• 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 BIBLIA Society for library and Information Science
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• v.32 no.3
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• pp.217-246
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• 2021

This study aimed to analyze the quality concepts and requirements of digital records as evidence and to find an implication to develop requirements for trusted digital records with securing authoritative qualities. To this end, this study compared requirements of records domain linking records process, records metadata and records systems with judicial domain on digital evidence, and identified the records requirements to secure the legal admissibility linking records and judicial domain. This study analyzed the relationship of quality concepts between digital records and digital evidence, found the legal admissibility is highly related to the reliability, and derived that it needs the measure to secure the reliability at the stage of records creation and capture. To prove authenticity of digital evidence, this study identified importance of records process, records metadata and records system, and proposed the necessity of measurement to secure records' evidence.

• IE interfaces
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• v.7 no.2
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• pp.25-30
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• 1994

ISO 9000 is a series of several standards(ISO 8402, 9000, 9001, 9002, 9003, 9004,...). ISO 9000 is a standard explaining fundamental concepts, defining important terms, and providing guidance for selecting among the other standards. ISO 9001, the most comprehensive standard to ensure quality in design, development, production, installation, and servicing. ISO 9002 is used to assure conformance to specification, installation and servicing. ISO 9003 has the least requirement among three standards and applies to inspection and final testing. ISO 9004 is a standard developed for internal use only and not applicabe to contractual arrangements. In this paper, quality system requirements for ISO 9000 series are also specified.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.34 no.3
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• pp.79-89
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• 2011

Since commercial operation of Kori-1 nuclear power plant in 1978, twenty units are under operation and six units are under construction at 2011 present. Nuclear power become a main energy source in our country. However, the plant was constructed by a USA vendor in its beginning period, the Quality Assurance requirements of USA was applied. Even though Quality Assurance requirements were newly established to the Korea Atomic Energy Act, its contents are quite similar to those of USA. And 10 CFR 50 App.B, ASME NQA-1 apply to most of nuclear industries as a quality assurance plan. In this paper, Quality Assurance requirement of domestic nuclear industries has been investigated and applicable method of ISO Quality Assurance application to the nuclear industries is suggested by a comparison ISO 9000 and nuclear quality assurance specification.

• Asian Journal of Business Environment
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• v.5 no.2
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• pp.23-29
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• 2015

Purpose - This theoretical study develops practical recommendations for implementing a quality management system (QMS) in Kazakh organizations to ensure the effectiveness and safety of products and services. We discuss the improvement of Kazakhstan's quality standards based on the requirements of ISO 9000. Research design, data, and methodology - We provide methods for improving the quality standards system, ranging from research and development to the sale of products. We also propose to establish a special quality systems award to motivate enterprises toward product quality improvement. The study's methodological basis included Kazakhstan's legislative and regulatory Acts, and international and national standards defining QMS requirements for scientists worldwide to develop and implement a QMS for enterprises. Results - Aligning the QMS reduces Kazakh companies' costs for the detection and correction of defects, and the external and internal loss caused by the defects. Effective QMS also reduces management costs. Conclusion - This article can help increase the transparency of organizations for their leaders and (if necessary) the external environment, and improve the accuracy, quality, and timeliness of decision-making.

• Aerospace Engineering and Technology
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• v.7 no.1
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• pp.245-253
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• 2008

Quality for civil aviation is very important to maintain the safety of aircraft and public, and strict quality requirements are prescribed in aviation regulations to ensure that each article produced conforms to the type design and is a condition for safe operation. In this study, the quality system requirements for aircraft and parts will be reviewed a concept of FAA's ACSEP(Aircraft Certification System Evaluation Program) and policy for aviation quality system evaluation in comparison with AS9100 for aviation quality management system.

• The Journal of Korean Association of Computer Education
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• v.9 no.4
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• pp.43-54
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• 2006

In general, user requirements in web-based learning systems are divided into functional and non-functional requirements. Developers are responsible for the verification of quality related requirements, which is known to be difficult to perform. This paper suggests a verification method that can be applied in the area where the conformance of implementation for non-functional requirements is required. The paper performs tests for non-functional requirements by using the information extracted from quality related features that have imposed constraints on design activities.

• Journal of Korea Multimedia Society
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• v.21 no.6
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• pp.685-697
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• 2018

(Most companies that perform BPR have not achieved satisfactory results or have not performed successful BPRs. There are many reasons for this, but the most important one has caused problems that do not accurately reflect the requirements of various stakeholders. In this paper, we will apply the BPR consulting methodology to a new value innovation requirements engineering process based on the Blue Ocean strategy, which is a way to create a new market without competition by customerizing potential customers by satisfying new customer expectations and needs. This paper uses a requirements engineering process that can generate customer value by applying the ERRC(Erasure Reduce Raise Create) analysis method, which is the core of the Blue Ocean Strategy Framework[1,2]. We will also apply the Six Sigma DFSS (Design For Six Sigma) methodology to improve quality and process through quantitative and systematic analysis. The proposed approach was presented to the BPR consulting to present a practical case, and the results of the empirical analysis of the system user to validate the results of BPR consulting.

• International Journal of Quality Innovation
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• v.8 no.2
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• pp.1-19
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• 2007

Achievement of objectives of education and training is one of significant factors influencing quality of life. Higher education institutions use different work, teaching methods and tools; however they are inadequate in many cases. Today higher education institutions have problems concerning sustention and rise of certain level of education by giving the job for graduates, using of new technologies that help to present, manage, evaluate and control knowledge. The main objectives of quality management system (QMS) at higher education institutions are as follow: to assure continuous improvement of education quality; to demonstrate performance results and relevant facts to the interested parties (customers of college or university, social partners, administrative institutions) showing the abilities of education institution to prepare high qualification specialists that fully correspond to changing requirements of labour market. The QMS at education institutions should be designed as continuous process, considering that the quality of final product is the result achieved in primary processes. The process shall involve all interested parties. Parameters and indicators of education quality can help to analyze the efficiency and effectiveness of existing QMS. The results of quality audits should be also taken into account when designing and implementing QMS at organization. Literature review showed that for the assurance of education quality three different approaches prevail: total quality management (TQM); requirements of quality awards and assessment models; and QMS corresponding to the requirements of ISO 9001 standard. The case study of QMS design and implementation at Vilnius Law and Business College is presented in the paper. The peculiarities, difficulties and obstacles of QMS implementation in the higher educations institutions are analysed in more detail in this article.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.130-140
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• 2024

Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.