DOI QR코드

DOI QR Code

A Study on the Integration of Quality Management and Product Safety Management System based on International Standards

국제 표준 기반하에서 품질경영과 제품안전경영 시스템의 통합 구축 방안

  • Jung, Sung Hwan (Dept. of Industrial Safety & Health Engineering, Yuhan University)
  • 정성환 (유한대학교 산업안전보건융합학과)
  • Received : 2021.05.14
  • Accepted : 2021.06.18
  • Published : 2021.06.30

Abstract

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.

Keywords

References

  1. Domingues, P., Sampaio, P., and Arezes, P.M., Management Systems Integration : Survey Results, International Journal of Quality & Reliability Management, 2017, Vol. 34, No. 8, pp. 1252-1294. https://doi.org/10.1108/IJQRM-03-2015-0032
  2. ISO 9001 Quality Management Systems-Requirements, ISO, 2015.
  3. ISO 10377 Consumer Product Safety-Guidelines for Suppliers, ISO, 2013.
  4. ISO 10393 Consumer Product Recall-Guidelines for Suppliers, ISO, 2013.
  5. Jung, S.H., A Comparative Analysis of ISO 9001:2015 and ISO 10377:2013 for the Integrated Establishment of Quality and Product Safety Management System, Yuhan University Journal, 2019, Vol. 21, No. 1, pp. 113-130.
  6. Kim, H.G., Kang, B.H., and Park, D.J., A Fundamental Concept of Risk-Based Thinking and Risk Management for ISO 9001:2015 Certification, Journal of Society of Korea Industrial and Systems Engineering, 2017, Vol. 40, No. 3, pp. 38-48.
  7. Korea Accreditation Center, http://www.kab.or.kr.
  8. KS A ISO 10377 Consumer Product Safety-Guidelines for Suppliers, Korean Industrial Standards Council, 2019.
  9. KS A ISO 10393 Consumer Product Recall-Guidelines for Suppliers, Korean Industrial Standards Council, 2019.
  10. KS Q ISO 9000 Quality Management System- Fundamentals and Vocabulary, Korean Industrial Standards Council, 2021.
  11. KS Q ISO 9001 Quality Management Systems-Requirements, Korean Industrial Standards Council, 2018.
  12. KS Q ISO/TR 10013, Guidelines for Quality Management System Documentation, Korean Industrial Standards Council, 2011.
  13. Lee, J.-H. and Ro, H-B., A Simple Model for Evaluating Product Liability Activities, Journal of Korean Society for Quality Management, 2007, Vol. 35, No. 4, pp. 101-110.
  14. Lee, K.S. and Kim, C.S., Product Liability Prevention and Defense, Seoul Korea, Minyoungsa, 2009, pp. 112-115.
  15. Moon, J.S. and Kim, H.W., Product Safety Assurance Plan through Consumer Safety Management System Establishment, Journal of the Korean Consumer Safety Association, 2011, Vol. 1, No. 1, pp. 1-10.
  16. Park, D.J., Yoon, M., Kang, B.H., and Kim, H.G., An Empirical Analysis on ISO 9001:2015 Transition Audits, Journal of Society of Korea Industrial and Systems Engineering, 2018, Vol. 41, No. 4, pp. 70-80.
  17. Park, Y.T., Quality Management Theory, 2nd ed., Seoul Korea, KSA media, 2018, pp. 421-462.
  18. Poltronieri, C.F., Ganga, G.M.D., and Gerolamo, M.C., Maturity in Management System Integration and its Relationship with Sustainable Performance, Journal of Cleaner Production, 2019, Vol. 207, pp. 236-247. https://doi.org/10.1016/j.jclepro.2018.09.250
  19. Rebelo, M.F., Silva, R., and Santos, G., The Integration of Standardized Management Systems : Managing Business Risk, International Journal of Quality & Reliability Management, 2017, Vol. 34, No. 3, pp. 395-405. https://doi.org/10.1108/IJQRM-11-2014-0170
  20. Ro, H.-B. and Lee, J.-H., A Stepwise Approach to Product Safety Management, Journal of Korean Society for Quality Management, 2010, Vol. 37, No. 3, pp. 83-93.
  21. Yoo, W.J., Research about Integrated System Construction Design of ISO 9001:2000, KS and Product Safety Management by PL(Product Liability) Law Practice, Journal of Korean Society for Quality Management, 2003, Vol. 31, No. 4, pp. 188-193.