2,375 results on '"ISO 9001"'
Search Results
2. Applied Research on the Evaluation of the Management System of a Welded Structure Manufacturing
- Author
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Valentin Pîrvu, Corneliu Rontescu, Ana-Maria Bogatu, and Dumitru-Titi Cicic
- Subjects
management system ,internal audit ,iso 9001 ,iso 3834-2 ,Transportation engineering ,TA1001-1280 - Abstract
The implementation of a management system has increasingly become a necessity for organizations, one of the main purposes being to establish actions to achieve quality objectives. Currently there are many management systems but for a manufacturer of welded structures, in addition to the quality management system according to EN ISO 9001:2015 it is recommended to implement EN ISO 3834-2:2021 “Quality requirements for fusion welding of metallic materials. Part 2: Comprehensive quality requirements” The paper presents applied research on the assessment of the management system of a welded structure manufacturing organisation by conducting two internal audits at 7-month intervals as well as the analysis of the evolution of the management system after the implementation of corrective measures established after the first audit performed.
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- 2024
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3. Stakeholder Perspectives and Experiences of Implementation of Accreditation and the ISO 9001 Programs in Hospitals of Iran: A Qualitative Study.
- Author
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Behbahani, Sara Abbaspour, Arab, Mohammad, Mirzaei, Abasat, and Tajvar, Maryam
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HOSPITAL accreditation , *EXECUTIVES' attitudes , *ATTITUDE change (Psychology) , *HOSPITALS , *ACCREDITATION - Abstract
Background: Accreditation and ISO 9001 programs in hospitals are widely adopted for quality control and quality improvement in healthcare. Objectives: The objective of this study is to identify stakeholders' perspectives and experiences regarding the implementation of accreditation and ISO 9001 programs in hospitals affiliated with the Social Security Organization in Alborz Province, Iran. Methods: In this qualitative study, participants were selected based on purposive sampling. For data collection, semi-structured one-to-one interviews were conducted with hospital staff in different positions (n = 30). All interviews were digitally recorded, transcribed verbatim, and analyzed using thematic analysis. Results: Based on the analysis, 10 primary themes and 88 subthemes were identified. The 10 primary themes were categorized as experiences, strengths, weaknesses, effective factors, and recommendations for the implementation of accreditation and ISO 9001 programs in hospitals. Proper planning, benchmarking, physician involvement, increased resources, and more training are suggested for the successful implementation of accreditation in hospitals. Additionally, fostering a positive culture, focusing on the executive dimension, changing managerial attitudes, training, and supporting and motivating staff are the most important recommendations for the implementation of the ISO 9001 program. Conclusions: The results provide important insights into the dimensions of implementing accreditation and ISO programs in hospitals, which can be used by health policymakers and managers to improve the implementation of these programs in Iranian hospitals. [ABSTRACT FROM AUTHOR]
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- 2024
4. Quality Objectives in Standardized Quality Management Systems.
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Bugdol, Marek
- Subjects
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HEALTH services administration , *DOCUMENTATION , *AUDITING , *HEALTH facility administration , *INTERVIEWING , *SOCIAL factors , *GOAL (Psychology) , *DESCRIPTIVE statistics , *WORK experience (Employment) , *ORGANIZATIONAL change , *ECONOMIC impact , *QUALITY assurance , *HEALTH facilities , *ORGANIZATIONAL goals , *REGULATORY approval , *PATIENT satisfaction , *MANAGEMENT - Abstract
Background and Objectives: The effectiveness of a quality management system consistent with the ISO 9001 standard depends on how quality objectives are established and pursued. The aims of this article are to identify quality objectives in selected certified organizations providing medical services, assess their compliance with the requirements of the ISO 9001 standard, and determine factors influencing such objectives. Methods: The first theoretical part of the article is based on a systematic literature review. The empirical part contains an analysis of documentation related to quality management systems and conducted audits. The data were collected during 42 quality management system audits conducted in 16 health care organizations in the years 2015-2020. Uncategorized interviews were conducted with quality management system representatives. The data were verified by interviews with 6 management system auditors having at least 15 years’ experience in auditing health care organizations. The assessment of the methodological correctness is based on the ISO 9001:2015 standard criteria. Results: The most frequently formulated quality objectives include improving customer satisfaction, task-based objectives related to planned works, improvements, and development of new medical services. The quality objectives fulfill the requirements of the ISO 9001 standard. However, they are not ambitious. The most significant factors influencing the processes of goal setting are economic (financial incentives, available resources for modernization), social (community needs), and managerial (the scope of performed analyses, the quality of the audit process, and the calculation of necessary effort). Conclusions: Health care organizations need to pursue more ambitious objectives, intensify the use of performed medical analyses, and integrate quality objectives into management remuneration systems. [ABSTRACT FROM AUTHOR]
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- 2024
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5. Action plan proposal to obtain triple certification in a natural gas transportation company.
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Guerra Bueno, Cintia, Costa Pinheiro, Jorge Lucas, da Silveira Marques, Wagner, Fragoso da Silva, Telma Fidelis, and Besser Freitag, Alberto Eduardo
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Goal: for large gas transportation companies, it is of strategic relevance to be compliant with ISO 9001, ISO 45001, and ISO 14001 certifications, acknowledging their Integrated Management System (IMS). Based on this context, the purpose of this study was to propose an action plan to obtain triple certification for a Brazilian natural gas transportation company. Design/Methodology/Approach: the methodology comprised research of applied nature, exploratory and descriptive objectives, qualitative approach, with a single case study investigation strategy, and data collected through triangulation, combining documents, interviews, and field observation. Results: First, an action plan, which enabled the company to achieve triple certification in ISO 9001, ISO 45001, and ISO 14001 standards. Second, a table correlating seventeen IMS elements with technical and academic literature, and guidance documents of the studied company, making it easier to visualize interdependencies. Limitations of the investigation: The main one is the generalization limit of the conclusions, models or theories developed from a single case study, used in this work. These limitations do not reduce the importance of the results found, since the proposed action plan enabled the natural gas transportation company to obtain the desired triple certification. Practical implications: the proposed action plan may support other companies to achieve triple certification. Originality / Value: no research has been identified in the international literature that deals with triple certification for companies operating in the natural gas transportation market, specifically, the correlation of IMS elements with literature references and guidance documents of the studied company. [ABSTRACT FROM AUTHOR]
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- 2024
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6. ISO 9001 research mapping: Trends, findings, and future issues.
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Rakhmawati, Tri, Widianti, Tri, Damayanti, Sih, Astrini, Nidya J., Sumaedi, Sik, Yaman, Aris, and Bakti, I Gede Mahatma Yuda
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CONCEPTUAL structures ,CRITICAL success factor ,BIBLIOMETRICS ,BIBLIOGRAPHIC databases ,SYSTEM integration ,CONTENT analysis - Abstract
This study analyzes the existing literature on ISO 9001 to identify trends, key scholars, influential journals, significant papers, and this body of work's overall intellectual, social, and conceptual landscape. The study also proposes potential avenues for further research based on its findings. Bibliometric and content analysis were used to examine 929 relevant journal articles published between 1987 and 2023 and indexed by Scopus or Web of Science (WoS). Bibliometric analysis and visualization of results were conducted using the Bibliometrix R package and Biblioshiny application. This investigation unveils the intellectual, social, and conceptual structures within the literature concerning ISO 9001, shedding light on bibliographic features such as prominent scholars, leading journals, and noteworthy papers. Nine distinct research clusters were identified: integrated management systems; the effects of ISO 9001 implementation and certification; the diffusion of management system standards; ISO 9001:2015; the effective implementation of ISO 9001; levels and difficulties in management system integration; internalization of ISO 9001, withdrawal of ISO 9001 certification, and critical success factor of ISO 9001 implementation; ISO 9001 implementation and lessons learned; and diffusion of ISO 9001-based quality management systems. Key findings from each cluster were synthesized. This research is a valuable resource for scholars and practitioners seeking insights into the current state of ISO 9001 research and areas that warrant further exploration. [ABSTRACT FROM AUTHOR]
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- 2024
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7. The effect of corporate social responsibility on firm performance: Insights from ISO 9001‐certified manufacturing firms in Ghana.
- Author
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Gyekye, Kwabena Agyarko, Agana, Joseph Akadeagre, Mireku, Kwame, Domeher, Daniel, and Koranteng, Eric Tieku
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SOCIAL responsibility of business ,ORGANIZATIONAL performance ,PANEL analysis ,EMERGING markets ,MARKET value ,SIX Sigma - Abstract
The purpose of this paper is to examine the effect of corporate social responsibility (CSR) on the performance of ISO 9001‐certified manufacturing firms in Ghana. Specifically, we explore the effect of CSR on the market value and profitability of manufacturing firms in Ghana that have adopted ISO 9001. We use panel data estimation techniques to examine the empirical link between CSR activities and the performance of ISO 9001 certified manufacturing firms. Our panel data was pooled from a total of 65 ISO 9001‐certified manufacturing firms in Ghana observed over 5 years yielding a total of 325 firm‐year observations. Our empirical results show that there is a positive relationship between CSR, market share and profitability of ISO 9001‐certified manufacturing firms. The results are indicative that firms stand to gain if they adopt a more deliberate strategy toward CSR activities. This study provides significant input to the extant literature and offers a comprehensive guide to policy makers and management of ISO 9001‐certified manufacturing firms on CSR engagement in emerging economies like Ghana. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Action plan proposal to obtain triple certification in a natural gas transportation company
- Author
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Cintia Guerra Bueno, Jorge Lucas Costa Pinheiro, Wagner da Silveira Marques, Telma Fidelis Fragoso da Silva, and Alberto Eduardo Besser Freitag
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Integrated management system ,Certification ,ISO 9001 ,ISO 45001 ,ISO 14001 ,Production management. Operations management ,TS155-194 - Abstract
Goal: for large gas transportation companies, it is of strategic relevance to be compliant with ISO 9001, ISO 45001, and ISO 14001 certifications, acknowledging their Integrated Management System (IMS). Based on this context, the purpose of this study was to propose an action plan to obtain triple certification for a Brazilian natural gas transportation company. Design / Methodology / Approach: the methodology comprised research of applied nature, exploratory and descriptive objectives, qualitative approach, with a single case study investigation strategy, and data collected through triangulation, combining documents, interviews, and field observation. Results: First, an action plan, which enabled the company to achieve triple certification in ISO 9001, ISO 45001, and ISO 14001 standards. Second, a table correlating seventeen IMS elements with technical and academic literature, and guidance documents of the studied company, making it easier to visualize interdependencies. Limitations of the investigation: The main one is the generalization limit of the conclusions, models or theories developed from a single case study, used in this work. These limitations do not reduce the importance of the results found, since the proposed action plan enabled the natural gas transportation company to obtain the desired triple certification. Practical implications: the proposed action plan may support other companies to achieve triple certification. Originality / Value: no research has been identified in the international literature that deals with triple certification for companies operating in the natural gas transportation market, specifically, the correlation of IMS elements with literature references and guidance documents of the studied company.
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- 2024
- Full Text
- View/download PDF
9. Stakeholder Perspectives and Experiences of Implementation of Accreditation and the ISO 9001 Programs in Hospitals of Iran: A Qualitative Study
- Author
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Sara Abbaspur behbahani, Mohammad Arab, Abasat Mirzaei Mirzaei, and Maryam Tajvar
- Subjects
Accreditation ,ISO 9001 ,Hospital ,Iran ,Economic biology ,QH705-705.5 - Abstract
Background: Accreditation and ISO 9001 programs in hospitals are widely adopted for quality control and quality improvement in healthcare. Objectives: The objective of this study is to identify stakeholders’ perspectives and experiences regarding the implementation of accreditation and ISO 9001 programs in hospitals affiliated with the Social Security Organization in Alborz Province, Iran. Methods: In this qualitative study, participants were selected based on purposive sampling. For data collection, semi-structured one-to-one interviews were conducted with hospital staff in different positions (n = 30). All interviews were digitally recorded, transcribed verbatim, and analyzed using thematic analysis. Results:Based on the analysis, 10 primary themes and 88 subthemes were identified. The 10 primary themes were categorized as experiences, strengths, weaknesses, effective factors, and recommendations for the implementation of accreditation and ISO 9001 programs in hospitals. Proper planning, benchmarking, physician involvement, increased resources, and more training are suggested for the successful implementation of accreditation in hospitals. Additionally, fostering a positive culture, focusing on the executive dimension, changing managerial attitudes, training, and supporting and motivating staff are the most important recommendations for the implementation of the ISO 9001 program. Conclusions: The results provide important insights into the dimensions of implementing accreditation and ISO programs in hospitals, which can be used by health policymakers and managers to improve the implementation of these programs in Iranian hospitals.
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- 2024
- Full Text
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10. ISO 9001 Certification of the Specialization Schools of the Health Area of the University of Padova
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Zuliani, Filippo, Fedele, Andrea, Crismani, Andrea, Scipioni, Antonio, Stefanakis, Alexandros, Series Editor, Nikolaou, Ioannis, Series Editor, Kirchherr, Julian, Editorial Board Member, Komilis, Dimitrios, Editorial Board Member, Pan, Shu Yuan (Sean), Editorial Board Member, Salomone, Roberta, Editorial Board Member, Lagioia, Giovanni, editor, Paiano, Annarita, editor, Amicarelli, Vera, editor, Gallucci, Teodoro, editor, and Ingrao, Carlo, editor
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- 2024
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11. Implementation of a Quality Management System According to ISO 9001:2015: The Case of a Textile Company
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Buele, Jorge, Villacís-Guerrero, Jacqueline del Pilar, Tierra-Arévalo, Miryam Liliana, Tierra-Arévalo, José, Kacprzyk, Janusz, Series Editor, Gomide, Fernando, Advisory Editor, Kaynak, Okyay, Advisory Editor, Liu, Derong, Advisory Editor, Pedrycz, Witold, Advisory Editor, Polycarpou, Marios M., Advisory Editor, Rudas, Imre J., Advisory Editor, Wang, Jun, Advisory Editor, Montenegro, Carlos, editor, Rocha, Álvaro, editor, and Cueva Lovelle, Juan Manuel, editor
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- 2024
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12. Fallacy of continual improvement in the longitudinal study of ISO 9001 and IATF 16949 standards
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Yadav, Neeraj and Heriyati, Pantri
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- 2024
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13. Does the Deployment of the ISO 9001 Standard Have an Effect on Intellectual Capital?
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Mokhlis, Chams-Eddoha, Diop, Yamadou, and Boualou, Widad
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ISO 9001 Standard ,HUMAN capital ,SOCIOTECHNICAL systems ,VALUE creation ,CONCEPTUAL models ,INTELLECTUAL capital - Abstract
Purpose: The objective of this paper is to verify whether the ISO 9001 standard has an impact on the three components of intellectual capital, namely: human, structural, and relational capital. Design/methodology: Drawing on the absorptive capacity theory, the knowledge creation theory, and the socio-technical systems theory, we developed a conceptual model that was tested on a sample of 100 Moroccan companies certified under ISO 9001. Findings: The results indicate a direct impact of the ISO 9001 standard on human capital, an indirect impact on structural capital through human capital, and finally, the ISO 9001 standard influences relational capital through a serial mediation of human and then structural capital. Originality/value: This paper is a response to the current international debate on the importance of intellectual capital for value creation. Indeed, for intellectual capital to create value, it must be developed, and ISO 9001 standard precisely enables this development, as demonstrated by the results. Considering that more than a million organizations hold ISO 9001 certification worldwide, this aligns with the international scope of the debate on intellectual capital. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Model-driven gap analysis for the fulfillment of quality standards in software development processes.
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Giachetti, Giovanni, de la Vara, José Luis, and Marín, Beatriz
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AGILE software development ,QUALITY standards ,COMPUTER software development ,COMPUTER software quality control ,ISO 9001 Standard - Abstract
Society today is moving towards rapid digitalization of almost every aspect of our lives. From healthcare and transport to work or entertainment, we depend on software products that need to function properly. The adequate construction of these software products can be evaluated and certified by means of quality standards. However, adopting quality standards is a complex and time-consuming task that requires experienced practitioners with advanced knowledge about standards and development practices. This presents a dichotomy for development companies that are transitioning to more agile schemes, where the necessary quality knowledge is scarce and poorly documented, and is slowly learnt and applied by novel practitioners. To overcome these issues, this paper presents a model-driven approach to automate the analysis of software development processes that must be aligned to quality standards. The approach has been implemented in an open-source tool and applied to a case study to automatically generate a gap analysis by reusing expert knowledge related to the ISO 9001 standard. The application has demonstrated it is possible to reduce the effort required from expert practitioners to perform the analysis and improve development processes to ensure the fulfillment of specific quality standards. [ABSTRACT FROM AUTHOR]
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- 2024
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15. Improving the Improvement
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Darío Alentorn
- Subjects
Quality ,Risk ,Improvement ,ISO 9001 ,ISO 31000 ,Technology ,Engineering (General). Civil engineering (General) ,TA1-2040 - Abstract
This work reflects on the benefits of applying risk-based thinking for improvement in a quality management system. Based on the crucial role of theory and on the belief that conceptual accuracy and clarity are the main key to an effective practice, this work studies and analyzes the state-of-the-art core concepts of improvement and risk management, through international and national standards, including ISO 9000, ISO 31000 and ANSI-PMI Standards, among others. Consequently, reformulations of the main definitions about improvement are proposed, with the contribution of risk-based thinking concepts, in order to provide a wider perspective of the knowledge platform that has been built. The structure of this paper consists of: Summary, Introduction, Framework, Analysis and Discussion, Conclusions and References.
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- 2024
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16. The effectiveness of the implementation of ISO 9001 on SMEs performance: the case of an emerging economy
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Alshahrani, Mohammed Awad and Husain, Khalid Sami
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- 2024
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17. Systematic review on the implementation of metrological assurance systems for medical devices in Latin America
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Harold M. Farfán-Vargas, Dante Espinoza-Morriberon, Marcia M. Moya-Salazar, Hans Contreras-Pulache, and Jeel Moya-Salazar
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metrological characterization ,medical devices ,Latin America ,ISO 9001 ,quality assurance ,ISO 17025 ,Medicine (General) ,R5-920 - Abstract
BackgroundMetrology plays a crucial role in small healthcare service businesses to ensure the quality of products and services. While legal metrology in healthcare exists in some regions, it lacks harmonization. In other countries, there is limited presence of metrology in medical and biomedical engineering. We aimed to evaluate the implementation of metrological assurance systems for medical devices in Latin America.MethodsA systematic review was conducted following PRISMA 2020 guidelines and registered with PROSPERO (CRD42022359284). Searches were performed across 13 databases from October 30th to November 3rd, 2022. The search equation was “(((quality assurance) AND (metrology)) AND (medical devices)).” A total of 7,789 documents were identified, of which only 16 met the inclusion criteria.ResultsThe majority of studies (75%) were conducted in Colombia, with a significant portion being undergraduate theses. The primary normative references used in the analyzed studies were ISO 10012 and ISO 17025, with the majority (68.75%) relying on national legislation for their approach. One study in Colombia referenced eight standards, and one in Brazil analyzed user involvement in medical device management. Among the included studies, 56.25% were conducted in healthcare institutions, mainly clinics. Most studies provided implementation guidelines, with ISO 10012 being prominent, alongside ISO 17025, which implicitly addresses ISO 9001 elements. Global bias was low across all studies.ConclusionOur results underscore the importance of metrological assurance in managing medical devices in Latin America. The utilization of international standards and national legislation illustrates the diverse approaches adopted by different institutions. Future research should focus on optimizing metrological practices to enhance quality and safety in healthcare.
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- 2024
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18. IMPACT OF ISO 9001 QUALITY MANAGEMENT SYSTEM ON SMES: THE EXAMPLE OF GEORGIA.
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Agamanashvili, Ekaterine and Tsintsadze, Asie
- Abstract
In the current era of globalization, many companies worldwide have adopted a quality management system that is recognized internationally. The International Organization for Standardization reports that over a million organizations across 170 countries have been granted the ISO 9001 certification as proof of their compliance with the quality management system standard (ISO, 2023). However, when we examine the certification data of Georgian businesses, only 134 companies in the country (ISO Survey, 2022) have been certified with the ISO 9001. The research conducted by various scholars indicates that ISO 9001 is a critical tool for enhancing competitiveness. Obtaining the ISO certification is an effective way to increase customer trust, and satisfaction, reduce production costs, and continuously improve companies. The research aims to determine the effectiveness of the quality management system in small and medium-sized businesses in Georgia. It also highlights the benefits that service companies receive after obtaining an ISO certificate, such as increased process efficiency, improved service quality, better risk management, and a better company reputation. However, the study revealed that there is low awareness of the quality management system in Georgia, and the cost of certification is a hindrance for entrepreneurs when making a decision. [ABSTRACT FROM AUTHOR]
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- 2024
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19. Overcoming the challenges of moving from ISO/TS 16949 to IATF 16949: recommendations for implementing a quality management system in automotive companies
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Bozola, Patrícia Maria, Nunhes, Thais V., Barbosa, Luís César Ferreira Motta, Machado, Marcio C., and Oliveira, Otavio José
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- 2023
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20. Caracterización de la norma ISO 9001:2015 a través de la mejora continua para su implementación en organizaciones con inteligencia artificial
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Carlos Vázquez Cid de León, Asenet Nizandaya Alcántara Sánchez, and Salvador Montesinos González
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caracterización ,iso 9001 ,sistemas de calidad ,mejora continua ,Technology (General) ,T1-995 ,Industrial engineering. Management engineering ,T55.4-60.8 - Abstract
La norma ISO 9001:2015 es un estándar aplicado a los sistemas de gestión de la calidad y su implementación tiene como objetivo mejorar la calidad de los productos o servicios que brinda una organización para satisfacer los requisitos del cliente, así como los requisitos legales y reglamentarios. Esta norma utiliza un enfoque basado en procesos, que incluye el ciclo de mejora continua de planificar-hacer-verificar-actuar (PHVA), y abarca siete puntos auditables que se integran en el sistema. En relación con ello, para lograr el objetivo de esta investigación, se empleó un tipo de investigación descriptiva, transeccional y no experimental, cuyos resultados incluyen una caracterización de la norma ISO 9001:2015, así como una propuesta que aborda los puntos auditables a través de diferentes herramientas y métodos, con el fin de cumplir con los requisitos de dicha norma. Al finalizar la revisión de la literatura, se ha concluido que existen artículos que solo abordan una pequeña parte de la norma, lo que ha llevado a ampliar esta investigación para generar una propuesta que sea de utilidad y sirva como una guía metodológica para las organizaciones que busquen certificarse en dicha norma, con el objetivo de lograr la mejora continua.
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- 2023
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21. Soft quality management practices and product innovation ambidexterity: the mediating role of market orientation ambidexterity
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El Manzani, Younès, El Idrissi, Mostapha, and Lissaneddine, Zakaria
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- 2023
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22. POMIAR JAKOŚCI USŁUG MEDYCZNYCH METODĄ SERVQUAL NA PRZYKŁADZIE PRYWATNEJ PRZYCHODNI.
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WULCZYŃSKA-DĄBROWA, Dorota
- Abstract
Copyright of Management & Quality / Zarządzanie i Jakość is the property of Scientific Society of Organization & Management / Towarzystwo Naukowe Organizacji i Kierownictwa and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
23. ORGANIZATIONAL CITIZENSHIP BEHAVIOR FOR INTEGRATED MANAGEMENT SYSTEMS PERFORMANCE.
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Simon, Alexandra
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This paper attempts to adopt the Organizational Citizenship Behavior (OCB) theory to understand how individual, voluntary quality, environmental and Organizational Health and Safety (OHS) actions of employees impact Integrated Management System (IMS) performance. The methodology involves an exploratory qualitative analysis based on interviews to IMS managers located in the North-East of Spain. The findings from the case study analysis discover several OCB related dimensions which are necessary to maintain and improve the IMS within organizations. Among them, values such as altruism, organizational loyalty, and selfdevelopment of non-mandatory IMS actions are highlighted. The paper contributes to both the fields of IMS and OCB by providing novel knowledge on how voluntary initiatives for the quality, the environment and OHS positively influence IMS practices, its internalization level, and its efficiency. [ABSTRACT FROM AUTHOR]
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- 2023
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24. INFORMATION SECURITY AND QUALITY MANAGEMENT SYSTEMS INTEGRATION: CHALLENGES AND CRITICAL FACTORS
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Ana Paula Alves Fiore, Ana Lucia Figueiredo Facin, and Jorge Muniz Jr
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enabler factors ,integrated certified management systems ,iso 27001 ,iso 9001 ,analytic hierarchy process ,Management. Industrial management ,HD28-70 - Abstract
Implementing a new management system in organizations that already have a certified management system can be challenging. This research discussed enabler factors that influence the integration of an information security management system certified following ISO 27001 with a quality management system certified following ISO 9001. Five factors were identified as the basis of this research: Implementation Model, Human Resources, Resources Availability, Standard Issues, and Standards Integration. Four factors were validated through the qualitative study with consultants specialized in implementing and integrating these standards. Then, by prioritizing these factors through the Analytic Hierarchy Process method, it was found that the most relevant aspect is Standards Integration for the managers from the institution object of study. For specialist consultants, the most pertinent factor is Human Resources.
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- 2023
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25. ISO 9001 certification and decertification : Firm strategies to optimize quality management systems
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- 2024
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26. Quantifying the impact of ISO 9001 standard on the project and engineering management and success factors; A case of construction industry
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Khatatbeh, Ahmed Ali
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- 2023
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27. Total quality management in Peruvian goods companies during the COVID-19 pandemic
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Benzaquen, Jorge Benny and Narro, Juan Pedro
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- 2023
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28. Implementation of ISO 9001 in SMEs: A Systematic Literature Review
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Susanto, Danar Agus, Karningsih, Putu Dana, Suef, Mochamad, Prasetya, Bambang, Striełkowski, Wadim, Editor-in-Chief, Black, Jessica M., Series Editor, Butterfield, Stephen A., Series Editor, Chang, Chi-Cheng, Series Editor, Cheng, Jiuqing, Series Editor, Dumanig, Francisco Perlas, Series Editor, Al-Mabuk, Radhi, Series Editor, Scheper-Hughes, Nancy, Series Editor, Urban, Mathias, Series Editor, Webb, Stephen, Series Editor, Illiyyun, Naili Ni'matul, editor, Supriadi, Endang, editor, Safitri, Ririh Megah, editor, and Masrohatun, Masrohatun, editor
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- 2023
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29. Pharmaceutical Quality System
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Schellekens, Reinout, Smith, Julian, Le Brun, Paul, editor, Crauste-Manciet, Sylvie, editor, Krämer, Irene, editor, Smith, Julian, editor, and Woerdenbag, Herman, editor
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- 2023
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30. Outlook: Agile as the New Normal?
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Adam, Patricia A. and Adam, Patricia A.
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- 2023
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31. Agile in ISO 9001: How Does That Work?
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Adam, Patricia A. and Adam, Patricia A.
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- 2023
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32. Comparación del desempeño económico entre empresas industriales alimentarias certificadas y no certificadas con la norma ISO 9001
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Amanda Victoria Aravena Andrade and Tamara Vega Oliveros
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iso 9001 ,desempeño económico ,bolsa de valores de lima ,certificación internacional de calidad ,resultados financieros ,Technology (General) ,T1-995 ,Industrial engineering. Management engineering ,T55.4-60.8 - Abstract
En el Perú, existe un número reducido de compañías acreditadas con la Certificación Internacional de Calidad ISO 9001; se desconoce si esta norma contribuye en el desempeño económico de dichas empresas. Por ello, la investigación tuvo como objetivo comparar los resultados financieros entre empresas industriales alimentarias que cuentan con la Certificación ISO 9001 respecto de las que no. Para tal efecto, se realizó la prueba no paramétrica de comparación de medianas U de Mann-Whitney, debido a que los datos analizados no se ajustaban a la distribución normal. Como principal hallazgo se obtuvo que no existe diferencia estadísticamente significativa entre los resultados financieros de ambos grupos; sin embargo, específicamente en el indicador de rotación de activos, las empresas que han implementado los lineamientos de la norma internacional de calidad, en promedio, convierten sus activos en efectivo un mayor número de veces.
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- 2023
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33. Forecasting of ISO 9001 and ISO 14001 Certifications in Bangladesh Through ARIMA Model.
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Pushpo, Faria Haque and Kutub Uddin, Md.
- Subjects
STANDARDS ,DIGITAL technology ,MANUFACTURING processes ,TOTAL quality management ,SUPPLY chain management - Abstract
ISO 9001 and ISO 14001 are widely accepted international standards worldwide for continual improvement in terms of quality and environmental impact respectively. This study aims to predict the diffusion of ISO 9001 and ISO 14001 certifications in Bangladesh from 2022 to 2030. Auto‐Regressive Integrated Moving Average (ARIMA) approach has been applied to choose the best fit model. The ISO survey of certifications was considered as main source of data. From the analysis, it is observed that, ARIMA (1, 0, 1) and ARIMA (2,1,0) are the best fitted models for ISO 9001 and ISO 14001 respectively in predicting the certification in Bangladesh. The forecasted number of certification for the year 2030 is obtained as 833 for ISO 9001 and 494 for ISO 14001 in Bangladesh. The finding of the study concludes wide scope of diffusion in future. This study will contribute to enrich existing literature and guide policy makers in policy formulation. This study will also encourage researchers for further analysis in different context. [ABSTRACT FROM AUTHOR]
- Published
- 2023
34. QHFSS DNA laboratory – ISO/IEC 17025 conformance and accreditation
- Author
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Sean Doyle
- Subjects
Accreditation ,Conformance ,Non-conformity ,International standards ,ISO/IEC 17025 ,ISO 9001 ,Criminal law and procedure ,K5000-5582 - Abstract
This paper reviews evidence placed before a Commission of Inquiry (CoI) established by the State of Queensland, Australia, to consider the quality and reliability of DNA evidence. It also assesses whether the criticism levied in that report, of ISO/IEC 17025 being insufficient to assure the quality and reliability of DNA evidence, is warranted. The main conclusion drawn is that properly applied and embraced as a means of continuous improvement, conformance with ISO/IEC 17025:2017 alone is sufficient to assure the quality and reliability of the scientific outputs from a forensic science laboratory.Furthermore, it is clear from the observations and findings of the CoI and those recorded in this paper that the forensic science laboratory in question did not conform to ISO/IEC 17025:2017. Had it done so then the risk of the quality failures that led to the CoI would at least have been reduced and perhaps even avoided.
- Published
- 2024
- Full Text
- View/download PDF
35. The effect of quality management system (ISO 9001) on operational performance of various organizations in Indonesia
- Author
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Arfan Bakhtiar, Aditya Nugraha, Hery Suliantoro, and Darminto Pujotomo
- Subjects
quality management ,certification planning ,ISO 9001 ,organizational performance ,procedure application ,quality culture ,Business ,HF5001-6182 ,Management. Industrial management ,HD28-70 - Abstract
AbstractAn organization improves its performance by implementing ISO 9001, but there are not many scientific journals that discuss this. The purpose of this article is to examine the effect of the quality management system (ISO) 9001 on organizational performance to achieve business sustainability. This study examines four variables, namely ISO 9001 certification planning, organizational commitment, application of procedures on organizational performance and quality culture as mediating variable. Data collection was conducted in the form of a survey by e-mailing the questionnaire to 1000 ISO 9001 certified organizations selected using the purpose sampling technique. This research used a closed questionnaire and a Likert scale of 1–5. Data calculation utilized a Partial Least Squares (PLS) analysis to distinguish outer and inner model analyses, as well as to test the hypotheses. The results show that ISO 9001 certification planning, organizational commitment, and application of procedures have a significant effect on quality culture. ISO 9001 certification planning and organizational commitment do not have a significant effect on operational performance, but the application of procedures and quality culture significantly influence operational performance. It is clear that an increase in organizational performance greatly influences by ISO 9001 implementation and a quality culture as a mediating variable.
- Published
- 2023
- Full Text
- View/download PDF
36. TÜRKİYE MERKEZLİ BİLİŞİM İŞLETMELERİNDE KALİTE YÖNETİMİ VE DİĞER YÖNETİM SİSTEMİ STANDARTLARI: KURUMSAL İNTERNET SİTELERİ ÜZERİNDEN BİR ANALİZ
- Author
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AKDENİZ, Ekin
- Subjects
- *
CORPORATE websites , *SOFTWARE as a service , *CONTENT analysis , *TOTAL quality management , *DATA analysis , *COMPUTER software - Abstract
Purpose of presented study is to investigate the interest of Türkiye-based IT organizations in QM (quality management), ISO 9001 and other ISO MSSs (management system standards). Within the scope of this purpose, a study was conducted on organizations included in IT-500 lists. Corporate websites of IT organizations in categories of hardware, software and services were systematically examined. Methodologically, content analysis was applied in data analysis and corporate websites of IT organizations constituted the data source. Results and evaluations of study are presented separately on the basis of quality certificate, other certificates, quality policy and other policies, and when analyzed holistically, it has been revealed that large-scale service category organizations care more about QM and other MSSs. Right after service category, hardware category organizations take their place in the ranking. However, large-scale software organizations lag behind hardware and service organizations. Small-scale software organizations, which are ahead of other small-scale categories, reached same figures as large-scale software organizations. Analyzing corporate websites of IT organizations, presenting their interest in QM and other MSSs, addressing their policies, evaluating them on the basis of largescale and small-scale organizations in aforementioned categories indicate the importance and show the contribution of the study to the academic field. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
37. Integrating ISO 9001 and Industry 4.0. An implementation guideline and PDCA model for manufacturing sector.
- Author
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Chiarini, Andrea and Cherrafi, Anass
- Subjects
INDUSTRY 4.0 ,MANUFACTURING industries ,ENTERPRISE resource planning ,ISO 9001 Standard ,SMART cities ,ARTIFICIAL intelligence ,INTELLIGENT sensors - Abstract
The main purpose of this paper is to develop an implementation guideline for manufacturing companies integrating ISO 9001 requirements and Industry 4.0 technologies. The implementation guideline follows the Plan-Do-Check-Act model of ISO 9001 standard. We interviewed 25 experts and observed the quality management documentation of seven European manufacturing companies. Results emerged using thematic content analysis and we gained further insights from interviewees, allowing us to propose suggestions garnered from the interviews. The guideline demonstrates how requirements can be integrated with Industry 4.0 technologies such as radiofrequency identification tags, smart sensors, the internet of things, smart human interface, enterprise resource planning modules, artificial intelligence to improve a typical ISO 9001 quality management system. Some issues emerged relating to the fear of losing jobs, validation of quality control equipment based on artificial intelligence, and decision-making and problem-solving processes. The implications of this research are mainly related to the opening of a new debate concerning the integration between ISO 9001 and Industry 4.0 as well as the proposal, to our knowledge, of the first tentative integration. Manufacturing companies can use the guideline for integrating their quality management system with Industry 4.0 technologies while considering also the practical suggestions provided by the experts. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
38. An empirical examination of ISO 9001's influence on sustained success of companies.
- Author
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Idris, M Chukri and DURMUŞOĞLU, Alptekin
- Abstract
The purpose of this study was to study the impact of ISO 9001 on the main factors of the sustained success of companies. A background theoretical study was conducted on sustained success factors and the impacts of ISO 9001 implementation on companies' performance. Then, the impacts of ISO 9001 on industrial companies in Turkey were identified and validated through questionnaires and interviews. The study revealed that all the SSFs were positively influenced by ISO 9001. Despite the contradictions in the literature, the study shows ISO 9001 has a positive effect on the innovative ability of these companies and a clear positive effect on adopting spiritual values. But ISO 9001 does not support a shift toward a less bureaucratic culture. This study was limited by the difficulty of distinguishing the findings based on the sectors and sizes of the companies. Although the findings could cover all areas, this research was only conducted in industrial companies based in Turkey. At the time of undertaking the current study, there are no empirical studies on the effect of ISO 9001 on the SSFs; in this study, the effect of ISO 9001 implementation on these factors was practically validated. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
39. ПОНЯТТЯ СИСТЕМИ УПРАВЛІННЯ ЯКІСТЮ ТА МЕТОДОЛОГІЯ ОЦІНЮВАННЯ ЯКОСТІ В ОРГАНАХ ПУБЛІЧНОЇ ВЛАДИ.
- Author
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Дзюба, Григорій
- Abstract
The article is devoted to the analysis of the definition of the quality management system (QMS) according to various sources, including the national quality standard DSTU ISO 9001:2015, the views of domestic and foreign scientists. Approaches to the definition of QMS are considered in the context of its role as a strategic decision of the organization to improve overall effectiveness and sustainable development. The authors of the article take into account the definition of Tuomi V., who sees QMS as a process management system with a focus on customer satisfaction while minimizing the cost to the organization, and also express the points of view of A. Oleshka. and Momota I.O. As a result of combining the methodological approach of Tuomi V. and the formal approach to the definition of QMS, the article proposes a new definition: QMS is a set of procedures, methods, instructions and organizational structure necessary for managing processes in order to achieve the maximum result at the minimum costs of the organization. Given the variety of approaches to understanding QMS, this new definition can become a useful tool for practical application and further research of quality management systems in various fields of activity. In addition, the article examines the development of the concept of quality and the quality management system (QMS) in international business processes. The transition period from the 80s to the 90s of the last century, when the concept of «quality» expanded its application from production processes to the sphere of services, was analyzed. The implementation of QMS in the US public sphere and the process of harmonization of national quality standards in Europe based on ISO 9000 standards are also investigated. The article also describes in detail the role of the International Organization for Standardization (ISO) in the development of international standards and the promotion of international trade. The main functions of ISO are emphasized, as well as the chronological development of ISO 9000 standards, in particular the ISO 9001:2015 version. The article also notes the research of domestic and foreign scientists who studied the implementation of international quality standards in practice at various levels, including local authorities. Auxiliary references to the works of Pakhomova T. and Lakhizha M.I., Tuomi V., who were engaged in the analysis and research of quality management systems, are indicated. The international standard ISO 9001, which defines the requirements for the quality management system, was considered. The standard provides for the ability of the organization to satisfy the needs of consumers on an ongoing basis through the effective application of the quality management system. It is general and is used in all organizations, regardless of their type, size and type of products or services. The ISO 9001 standard is based on the PDCA cycle (planning, action, verification, implementation). It provides guidance on planning, implementation, quality assessment, and continuous improvement of a product or service. The standard implementation process includes resource allocation, customer communication, internal quality audit, process monitoring and corrective actions. The author emphasizes that the implementation of the PDCA cycle in the activities of public authorities will help to improve the quality of providing public services to citizens. Completing tasks according to such a mechanism will create a high-quality precedent that can be relied upon for the implementation of subsequent projects. The introduction of quality standards will also provide a convenient basis for public managers in solving operational tasks and ensuring constructive communication with citizens. It is noted that ignoring the wishes of customers can negatively affect the profitability of the organization. The possibility of applying the methodology for assessing the quality of public services on the basis of citizens' feedback for public bodies in Ukraine is being investigated. There are two main reasons for the use of this methodology by public managers: assessment of the actual state of public service provision and prioritization of efficiency improvement processes in crisis areas of citizen service. Examples of the implementation of this methodology in other countries and research results showing the significant impact of ISO 9001 quality standards on the quality of public services are presented. It is noted that this methodology can help public managers understand the level of effectiveness of interaction between public authorities and citizens and contribute to the implementation of quality standards in areas that need it, especially in wartime. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
40. The effectiveness of quality management strategies in health care organizations: an analysis of quality standards implementation and clinical performance improvement.
- Author
-
Petryk, Serhii, Andrieiev, Ievgenii, Tishko, Dmytro, Kurbanov, Anton, and Yunger, Vitaliy
- Subjects
TOTAL quality management ,QUALITY standards ,LITERATURE reviews ,QUALITY of service ,MEDICAL care ,EVIDENCE-based design (Architecture) ,PERFORMANCES - Abstract
Quality management strategies in healthcare institutions require an increasingly refined quality management system. This study aims to analyze the ISO 9001:2015 Standard for the implementation of a quality management system in the field of medical services provided by healthcare facilities, as well as to determine patterns during performance to assess the effectiveness of the quality management strategy. The article discusses key factors for achieving the quality management strategy through the implementation of a quality management system to improve clinical indicators. This system, according to the requirements of the ISO 9001:2015 Standard, ensures quality service provision. A cyclical sequence of actions is used to analyze quality management system implementation. It is applied to quality service processes in healthcare organizations and reflects some key aspects (planning, execution, activities, and verification of all relevant processes as described in the ISO 9001:2015 Standard). The authors have examined the quality management strategy based on the literature review and the analyzed standard. This strategy includes leadership, adapting quality improvement initiatives, setting the boundaries of managerial and clinical policies. All the above allow the integration of quality improvement initiatives into a sustainable, organized system with continuous enhancement. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
41. Integrated management system at higher education institutions: Case study from Poland.
- Author
-
Tutko, Marta and Woźniak, Piotr
- Subjects
HIGHER education ,DOCUMENTATION ,APPLIED sciences ,DATA analysis - Abstract
Integrated management systems in enterprises are of interest to researchers, but at higher education institutions (HEIs) this issue has not been the subject of in-depth research to date. The main purpose of this article is to explore the integration process of standardized management systems (MS), namely quality MS (compliant with ISO 9001), environmental MS (ISO 14001) and energy MS (ISO 50001) at HEIs. The objectives are: (1) examining the reasons for integrating standardized MSs at HEIs, and (2) identifying the stages of the standardized MS integration process at HEIs corresponding to the Plan-Do-Check-Act (PDCA) cycle. To achieve this goal, a case study research strategy was adopted. One case, namely the University of Applied Sciences in Nysa, Poland, was analyzed. Multiple sources were used to obtain the data, and these were documentation, archives, interviews and participant observations. It was concluded that the main reason why the authorities of the analyzed HEI made the decision to integrate quality, environmental and energy MSs was to improve the university's performance. This research made it possible to identify activities carried out at the HEI in the process of MS integration which correspond to all stages of the PDCA cycle. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
42. STRUCTURE AND FREQUENCY OF PRODUCT NONCONFORMITIES IN THE CONTEXT OF CUSTOMER SATISFACTION
- Author
-
Nenko Brkljač, Nenad Munić, Aleksandar Mićović, Aleksandar M. Kovačević, and Predrag Rakonjac
- Subjects
quality ,nonconformities ,customer satisfaction ,iso 9001 ,beta distribution ,Management. Industrial management ,HD28-70 - Abstract
The main goal of this paper is to evaluate the non-conformity of a product from the end-user point of view (assessment of conformity through second-party audits). A test sample of 510 reports about the estimation of compliance with the end-user requirements included. In doing the research, we identified 246 non-conformities, which we classified into three categories, documentation non-conformities, non-conformities established by verification, and non-conformities determined by validation. Empirically, we found the most significant group of non-conformities and calculated confidence limits for this group by using the beta distribution. We applied this type of distribution because it is a very flexible type, and it covers a wide range of different shapes depending on the values of parameters. The analysis of the obtained quantitative indicators of non-conformity showed that the purpose of the product is of the utmost importance to the end user. In connection with the non-conformity indicators, we analyzed the requirements of point 8.2 "Requirements for products and services" of ISO 9001:2015. In accordance, the manufacturer recommends the aspects on which to focus during the process of designing, developing, manufacturing and defining the requirements of the quality of its product.
- Published
- 2023
- Full Text
- View/download PDF
43. What contributes to auditee satisfaction in external ISO 9001 audits?
- Author
-
Lenning, Jan, Gremyr, Ida, and Raharjo, Hendry
- Published
- 2022
- Full Text
- View/download PDF
44. Project management performance of construction projects in Jordan: a comparative study of ISO 9001-certified and non-certified companies
- Author
-
Sweis, Rateb Jalil and Jaradat, Mais
- Published
- 2022
- Full Text
- View/download PDF
45. What would QMS implementation really bring to a company?‐ Theoretical review on benefits and disadvantages researched in practice
- Author
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Zivaljevic, Aleksandra, Zakic, Katarina, and Bevanda, Vuk
- Published
- 2022
- Full Text
- View/download PDF
46. Plan de Integración de las Normas ISO 9001 e ISO 45001. Caso de estudio: Cooperativa de Ahorro y Crédito CANAPRO C. A. C. Tunja.
- Author
-
Mejia Espitia, Miguel Leonardo, Cipagauta Esquivel, Edna Carolina, and Wilches Torres, Laura Daniela
- Subjects
COOPERATIVE societies - Abstract
Copyright of Signos is the property of Universidad Santo Tomas and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
- View/download PDF
47. INFORMATION SECURITY AND QUALITY MANAGEMENT SYSTEMS INTEGRATION: CHALLENGES AND CRITICAL FACTORS.
- Author
-
Fiore, Ana P. A., Facin, Ana L. F., and Muniz Jr., Jorge
- Subjects
INFORMATION technology security ,TOTAL quality management ,ANALYTIC hierarchy process ,SYSTEM integration ,HUMAN resources departments - Abstract
Implementing a new management system in organizations that already have a certified management system can be challenging. This research discussed enabler factors that influence the integration of an information security management system certified following ISO 27001 with a quality management system certified following ISO 9001. Five factors were identified as the basis of this research: Implementation Model, Human Resources, Resources Availability, Standard Issues, and Standards Integration. Four factors were validated through the qualitative study with consultants specialized in implementing and integrating these standards. Then, by prioritizing these factors through the Analytic Hierarchy Process method, it was found that the most relevant aspect is Standards Integration for the managers from the institution object of study. For specialist consultants, the most pertinent factor is Human Resources. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
48. RAZLIKE U PERFORMANSAMA POSLOVANJA JEDINICA LOKALNE SAMOUPRAVE U BOSNI I HERCEGOVINI SPRAM IMPLEMENTACIJE STANDARDA ISO 9001.
- Author
-
KAKEŠ, DINO and FAZLOVIĆ, SENAD
- Subjects
PUBLIC administration ,ISO 9001 Standard ,MUNICIPAL services ,PUBLIC sector ,TOTAL quality management - Abstract
Copyright of Ekonomske Ideje i Praksa is the property of Centar za Izdavacku Delatnost Ekonomskog Fakulteta u Beogradu and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
- View/download PDF
49. Investigating the Key Factors Influencing the Process Innovation Capability in Organizations: Evidence from the Republic of Serbia.
- Author
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Žižakov, Marina, Vuckovic, Teodora, Vulanović, Srđan, Dakić, Dušanka, and Delić, Milan
- Abstract
Research exploring quality management, knowledge management, and innovations in organizations has received significant attention from academics worldwide, providing different insights. Innovation has been widely seen as an essential organizational performance driver. This study aims to accentuate the importance of quality management and knowledge management and their direct, mediating, and total effect on an organization's process innovations. The double-reflective second-order construct model was analyzed following the most recent methodology guidelines. Eventually, partial least squares structural equation modeling (PLS-SEM) was used to test the research hypotheses and investigate the relations between the latent factors. The results from 264 Serbian companies that implemented ISO 9001 standard point to quality management's direct effect on process innovations and knowledge management's mediating effect on process innovation. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
50. ISO 9001:2015 vs. Factory Production Control (FPC) to ensure the quality of construction products used in road and bridge engineering
- Author
-
Joanna Prasalska-Nikoniuk, Mariusz Urbański, and Robert Ulewicz
- Subjects
iso 9001 ,factory production control ,fpc ,road and bridge engineering products ,Technology ,Ecology ,QH540-549.5 - Abstract
The study aims to define the elements of common FPC requirements and the ISO 9001:2015 standard in plants producing construction products of road and bridge engineering. The quality management system ISO 9001: 2015 may be recognized as an FPC system by-product certification organization and by the producers themselves, provided that specific requirements specified in the product standard or national technical assessment are also met.
- Published
- 2022
- Full Text
- View/download PDF
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