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A Study on the Quality Management Standards and Application for Improving R&D Activities as a Regulatory Support Process

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한국방사성폐기물학회 학술논문요약집 (Abstracts of Proceedings of the Korean Radioactive Wasts Society)
한국방사성폐기물학회 (Korean Radioactive Waste Society)
초록

Since the National R&D Innovation Act was enacted in 2022, it became a crucial issue how to qualify or improve R&D activities and disseminate their outcomes. Many organizations have referred to various quality management standards such as the American National Standards Institute/American Society for Quality (ANSI/ASQ) Z1.13, International Organization for Standardization (ISO) 9001, and the American Society of Mechanical Engineers Nuclear Quality Assurance-1 (ASME NQA-1), as a means to set up their own quality system. ISO is the international standard for implementing a quality management system (QMS), which provides a framework and principles for managing an organization’s QMS, with the aim of ensuring that the organization consistently provide products or services that meet regulatory requirements. ISO 9001 can cover all aspects of an organization’s operations, and it can also be expanded to include R&D areas. The introduction of ISO 9001 to R&D aims to improve R&D practices and establish a standardized process framework for conducting R&D. ANSI/ASQ Z1.13 provides quality guidelines for research and consists of 10 sections covering various aspects of research quality, emphasizing ethical conduct, clear objectives, reliable data collection, and analysis. ASME NQA-1 is one of quality assurance standards for nuclear facility applications, but it has been extended and applied to R&D activities in the nuclear fields. It just focuses on planning, procedures, documentation, competence, equipment, and material control. KINAC has conducted extensive research on verifying and regulating nuclear activities while providing support for national nonproliferation technologies and policies. In addition to the quantitative growth achieved so far, efforts are being made to establish a qualitative and integrated management system. As a first step to achieve this goal, this study reviewed international standards and methodologies for research quality and derived the key components for R&D quality management. Moreover, the appropriate outline of quality management system framework was proposed for R&D as a regulatory support process, based on the ISO 9001. The implementation of quality management standards and procedures for R&D in KINAC, which could lead to improved research practices, more reliable data collection and analysis and increased efficiency in conducting R&D activities.

저자
  • Hyun Young Kim(Korea Institute of Nuclear Nonproliferation and Control (KINAC)) Corresponding author
  • Jaeyeong Jang(Korea Institute of Nuclear Nonproliferation and Control (KINAC))