• Journal of Korean Society of Industrial and Systems Engineering
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• v.44 no.2
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• pp.124-131
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• 2021

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 Korean Society of Law and Medicine
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• v.13 no.1
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• pp.199-247
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• 2012

According to the review and analysis of medical cases that are assigned to the Supreme Court and all local High Court in 2011 and that are presented in the media, it was found that the following categories were taken seriously, medical and pharmaceutical product liability, the third principle of trust between medical institutions, negligence and causation estimation, responsibility limit, the meaning of medical records and related judgment of disturbed substantiation, Oriental doctors' duties to explain the procedures, IMS events, whether one can claim for each medical care operated by non-physician health care institutions to the nonmedical domain in the National Health Insurance Corporation, and the basis of norms for each claim. In the cases related to medical pharmaceutical product liability, Supreme Court alleviated burden of proof for accidents with medical and pharmaceutical products prior to the practice of Product Liability Law and onset the point of negative prescription as the time of damage strikes to condition feasibility of the specific situation. In the cases related to the 3rd principle of trust between medical institutions, the Supreme Court refused to sentence the doctor who has trusted the judgment of the same third-party doctors the violations of the care duty. With respect to proof of a causal relationship and damages in a medical negligence case, the Supreme Court decided that it is unjust to deny negligence by the materials of causal relationship rejecting the original verdict and clarified that the causal relationship shall not deny the reasons to limit doctors' responsibilities. In order not put burden on patients with disadvantages in which medical records and the description of the practice or the most fundamental and important evidence to prove negligence and causation are being neglected, the Supreme Court admitted in the hospital's responsibility for the case of the neonate death of suffocation without properly listed fetal heart rate and uterine contraction monitor. On the other hand, the Seoul Western District Court has admitted alimony for altering and forging medical records. With respect to doctors' obligations to description, the Supreme Court decided that it is necessary to explain the foreseen risks by the combination of oriental and western medicines emphasizing the right of patient's self-determination. However, questions have arisen whether it is realistically feasible or not. In a case of an unlicensed doctor performing intramuscular stimulation treatment (IMS), the Supreme Court put off its decision if it was an unlicensed medical practice as to put limitation of eastern and western medical practices, but it declared that IMS practice was an acupuncture treatment therefore the plaintiff's conduct being an illegal act. In the future, clear judgment on this matter should be made. With respect to the claim of bills from non-physical health care institutions, the Supreme Court decided to void it for the implementation of the arrangement is contrary to the commitments made in the medical law and therefore, it is invalid to claim. In addition, contrast to the private healthcare professionals, who are subject to redemption according to the National Healthcare Insurance Law, the Seoul High Court explicitly confirmed that the non-professionals who receive the tort operating profit must return the unjust enrichment and have the liability for damages. As mentioned above, a relatively wide range of topics were discussed in medical field of 2011. In Korea's health care environment undergoing complex changes day by day, it is expected to see more diverse and in-depth discussions striding out to the development in the field of health care.

• Proceedings of the Korean Society for Quality Management Conference
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• 2004.04a
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• pp.266-271
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• 2004

Recently, consumers require products with high-reliability and high-safety. Risk management system and product safety become more important issue In view of product liability. This paper aims to propose a risk assessment system which can be applied to product with high-reliability and high-safety, and also show an empirical application of the proposed risk assessment system for the development of motorcycle helmets.

• Proceedings of the Korean Institute of Industrial Safety Conference
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• 2002.05a
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• pp.503-508
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• 2002

최근 제조물 책임(Product Liability) 법의 영향으로 제품 안전(product safety)에 대한 관심이 높아지고 있다. 따라서, 그 동안 시스템 안전 분야에서 성숙되어온 여러 가지 안전성 분석 기법들이 실생활에 직접 연관된 제품 안전 문제에 적용될 수 있을 것으로 기대된다. 대부분의 안전성 분석 기법들이 제품 안전을 다를 수 있는 가능성을 가지고 있지만, 응용분야의 특성상 여러 가지 추가적인 고려사항이 있음을 알 수 있다. 본 논문은 제품 안전에 적용하기 위하여 기존의 안전성 분석 기법들을 검토하였다. 특히, 제품안전의 실무에 시급한 기법을 선정하여, 제품안전의 실무를 효과적으로 지원하기 위한 예로 FMEA의 개선방향을 제시하였다. 제조물 책임 개념이 단순히 소송이나 보험과 같은 사후 대응 중심의 노력으로 소모되지 않고, 제품의 경쟁력 향상으로 실효를 거두기 위해서는, 무엇보다 제품 안전을 위한 실무 방법론들이 시급하게 제시되어야할 것이다.(중략)

• Journal of Korean Society for Quality Management
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• v.27 no.3
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• pp.189-201
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• 1999

On November, 1998, Ministry of Finance and Economy in Korea announced officially to enforce the PL(Product Liability) Law within the country at the first half of the year 2000. Therefore, a companys responsibility for customers who are damaged by a defect in the products safety will be gradually strict and impose burden on management. This paper presents suggestions about PL prevention of domestic enterprise through the research of PL prevention strategies and prevention systems in the USA and Japanese leading enterprises.

• Journal of Korean Society for Quality Management
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• v.15 no.2
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• pp.20-26
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• 1987

An algorithm for the minimum total process percent defective under marginal costs is presented. Initial process is single series system, which is constructed by k process units, and each process is considered priority. Minimum of total process percent defective for parallel-series system exists when additional process setup costs are larger than marginal costs.

• Proceedings of the Korean Institute of Industrial Safety Conference
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• 2002.11a
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• pp.390-393
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• 2002

올해 7월 1일부터 제조물책임(Product Liability, 이하 PL)법이 시행되기 시작하였다. PL법은 그 목적에서 밝히고 있듯이 제조물의 결함으로 인하여 발생한 손해에 대해 제조업자 등의 손해배상책임을 규정함으로써 피해자의 보호를 도모하고 국민생활의 안전향상을 도모하기 위한 것이다. PL법에서 ‘결함’이라고 하는 것은 설계, 제조 그리고 표시사항의 결함과 통상적으로 기대할 수 있는 안전성이 결여되어 있는 것을 말함으로 기업이 대응하여야 할 범위는 과거에 생각하는 품질의 개념보다 높다고 하겠다.(중략)

• Proceedings of the Korean Institute of Industrial Safety Conference
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• 2003.05a
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• pp.264-269
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• 2003

제조물책임(PL; Product Liability)법이 시행됨에 따라 제품의 안전성 확보는 기업활동을 영위하기 위한 기본 조건으로 인식되어야 하므로, 기업은 제품안전에 관한 발상을 근본적으로 전환하지 않으면 안 되게 되었다. 그러나, 우리나라의 많은 중소기업은 법적 규제에 의한 기준을 충족시키는 데에 급급하여 자발적인 제품안전활동을 수행하는데 익숙치 못하며, 한편으로 법령에 의한 안전관리는 최소한의 안전성만을 보증한다는 취약성이 있다.(중략)

• Proceedings of the Korean Institute of Industrial Safety Conference
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• 2003.05a
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• pp.43-47
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• 2003

현대 과학기술의 발달과 더불어 생산되는 제품들은 점차 고도화·복잡화되고, 제품의 결함 또는 제품으로 인한 사고 원인을 소비자 스스로 밝혀내는 것이 거의 불가능하게 되었다. 따라서 제조물의 안전에 대한 우선적인 입증책임을 기업에게 요구하는 제조물책임법이 선진국에서 시행되었고, 최근 소비자의 권익 보호제도 확충으로 제조물에 대한 책임이 엄격화, 광범위화 되었으며, 유럽연합과 일본의 제조물책임법을 근간으로 제정한 국내의 제조물책임법이 2002년 7월 시행되었다.(중략)

• Proceedings of the Safety Management and Science Conference
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• 2000.05a
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• pp.175-192
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• 2000

본 논문은 우리나라에서도 2002년 7월1일 시행하게될 제조물책임법(PL)에 대비해 최근 우리나라 및 선진국인 미국, 일본을 중심으로 조사된 최근 사례를 결함별, 제품별, 국가별로 유형화하여 분석한다. PL법이 시행되기 전 많은 사례들이 발생하여 소송으로 제기되었고, 각 나라는 많은 시행착오를 거쳐 지금의 제조물책임(PL)을 수정, 보완되고 있는데 이러한 측면에서 외국의 사례와 우리나라의 사례를 비교, 유형화시켜 분석하고자 한다.