• Journal of Korean Society of Industrial and Systems Engineering
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• v.40 no.3
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• pp.38-48
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• 2017

ISO 9001 Quality Management Systems-Requirements has been revised in 2015. It has been updated four times since its publication in 1987. It is the most widely used International Standard in the world. There are over one million companies and organizations in over 170 countries certified to ISO 9001 from an ISO survey. Organizations are supposed to be certified to this new version by late 2018. The key changes in ISO 9001:2015 are to establish a High Level Structure (HLS) and focus on Risk-Based Thinking (RBT). Risk-Based Thinking means the process approach to decide how risk is addressed in establishing the processes to improve process outputs and prevent undesirable results. It pursues process planning and controls based on risks so that organizations can improve the effectiveness of the quality management system. It maintains and manages a Quality Management System that inherently addresses risks and meets objectives. In this article we firstly attempt to explain how to understand the fundamental concept of Risk-Based Thinking which is a systematic approach to consider risks rather than treating prevention as a separate component of a Quality Management System. We comment on the detailed requirements that contain risks in ISO 9001:2015 clauses. We also summarize recent advances on the risk assessment and management in line with ISO 31000:2009 Risk Management-Principles and Guidelines. We finally propose the practical risk management procedures for implementing ISO 9001:2015 with an emphasis on RBT. This article would contribute to help quality managers and practitioners convert to ISO 9001:2015.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.39 no.3
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• pp.71-82
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• 2016

The ISO (International Organization for Standardization) 9000 QMS (Quality Management System) standards specify requirements that need to demonstrate an organization's ability to consistently provide products or services. Korean companies have been implementing ISO 9000 QMS to compete in global markets. ISO 9000 QMS standards have been revised in 1994, 2000, 2008, and 2015 since the first release in 1987. The key change in ISO 9001:2015 is focused on risk-based thinking. It means that risk inherent within an organization is early identified and proactively controlled by use of all aspects of QMS rather than taking preventive actions. In this article we did literature review mainly on empirical study related to motivation and operation performance of ISO 9000 implementation. We present the necessity of changeover, features of new version, and comparison between new and old version. In order to see how well organizations can implement the new ISO 9001:2015 we focus on manufacturing companies that are going to convert to ISO 9001:2015 registration. We collect their key characteristics such as yearly sales, the number of MPI (Management Performance Indicators), the number of KPI (Key Performance Indicators), the number of quality control engineers, quality control engineer work experience, and the degree of adaptiveness between new ISO 9001:2015 QMS and QMS currently operating in manufacturing companies. Especially the degree of adaptiveness is analyzed by correlation analysis, regression analysis, ANOVA, and t-tests to discover the relationships among their characteristics. We found out that the degree of adaptiveness is linearly related to quality control engineer work experience and the number of MPI and KPI that is practically utilized in manufacturing companies. We summarize the implications discovered to help manufacturing industry convert to ISO 9001:2015 registration.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.41 no.4
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• pp.70-80
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• 2018

The International Organization for Standardization (ISO) published ISO 9001 Quality Management System (QMS)-Requirements in 1987 and has revised four times since then. ISO 9001:2015 is the latest edition. This latest edition has two most noticeable changes. The first major change of new edition focuses on performance with an emphasis on Risk-Based Thinking (RBT) to enhance the process approach. The new edition consists of ten clauses whose first three clauses are largely same as older edition but risks are clearly stated and stressed in last seven clauses, emphasizing on Plan-Do-Check-Act cycle at all levels in the organization. The second major change is that the new edition has the same overall structure as other ISO management system standards known as High Level Structure (HLS) with Annex SL. The companies obtained the certificate of new ISO 9001:2015 QMS by September 15, 2018 in order to maintain as an ISO QMS registered firm. In this article we collected transition audit data from more than 100 companies that registered ISO 9001:2015 QMS for recent three years. We performed a statistical analysis to disclose the relationships between the characteristics of companies and the minor nonconformities found in ISO 9001:2015 requirements during transition audit processes. We also aim to interpret the findings and deduce the implications of the statistical results.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.38 no.4
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• pp.1-10
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• 2015

ISO 9001, quality management system, is widely known as advancing internal efficiency and productivity in various industry. As a result, the number of companies that have adopted ISO 9001's certification have been increasing continuously year by year since ISO 9000' family standard was published in 1987s. This fact shows that a lot of businesses are trying to get the accreditation for improving the competitiveness of quality. The purpose of this study is to present that ISO 9001's certification motives affect to the requirement's implementation and show that the execution of requirements influences on management performance in the small manufacturer. In order to carry out this research, we obtained 96 survey sheets and inspected twenty assumptions based on the reliability, validity of the questionnaires. The results of regression analysis are summarized as follows; First, the factors of certification motive influence on the requirement's implementation except resources management. Second, the two elements of ISO 9001 requirement, resources management and product realization, have an important effect on the operational performance and financial performance considerably in the companies that choose the internal motive. Finally, the two requisites of ISO 9001 requirement, resources management and measurement, analysis and improvement, affect to the operational performance and financial performance significantly in the businesses that select the external motive. Based on the results, the companies that choose the internal motive have a good performance to execute the ISO 9001 requirements. Also, to implement the requirements of ISO 9001 is helpful for the companies to produce the operational and financial performance.

• Journal of Industrial Convergence
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• v.13 no.3
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• pp.27-39
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• 2015

This Study aims to analyze the management performances of the rubber products from the perspectives of ISO9001 Quality Management System, which is a new management technique for management innovation, in order to secure the competitiveness of the small and medium manufacturers of rubber products for automobile as automobile application components. The results of the analysis can be summarized as follows: First, as the results of the analysis of effect of the (1) responsibility of the management, (2) resources management, (3) realization of the products, and (4) measurement, analysis and improvement, which are the 4 core requirements of the ISO9001 Quality Management System, on the management performances of the small and medium sized manufacturers of the rubber components for automobile, it was found that only the responsibility of the management and resources management affect the management performance. The above research findings imply that the company must absolutely rely on the upper ranked groups rather than the lower ranked groups, and on the responsibilities of the management rather than the upper ranked groups in order to elevate the management performance of the small and medium sized manufacturers of the rubber components for automobile.

• Journal of Korean Society for Quality Management
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• v.46 no.2
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• 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.

• Convergence Security Journal
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• v.17 no.3
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• pp.65-71
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• 2017

"National important facilities" refers to facilities that have a great influence on national security and people's live s if enemy occupation, destruction, or functional paralysis is imposed by the Ministry of Defense Directive. In view of the case of nuclear plant hacking and the attack on the government building "National important facilities" could be the target of anti-social crimes. In the meantime, the "National important facilities" check is limited to the facilit y survey. so The purpose of this study is to develop generalized requirements. Therefore, comparing the requiremen ts of ISO 9001:2015 and ISO 27001:2013. There are only 8 differences(operating) out of 1-10. And the rest are used in common. In addition, we confirmed that the results of comparing the cases of domestic and foreign CPTED are within the "Six Principles". In Chapter 8, the principle of application of CPTED was inserted and the certification re quirements of the "National important facilities" management system were derived.

• The Journal of the Korea Contents Association
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• v.15 no.10
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• pp.468-480
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• 2015

The FTA between South Korea and China has been concluded in 2014. This means that there is high possibility of the economic integration in Northeast Asia. China's rapid growth has led the global economy, and the Northeast Asia has been attracting attention as the main market. Although the South Korean government cannot help continuing the overseas market-oriented policies, South Korea's construction orders in the Northeast Asia are insignificant, and their profitability is still low. It is time for South Korean construction industry to promote qualitative growth instead of quantitative growth. South Korean construction industry have to focus more on quality management to produce high-quality construction output. In order to support South Korean construction industry, Korean government needs to provide more advanced national quality management system. Therefore, this study compares national quality management systems in South Korea, Japan, and China, and suggests the direction of the South Korean national quality management system reform. In addition, another objective of this study is to confirm the importance of an ISO9001 based quality management system as a basis of the economic integration in Northeast Asia.

• Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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• v.9 no.1
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• pp.815-824
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• 2019

It is not easy to present a generalized operating model because the operating environment of a sport event is composed of a complex matrix structure. In this study, we propose 'standardization' which provides guidance of concept and process of sport event management to solve this sports event management problem. To purpose complete of this study, the frame was developed by the international standard ISO 9001: 2015 is applied. The standards framework for sports event process management system structure proposed in this study consists of scope of application, citing standard, Terms and definitions, organizational situation, leadership, planning, support, operation, performance evaluation, and improvement. This sport event process management system standard can be applied to any organization that wants to host, prepare, and operate sport events regardless of the form or scale of the sport event. In addition, this standard was focused on process management of life-cycle stages of sporting events, therefor it was possible to manage interrelationships and dependencies between processes and processes.