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.

1. 서 론
2. 품질경영시스템(QMS)과 제품안전경영시스템(PSMS)의 관계성 고찰
3. ISO 9001과 ISO 10377 요구사항 분석
    3.1 일반요구사항
    3.2 설계시 요구사항
    3.3 생산시 요구사항
    3.4 시장에서의 요구사항
4. ISO 9001기반의 ISO 10377 통합화 방안
    4.1 프로세스 통합화 방안
    4.2 문서 통합화 방안
5. 결 론
References

• Sung Hwan Jung(유한대학교 산업안전보건융합학과) | 정성환 Corresponding Author