• 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 for Quality Management
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• v.26 no.1
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• pp.27-47
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• 1998

The primary objective of this research is to provide the basis of total quality management policies by reviewing previous studies which investigated effective ways to reduce product liability exposure. Specifically, the present study intends (1) to examine recent patterns and trends of product liability law in OECD countries, (2) to propose quality management policies for preventing product liability litigations, and (3) to guide the proper implementation process of ISO 9000 certification programs. The survey results show that the shift from a negligence law theory to strict liability is evident in most countries. The trend has led to make it easier for consumers to bring product liability lawsuits. Furthermore, the damage awards won by consumers have been drastically increasing. To minimize product liability exposure, manufactures should reflect comprehensive product safety concepts in establishing total quality management policies. Cooperative activities are also required between departments in companies to reach safe and satisfactory quality level. These quality management activities should be performed consistently during the total product life cycle. Failure to comply with the ISO 9000 certifications might be used as an evidence of negligence or as evidence of a design defect in court. Previous lawsuit cases, however, reveal that ISO 9001-9003 registration process alone is not sufficient in terms of product liability pervention perspectives. Therefore, manufactures should take into account ISO 9004 before implementing any other section of ISO 9000 standards.

• 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.

• Journal of the Korean Professional Engineers Association
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• v.33 no.6
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• pp.87-92
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• 2000

As more and more companies pursue ISO 9000 certification, the adaptation of ISO 9000 has brought about some significant positive effects to domestic quality systems However, somenegative results occurred in domestic industries rushing to fulfill the requirements of these new quality systems. The primary objective of this research is to provide the efficient implemen tation process of ISO 9000 certification on the basis of total quality management concerning with ISO/ DIS 9000:2000, ISO/ DIS 9001:2000, ISO/DIS 9004:2000. this study has been conducted using the data collected from 325 Korean small and medium manufacturing companies which registered ISO 9000 certification in March 2000. The first, the adoption of a quality manage ment system needs to be a strategic decision of the organization. The design period of the adoption of a quality management system is influenced by the size of the organization, the products process, KS certification, the rate of management.

• Journal of the Korea Safety Management & Science
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• v.13 no.4
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• pp.161-169
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• 2011

International Organization for Standardization has recently published ISO 9001:2008 which is the basic requirements for a quality management system that an organization must fulfil to demonstrate its ability to consistently provide products that enhance customer satisfaction and meet applicable statutory and regulatory requirements. Not many empirical researches based on ISO 9001:2008 have been done up until now. In this article we outline transitional features for ISO 9000 quality management system (QMS) since its first publication in 1987. In order to effectively maintain ISO 9001:2008 QMS certification and continuously enhance quality management activities, we perform statistical analysis for the minor nonconformity data generated from follow-up audits for subcontractors of shipbuilding industry based on ISO 9001:2008 requirements. A Kruskal-Wallis test is used to show relationships between the minor nonconformity data and three classification criteria: the type of business, the size of business, and the number of follow-up audits.

• Journal of Korean Society for Quality Management
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• v.35 no.3
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• pp.1-20
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• 2007

International standards are established by the agreement of many nations' delegates that represent the opinions from all stakeholders such as suppliers, manufacturers, customers, beneficial groups, and governments. The international standards provide all stakeholders with a scientific basis that determines regulations regarding quality, health, environment and other necessary issues. Among many international standards, the well known ISO 9000 quality management system(QMS) has been installed in about 877,770 organizations in 161 countries up until now. This ISO 9000 QMS specifies requirements for detailed contents from supply of resources to delivery to customers for registering QMS certificate. This paper considers business values of ISO 9000 QMS by reviewing literature. We summarize issues related to installment and operation : motives, advantages, disadvantages, problems, obstacles, and lessons. We also summarize the integrated management system(IMS) issues and compare ISO 9000 with Total Quality Management(TQM). We present a comprehensive figure and tables based on the category of the main results of literature.

• International Journal of Quality Innovation
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• v.2 no.2
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• pp.1-23
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• 2001

Many studies reported that some organizations experience benefits of quality as well as the productivity due to the implementation of ISO9000. However, there are significant differences across countries, industries and organizations. This paper examines the current quality management practices in the Hong Kong construction industry under the ISO 9000 environment by a postal survey. It focuses on the success factors of ISO 9000 implementation in the industry. The findings support the views that changes in the organization are needed to realize the benefits brought by ISO 9000.

• Journal of the Korean Society for Railway
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• v.9 no.3 s.34
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• pp.325-329
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• 2006

Quite a few of persons often fall into an error that ISO has happened an additional work at construction sites. Supervision works, however, are carried out in compliance with 'Guidelines for the Supervision Works' which is including most ISO Requirements. Additional requirements needed for the supervision works are not many. This study has studied on the ISO application of supervision works in relation to, 1) ISO 9001 & KS A 9001 Quality Management System Basic Model, 2) The Process of Railway Construction Work Supervision Quality Management Plan, 3) Supervision Work Performance Guide Book(2005) & KS A 9001(2001) Standard, at the railway construction sites.

• Journal of Korean Society for Quality Management
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• v.32 no.4
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• pp.64-77
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• 2004

This paper first was focused on investigating the relative effect of each ISO 9001: 2000 certification factors on service quality and customer satisfaction in service industry. The empirical tests was conducted in service industry. The results are as follows. First, it shows that ISO 9001:2000 certification factors except requirements for quality management have a positive effect on service quality significantly. Second, it also indicates that service quality precedes customer satisfaction like other researches reported. Finally, different effects of ISO 9001:2000 certification factors on service quality are observed in the various industries.

• Journal of Korean Society for Quality Management
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• v.32 no.4
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• pp.78-91
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• 2004

The ISO 9000 Follow-up Management Practices (FMP) as an integrated area including training, QM systems, management commitment, customer focus, communication and related issues are examined. A sample of 191 small and medium-sized firms data from mail survey is analyzed by the SPSSWIN. A model of FMP including three factors (Systems, Training, and Customer Focus) is introduced. In this paper, a focus is laid on the comparison between ISO 9000:1994 vs. ISO 9000:2000 or 05 9000 certificates and between groups classified by the time length after certification, and on regression relationships between FMP level and business performance. The result shows that the difference of FMP level is significant between two versions and between groups. Quality level and system satisfaction are influenced significantly by the three factors.