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.

In the recent business environment, risks related to product safety problems are increasing. These are arising from various factors such as increasing product and production complexity, supply chain diversification, enhanced PL (product liability) law and strengthening regulations of the government. Accordingly, ISO (international organization for standardization) published standards of PSMS (product safety management system) for suppliers such as ISO 10377 and ISO 10393. Meanwhile, the ISO 9001 QMS (quality management system) was revised in 2015, and it has established itself as an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction. This study aims to suggest an integration framework of QMS and PSMS based on the recent ISO international standards. To this end, firstly, the relationship between QMS and PSMS is studied based on the quality and product safety definitions, PDCA (plan-do-check-act) cycle and risk-based thinking. Secondly, the requirements of ISO 10377 and ISO 9001 are compared and classified as the common and ISO 10377 specific requirements. Finally, integration steps of two systems are suggested and guidelines that can systemize the integrated requirements are presented in the aspect of processes and documentation. This study is expected to be used as a guideline that helps companies those have already acquired QMS certification to build an international-level product safety management system early.

The ISO 9000 Quality Management System(QMS) standard is an effective tool that can consistently meet the various requirements of stakeholders and promote customer satisfaction management. However, in the recent business environment, not only quality issues but also risks in various other areas are increasing. In particular, risks related to product safety problems which are arised from product convergence, diversification of methods of production and globalization of supply chain pose a great threat to the sustainability of companies. Accordingly, ISO published standards of Product Safety Management System(PSMS) for suppliers such as ISO 10377 and ISO 10393. This study aims to suggest an integration framework of QMS and PSMS based on ISO international standards. To this end, the relationship of QMS and PSMS are analyzed and the requirements of the both systems are integrated based on the Plan-Do-Check-Act(PDCA) cycle and risk-based thinking. In addition, guidelines that can systemize the integrated requirements are presented in the aspect of processes and documentation. This study is expected to be used as a guideline that helps companies that have already acquired QMS certification to build an international level product safety management system early.