품질비용 최적화를 위한 의료기기 품질경영시스템 관리 방안

Abstract

본 논문에서는 의료기기 산업 규제의 뼈대가 되는 ISO13485:2016 규격과 매칭하여 과거와 현재의 품질 이론을 통합하여 ISO13485:2016 각 항목과 과거 이론들 및 품질 비용 및 무결점에 대한 이론을 통합하여 고찰을 진행하였다. 결과적으로 업체가 ISO13485:2016 규격을 만족시키는 것에서 더 나아가 수준을 향상시켰을 때, 품질비용이 줄어 들 수 있음을 증명하였고, 품질비용을 최적화할 수 있는 방안에 대해 개선방안을 마련하였다. 향후 본 논문이 업체가 품질경영시스템을 ISO13485:2016 수준에서 더 상향하여 품질시스템을 구축하는 개선 활동에 활용되기를 기대한다. In the reality that regulations on medical devices are strengthened, manufacturing companies can gain a competitive advantage based on their technology based on their approach to regulation. Accordingly, this paper presents a direction compared to the past quality price theory and current law ISO13485:2016 that quality costs can be reduced depending on how the quality management system (QMS) for GMP acquisition, which is the most important to sell medical devices. It is difficult for companies to completely reproduce the management review of quality costs. This is because companies are verified for costs through an accounting audit, but it is often viewed as less important to verify the cost of quality. However, in the contents covered from III of this paper, the items of ISO13485:2016 were analyzed sequentially to explain why the failure cost paid by the company periodically occurred. Accordingly, an entity needs some input value (prevention cost, evaluation cost) to reduce the cost of failure, and the expected value will be known accordingly. It is a quality philosophy and theory published by Philip Crosby's Zero Fault and Feigenbaum's quality philosophy and theory in the 1970s and 1950s. The quality theory of this era is geared to quality cost. If the cost of defects can be corrected, it will immediately affect not only the relationship with customers but also the performance of the front line site. As time passed and the need to develop international common quality management system standards grew, ISO 9001 standard was published in the 2000s based on national standards of the United States, the United Kingdom, and Canada. Separately, quality system standards for medical devices were expressed in 1996. As a result, when there were theories by famous people including Crosby about the quality field, ISO13485 that is commonly applied in the medical device industry did not exist. The current latest version, ISO13485:2016 regulations, tells companies how to have a quality system, but there is no mention of quality costs. Therefore, in this paper, based on Crosby's "absolutes" on quality and Feigenbaum's philosophy of quality cost, the study to satisfy quality data according to the method of managing completely flawless data and non-conformity (defective) costs for quality management will be substituted into ISO13485:2016 to satisfy quality data. As a result, in this paper, by matching the ISO13485:2016 standard, which is the framework of the regulation of the medical device industry, the review was conducted by integrating the past and present quality theories and the theories of quality cost and defect. As a result, it was proved that quality costs could be reduced when the company improved the level further than satisfying the ISO13485:2016 standard, and improvement measures were prepared for ways to optimize quality costs. In the future, this paper is expected to be used for improvement activities in which companies build quality systems by raising the quality management system from the ISO13485:2016 level.