• Journal of Korean Society of Industrial and Systems Engineering
• /
• v.41 no.1
• /
• pp.11-23
• /
• 2018

This paper investigated relationship among internal as well as external motive to receive the ISO 13485 certification, countermeasure to the certification examination, active reception/execution level of the certification, and operational as well as financial performance of the medical device related enterprises in South Korea which received and are maintaining the ISO 13485 certification. SEM (structural equation model) and related analyses using AMOS 21.0 and SPSS 21.0 have been applied to verify the hypotheses of the research. Result of the research showed that internal as well as external motive for certification positively(+) affects active reception/execution level of the certification as well as countermeasure to the certification examination. The reception/execution level of the certification also positively(+) affects on the operational as well as financial performance of the certified enterprises. However, countermeasure to the certification examination was found out to negatively(-) affects the active reception/execution level of the certification and we can interpret that relatively more countermeasure to the certification examination burdens the employees of the enterprise, causing them to be less active on the reception/execution level of the certification. This research found that an enterprise's operational/financial performance improves when an enterprise introduces the ISO 13485 certification standard spontaneously on the purpose of improving its system and the certification system is applied to the enterprise actively, not passively. This research emphasizes the need to recognize the difference of the level of active reception implication among members of an enterprise according to the motive of introduction of the certification system.

• Journal of Korean Society of Industrial and Systems Engineering
• /
• v.38 no.4
• /
• pp.1-10
• /
• 2015

ISO 9001, quality management system, is widely known as advancing internal efficiency and productivity in various industry. As a result, the number of companies that have adopted ISO 9001's certification have been increasing continuously year by year since ISO 9000' family standard was published in 1987s. This fact shows that a lot of businesses are trying to get the accreditation for improving the competitiveness of quality. The purpose of this study is to present that ISO 9001's certification motives affect to the requirement's implementation and show that the execution of requirements influences on management performance in the small manufacturer. In order to carry out this research, we obtained 96 survey sheets and inspected twenty assumptions based on the reliability, validity of the questionnaires. The results of regression analysis are summarized as follows; First, the factors of certification motive influence on the requirement's implementation except resources management. Second, the two elements of ISO 9001 requirement, resources management and product realization, have an important effect on the operational performance and financial performance considerably in the companies that choose the internal motive. Finally, the two requisites of ISO 9001 requirement, resources management and measurement, analysis and improvement, affect to the operational performance and financial performance significantly in the businesses that select the external motive. Based on the results, the companies that choose the internal motive have a good performance to execute the ISO 9001 requirements. Also, to implement the requirements of ISO 9001 is helpful for the companies to produce the operational and financial performance.

• 한국디지털정책학회:학술대회논문집
• /
• 2007.06a
• /
• pp.127-143
• /
• 2007

As the informationized society develops, for companies to be industrially competitive in global competition, innovation of business administration through informationization is a nation-wide task that must be driven. Small-to-mid size companies also tend to recognize the need for informationization and build the information systems, improving their informationization levels. To reduce errors in bringing in and running the information systems and increase efficiency In using them, the need for the standard and guide for informationization in small-to-mid size companies has increased. Accordingly, the national office of small and medium business administration has developed the informationized management system (IMS) certification standard in order to provide a national motive to secure the means for management innovation of small-to-mid size companies and have them recognize informationization as a business strategy. Now, there arises the need for the IMS certification standard, which was developed in early 2000, due to changes in environments of small-and-medium businesses and problems that have been revealed in field applications. In this research, we have examined the current situations of informationization in small-and-medium businesses that were revealed by the 2005 survey on the levels of informationization in small and medium business, have drawn the problems that have occurred in the process of applying the IMS in many small-to-mid size companies, have devised the measures against those problems, and have proposed a new IMS certification standard that reflects those measures. This research has proposed only the direction for development of the IMS certification standard. Future researches should deal with detailed items and criteria for evaluation and continuous improvement of them.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
• /
• v.9 no.1
• /
• pp.141-144
• /
• 2005

Contents of this paper strengthen security of data by applying encryption algorithm to use cellular phone and settlement by Mobile that is used synchronization method and quotes and prevent damage of bar-code peculation etc.. If divide system step by step to execute this, step that create Mobile bar-code and transmits by individual terminal after encryption, step displaying to individual Mobile terminal, step that above individual Mobile terminal and main server form assimilation and these are consisted of step that quote confirming above information confirmation and motive availability. For the actual example, confirm effectiveness of certification system through simulation.