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This article discusses the prevalence of malaria in asymptomatic migrants from sub-Saharan Africa in Spain. The study used real-time PCR (qPCR) as a screening technique and found a prevalence of 5.0% among the screened migrants. The main species detected was Plasmodium falciparum, followed by P. malariae and P. ovale. The study also compared the sensitivity of qPCR with microscopy and found significant agreement between the two methods. However, the study has limitations, including its retrospective design and the inclusion of only self-referred patients. Overall, the findings highlight the importance of using nucleic acid amplification tests like qPCR for malaria diagnosis in this population. [Extracted from the article]

Purpose: This paper aims to analyze the impact of the adoption of ISO 14001 and ISO 9001 on the performance of Portuguese companies. The sample includes the companies listed on Euronext Lisbon, with economic, financial and specific information – the specific being environmental information and quality information – for the period between 2015 and 2019, which corresponds to the post-Troika period when some economic growth started to be witnessed. The specific information of each area is translated into the environmental certification by the ISO 14001 standard, the quality certification by the ISO 9001 standard, and sustainability reports. Design/methodology/approach: To achieve this aim, four variables were used as a measure of the companies' performance, Return on Assets (ROA), Return on Equity (ROE); Tobin's Q and EBITDA Margin. With this data, different panel models were tested to validate if ISO 9001 and ISO 14001 certifications impact Portuguese listed companies performance. Specifically, the authors have used the Generalized Method of Moments, GMM-System, an estimation method proposed by Arellano and Bover (1995) and Blundell and Bond (1998). Findings: The results show that, in general, the environment and quality variables fail to explain the dependent variables, that is, ISO certifications do not provide positive or negative variations in the performance of companies, suggesting that they are not yet as much for civil society, as well as for current or potential shareholders. When used as an independent variable, certification according to the ISO 14001 or 9001 standards, negative and significant oscillations were verified in the dependent variable, MgEBITDA, suggesting that only for managers this variable is determinant, but with a negative impact, given the high costs, it entails without pressure from other stakeholders. Originality/value: This study is the first to analyze the impact of the adoption of ISO 14001 and ISO 9001 on Portuguese companies' performance. This empirical study aims to show all investors, managers, regulators and civil society itself the long path that still needs to be taken toward sustainability. [ABSTRACT FROM AUTHOR]

Purpose: The authors extend the literature on decoupling by analyzing the microlevel effects of institutionalized practices within the framework of international standards. This study investigates the specific informal management practices that decision-makers embrace in order for organizations to achieve ISO 9001 certification without all regulations being adopted and followed according to the standard's original design and purpose. Design/methodology/approach: As the basis for its research framework, this paper adopts the neo-institutional theory. The research employs the comparative case study method and draws its data from a sample of 21 ISO 9001:2008 certified organizations in Bulgaria. Findings: The results show ambivalent behavior toward the ISO 9001 standard's formal requirements. This behavior is expressed through targeted noncompliance with (certain) regulations and procedures regarding top management commitment, as well as documented information which are formally adopted within the organization and certified as complying with the standard. Research limitations/implications: The study has implications for future research into decoupling, organizational learning, and standardization. In terms of limitations, the authors examined the process of decoupling from a micro perspective in Bulgaria only. Noncompliance with international standards such as the ISO 9000 may exhibit specific regional or national characteristics. Practical implications: Findings from this research encourage the International Standards Organization to respond to previous calls for revising the formal structure of ISO 9000 and other international management standards by considering a more flexible and liberal point of view. Originality/value: As opposed to previous studies which have explored decoupling from a macro perspective, this study focuses on how the internal constraints imposed by the standard's universal requirements are being mitigated at a micro level. That is, the authors provide a detailed account of the specific informal management practices which managers (deliberately) adopt in order to achieve certification without fully integrating the formal criteria imposed by international standards (e.g. ISO 9001). [ABSTRACT FROM AUTHOR]

Introduction and objective: The interest in improving the quality of care has led to the implementation of the International Organization for Standardization (ISO) 9001:2015 standard in the Child and Adolescent Psychiatry Unit of the Santiago de Compostela University Clinical Hospital (A Coruña, Spain). The objective of this work is to describe the methodology developed to obtain it, as well as the perceived experience of the process. Method: The steps carried out were: creation of a multidisciplinary quality work group and a work schedule; preparation of the Quality Manual, Process Map and definition of the scope of the Quality Management System; preparation and planning of satisfaction surveys; definition of operational and care processes; context and stakeholder analysis; definition of the risks and opportunities of the quality system; establishment of quality measurement indicators; establishment of actions to promote continued training; review of the quality system by the hospital management; and planning of the improvement objectives. Results: The agreed schedule was met, completing all the established tasks in a period of approximately 15 months. Finally, an evaluation of compliance with requirements/results was carried out through an internal and external audit, after which certification of the Unit was achieved according to the ISO 9001:2015 standard. Discussion and Conclusions: The implementation of the ISO standard should be considered the beginning of a working method that ensures continuous improvement, teamwork and establishes a culture of quality in the Unit through continuous monitoring of its activity. [ABSTRACT FROM AUTHOR]

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]

Purpose: Generic quality management system standard ISO 9001 and the automotive quality management system standard IATF 16949 both require organisations to demonstrate continual improvement in their customer satisfaction and the number of non-conformities identified during quality system audits. However, the long-term trends of these two parameters under ISO 9001 and IATF 16949 standards are not researched so far. It is expected that under continual improvement, organisations will achieve a step-function/stair-case shaped pattern. This study evaluates if this expectation is true when long-term performance of certified organisations is assessed. Design/methodology/approach: A longitudinal exploration of three organisations certified to ISO 9001 standard and three certified to IATF 16949 standard is done. The observations are further substantiated using secondary data for the same ten years period about customer satisfaction of the major automobile manufacturers. Findings: It is observed that none of the two indicators, i.e. the customer satisfaction and number of non-conformities, in any of the six organisations show step-wise/stair-case type improvement. All indicators followed random up and down patterns like ocean waves. It is paradoxical that certified organisations are claiming continual improvement and are remaining certified but there is actually no long-term improvement. Originality/value: Longitudinal studies for the generic quality management standard ISO 9001 and the quality system standard for automotive sector IATF 16949 are rare. The revelation about ocean wave patterns observed in the long-term trends for customer satisfaction and the number of non-conformities in ISO 9001 and IATF 16949 certified organisations is a startling finding. It is outlandishly different from the conventional perception of a staircase-styled continual improvement pattern expected a priori in certified organisations. [ABSTRACT FROM AUTHOR]

The Slovak Accreditation Agency for Higher Education (SAAHE) issued new standards and criteria for universities quality management systems in 2020 (SAAHES-IS 2020). Requirements and criteria determined in the SAAHES-IS 2020 are based on the Standards and Guidelines for Quality Assurance in the European Higher Education Area (ESG). However, some Slovak universities implemented and maintained their quality management system (QMS) according to the ISO 9001 standard in the past. The object of the research presented in our paper is a Slovak university certified according to the ISO 9001. The subject of the research is employee's awareness about selected requirements of both standards, ISO 9001 and SAAHES-IS 2020. The main objectives of the research are: (1) to identify common requirements of both standards, (2) to explore employees awareness related to the identified common requirements and (3) to create decision assumptions how processes should be assured, either in accordance with ISO 9001 or SAAHES-IS 2020. This paper has also a methodological benefit. It allows to compare any standardized management systems that have common requirements. Employees awareness of the selected quality requirements has three elementary pillars in our research. They are the knowledge about requirement definition, how the given requirement is assured in the management practice and how employee contributes in the given requirement assurance. [ABSTRACT FROM AUTHOR]

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]

This work aims to highlight the factors that characterize quality systems in the case of pressure equipment manufacturing. For the CE marking, according to the Pressure Equipment Directive (PED), the manufacturer may adopt conformity assessment modules based on the Quality System for production process, directly for the product, for its final inspection and testing or for full fabrication process, design included. At international level, the ISO 9001 standard is now consolidated and wide spread and was revised in 2015 with the introduction of new concepts. This article highlights the individual requirements of ISO 9001 which are directly and indirectly correlated with the Quality System factors required by PED. This allows to comply with the essential safety requirements of the directive following a Plan-Do-Check-Act approach and conforming to the formalization of the management systems provided by the High Level Structure. [ABSTRACT FROM AUTHOR]

Purpose: This work aims to present existing management system standards (MSSs) published by the International Organization for Standardization (ISO) through a bibliometric analysis, thereby outlining their academic research status and highlighting their relation to the Sustainable Development Goals (SDGs) as well as to environmental, social and governance (ESG) themes. Design/methodology/approach: The study firstly retrieves a preliminary set of MSSs standards from ISO and filters it in accordance with certain exclusion/inclusion criteria. Secondly, a bibliometric search is performed in the database Scopus. Thirdly, performance analysis is conducted to quantitatively measure the scientific output in academia, and science mapping of co-occurrences of keywords is applied to identify related topics. Thereby, the standards' relationships to sustainability are outlined. Eventually, the work discusses future research opportunities. Findings: The findings reveal that whereas research on MSSs focuses predominantly on only a few standards by now, there are actually numerous further standards that address sustainability-relevant topics, which are getting increasing attention among scholars as measured by the number of publications. Therefore, an action plan for future research is derived. Moreover, the findings support the argument of integrating MSSs to cover a broad range of corporate sustainability issues. Originality/value: The paper connects the concepts of MSSs and sustainability, an upcoming research branch yet characterized by shortage of academic studies (given that research continues to focus on a few standards such as ISO 9001, ISO 14001 and ISO 45001). The work therefore opens up the line for more in-detail research on less known but nevertheless sustainability-relevant ISO MSSs. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this publication is to examine approaches to determining the context of an organisation in light of the requirements of ISO 9001:2015 standard and the subject literature. The study aims to understand the essence of the analysis of the organisation's context. Design/methodology/approach: The study used a systematic literature review method. The steps of the procedure included the selection of publications from selected Web of Science and Scopus databases, as well as a review of publications available on Google Scholar, the analysis of paper abstracts to select them for full-text analysis, the identification of the main lines of research, and the identification of three perspectives of the analysis of the organisation's context: (1) those stemming from the strategic management output; (2) those determined by a quality management-centred approach; and (3) the integrated one that takes both approaches into account. Findings: The analysis of the organisation's context in the strategic management perspective focuses mainly on methods such as SWOT analysis and PEST analysis (sometimes extended by extracting additional factors for PESTEL analysis). The quality management perspective focuses on identifying customer requirements and substantiating stakeholders' needs. In contrast, the integrated perspective involves combining strategic and qualitative management methods for a comprehensive analysis of the organisation's context. Practical implications: The study provides organisations with insights into the diversity of context analysis methods and provides a basis for recommending the use of the integrated perspective for effective quality management. Originality/value: This work adds value by identifying and analysing different perspectives on the analysis of the organisation's context and demonstrating the potential for applying an integrated perspective. Promoting a better understanding of the organisation's context by management in light of the requirements of ISO 9001:2015 standard and the subject literature, can influence the alignment of quality management strategies with stakeholder and market needs. [ABSTRACT FROM AUTHOR]

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]

The analysis offers a vision of the need for the quality management system as a strategic decision that can help improve performance, provide a solid basis for sustainable development initiatives, the correct realization of processes and efficiency in services. This article shows the experience of the Bookkeeping and Management Cooperative Acerco in documenting and standardizing the processes of its quality management system, the way in which some of the requirements of the standard have been approached and the advantages of this. For this purpose, the International Organization for Standardization's 9001 standard of 2015, the organization's diagnostic methods and methodological elements of popular education are articulated, with a view to implementing a quality management system that has an impact on its members, customers and suppliers, consolidating its strengths and improving its weaknesses, seeking continuous improvement. [ABSTRACT FROM AUTHOR]

Copyright of Revista Internacional de Salud Bienestar y Sociedad is the property of Common Ground Research Networks 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.)

The article presents seven questions associated with quality management. despite changes introduced in different standardized management systems (MS) since the launch of ISO 9001 in 1987, there are various criticisms, problems and risks associated with them. Foremost, an organization's motivations to certify according to any standardized MS need to be considered.

The research's object was design a document management model with the help of the ISO 9001: 2015 STANDARD, for the generation, reception, conservation, control and elimination of documents within the ULEAM public company, so that the workers and administrative staff can carry out processes with better control in organizational activities. The methodological design of this work was based on the qualitativequantitative method, identifying through the opinion of professionals from the public company the analysis and structure of aspects related to compliance with the processes established in the document management department, it was applied techniques such as the interview and survey of administrative staff. The importance of carrying out a document management model to streamline processes and in turn have information quickly, efficiently and effectively, thus providing a better service. It was concluded with the importance of carrying out automated works to achieve a good backup of all the documentary information with the special help of authorized document management systems. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluates the implementation of ISO 9001 using total quality management on the engineering, procurement and construction phases in the Jordanian construction sector. Design/methodology/approach: A quantitative design has been employed with a total of 132 project team members selected from 5 construction organizations working in Jordan. A close-ended questionnaire was used to gather data which was later evaluated using descriptive and inferential statistics. Findings: The results show a significant role in project performance, customer satisfaction, project quality, cost-effectiveness, time effectiveness, shared cooperation and motivation of employees. It emphasizes the role of engineering in achieving the ISO 9001 standard. Quality standards in the construction project were also endorsed by 46.2% of participants, while 33.3% responded neutrally. The time effectiveness aspects of ISO 9001 endorsed by 38.5% participants 33.3% participants disagreed. Majority of the managers (61.5%) agreed that poor planning is a major barrier in the engineering phase (p-value, 0.011), followed by the incomplete design (56.4%) as the prime impeding factors linked to the decline of the quality in the construction sector. Originality/value: With the integration of the ISO 9001 quality standard, project managers can improve the project quality and make it cost-effective. The successful adaptation of the ISO 9001 certification allows the company to not only market its product/service but also internally audit itself for the possible deficits in its work capacity. [ABSTRACT FROM AUTHOR]

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.)

The development and scale‐up of lithium‐ion battery (LIB) production for a sustainable energy supply is advancing very rapidly and in versatile directions. Manufacturing processes and production steps are constantly developed and optimized to improve production efficiency. To integrate new machinery into a production line while conforming to the DIN EN ISO 9001 standards of certification, it is necessary to define the procedures for assuring product quality. Herein, a quality assurance concept is designed for an innovative flexible stacking process currently under development. Critical sources of errors are identified by employing the failure process matrix approach. On this basis, it is described how these errors are either avoided by suitable design of the machine components and its control or by which inspection technology is integrated to detect defective intermediate products. In the resulting quality assurance concept, a digital twin of the stacking machine is employed to constantly surveil process and product properties and also to facilitate the change of the produced products on the machine. Evaluating the quality management already in the design phase of the machine saves resources and enables a deeper understanding of the stacking process. [ABSTRACT FROM AUTHOR]

This research evaluates the perceptions from the conformity assessment community regarding the auditability of ISO 9001:2015 and the perception of its ease of use by the audited organisations. The study is supported on a survey promoted by the Strategic, Planning and Operations Task Group (SPOTG) of Subcommittee 2 of ISO TC 176 (TC 176/SC2) aiming at collect insights on using the standard and identify any need for future revisions. As an overall conclusion, in the view of certification bodies' auditors, programme managers and certification decision-makers, ISO 9001:2015 attained its main objectives. Nevertheless, it is suggested in the forthcoming ISO 9001 review cycle to adopt a more simplified language and to improve the ease of understanding and consistency of interpretations of the ISO 9001:2015 requirements. Additionally, suggestions for making clauses (e.g. 4.1. Understanding the organisation and its context, 6.1 Actions to address risks and opportunities, 7.1.6 Organisational Knowledge, and 4.2 Understanding the needs and expectations of interested parties) easier to apply and improving its auditability have also been identified. [ABSTRACT FROM AUTHOR]

Aim: The idea, and at the same time the aim of the paper, was to develop a model of instruments dedicated to the assessment and improvement of the quality of logistics services in coopetition and this goal was achieved. The presented article features, against the background of the coopetition of enterprises in a network, essential instruments for measuring the quality of logistics services both from the point of view of its essence as well as an innovative form of relationship, i.e. in the coopetition of enterprises in which logistics services, especially their quality, are of fundamental importance. Design/methodology/approach: Literature critical analysis. Analysis of international literature from databases as well as exploratory own research work and expert analyses. Results: The article presents the results of conceptual research on the use of an original model of instruments for measuring and improving the quality of logistics services in the coopetition of enterprises in the Deming Cycle standard and the ISO 9001 quality management system. Originality/value: Model of instruments for measuring, evaluating and improving the quality of services in competitive cooperation. The obtained results attest to the cognitive and practical value of the developed model of instruments. [ABSTRACT FROM AUTHOR]

Purpose: This paper investigates the impact of adopting quality management standards like ISO9001 on a firm's performance and the mediator role of human capabilities within firms in this relationship. The article analyses this mediator effect in the context of an emerging economy that set a policy reform aimed at increase ISO adoption and with a large share of informal labour markets. Design/methodology/approach: This study implements a quantitative approach, applying a Difference in Differences-DiD model with a Propensity Score Matching on fixed effect panel data analysis of a sample of certified and non-certified firms using firm-level data obtained from the national statistics office of Colombia. This methodology allows having comparable groups before the policy implementation. It reduces differences in observable characteristics and controls for parallel trends in primary outcomes before the policy reform. Findings: The research findings suggest that after Colombian policy reform of the quality system (2006), firms that adopted ISO 9001 certification increased innovation (5.2%), labour productivity (4.6%), sales (5.7%) and wages (4.9%). Furthermore, it shows that the share of permanent workers is an essential mediator in adopting quality programs. Adopters firms with a large percentage of temporary workers weaken their initial investment in quality infrastructure. Research limitations/implications: This research does not consider one key aspect. This is the lack of information about the organizational culture inside Colombian organizations that is related to a successful implementation of Quality Management standards like ISO 9001. However, it does not affect the conclusion about the mediation effect of human capital in the relationship between ISO 9001 and firm performance. Practical implications: The study covered all the Colombian manufacturing firms with ten or more employees. It provides critical insight for managers to value implementing ISO 9001 certification and appropriately put attention to enhancing their firms' human capital in emerging economies. Also, a policy implication of the paper is that governmental efforts to strengthen quality infrastructure in emerging economies should also include steps to increase a firm's investment in human capital. Originality/value: This study provides further support for government policies to strengthen firms' incentives to adopt modern management practices. The strong effects of implementing these management practices on sales, productivity and innovation have been identified. Furthermore, the investments in quality infrastructure must be accompanied by investment in human capital and workforce stability. [ABSTRACT FROM AUTHOR]

The purpose of this study was to offer a new approach to evaluate the index of ISO 9001 standard, as so far countries are listed for the ISO 9001 standard based only on the number of ISO 9001 certificates issued for each country, and this perception does not correspond to reality, because some countries that are listed per alphabetic order on top, doesn’t enjoy the property of having a better ranking when it comes to rank countries per number of ISO 9001 certificates issues, or when it comes to rank countries about their weight on the issue. On the other side, listing countries simply by the number of ISO 9001 certificates issued, doesn’t reflect the real weight of countries on the issue, because this rank should be adjusted with the number of businesses of countries taken into consideration, better understanding of ranking models used. A new approach to ranking countries about this issue is needed, reflecting the issue of taking into consideration the number of ISO 9001 certificates issued in a country per number of businesses in that country, as a better way of evaluating the index of ISO 9001 standard. The methodology/method used to conduct this study were (1) the data collection on the number of ISO 9001 certificates issued per country, (2) the data collection on the number of businesses in each country, (3) the division of the number of ISO 9001 certificates issued with the number of businesses, (4) construction of a new ranking list of countries based on the ISO 9001 standard index, (5) inversing the list to give the right value/rank of countries, and graphics draw of the new approach for better visualization and understanding the issue. The main conclusion of this study is that a new approach is needed to evaluate the index of ISO 9001 standard as a more appropriate indicator for listing/ranking countries and this serves all those interested in the academic field, public administration, and the reports and studies of the national and international level of organizations, to create a better perception of doing business in general and on the aspects of quality management in particular, especially when it comes to making the most appropriate comparisons between countries on these issues, weighting them numerically and graphically, as well as helps on understanding, and for a better approaching of socio and economic issues related to ISO standards and continuous improvement of people and organizations.

Total Quality Management (TQM) facilitates the achievement of continuous quality improvement by implementing several strategies, techniques, system and tools. Out of them, ISO 9001 standard based Quality Management System (QMS) was adopted widely by the organisations for achieving continuous quality improvement. Yet the outcome has not been very effective due to the absence of immutability and traceability in the theory and practices of this approach. This deficiency can be overcome if blockchain technology is used. Hence, the need of the hour is to integrate blockchain technology with ISO 9001:2015 standard based QMS. In order to meet this need, a framework has been presented in this paper. This framework facilitates the usage of smart contracts and hyperledger for achieving traceability and immutability while operating the ISO 9001:2015 standard based QMS. Further, the application of Internet of Things and artificial intelligence are indicated for implementing this integrated framework to achieve the goals of implementing TQM. The paper is concluded by mentioning that implementation in organisations in which ISO 9001:2015 standard is under operation would facilitate to check the practical viability of the framework proposed in this paper. [ABSTRACT FROM AUTHOR]

The purpose of this study is to investigate how effectively the ISO 9001:2015 Quality Management System is implemented in SMEs within the framework of the updates (e.g., risk based thinking) that came with its latest version and to reveal the challenges for the implementation of the system. In the study, it was also aimed to explain why SMEs need a quality management system and to develop suggestions for improvements that can be made to increase the success of the implementation. In the study, ISO 9001:2015 Quality Management System applications were examined in 22 SMEs operating in Kayseri province, and their adaptation to the new concepts and issues in the standard, the nonconformities and the difficulties they encountered in practice were evaluated. In this context, interviews were conducted accordance with a predefined interview protocol to collect data, thereby validating the reliability of the research. Qualitative data collected via a semi-structured questionnaire were transformed into findings with descriptive statistics and content analysis. In this study, on the basis of new concepts and themes introduced with the ISO 9001:2015 version, especially such new themes as "business planning and strategic direction", "process risk", "product and service risk", "risk associated with the control of externally provided process, product and service" were examined in detail through PDCA cycle and identified the extent to which these themes were applied in SMEs with evidences. In terms of adaptation of SMEs to these changes, different practices were observed according to firm scale. As the size of SMEs increased, the reactions to the changes in the ISO 9001 standard were welcomed and the effiency of the implementation increased. It was observed that there were nonconformities in the implementation of the process approach in the quality management system, leadership and commitment, competence, awareness, internal audit and determining risks and opportunities. The challenges experienced by SMEs in applying and maintaining the standard were determined as follows: Different interpretation of the concepts in the ISO 9001 standard by individuals, too much documentation, lack of awareness for the importance of the standard, lack of motivation, and inadequacy of Standard training. The study provides important findings for SME managers, practitioners, and researchers interested in implementing ISO 9001:2015 QMS requirements. [ABSTRACT FROM AUTHOR]

The purpose of this article is to present how modern organisations enhance their safety using quality management systems. The paper evaluates the impact of the ISO 9001:2015 requirements on the level of safety of the organisation. It cites arguments both in favour, as well as against, the implementation of the standards. At the same time, the requirements of the standard, which can serve not only to ensure the safety of the organisation's operations and management, but also to achieve an appropriate level of development, were also evaluated. The essential elements for ensuring the safety of the organisation are presented in relation to selected aspects of the standard, with a particular emphasis on activities related to the need to analyse risks and opportunities to ensure the success of the organisation.

In maximizing some of the pillars / indicators that have become superior, Indonesia needs to implement a quality management standard system to ensure that some of the pillars / indicators that have become superior have been in accordance with the wishes and expectations to be able to compete with other countries. This research aims to find out the significant factors that affect the success of chemical manufacturing companies in implementing ISO 9001:2015 quality management systems and affect the success of chemical manufacturing companies in implementing ISO 9001:2015 quality management systems that impact customers which in this case is indicated by the company's performance. The population in this study was the company's employees in the Chemicals and Goods Industry of Chemicals which amounted to 15 companies with a total of 103 employees, with the number of samples based on proportionate stratified random sampling as many as 103 samples. The data analysis method uses the Structural Equation Model-Partial Least Square (SEM-PLS) and one of the Statistical Processing Control is a pareto diagram to be able to detect specific causes as early as possible. The results found that the implementation of the ISO 9001:2015 quality management system was found to have a positive and significant influence on customer impact and organizational performance. The results of variance accounted for (VAF) testing of the implementation of ISO 9001:2015 quality management system were found to have an indirect-only mediation effect on the relationship between external auditing, employee involvement, finance, infrastructure, motivation, team work, top management commitment, training and education, to impact to customer. The implementation of the ISO 9001:2015 quality management system mediates the relationship between external audits, team work positively and significantly on organizational performance. The implementation of ISO 9001:2015 quality management system was found to have an indirect-only mediation effect on the relationship between employee involvement, finance, infrastructure, motivation, top management commitment, and training and education to organizational performance. [ABSTRACT FROM AUTHOR]

Background. The International Standardization Organization operates the world's most widely recognized quality management system standard, the ISO 9001:2015. In the healthcare sector, the adoption of this standard within an organization helps to improve the overall performance and provides a foundation for development and continuous progress. Our study aims to describe the implementation process of a quality management system according to the ISO 9001:2015 standards in an Angiology Unit of an Italian University hospital. Methods. The project was structured in 5 operational phases, which were carried out during a time frame of 14 months (March 2018-May 2019) and entailed several improvement actions associated with quality and safety outputs such as clinical management, clinical practice, safety, and patient-centeredness. Results. Implementation of the quality management system led to the improvement of many aspects of the processes performed in the Angiology Unit, both in the outpatient and day hospital setting. Overall, the project positively impacted on systems for patient safety, particularly in communication and data transmission, and clinical leadership. Conclusions. The implementation of the ISO 9001 certification is a process that apparently may seem expensive in terms of resources used, commitment, work, comparison, but it leads to substantial and always progressive improvements in the offer of Services to the user, safety both for the users and for the healthcare personnel involved, in addition to the care processes that translate into significant benefits in terms of quality of care for patients, as well as management savings for the organization. [ABSTRACT FROM AUTHOR]

Purpose: This study used a qualitative approach on five case studies in Brazilian industrial companies. The research used interviews, document analysis and on-site visits to collect and analyze data. The companies were selected based on the following criteria: operating in the industrial sector, updating their quality management system (QMS) process to ISO 9001: 2015 and agreeing to participate in this study. Design/methodology/approach: This article aims to investigate the strategies of industrial companies adopted for ISO-9001:2015 certification in light of the six major advances concerning the previous version. Thus, QMS of other organizations can incorporate identified lessons learned, whether certified or not. Findings: The main finding of the research is the systematization of a set of lessons learned in the experiences of implementing the six significant advances of ISO 9001 concerning the previous version by industrial companies in the State of São Paulo in Brazil. These lessons can and should be used by other organizations to improve their QMSs. Practical implications: The practices identified in this empirical research can serve as benchmarking to assist quality managers from other companies in QMS certification based on ISO 9001: 2015 or even those not certified but interested in updating their QMSs. Therefore, lessons learned can significantly minimize efforts to improve your projects, processes, products and services. These findings can also help industrial companies improve their production efficiency and effectiveness through quality improvement. Originality/value: The main novelty of the research is the consolidation of theoretical and practical analysis of the main changes in the latest version of the ISO 9001 standards. The efforts to fulfill those changes result in lessons learned. The "lessons learned" will form a new block of knowledge that will subsidize theoretical (new research) and practical (formulation of a new ISO 9001 standard and helps quality managers improve their systems). [ABSTRACT FROM AUTHOR]

The standard ISO 9001 is widely diffused throughout the world. The aim of the research is: (i) to evaluate companies' perception of the latest version of the standard (2015) in terms of motivations that led companies to the implementation of a Quality Management System (QMS), and the subsequent benefits and barriers obtained from its adoption and (ii) to consider organisation's knowledge of ISO 9004:2018 guidelines for obtaining a sustainable success and evaluate the main benefits organisations can obtain from adopting it, considering company dimension as a discriminating variable. The research was conducted through a questionnaire proposed to 3,975 certified companies, using simple random sampling; 493 participated to the survey and gave shape to the reference sample. The results show that larger companies have a more mature QMS, and while Micro companies approach the certification mainly for external reasons, more internal motivations are developed from larger ones. The revision of ISO 9001 requires adaptations in existing QMS and it has been revealed that the intensity with which the benefits are perceived by companies increases as their size increases, most likely because the size of a company influences its level of QMS maturity, and therefore its ability to adapt to the standard. [ABSTRACT FROM AUTHOR]

This article aims to give a detailed view of Risk Management canvas in a public organization and observe how Covid 19 was an element that made questions arise on whether probabilistic methods in evaluating risks are still reliable. We are intending to understand the unique case of the national office of airports of Marrakech (ONDA), through a qualitative method with case study approach. Data analysis is based on direct interviews with four of the company's managers. We were able to get to a first level of understanding how Risk as a concept, is perceived in the Moroccan public sector. The findings show that ONDA is advanced in the matter of risk management practices and adopt the latest tool recommended by ISO 9001: 2015 standard. It however still uses a preventive approach with probabilistic methods that proved useless to face Covid 19 pandemic. [ABSTRACT FROM AUTHOR]

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The purpose of this study was to offer a new approach to evaluate the index of ISO 9001 standard, as so far countries are listed for the ISO 9001 standard based only on the number of ISO 9001 certificates issued for each country, and this perception does not correspond to reality, because some countries that are listed per alphabetic order on top, doesn't enjoy the property of having a better ranking when it comes to rank countries per number of ISO 9001 certificates issues, or when it comes to rank countries about their weight on the issue. On the other side, listing countries simply by the number of ISO 9001 certificates issued, doesn't reflect the real weight of countries on the issue, because this rank should be adjusted with the number of businesses of countries taken into consideration, better understanding of ranking models used. A new approach to ranking countries about this issue is needed, reflecting the issue of taking into consideration the number of ISO 9001 certificates issued in a country per number of businesses in that country, as a better way of evaluating the index of ISO 9001 standard. The methodology/method used to conduct this study were (1) the data collection on the number of ISO 9001 certificates issued per country, (2) the data collection on the number of businesses in each country, (3) the division of the number of ISO 9001 certificates issued with the number of businesses, (4) construction of a new ranking list of countries based on the ISO 9001 standard index, (5) inversing the list to give the right value/rank of countries, and graphics draw of the new approach for better visualization and understanding the issue. The main conclusion of this study is that a new approach is needed to evaluate the index of ISO 9001 standard as a more appropriate indicator for listing/ranking countries and this serves all those interested in the academic field, public administration, and the reports and studies of the national and international level of organizations, to create a better perception of doing business in general and on the aspects of quality management in particular, especially when it comes to making the most appropriate comparisons between countries on these issues, weighting them numerically and graphically, as well as helps on understanding, and for a better approaching of socio and economic issues related to ISO standards and continuous improvement of people and organizations. [ABSTRACT FROM AUTHOR]

This article examines and analyses the use of ISO international standards to assure the quality of higher education. It identifies the specifics of the ISO international quality management system in higher education. It makes a comparative analysis of basic principles of ESG, ISO 9001:2015 and ISO 21001 and determines that ISO 9001 standards are general in nature, they do not offer any specific model of the quality assurance management system and provide an organization with the freedom to create its own industry-specific quality assurance system meeting the requirements of the general management system. Therefore, these standards should be used to develop and establish the quality assurance system in higher education. It is stated that ISO 21001 Educational Organizations - Management Systems for Educational Organizations, specially developed for the educational industry, includes the methodological framework to create the effective management system for educational institutions and provides additional mechanisms for the ESG efficient implementation and development. The application of ISO standards in higher education will help improve the quality of rendered services, increase the competitive ability of higher education institutions and stimulate the development of innovative society in the global perspective. [ABSTRACT FROM AUTHOR]