A prerequisite for improving the quality of a product is to enhance the quality of its parts supplied from outsourced enterprises. An enterprise certified by ISO 9001 Quality Management System is expected to develop their effective quality assurance system and maintain it through continuous control and improvement, thereby ensuring the good quality of products that they produce. However, it is reported that small and medium–sized enterprises certified by ISO 9001 have difficulty establishing an effective quality assurance system. This study aims to propose a new method of improving a quality assurance system that can be more effective in small and medium–sized enterprises. This study collectively considered requirements specified in several international standards on quality system and the results of expert group brainstorming to identify evaluation areas and items for assessing a quality assurance system. Based on these evaluation areas and items, a set of checklists for diagnosing and improving a quality assurance system was developed. In order to demonstrate the usefulness of the proposed method, this study applied it to ten small and medium-sized enterprises and could identify four approaches for improving their current quality assurance system. The presented improvement method, which consists of establishment of quality goals and quality innovation plan, defective products corrective activities, 4M and design change process, improvement of customer quality information management, is expected to be utilized as a useful tool for the enhancement of the quality assurance system of small and medium-sized enterprises.