• 대한방사선기술학회지:방사선기술과학
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• 제38권4호
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• pp.331-336
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• 2015

식품의약품안전처 고시 "의료기기의 전기 기계적 안전에 관한 공통기준규격"이 IEC 60601-1 [3판] 따라 개정되었고 IEC-60601-1의 개별규격인 IEC 60601-2-54 또한 촬영 및 투시용 X선 장치의 기본 안전과 필수 성능에 관한 개별 기준규격으로 고시화 될 예정이다. 따라서 개별 규격의 도입에 앞서 주요 요건을 소개하고자 이 기술보고서를 작성하였다. IEC 60601-2-54의 목적은 촬영 및 투시를 위한 의료용 전기기기(이하 ME 기기) 및 ME 시스템에 요구되는 기본 안전과 필수 성능 요구사항을 확보하려는 것이다. IEC 60601-2-54는 방사선 촬영 및 투시장치의 X선 고전압장치, X선 기계장치, 방사선 방어 등에 관한 내용이다. 의료기기의 전기 기계적 안전에 관한 공통기준규격, 의료기기의 전자파 안전에 관한 공통기준규격, 의료기기의 방사선안전에 관한 보조기준 규격이 본 규격에 적용되었다. IEC-60601-2-54가 고시화될 경우 촬영 및 투시용 X선 장치의 기본 안전과 필수 성능에 관한 이해를 넓히고 국내 의료기기 산업의 국제화에 일조할 것이라고 판단된다.

• International Journal of Quality Innovation
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• 제1권1호
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• pp.24-31
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• 2000

QS-9000 was established by Chrysler, Ford, General Motors and some Truck Manufactures to solve problems of efforts to prepare original standards for each company. When we compare the requirements in QS-9000 with those in ISO 9000, we may observe that those of QS-9000 are more specific, since the user of the standard is limited to the automobile industry. In particular, the requirements on statistical techniques are described in more detail. In this paper, we present the requirements on statistical techniques in QS-9000. Specifically, we review the contents of QS-9000 and explore the philosophy and the minimum requirement on statistical techniques behind the description.

• Industrial Engineering and Management Systems
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• 제11권1호
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• pp.70-81
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• 2012

The subject of "Design Requirements" (DR) is central to the design of software and engineering systems. The main reason for this is that quality aspects are usually closely tied to requirements, among other things. In this review paper, we consider how the subject of requirements is being managed in these two seemingly different design disciplines. Two important aspects are covered, namely: (a) requirements development, describing various activities leading to requirements documentation, and (b) requirements change management, describing various activities needed for the proper treatment of the inevitable changes in requirements. Similarities and differences on how these two aspects are handled in software and engineering systems are highlighted. It is concluded from this literature survey that the management of software requirements is quite coherent and well established as a science. On the other hand, management of engineering systems requirements suffer from being unstructured, in particular when requirements changes are involved. Important gaps and future important research areas are identified.

• 대한디지털의료영상학회논문지
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• 제11권2호
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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.

• 한국품질경영학회:학술대회논문집
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• 한국품질경영학회 1998년도 The 12th Asia Quality Management Symposium* Total Quality Management for Restoring Competitiveness
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• pp.429-434
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• 1998

QS-9000 was established by Chrysler, Ford, General Motors and some Truck Manufactures to solve problems of efforts to prepare original standards for each company. When we compare the requirements in QS-9000 with those in ISO 9000, we may observe that those of QS-9000 are more specific, since the user of the standard is limited to the automobile industry. In particular, the requirements on statistical techniques are described in more detail. In this paper, we present the requirements on statistical techniques in QS-9000. Specifically, we review the contents of QS-9000 and explore the philosophy and the minimum requirement on statistical techniques behind the description.

• Asian Journal of Business Environment
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• 제5권3호
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• pp.17-21
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• 2015

Purpose - This paper compares current requirements for depreciation accounting from the Financial Accounting Standards Board in America for equity securities and all debt securities with determinable fair value, and disclosure requirements related to the fair value of securities below registered cost with the requirements of the international Financial Reporting Standards Board and accounting standards committee. Research design, data, and methodology - Mini-review statements are examined relating to depreciation of investments in America and the Financial Accounting Standards depreciation of investments in Iran that meet the requirements of international reporting standards and the Iranian Accounting Standards Committee. Results - Accounting rules for depreciation of investments in securities requires a good deal of judgment. In particular, devaluation decisions during the recession and market crisis were controversial, although even with no clear guidelines on devaluation, sometimes such decisions were simple. Conclusions -Companies can choose from formal policies applied uniformly and documentations of interest to provide a summary of the principles and conclusions obtained through disclosure, enabling market participants to assess the entity's conclusions reasonably, thereby easing investor and market worries.

• Journal of electromagnetic engineering and science
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• 제13권4호
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• pp.199-207
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• 2013

Meeting electromagnetic compatibility (EMC) requirements can be a significant challenge for engineers designing today's electronic devices. Traditional approaches rely heavily on EMC design rules. Unfortunately, these design rules aren't based on the specific EMC requirements for a particular device, and they don't usually take into account the specific function of the circuits or the many design details that will ultimately determine whether the device is compliant. This paper describes a design methodology that relates design decisions to the product's EMC requirements. The goal of performance-based EMC design is to ensure that electronic designs meet EMC requirements the first time the product is tested. More work needs to be done before this concept reaches its full potential, but electronic system designers can already derive significant benefit by applying this approach to products currently under development.

• 대한안전경영과학회:학술대회논문집
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• 대한안전경영과학회 2006년도 춘계공동학술대회
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• pp.355-362
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• 2006

This paper is to introduce guidelines for automotive and food quality management system. International standards such as ISO/TS 16949 and ISO 15161 are considered. This study is to discuss particular requirements for the application of ISO 9001 : 2000 for automotive production and relevant service part organization , and guidelines on the application of ISO 9001 : 2000 for the food and drink industry.

• 패션비즈니스
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• 제27권6호
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• pp.37-46
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• 2023

This study aims to develop workwear prototypes by applying a systematic approach considering the characteristics of workwear. A case study was conducted before this study to derive workwear's four characteristics: 'Ergonomic Pattern-Making, Certified Fabric, Specialized Color, and Customized Details.' a prior study proposed the integrated framework combining these characteristics with the FEA model. The new framework identified that these characteristics are considered in terms of functionality, expression, and aesthetics; it can increase workers' satisfaction and meet the market demand without concentrating on only particular aspects. Before prototype production, the requirements for each characteristic of workwear were analyzed through theoretical research of previously published related papers. The study primarily gathered workwear requirements data and sources from consumer satisfaction surveys and investigations into the wearing conditions of work clothes. When considering all aspects of pattern-making, fabric, color, and detail in functionality, 'comfort movement, body protection, improved work efficiency' were identified as necessary. Expressive requirements were fundamental, including 'reflecting the wearer's preferences, expressing a sense of belonging and identity. It was clear that incorporating design elements and applying current trends to the aesthetic requirements of work clothes was necessary. Four prototypes comprised two top and bottom sets and two overalls using these requirements. The framework was used throughout the entire process of planning, producing, and evaluating prototypes, and through this, the results fulfilled the requirements. This study is significant because it produced workwear prototypes using an integrated approach that considered functional, expressive, and aesthetic aspects.

• 한국정보과학회논문지:컴퓨팅의 실제 및 레터
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• 제15권3호
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• pp.167-177
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• 2009

본 논문은 MyGuide라는 컨텍스트 인지 전시물 안내 시스템에 Simtext 개발 방법론을 적용한 개발 사례를 소개한다. 특히, 개발과정에서 컨텍스트와 관련되어서 고려할 사항, 문제를 해결한 방법 등을 소개한다. MyGuide 개발의 요구사항 도출단계에서는 비즈니스 로직과 컨텍스트 서비스를 위한 요구사항을 분리해서 도출함으로써 시스템의 복잡도를 줄일 수 있었다. 설계 단계에서는 컨텍스트 모델링, 아키덱처 설계, 클래스 및 데이타베이스 설계를 순차적으로 수행하였다. 특히 컨텍스트 모델링은 시스템의 요구 사항에 부합하도록 하였으며, 컨텍스트 모델에 따라 클래스와 데이타베이스를 설계하였다.