• 제목/요약/키워드: Summary Management

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ISO14971:2019 세부분석과 Post Market Surveillance의 적용 방안 - IVDR 요구사항 중심으로 (ISO14971:2019 detailed analysis and Post Market Surveillance Application Method - Focusing on IVDR requirements)

  • 강일규
    • 대한의용생체공학회:의공학회지
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    • 제43권4호
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    • pp.199-213
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    • 2022
  • EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

Challenges to Achieving Universal Health Coverage Throughout the World: A Systematic Review

  • Darrudi, Alireza;Khoonsari, Mohammad Hossein Ketabchi;Tajvar, Maryam
    • Journal of Preventive Medicine and Public Health
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    • 제55권2호
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    • pp.125-133
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    • 2022
  • Objectives: No systematic review has explored the challenges related to worldwide universal health coverage (UHC). This study reviewed challenges on the road to UHC. Methods: A systematic electronic search of all studies that identified the challenges of worldwide UHC was conducted, without any restrictions related to the publication date or language. A hand search and a bibliographic search were also conducted to identify which texts to include in this study. These sources and citations yielded a total of 2500 articles, only 26 of which met the inclusion criteria. Relevant data from these papers were extracted, summarized, grouped, and reported in tables. Results: Of the 26 included studies, 7 (27%) were reviews, 6 (23%) were reports, and 13 (50%) had another type of study design. The publication dates of the included studies ranged from 2011 to 2020. Nine studies (35%) were published in 2019. Using the World Health Organization conceptual model, data on all of the challenges related to UHC in terms of the 4 functions of health systems (stewardship, creating resource, financing, and delivering services) were extracted from the included studies and reported. Conclusions: This study provides a straightforward summary of previous studies that explored the challenges related to UHC and conducted an in-depth analysis of viable solutions.

도시 가로수의 관리개선을 위한 공무원 의식조사에 관한 연구 (A Study on the Awareness Survey of Government Officials for Improvement of Urban Roadside Tree Management)

  • 성현찬
    • 한국환경복원기술학회지
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    • 제6권2호
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    • pp.27-38
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    • 2003
  • This study aimed to provide basic data for future management of roadside trees by analyzing problems associated with plantation and management of roadside trees through categorization of functions and organizational structure, plantation and management, and management regulations and generating improvement opportunities based on the result of a survey on the awareness of government officials who are directly in charge of managing roadside trees in 31 cities & counties within Kyonggi province. The summary of key results of this study is as follows. First, "roadside tree-related function" is still not considered to be independent. About a half of government officials in charge did not majored in this field and they spent only about "2.09hours", in average, in the roadside tree-related function out of 8 working hours per day. Second, regarding problems and improvement opportunities in roadside tree-related function, lack of time was considered to be the biggest problem in overall management of roadside trees. As for improvement opportunities, "increase of dedicated manpower" and "system development" to facilitate efficient processing were suggested. Third, an annual budget for roadside tree-related affairs was merely 92 million won per city/county. A registry for management of roadside trees was kept manually. As for the roles of roadside trees, improvement of landscape and securing of green area itself were valued highly. Fourth, Ginkgo biloba, Zelkova serrata, and Prunus yedoensis were suggested to be the most appropriate species for roadside tree and Platanus occidentalis, Populus albaglandulosa, Populus euramericana, and Robinia pseudo-acacia were mentioned to be the least appropriate species.

사업주의 안전경영의지가 산업재해에 미치는 영향 분석 - 안전분위기와 안전지출의 매개효과를 중심으로 - (An Analysis of the Effect of Employer's Safety Management Commitment on Occupational Accident - Focusing on the Mediating Effect of Safety Climate and Safety Expenditure -)

  • 조동제
    • 한국안전학회지
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    • 제38권1호
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    • pp.62-69
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    • 2023
  • We need a new approach to reduce serious occupational accidents. This needs a commitment to secure employer's safety, characterized by a culture that prevents occupational accidents and appropriates safety expenditure. This study analyzed the factors that relate how a safety management commitment to safety climate in the workplace and safety expenditure affects the generation of occupational accidents. The summary of the result is as follows. First, both safety climate and safety expenditure have direct negative effects on the generation of occupational accidents (-0.136 [p = 0.010] and -0.100 [p = 0.008] respectively). Second, the safety management commitment has no significant direct effect towards generating occupational accidents (p = 0.105). Third, the safety management commitment has positive effects toward both building a safety climate and increasing safety expenditure (0.664 [p = 0.000] and 0.178 [p = 0.000] respectively). The safety management commitment however, has negative effects on generating occupational accidents (-0.090 [p = 0.004] through safety climate and -0.018 [p = 0.004] through safety expenditure). Hence, the safety management commitment has positive effects on decreasing occupational accidents through safety climate and safety expenditure (-0.108 [p = 0.004]). In conclusion, the safety management commitment by employers reduces occupational accidents through its impact on safety climate and safety expenditure in work places. Therefore, in order to reduce accidents, the employer should focus on creating a safety climate and investing in safety expenditure in the work place.

병원내 안전관리 향상을 위한 항목 및 지침 선정 (Selecting QA Items & Guidelines for Hospital Safety Management)

  • 박지원;김용순;진혜영
    • 한국의료질향상학회지
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    • 제3권1호
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    • pp.78-93
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    • 1996
  • Background : The goal of this study was to establish the QA items and guidelines for preventing and improving of safety management. Therefore we investigated the nurses' recognition and knowledge of the safety and risk procedures and policies, and the agreement between the nurses beliefs on the degree of importance of those procedures and policies, with actual implementation in hospitals. Method : The subjects of this study were 201 nurses who participated in a program called continuing education for nurses, which held in December, 1993. Result: The results of this study were as follows: 1. Among 18 types of hospital risks, the items that scored highest or the need of closer attention in safety management was the needle stick, medication errors, falling, and bed sores. 2. In most questions of the 18 incidences, the nurses showed that the estimated result would have positive signs except for hospital infections, burns, and bed sores. 3. Even though the survey shows that incidences and types of occurences varies according to the person's age and the time of incident, they mostly occur between midnight to 6AM. Falls and bed sores can be seen more in the elderly. Medications errors, hospital infections and burns are frequently found between the ages of one through twenty. 4. There was a higher mean score for recognizing the importance of those items than the importance of implementing them. Conclusion : In summary, nurses did perceive the need of safety management but the hospital policy for proper safety management was not established. So we recommended that the hospital administration would undertake an early detection and proper management system for hospital precautions, based on QA items & guidelines presented in this study.

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Patterns and Trends with Cancer Incidence and Mortality Rates Reported by the China National Cancer Registry

  • Chen, Peng-Lai;Zhao, Ting;Feng, Rui;Chai, Jing;Tong, Gui-Xian;Wang, De-Bin
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권15호
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    • pp.6327-6332
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    • 2014
  • National cancer registration reports provide a huge potential for identifying patterns and trends of important policy, research, prevention and treatment significance. As summary reports written on an annual basis, the China Cancer Registry Annual Reports (CCRARs) fall short from fully addressing their potential. This paper attempts to explore part of the patterns and trends hidden behind published CCRARs. It extracted data for cancer incidence rates (IRs) and mortality rates (MRs) for 2004, 2006 and 2009 from relevant CCRARs and portrayed 4 kinds of indicators in line graphs. The study showed that: a) all of the line graphs of age-specific IRs and MRs characterized typical "growth curves or histogram"; b) graphs of IRs and MRs for males and urban areas had higher peaks than that for females and rural regions; c) most of the line graphs of IR/MR ratios comprised a starting peak, a secondary peak and a decreasing tail and the secondary peaks for females and urban areas were higher than those for males and rural areas; d) most of the urban versus rural IR ratios valued above one, but most the urban versus rural MR ratios, below one; e) the accumulative IRs and MRs showed a stable increasing trend from 2004 to 2009 for urban areas, but mixed for rural regions.

국내 기록관리학 분야 학회지 논문 분석을 통한 연구동향 연구 (A Study on the Research Trends of Records and Archives Management in Korea through an Analysis of Journal Articles)

  • 김규환;남영준
    • 한국문헌정보학회지
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    • 제43권4호
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    • pp.217-239
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    • 2009
  • 본 연구는 국내 기록관리학 분야의 학회지 논문을 분석함으로써 국내 기록관리학 분야의 연구동향을 제시하고자 하였다. 이를 위해 최근 10년간 발표된 학회지 논문으로부터 주제영역과 연구배경 정보(연구시기와 학회지)와 연구자특성 정보(소속 및 전공)를 추출하였다. 이를 토대로 연구배경 및 연구자특성에 따른 국내 기록관리학 분야 주제영역의 분포와 상관성을 분석하였다. 분석방법으로 빈도분석과 대응분석을 사용하였다. 분석결과 첫째, 국내 기록관리학 분야의 주제영역은 최근 10년동안 시간의 흐름에 따라 주제영역이 출현하고 쇠퇴한 것으로 분석되었다. 둘째, 조사대상 학회지마다 특정적인 주제영역을 가지고 있는 것으로 분석되었다. 셋째, 연구자 소속기관마다 특정적인 주제영역을 가지고 있었으나 연구자 전공별로 그렇지 못한 것으로 분석되었다.

일제하 조선총독부의 공문서 분류방식 (The Classification System of the Official Documents in the Colonial Period)

  • 박성진
    • 기록학연구
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    • 제5호
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    • pp.179-208
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    • 2002
  • In this paper, I explained the dominating/dominated relationship of Japan and Colonized Korea by analysing the management system of official documents. I examined the theory and practices of the classification used by the office of the Governor-General for preserving official documents whose production and circulation ended. In summary, first, the office of the Governor-General and its municipal authorities classified and filed documents according to the nature and regulations on apportionment for the organizations. The apportionment of the central and local organs was not fixed through the colonial period and changed chronologically. The organization and apportionment of the central and local organs reflected the changes in the colonial policies. As a result, even in the same organs, the composition of documents had differences at different times. The essential way of classifying documents in the colonial period was to sort out official documents which should be preserved serially and successively according to each function of the colonial authorities. The filing of documents was taken place in the form of the direct reflection of organizing and apportioning of the function among several branches of the office of the Governor-General and other governmental organs. However, for the reason that filing documents was guided at the level of the organs, each organ's members responsible for documents hardly composed the filing unit as a sub-category of the organ itself. Second, Japan constructed the infrastructure of colonial rule through the management system of official documents. After Kabo Reform, the management system of official documents had the same principles as those of the Japan proper. The office of the Governor-General not only adopted several regulations on the management of official documents, but also controlled the arrangement and the situation of document managing in the local governmental organizations with the constant censorship. The management system of documents was fundamentally based on the reality of colonial rule and neglected many principles of archival science. For example, the office of Governor-General labelled many policy documents as classified and burnt them only because of the administrative and managerial purposes. Those practices were inherited in the document management system of post-colonial Korea and resulted in scrapping of official documents in large quantities because the system produced too many "classified documents".

중소 제조업체의 친환경적 경영활동이 직무향상에 미치는 영향 (Effect of Environmentally Friendly Management Activities of SMEs on Job Improvement)

  • 배상목
    • 산업진흥연구
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    • 제8권1호
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    • pp.47-53
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    • 2023
  • 본 연구는 중소 제조업체의 친환경적 경영활동이 직무향상에 미치는 실증 연구로서 친환경 경영의 현황을 파악하고자 중소기업 제조업체를 대상으로 설문지 총 128개를 분석하였다. 분석결과를 요약하면 다음과 같다. 첫째. 중소기업의 친환경적 경영활동 중 사회적 활동은 직무향상에 통계적으로 유의한 영향을 미치지 못한 것으로 분석되었고, 둘째. 환경적 활동은 업무생산성에 𝛽= .394(p<.001)로 유의미한 영향을 미치는 것으로 나타났고, 직무만족에서는 𝛽=.216, p<.05로 낮은 인과관계를 보이며, 셋째. 경제적 경영활동은 직무만족에서 𝛽= .388(p<.001)로 유의한 영향을 미친 것으로 나타났다. 또한, 업무생 산성에는 β= .267(p<.01)로 낮은 인과관계를 확인하였다. 따라서 직무향상에 미치는 영향 중 업무생산성은 환경적 활동이, 직무만족은 경제적 경영활동이 직무향상에 영향을 미치는 것을 알 수 있었다. 본 연구는 중소기업의 친환경적 경영활동을 위한 환경조성과 경쟁력 있는 전략적 방향 제시 및 연구의 기초자료 제공에 의미가 있다.

RSS 기반 과학기술정보 배급표준 시스템(STI-RSS)의 개발과 활용방안에 대한 연구 (A Study on the Implementation and Service of the RSS Based Science and Technology Information Syndication System(STI-RSS))

  • 권이남;김재수;신동구;전성진;정택영
    • 정보관리연구
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    • 제36권4호
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    • pp.175-198
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    • 2005
  • 최근 이메일 서비스의 보완 수단으로서 RSS(Really Simple Syndication)를 이용한 정보 서비스가 활성화되고 있다. 과학기술 분야의 정보는 매우 방대하고 다양하며, 정보의 발생주기 및 서비스 또한 복잡한 특성을 가지고 있다. 단일 정보를 제공하는 기관인 경우 RSS를 이용한 정보 서비스는 정보를 제공하는 하나의 채널을 확보하는 의미에서 구현 시 고려해야 할 요소가 많지 않지만, 다양하고 방대하며 전문적인 과학기술정보의 특성을 반영한 RSS 서비스는 보다 정교한 설계와 구현을 필요로 한다. 본 연구에서는 RSS와 다른 정보배급 프로토콜을 비교하고, 국내외 RSS 동향조사를 수행하였으며, 과학기술정보의 특성을 고려한 RSS 기반 과학기술정보배급 시스템(STI-RSS)의 구현을 고찰하고 이의 활용방안을 제시하고자 한다.