• 산업경영시스템학회지
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• 제40권3호
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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.

• 산업경영시스템학회지
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• 제39권3호
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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.

• 산업경영시스템학회지
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• 제41권4호
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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.

• 산업경영시스템학회지
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• 제38권4호
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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.

• 산업융합연구
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• 제13권3호
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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.

• 품질경영학회지
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• 제46권2호
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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.

• 산업경영시스템학회지
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• 제44권2호
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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.

• 융합보안논문지
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• 제17권3호
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• pp.65-71
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• 2017

'국가중요시설'이란 국방부훈령에 의하면 적에 의하여 점령 또는 파괴되거나 기능이 마비될 경우 국가안보 및 국민생활에 심대한 영향을 미치는 시설을 말하며, 원자력발전소 해킹사건, 정부청사 무단침입 사건 등을 볼 때 국가중요시설이 반사회적 범죄의 표적이 될 수 있음을 보여주었다. 그간 국가중요시설 점검은 시설조사에 국한되어 있어 본 연구에서 범용화된 요구사항을 개발하고자 하였다. 이에 국제표준화기구(ISO)의 품질경영시스템(ISO 9001:2015)과 정보보안관리시스템(ISO 27001:2013)의 요구사항을 비교한 결과, 1~10장 중 8장(운영)만 차이가 있고 나머지는 공통으로 사용하였다. 또한 국 내외 환경설계를 통한 범죄예방(CPTED)의 적용사례를 비교한 결과가 "6가지 적용원리" 범주 내에 있음을 확인하였다. 이를 통해 품질경영시스템 요구사항 중 8장에 CPTED의 적용원리를 도입하여 국가중요시설 관리시스템 인증 요구사항을 도출하였다.

• 한국콘텐츠학회논문지
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• 제15권10호
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• pp.468-480
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• 2015

한 중간 FTA가 타결되어 동북아 통합경제권 실현에 대한 가능성이 높아졌다. 중국의 고도성장은 세계경제를 주도하고 있고, 동북아권역은 세계 경제에 있어서 주요시장으로 주목 받고 있다. 또한 우리정부의 해외시장 중시정책은 계속될 수밖에 없으나, 동북아권역에서의 건설수주는 미미한 수준이며, 수익성은 일본에 비해 아직 취약하다. 이제부터는 양적인 성장보다는 질적인 성장을 추구하는 건설산업으로의 체질개선을 도모해야 하는 시점이며, 고품질의 결과물을 도출하기 위하여 품질관리에 대하여 관심을 가져야 하고, 그 기반이 되는 품질관리체계가 보다 발전된 모습으로 거듭나는 계기로 만들어야 하는 이유인 것이다. 이에 국내 건설품질관리체계를 일본과 중국을 대상으로 비교하여 경제권 통합을 염두에 둔 품질관련 체계개편과 수준향상을 유도할 발전방향을 제안하고자 한다. 또한 경제권 통합의 실현 기반이 되는 ISO 9001에 의한 품질경영시스템의 중요성을 다시 한 번 확인하는 것을 본 연구의 목표로 한다.

• 예술인문사회 융합 멀티미디어 논문지
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• 제9권1호
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• pp.815-824
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• 2019

스포츠이벤트의 운영 환경은 크기, 종류, 지역에 따라 다양하고, 단위업무별 업무가 독립적이지 않고 상호 유기적인 관계를 이루고 있으며, 복잡한 이해관계자가 매트릭스구조로 이루어져 있어 일반화된 운영 모델을 구축하는 것은 결코 쉬운 일은 아니다. 이 연구에서는 이러한 문제를 해결하기 위해 스포츠이벤트 관리의 개념 및 프로세스의 지침을 제공하는 '표준'을 제안한다. 표준개발을 위해 산업분야 및 활동의 품질경영을 위한 국제 표준 규격인 ISO 9001:2015에서 제시하는 프레임을 따라 표준화를 진행하였다. 이 연구에서 제안하는 표준의 구성은 적용범위, 인용표준, 용어와 정의, 조직의 상황, 리더십, 계획수립, 지원, 운용, 성과평가, 개선으로 구성되어 있다. 이 연구에서 제시하는 스포츠이벤트 프로세스 관리 시스템 표준은 스포츠이벤트의 형태 또는 규모에 관계없이 스포츠이벤트를 유치하고, 준비하여, 운영하고자 하는 모든 조직에 적용될 수 있다. 또한, 스포츠이벤트의 생애주기 단계별 프로세스 관리에 초점을 맞춘 접근방법을 시도하여, 프로세스와 프로세스 간 상호 관련성과 의존성을 관리 할 수 있도록 하였다.