• Title/Summary/Keyword: Requirements of Compliance

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Analysis of ISO 9000 Quality Certification for Small and Medium Industrial Companies (중소제조기업의 ISO 9000 품질인증실태 및 개선방안에 관한 연구)

  • 유재권;정수일
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.23 no.54
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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.

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A Study on Fire Prevention Requirements and Tests for Small Aircraft (소형항공기의 화재방지 요건 및 시험에 관한 연구)

  • Yoo, Seung-Woo;Jin, Young-Kwon
    • Journal of Aerospace System Engineering
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    • v.5 no.1
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    • pp.7-12
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    • 2011
  • The goal of fire prevention research is to eliminate fires as a cause of fatal accidents and there are two main areas of research. One is to prevent flame propagation during in-flight and it addresses fire hazards. The other is to minimize the possibility of flame penetration or fuselage burn-through and it aims toward post-crash survival include crash protection, emergency evacuation and post-evacuation survival. Civil aviation authorities world-wide are trying to identify threats and measure performance for fire prevention. The results of research are standardized and given as general directions of test methods. This paper has prepared to study and present the means of compliance to the fire prevention requirements and applicable test methods.

Abnormal Operation Analysis of the Wolsong 2,3,4 Heat Transport System (월성 2,3,4호기 열수송계통의 비정상 운전 해석)

  • Shin, J.C.
    • Journal of Energy Engineering
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    • v.25 no.1
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    • pp.15-22
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    • 2016
  • The heat transport system transients of Wolsong 2,3,4 nuclear power plants were analysed during abnormal operating conditions. The compliance with requirements of AECB Regulatory Document R-77 for CANDU reactor was estimated. The analysis results showed that for each postulated accident the peak pressure values in the reactor headers are within the acceptance criteria given in ASME code requirements. The effect of LRV that is one of the overpressure protection device was very minor.

A Study on the ISO 9001 Application of Railway Supervision work (철도 감리 업무의 ISO 9001 적용에 대한 고찰)

  • Jang Seog-Jae;Hwang In-Bum;Sung Jung-Hwa;Kim Hae-Seok
    • Journal of the Korean Society for Railway
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    • v.9 no.3 s.34
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    • pp.325-329
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    • 2006
  • Quite a few of persons often fall into an error that ISO has happened an additional work at construction sites. Supervision works, however, are carried out in compliance with 'Guidelines for the Supervision Works' which is including most ISO Requirements. Additional requirements needed for the supervision works are not many. This study has studied on the ISO application of supervision works in relation to, 1) ISO 9001 & KS A 9001 Quality Management System Basic Model, 2) The Process of Railway Construction Work Supervision Quality Management Plan, 3) Supervision Work Performance Guide Book(2005) & KS A 9001(2001) Standard, at the railway construction sites.

Development of Airworthiness Database System with Validation Process for Design Programs of General Aviation Aircraft

  • Lwin, Tun;Lee, Jae Woo;Kim, Sangho;Lee, Hyojin
    • International Journal of Aeronautical and Space Sciences
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    • v.13 no.4
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    • pp.435-445
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    • 2012
  • In this paper, a design process is established by integrating aviation safety requirements for the development of general aviation aircraft. An Airworthiness-Design Integration System, which integrates certification requirements with the entire design/analysis process, is developed and presented. For the proposed system, KAS 23/FAR 23/AC 23/CS 23 certification regulations are analyzed to determine design constraints and system compliance checks and to construct an ER&G (Engineering Requirement and Guide) and a Design-Certification Related Table (DCRT). Furthermore, through building a DB (Data Base), the management of design and certification related resources for developing a FAR 23 class aircraft are made. Certification tools and resources are also efficiently managed by the DB. The connection between the certification requirements and the detailed design process is proposed in this system. Tracking of this proposed method is validated by configuring a USE CASE and a system. The Airworthiness-Design Integration system will be constructed based on the system's design plan, certification system, and usage scenarios.

Guided Missile Initiation Technologies, Now and Tomorrow (유도무기 착화기술의 현황과 발전 전망)

  • 장석태
    • Journal of the Korean Society of Propulsion Engineers
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    • v.4 no.1
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    • pp.102-108
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    • 2000
  • The comparative evaluation/analysis of the initiation technologies currently being used, and the advanced initiation technologies currently being developed lot the aerospace and defense applications was performed. The evaluation criteria used were the compliance, performance, reliability, safety, and cost. The results clearly indicate that there is no one single initiation technology that will satisfy entire spectrum of initiation system requirements. Each initiation system architecture would require different initiation technologies that will satisfy the overall system performance requirements. However, laser initiation, particularly, the laser diode initiation has been getting more attention in recent years. The laser diode initiation, for most part, eliminates EMI and ESD concerns. In addition, laser diode initiation system can also be designed into relatively small packages, are optically connected systems by very light weight cables, are relatively easily designed to meet variety of initiation system requirements. Due to the these compelling factors, laser diode initiation has potential of becoming common initiation systems for many different aerospace and defense application.

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Transient Analysis of the CANDU-9 480/SEU Reactor (CANDU-9 480/ SEU 원자로의 과도변화해석)

  • J. C. Shin;Park, J. H.;K. N. Han;H. C. Suk
    • Nuclear Engineering and Technology
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    • v.27 no.5
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    • pp.687-700
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    • 1995
  • The thermal-hydraulic transient analysis of the proposed CANDU-9 plant was peformed. Several major transients ore analyzed if they meet the heat transport system design requirements. The proposed heat transport system configuration and the preliminary sizes of system equipment are justified by analysis in terms of the fuel integrity and the high system pressure limit during transients. The compliance with AECB R-77 requirements for CANDU-9 reactor was estimated. The analysis results showed that for each postulated accident the peak pressure values in the reactor headers are within the acceptance criteria given in ASME code requirements and the fuel overheating is prevented. One pump start-up during the reactor start-up operation was analyzed to investigate the How reversal through the fuel channel, which is specific in the proposed CANDU-9 plant.

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A Study on the Analysis and Improvement of Medical Device Standards in Korea (국내 의료기기 표준 분석 및 개선에 관한 연구)

  • Yong Wan Kang;Kyung Ah Kim
    • Journal of Biomedical Engineering Research
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    • v.44 no.3
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    • pp.204-210
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    • 2023
  • This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

A Study on Data Compliance Measures of Digital Healthcare Service - Focusing on Personal Information Lifecycle (디지털 헬스케어 서비스의 데이터 컴플라이언스 방안에 관한 연구 - 개인정보 라이프사이클을 중심으로)

  • Jung, Jaeeun;Yang, Jinhong
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.15 no.2
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    • pp.134-143
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    • 2022
  • 'Data' is the key component that leads Digital Healthcare. Most of the Healthcare Data is personal information of data subject and includes Sensitive Information. It is very important for companies to use data lawfully and safely during the lifecycle of data collection, use, provision, and destruction. However, small and medium-sized enterprises(SMEs), ventures, and startups, which account for 78% of the Healthcare Services Industry, have had difficulties in performing tasks related to personal information protection. The personal Information Protection Act's requirements depending on the purpose of using Personal Information are different. Also, the requirements for each personal information lifecycle are varied. Therefore, this study suggests six purposes for companies to use healthcare data. It examines the considerations during the lifecycle in which personal information is collected to be destroyed.

A Study on Certification System for Aircraft Engines and Auxiliary Power Units (항공기 엔진 및 보조동력장치 인증제도 현황)

  • Lee, Eunhee;Lee, Kang-Yi;Kim, Jinhee
    • Proceedings of the Korean Society of Propulsion Engineers Conference
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    • 2017.05a
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    • pp.194-197
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    • 2017
  • Aircraft engine and auxiliary power units are certified in processes of design, production according to airworthiness requirements. The aircraft engines shall demonstrate compliance with the design and production through the Type Certificate and the auxiliary power unit shall demonstrate compliance with the design and production through the Technical Standards Order Approval. MOLIT(Ministry of Land, Infrastructure and Transport) established the law and the airworthiness requirements for aircraft engines such as KAS Part 33 but didn't issue the Technical Standards Order for auxiliary power unit. In this paper, we proposed and explained the plan for improvement of our aircraft engines industry through building and expanding the certification infra-structure for aircraft engines and auxiliary power unit.

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