software-positive human resources policy, that is based on the analysis of the survey results. Our study will be able to contribute to construct policies to support digital convergence industry and to strengthen technical assistance and expertise to build training programs for the spread of global Web standards (HTML5).

A Study on Transparency Enhancing Model of Global ERP System using International Financial Reporting Standards (국제회계기준을 활용한 글로벌 ERP 시스템의 투명성 향상 모델에 관한 연구)

  • Chang, Young-Hyun;Park, Dea-Woo;Kim, Ji-Eun;Nam, Mi-Rang
    • Proceedings of the Korean Society of Computer Information Conference
    • /
    • 2011.06a
    • /
    • pp.25-27
    • /
    • 2011
  • 본 논문에서는 경제의 글로벌화를 반영하는 세계적인 현상인 국제회계기준 채택에 대하여 회계 관련사항을 내재하고 있는 기업의 전사적 관리 소프트웨어인 국산 ERP 시스템에 대하여 세금처리의 투명성을 향상시킬 수 있는 방법론적 모델을 해외 ERP의 장점을 통하여 연구한다. 국제회계기준은 기업요소에서 가장 중요한 자본의 국제적인 이동이 기본적 사항으로 기업의 소재지에 대한 국가표시와 관계없이 재무제표의 정보가 투명하고 비교 가능하도록 국제적으로 단일한 회계기준이 사용을 요구한다. 이러한 환경 변화에 따라 국제회계기준(International Financial Reporting Standards: IFRS)의 필요성과 중요성이 확대되어지고 있으며 국제회계기준위원회(International Accounting Standards Board: IASB)의 영향력까지 강화되어지고 있다. 본 논문은 국제회계기준에 맞춘 회계처리 부분의 투명성 향상 모델을 연구하기 위하여 국내에서 많이 사용되고 있는 국산 ERP 소프트웨어 프로그램에 대하여 국제회계기준과 상반되는 현상을 유발하는 기준이 되는 부분을 상호 보완할 수 있는 해외 ERP 소프트웨어 프로그램을 기반으로 기업 시스템을 분석, 구현한다. 국산 ERP 시스템의 국제회계기준 처리와 관련된 단점은 송장의 수정, 삭제가 용이하며 수정, 삭제 후 이력이 남지 않는 부분이다. 이 부분은 국제회계기준에서는 신뢰성에 대한 중대한 문제를 유발하므로 외산 ERP패키지의 장점인 수정과 삭제 단계가 계층적이며 수정, 삭제를 하더라도 필수적으로 이력전체가 저장되는 시스템을 연구하며 특히 세금처리 부분이 상이한 점을 보완하기 위한 모듈을 추가한다. 수정, 삭제에 대한 이력관리는 담당자의 전문적 능력평가와 동시에 실수와 오류부분에 대한 통계를 통하여 관리의 향상성을 추구하여 투명성이 향상된 모델 구축에 활용할 수 있다.

  • PDF

Analysis of Sustainability Report Content Using GRI: Public and Private Enterprise Perspective (GRI를 이용한 지속가능보고서 구성 분석: 공,사 기업 관점으로)

  • Yun, Ji Hye;Lee, Jong Hwa
    • Knowledge Management Research
    • /
    • v.23 no.3
    • /
    • pp.153-171
    • /
    • 2022
  • With the global ESG management craze, domestic and foreign companies voluntarily declare sustainable management and actively respond by establishing strategies. The Financial Services Commission mandates the disclosure of sustainability reports representing ESG management sequentially and will expand to SMEs in the future. Information disclosure of sustainability reports is mainly done through international standards such as GRI, SASB, and TCFD, and many domestic companies use GRI Standards guidelines. This study examines the composition system of sustainability reports and compares public and private companies with GRI Standards to analyze sustainable management by type. This study revealed that public enterprises focused on social and labor, while private enterprises focused on the economy and environment through TF-IDF modeling. In addition, the electronic and information communication industries focused on product responsibility. Unlike previous studies that quantified and analyzed sustainability management according to grade, the current study analyzed sustainability reports, which are unstructured data. Therefore, the results of this study are expected to provide valuable theoretical and practical implications for researchers and supervisors interested in ESG management.

Research on Clothing Origin Certification Systems in Major Overseas Countries (해외 주요국가의 의류 원산지 인증제도 연구)

  • Sieun Lim;Sowon Hahn
    • Journal of Fashion Business
    • /
    • v.27 no.3
    • /
    • pp.63-74
    • /
    • 2023
  • As "Made in Korea" has high branding power in the fashion industry, domestic clothing manufacturers also need to consider branding the country of origin. Therefore, the purpose of this study was to reconsider the need for a domestic certification system and suggest a direction by analyzing apparel origin certification systems operating overseas. The results of this study could be used for planning certification standards and operating methods suitable for regional characteristics and industrial environments when establishing a certification system for clothing produced in Korea. The case study subjects were Japan's J∞ Quality, USA's Made in New York, Italy's 100% Made in Italy, and France's Origin France Guarantee has been classified as certification criteria related to the country of origin include items related to the production process rate in the region and the production area for each production process/stream. Manufacturing technology and design are used for quality standards, safety, hygiene compliance, production facilities, and quality control and are applied to working environment standards. The certification system selects and operates standards according to each country's industrial environment, certification subject, and purpose. Therefore, when designing a domestic apparel certification system, a feasible promotion plan should be established that considers the current state of the domestic industry, which will serve as a driving force for the growth of the apparel manufacturing industry and an opportunity to increase the trust of global fashion consumers.

An Advanced Evaluation Process for National R&D Projects based on Global Standards (글로벌스탠다드기반의 국가연구개발사업 평가프로세스)

  • Song, Byung-Sun;Lee, Sun-Hye;Lee, Nam-Yong;Rhew, Sung-Yul
    • The Journal of Society for e-Business Studies
    • /
    • v.13 no.3
    • /
    • pp.103-119
    • /
    • 2008
  • Over the last two decades, national R&D projects have been increased rapidly. The government has tried to improve the success of national R&D projects. But the weakness of the evaluation process for national R&D projects, there remains some problems. In order to solve those problems this study proposed an advanced evaluation process of national R&D projects on the basis of ISO/IEC15288, ISO/IEC12207 and ISO/IEC14598. The evaluation process consists of preparing evaluation, establishing evaluation requirements, specifying evaluation, designing evaluation, executing evaluation and reporting evaluation. The evaluation process is an artifact-oriented process. The results of this study can be used for reforming the evaluation process of national R&D projects.

  • PDF

An Analysis of 3GPP and 3GPP2 Communication Networks for Supporting Location Based Services (위치기반서비스를 제공하는 3GPP와 3GPP2 통신망 비교 분석)

  • Kim, Do-Hyeon;Jin, Hui-Chae;Ha, Su-Uk
    • Journal of Korea Spatial Information System Society
    • /
    • v.4 no.2 s.8
    • /
    • pp.23-34
    • /
    • 2002
  • Various tries are in progress to expand the usability of wireless telecommunication harminized internet technology. The most typical example among those services is LBS(Location Based Service). Nowaday, Standards for telecommunication system of LBS centers round on 3GPP(3rd Generation Partnership Project) and 3GPP2. In this paper we compare the telecommunication system of 3GPP and 3GPP2 in order to make domestic standards of telecommunication system to provide LBS. First, we investigate network models and interfaces of GSM(Global System for Mobile) and ANSI(America National Standard Institute)-41/PCS1900 - Telecommunication type of 2nd generation. Also we consider those of UMTS (Universal Mobile Telecommunication System) and cdma2000 - Telecommunication type of 3nd generation. Then we analysis function components for LBS of each network models details.

  • PDF

Three Sides of Korean Genetically Modified Food Controversies: Global Standards, Right-to-know and Counter-experts (유전자변형식품에 관한 세 가지 논의: 국제기준, 알권리, 대항 전문성)

  • Kim, Hyo-Min;Yeo, Jae-Ryong;Yoo, Soo-Hyung
    • Journal of Science and Technology Studies
    • /
    • v.11 no.2
    • /
    • pp.31-66
    • /
    • 2011
  • The main issue in Korean debates over genetically modified (GM) foods have been government's responsibility to guarantee consumers' right-to-know and make informed choice. Counter-experts' critique over the current regulatory processes based upon substantial equivalence have not been widely publicized. Through interviews and textual analysis, this paper explored three groups' performances in Korean GM food controversies-regulatory scientists, civil society organizations, and counter-experts. Analytic focus was made upon how each of the groups interact with current GM food regulations. While making conflicts with regulatory scientists and their 'discourse of compliance with global standards,' counter-experts were excluded from regulatory processes. This article suggests that the processes and contexts in which counter-experts failed to form strong alliance with other groups need to be examined in order to further understand the specific contours of Korean GM food controversies.

  • PDF

Geometry Transformation in Spatial Domain Using Coefficient Changes in Frequency Domain toward Lightweight Image Encryption (주파수 영역에서의 계수 값 변환에 의한 공간 영역에서의 기하학적 변환과 이를 이용한 이미지 경량 암호화)

  • Joo, Jeong Hyun;Yi, Kang
    • Journal of KIISE
    • /
    • v.42 no.2
    • /
    • pp.162-168
    • /
    • 2015
  • Image data is mostly stored in compressed form because of its huge size. Therefore, a series of cumbersome procedures is required to apply a transformation to image data: decompression, extraction of spatial data, transformation and recompression. In this paper, we employ DCT(Discrete Cosine Transform) coefficients to change the spatial presentation of images. DCT is commonly used in still image compression standards such as JPEG and moving picture compression standards such as MPEG-2, MPEG-4, and H.264. In this paper, we derived mathematically the relationship between the geometry transformation in the spatial domain and coefficient changes in the DCT domain and verified it with images in the JPEG file format. Because of the efficiency of transformation in the frequency domain, our findings can be utilized for light-weight partial image encryption for privacy data protection or entertainment contents protection.