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.

미국 정부는 2011년 식품안전현대화법(FSMA, Food Safety Modernization Act)을 제정하였으며 단계적으로 실시 및 실시예정에 있다. 이중 농산물안전(Produce Safety) 최종규칙은 농산물 재배, 수확, 포장 및 보관과 관련된 생물학적 위해요소에 초점을 맞추고 있는데, 영농규모 등에 따라 2017년 1월부터 단계적으로 시행되고 있다. FSMA 의 농산물안전 규칙 중 현장에서 준수해야 하는 조항을 55개 선별하여 한국 GAP기준과 비교한 결과, 비교 대상 인 두 개의 기준이 조항별 관리사항에 대해 1:1로 단순비교하기에는 어려운 점이 있으나 상당수의 한국 GAP기준이 대응이 가능하다. 다만 한국 GAP기준은 포괄적 기준으로 평가자에 따라 다른 판단을 할 여지가 많으므로 기준의 세부 사항의 보강이 필요하다. 조항별로 보면, 작업자 안전위생(FSMA Subpart D)에 대하여 한국 GAP기준은 가장 높게 대응이 되며, 그 다음으로는 가축 및 야생 동물(FSMA Subpart I), 건물·장비·도구(FSMA Subpart L), 재배·수확 등의 활동(FSMA Subpart K) 순으로 대응이 되고 있다. 그러나, 농업용수 관리(FSMA Subpart E)와 관리자의 자격 및 교육(FSMA Subpart C)에 대해서는 다소 미 흡한 실정이며, 가축분뇨기반 퇴비 관리(FSMA Subpart F) 에 대해서는 대응이 취약한 편이다. FSMA 규칙은 인증 기준은 아니나, 세계적으로 식품안전의 표준을 선도하는 미국이 제시한 규칙인 만큼 파급력이 상당할 것으로 예상 된다. 따라서 국내 농산물 기준 중 FSMA 규칙에서 강조 하는 미생물적 안전성에 대응하는 기준이 GAP기준이므로 한국 GAP기준의 재검토를 통해 우리 농산물의 품질 향상 및 수출확대에 도움이 되기를 바란다.