• Journal of Korean Society of Industrial and Systems Engineering
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• v.24 no.66
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• pp.59-67
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• 2001

This thesis is to research for analysis of ISO 9000 Quality Management System application status of small & medium-sized Industrial Companies. For this research, 10 companies certified by ISO 9000 standard were selected. By using an evaluation method and a software for analysis of application, this thesis compared, analyzed and evaluated the application status before and after certificate of ISO 9000, and identified the performance and difficulty of QMS application, and then proposed improvement methodology for ISO 9000 effective application.

• Proceedings of the Safety Management and Science Conference
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• 2006.04a
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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.

• Journal of the Korean Society of Safety
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• v.27 no.2
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• pp.92-97
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• 2012

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

• Proceedings of the CALSEC Conference
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• 2003.09a
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• pp.45-53
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• 2003

This paper addresses the issues related to the development of product model and applications fer nuclear power plants based on STEP and PLIB standards. The ISO standards which can be applied are; STEP(Standard for the Exchange of Product Model Data) AP(application protocol) 221/231, AP 230/225, AP 227, ISO 13584 PLIB, ISO 15926 RDL. The data models of the AP's and ISO 15926 RDL are reviewed and an application system is proposed to exchange and share the design data of the nuclear power plant.

• Korean Journal of Computational Design and Engineering
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• v.13 no.5
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• pp.342-351
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• 2008

ISO 10303-AP241 is an Application Protocol of ISO 10303, which specifies the representation of AEC facility's life cycle information. The Working Draft of AP241 was submitted to the TC184/SC4 of ISO in July, 2007 by Korean team of ISO TC184/SC4/WG3. This paper introduces the currently developed draft Ap241 core model, and describes the life cycle support modules which are required to represent the life cycle information of AEC facilities. The draft core model is developed as a generic data model which is useful as a basis for implementation in a data warehouse. This core model could be used in combination with reference data such as PLCS RDL, Gellish table and RDL of ISO 15926. These concepts already exists in ISO 10303-AP221, AP239 and ISO 15926. In order to support maintenance and feedback of operational information concerning the AEC facilities, the AP241 team re-used many modules from AP239, and developed various STEP Application Modules which are adapted from the ISO 15926.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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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.

• Transactions of the Korean Society of Automotive Engineers
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• v.22 no.3
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• pp.68-74
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• 2014

As the number of ECUs (Electronic control units) are increasing, reliability and functional stability of a software in an ECU is getting more important. Therefore the application of functional safety standards ISO 26262 is making the software more reliable. Software fault injection test (SFIT) is required as a verification technique for the application of ISO 26262. In case of applying SFIT, an artificial error is injected to inspect the vulnerability of the system which is not easily detected during normal operation. In this paper, the basic concept of SFIT will be examined and the application of SIFT based on ISO26262 will be described.

• CDE review
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• v.4 no.3
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• pp.67-69
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• 1998

• 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.

• Journal of the Ergonomics Society of Korea
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• v.32 no.3
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• pp.279-291
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• 2013

Objective: The aim of this study was to compare old standard EN 954-1 and new standard EN ISO 13849-1 through case study and provide necessity of adaptation of EN ISO 13849-1 in Korea. Background: International and EU harmonized standard EN ISO 13849 "safety of machinery - Safety-related parts of control system" is classified into Part 1: General principles for design and Part 2: Validation. EN ISO 13849-1 standard was introduced in Official Journal of the European Union on September 8, 2009 as harmonized standard, and old standard EN 954-1 was withdrawn on December 31, 2011. So, EU decided to use of EN ISO 13849-1 standard forcibly from January 1, 2012 for safety of machinery. New machines need to be CE marked if they are to be placed on the market in the European Economic Area(EEA), Switzerland or Turkey, and Korean machine builder should apply EN ISO 3849-1 standard for safety of machinery accordingly. However, current Korean Safety Certification system(KCs mark) for dangerous machinery is not referred to EN ISO 13849-1 standard as safety standard. There is a need of research for adaptation of EN ISO 13849-1 standard in Korea as safety standards for new design of safety-related control system which use mostly electronic components. Method: Five case studies of representative designs for safety-related control system in accordance with EN 954-1were selected according to safety category from B to 4. And these five representative designs were tried to change new design in accordance with EN ISO 13849-1 standard. The results of comparison were analyzed in aspect of economy and technical complexity. Results: The results showed that EN ISO 13849-1 provided quantitative method of application and it enabled designers to create safety-related control systems that require fewer components and less wiring, with many of the components being to a lower specification and, therefore, less costly. Conclusion: EN ISO 13849-1 standard is good for electronic safety-related control systems compare to EN 954-1. By considering the importance of application of EN ISO 13849-1 and benefits, the application of EN ISO 13849-1 as safety standard for safety of machinery is urgent in Korea. Application: The results of comparing EN 954-1 and EN ISO 13849-1 standard might help to determine the adaptation of EN ISO 13849-1 standard for safety of industrial machinery in Korea.