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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 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]

ISO 9001 is a certifiable international standard issued by ISO (International Organisation for Standardisation). Several benefits related to employees, companies, and the business environment are correlated to this standard. The Bayesian statistic can be used to fit regression models to data, presenting some advantages. The objective of this study is to verify, through Bayesian regression models, the relationship between the numbers of ISO 9001 certificates issued in Brazilian states and the macroeconomic factors. Furthermore, this study also aims to compare the relationships in the states with the relationships in the region of each state. The estimated model parameters indicate a significant relationship between some macroeconomic factors and the number of ISO 9001 certificates for the Brazilian state. Hence, considering the macroeconomic factors as indicators of specifics of the state economy, the local relationship between these aspects and the business environment, indicated in part by the number of ISO 9001 certificates, can be better understood. The most economically important states influence substantially the relationships of their regions. The main novelty of this paper is the analysis of the relationship between the Brazilian macroeconomic factors and the number of ISO 9001 certificates issued at state and regional levels. [ABSTRACT FROM AUTHOR]

Research on internal audits of quality management systems is scarce, and no clear study exists that could guide practitioners in improving the auditing practice and help researchers advance existing knowledge. Thus, the aim of this paper is to review empirical research on internal audits of ISO 9001 to synthesise advice for increasing the value of internal audits and to establish a research agenda. The research method used in this paper is a systematic literature review. The result from a thematic analysis revealed two main causes for why internal audits should be improved, three main areas of what to improve, and three groups of suggestions for how audits can be improved. In conclusion, this review show that earlier research agrees on that internal audits focus too much on compliance and less on improvements, and that auditors should improve their knowledge, skills, and audit planning. The implications of this paper are consolidated in four propositions for future research, focusing the need for (1) more research contributing to both practice and theory, (2) enhanced focus on organisational needs and improvement opportunities, (3) changes in audit planning and auditor skills to enable process-oriented auditing, and (4) how to implement changes in internal auditing. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to investigate through an exploratory research the factors that are important for improving quality performance in SMEs through internal audits. The research employed a Delphi method and a 95% confidence interval (CI) using a sample of Italian SMEs. The quantitative results have been enriched by qualitative suggestions. The findings show that the important factors for improving quality performance are auditing key performance indicators (KPIs) as well as economic and financial indicators and controlling improvement initiatives. It is also important to have top-management commitment and to employ tools and principles from the Lean Six Sigma and TQM movements. Some controversial results pertaining to the use of managers for internal audits were revealed as well as auditors' knowledge of the products/services. Further, respondents believed that audits should be based on process mapping rather than formal procedures and that it was unnecessary to utilise qualified auditors. Although this research paper has its main limitation in collecting data from Italian SMEs only, we believe that the findings of this research could be useful to practitioners who want to improve the performance of the ISO 9001 Quality Management System (QMS). The findings also open avenues for further research. [ABSTRACT FROM AUTHOR]

The ISO 9001: 2015 incorporated requirements for risk-management approach in its most recent version as part of the assured quality concept evolution. In this context, the research aims to analyse if an organisation has practices implemented to meet the requirements associated with the risk management to enable ISO 9001: 2015 implementation and certification. To accomplish this, a case-based research was adopted at an automotive company. The research results indicated that risk management approach is part of the culture at the analysed company and is already being addressed in some of the organisation's processes, among which are the product development process, supply chain management, and machine and equipment management. The paper also suggests a checklist for assessing the ISO 9001: 2015 risk management requirements compliance, which can be used as a framework for future research replication, including different segments of the industry, as well. [ABSTRACT FROM AUTHOR]

The aim of this study was to analyse the simultaneous effect of a set of predictors of the impact perceived by teachers and managers of implementing two Quality Management Systems (QMS): European Foundation for Quality Management (EFQM) and ISO:9001 STANDARDS. A sample of 2869 subjects from 114 Spanish schools has been taken, to which a 91-item questionnaire has been applied to assess the perceived impact that the implementation of QMS has had on the schools. Data analysis was carried out using hierarchical-linear modelling. Results show a high level of impact in Management and Planning system and medium impact in Communication, the Learning Process and External Relations. The main predictors of the impact are the position and years of service at the school (on Level 1 -Subject-) and ownership, school size and QMS implemented (on Level 2 -Schools-), finding that the impact perceived in schools with EFQM was higher. The specialised literature shows the scarcity of studies on the impact that QMS have on organisations, especially in the education sector. Thus, this study provides conclusions to the scientific and professional community with objective evidence of predictors of the impact perceived by teachers and managers of implementing QMS in schools. [ABSTRACT FROM AUTHOR]

For most countries around the world, small and medium-sized enterprises (SMEs) play an important role in the economic development, but they are usually embedded with weak competition as opposed to big enterprises. The pursuit of quality is often adopted by SMEs as the main strategy to raise their competitive advantage. In order to reveal the SMEs' implementation status of quality practices, and also to find out where to be improved, we first develop a 'systematic framework of quality management with five stages' for SMEs, and then conduct the related empirical study to investigate the implementation status of the practices in these five stages for SMEs. We also analyse the implementation performance of the practices by using a developed implementation-effectiveness analysis model. SMEs usually implement more practices belonging to the lower stages, but the adoption of total quality management (TQM) is an exception, since the governments in Taiwan provide financial motivation to support SMEs to implement the quality practices of TQM. Based on the analytical results of the implementation-effectiveness analysis model, SMEs need to raise the implementation levels on the critical practices which will result in significant effectiveness degree, for examples, lean production, process capability control, customer relationship management, and performance management. [ABSTRACT FROM AUTHOR]

The study investigates the relationship between quality management practices (QMPs), quality management system (QMS), firm performance and competitive positioning in the context of micro, small and medium enterprises (MSMEs). We build a structural model showing how QMS mediate the relationship between QMPs and firm performance and further integrate the model to investigate the effect of firm performance on competitive positioning. We found a significant direct relation (0.15 < β < 0.45) between strategic, tactical and operational QMPs and firm performance and observed that their relationship is stronger (0.64 < β < 0.69) in the presence of QMS. Results further imply that although QMS does not directly influence competitive positioning (β = 0.05, p > 0.05), it does so indirectly by improving firm performance (0.43 < β < 0.55). Thus, implementing QMPs, along with obtaining QMS certification provide most privileges concerning firm performance. Further, emphasis on cost, quality, flexibility and delivery to delight customers seems to provide a medium by which MSMEs can sustain competitive advantage. [ABSTRACT FROM AUTHOR]

The purpose of this study is to assess whether companies conduct preparations, such as managing culture, before starting to implement an ISO 9001 Quality Management System (QMS). Based on a literature review, the paper develops a model of firm preparation for ISO 9001 certification and several research hypotheses. The survey research method adopted consists of data collection through questionnaires – sent to hotels of four and five stars, in Portugal, in two different moments (2012 and 2014) – and of a longitudinal data analysis based on non-parametric statistical tests. Results show that the majority of companies conduct preparations before starting to implement an ISO 9001 QMS. However, most companies do not assess their initial situation, nor do they plan for the preparations. One of the significant implications from this research is that a more coherent and integrated approach in ISO 9001 preparation is required. Other implications for practice and for research are also noted. This is the first study, as far as the authors are aware of, that addresses the topic of planning for the preparations that a company can make before starting to implement an ISO 9001 QMS. [ABSTRACT FROM AUTHOR]

In this study, it is shown the attitudes and approaches behind the two important function-specific management system standards developed by International Organization for Standardization, namely quality management system (QMS) based on ISO 9001:2008 and risk management system (RMS) based on ISO 31000:2009, are largely similar and complementary. Also, both these management systems (MSs) are essential elements of organisational performance management system. Thus, as the key result, integration of the above MSs is suggested and a conceptual model to support this integration is introduced. The integration model is called risk-based quality management system. The main driver for such integration are: to reduce the number of MSs in an organisation and hence to decrease the number of resources employed and to enhance the organisation performance as both RMS and QMS are two sides of the same coin. The proposed risk-based conceptual model is built upon a review and analysis of authoritative journal papers in the field which shows there are some gaps. The risk-based conceptual model is developed on the basis of total quality integration model and the process approach. Finally, to implement the proposed model, an implementation methodology is suggested. [ABSTRACT FROM AUTHOR]

Based on reverse thinking, this research defines the concept of the 'ISO 9001 effectiveness gap' for the first time and establishes the ISO 9001 effectiveness gap model. A research study was carried out in 413 ISO 9001 certified companies in Beijing City, Shandong Province, Anhui Province and Guangxi Province, which are representative in China. Data were obtained through a structured questionnaire and have been analysed with exploratory and confirmatory factor analyses using Smart PLS 3. The present study findings show that motivation barriers, top management barriers, employee barriers, resource barriers, and certification organisation barriers all have positive impacts on the ISO 9001 effectiveness gap. In addition, the research also finds that top management barriers play a central role in the model of the ISO 9001 effectiveness gap and that employee barriers are affected by some other factors. It is also important to note that the role of certification organisation barriers cannot be ignored. The present study findings can provide some inspirations for different participants such as companies, certification organisations and government to design efficacious strategies to reduce the ISO 9001 effectiveness gap. [ABSTRACT FROM AUTHOR]

We review existing work on synergies between information systems (IS) and quality management systems (QMS) and propose avenues to advance them further, leading to a whole that is greater than the sum of the two parts, moving away from current practice, where the lifecycles of IS and QMS are handled independently, by different teams, equipped with disconnected tools and methodologies. We start with a literature review that makes sense of a puzzle of 91 articles published since 1979. Three focal categories of papers are identified and discussed, namely (1) IS in support of QMS, (2) QMS in support of IS, and (3) a shared view of IS and QMS. As 80% of the papers address the limited perspective of one type of system being dominant, in the second part of the paper we propose a map for further research. [ABSTRACT FROM AUTHOR]

Compared with the traditional physical market, the problems of information asymmetry and quality uncertainty are more serious in online shopping markets, especially for the fast-developing Chinese online shopping market. In recent years, the interested parties including the online shopping platform, the government regulatory agency and the seller have strengthened product quality control. But in the academic field, there is still a gap in systematic research in this field. Based on the research gap, this article constructs the model of three-level product quality control in Chinese online shopping, then builds an index system of the product quality control ability of the online shopping platform in four dimensions: trust, website informativeness, product diagnosticity and social presence, and finally evaluates the quality control ability of Taobao. Some conclusions are reached. Firstly, the product quality control of Chinese online shopping operates by the three-level control system including the government regulatory agency, the online shopping platform and the seller. Secondly, trust is the most important index to evaluate the product quality control ability of the online shopping platform. Thirdly, after a few years' rectification, the product quality control ability of Taobao is good currently. [ABSTRACT FROM AUTHOR]

A quality management system is an important tool for improving an organisation's performance. It is widely applied in private companies, but is rarely used in the field of scientific research by public bodies. The aim of this study is to describe how an ISO 9001:2008 quality system can improve the performance of a research institute by introducing the 4A's strategy: Audit, Awareness, Assessment, and Accountability. Data collected before 2007 are compared to those obtained in the period between 2008 and 2012, and data analysis shows a general improvement in all Institute performance indicators. We could assert that paying maximum attention to the transparency of objectives, prevention, and systematic evaluation of continuous improvement provide surprising scientific and economic dividends even in a public research body with very limited carrot-and-stick potential regarding incentives and rewards for personnel. [ABSTRACT FROM AUTHOR]

The successful implementation of quality management systems in higher education relies on the ability to address topics meaningful to stakeholders. A topic that is moving to the top of many higher education institutions agendas and is meaningful to students, faculty and management is student dropout. Alongside its social and personal consequences, dropout impairs cost efficiency and the institution's image. This paper shows that in spite of the complex web of factors influencing student dropout, simple models for the identification of students at risk of dropping out can be derived and used to support decision-making. The paper starts with an introduction to dropout models. Next, the difficulty in implementing quality management systems in higher education is addressed; details about a process for the identification of at-risk students are presented. A case study is used to show that it is possible to identify at-risk students using only academic data and administrative records. Finally, the advantage of including an at-risk student identification process within the framework of a higher education quality management system is discussed. [ABSTRACT FROM PUBLISHER]

During the past three decades, ISO 9001 certifications have facilitated contemporary organisations to systematically achieve continual quality improvement. In the same period, Six Sigma has propelled organisations towards achieving zero defect manufacturing. Though these objectives are closely coinciding, the synergy of implementing ISO 9001 standard and Six Sigma has been eluding the contemporary organisations. This situation creates a need to globally view the development that has been occurring in the direction of integrating ISO 9001 certification and Six Sigma. This study reports a literature review conducted in this context. The result of this literature review indicated that, very little work on integrating Six Sigma and ISO 9001 standard has so far been carried out. Hence, it is concluded that the recent most version, namely ISO 9001:2008 standard is to be amended with the ideals of Six Sigma. In order to carry out this task, a roadmap is contributed in this paper. [ABSTRACT FROM AUTHOR]

This paper analyses interactions between two parties (management and employees) with regard to the question of how to successfully manage and implement a quality management system (QMS). It also introduces practical possibilities for improving the employees’ understanding of why a QMS must be applied and how management should behave to make it possible. The paper also introduces a role of a third party (a quality representative) who must carefully choose his actions and must, above all else, be aware of the importance of open communication channels among the first two parties. Data were obtained from a research study using a survey among employees of a Slovenian information and communication technology company over a 2-year period. We found that communication between employees and management has significant importance on employee satisfaction. Therefore, communication is the essential element of successful and continuous improvement of the quality management system, in which management must be the first to show the awareness of the real purpose of the QMS, and must attract their employees’ attention as well as acknowledge their expectations. However, it should be noted that this factor can be stronger in a high technology company with a higher level of employee education. Conclusions are offered to improve the relationship among all parties through an improved status of the quality representative position over employees, his formal direct access to the management and the right to exercise and manage internal auditing of the system. Nevertheless, informally his role is far greater and consists once again of the crucial element of successfully and continuously improving of the QMS: communication. [ABSTRACT FROM AUTHOR]

This study attempts to examine Six Sigma activities of domestic industries in Taiwan. A suitable research structure includes managerial and performance variables for the industrial environment in Taiwan. Managerial independent variables include the factors of 'strategy', 'project', 'training' and 'customer'. Meanwhile, the performance dependent variables include the factors of 'delivery', 'flexibility', 'quality' and 'cost'. Through questionnaire investigation and collecting samples, this study applies a questionnaire investigation to local and transnational enterprises that have implemented Six Sigma in Taiwan, and then conducts analysis and makes suggestions. The investigation also explores the drivers and obstacles associated with the implementation of Six Sigma. The study sample comprised 19 firms, including ten Taiwanese enterprises, and nine transnational enterprises. Using SPSS statistical skills, topics examined in this investigation included drivers and obstacles associated with the implementation of Six Sigma, analysis of the mean differences between managerial and performance variables, and cognitive analysis of the differences between local enterprises and transnational enterprises in Taiwan. [ABSTRACT FROM AUTHOR]

This article examines the selection criteria used by hospital managers when choosing a quality management system (QMS): ISO 9001, Joint Commission (JC), EFQM, or a combination of them. Furthermore, this study provides a view of how extensive is the use of QMS in the main Spanish hospitals. Between December 2004 and March 2005, a questionnaire was sent to Spanish hospitals of size > 400 beds. Of the 101 hospitals that met the conditions of research, 42 responded to the survey: a response index of 41.58% (95% reliability and maximum margin of error of 11.6%). We have deduced the selection criteria from a contents analysis of the three models. We have confirmed two hypotheses: first, that there are 16 relevant selection criteria for hospitals when deciding on a QMS; and secondly, that they choose QMS on the basis of the priority they attribute to given selection criteria. The data lead us to the following conclusion: implementation of QMS in Spanish hospitals is quite extensive: 71.4% use ISO 9001; 11.9% JC, and 69% EFQM. The combined use of ISO 9001 and EFQM (47.6%) has also been noted. 15 of 16 criteria have been shown to be relevant, and no new criteria have been discovered. [ABSTRACT FROM AUTHOR]

Workers sometimes violate, more or less deliberately, Quality Management System (QMS) procedures and rules, and two of the most essential causes of such violations are the attitude and motivation of the workers. The effectiveness of a QMS may therefore benefit from management tools aimed at promoting desired behaviour. The result could then be a behaviour-oriented frame for the QMS. The concept of individual accountability, a pivotal concept in performance management models, may serve to develop such a frame. In this study, the relationship between individual accountability factors and the effectiveness of a QMS is investigated. Individual accountability is conceived of as the interplay among three factors: system clarity, social support and personalized responsibility. Data were obtained by conducting a survey and by interviewing employees of a large gas company. We found positive relationships between all three accountability factors and belief in the QMS as well as use of the QMS. Personalized responsibility and social support appeared to strengthen the relationship between system clarity and belief in the QMS, whereas the same factors appeared to weaken the relationship between system clarity and use of the QMS. Apart from being motivators in themselves, the three accountability factors thus seem to form a system of interrelated factors. [ABSTRACT FROM AUTHOR]

Reverse logistics management addresses a number of processes that have a direct or indirect impact to cost of quality. The development and implementation of a diagnostic tool to fully identify and measure this impact can indicate the way improvement of reverse logistics management may lead to final cost reduction through reduction of cost of quality. Internal reverse logistics management is also taken under consideration. The mechanism of the diagnostic tool is process oriented and provides cost functions for selected processes. An assessment procedure follows for goal setting and action planning. The existence of a quality management system is a prerequisite for the implementation of the tool. Additionally, there are specific arrangements to increase the effectiveness of the tool and to facilitate its compatibility with the special characteristics of the organization. The implementation of the tool can benefit organizations in a number of ways, all of which contribute to competitiveness increase. [ABSTRACT FROM AUTHOR]

This research analyses the factors that determine the performance of ISO 9000 standards in Japanese industries. A questionnaire survey was conducted to collect data from ISO 9000 certified companies nationwide. Our research hypothesis is that the performance of ISO 9000 depends upon the aspects that motivate a company to obtain certification, the process followed or approach taken during preparation for registration, the maintenance activities after certification, and the practice of previous or existent quality measures within the organization. These measures should predict how successful the standards are for an organization. In order to test the hypothesis, statistical data analysis includes t-test of the means, factor analysis, and regression. Slightly different trends are found in small, medium, and large organizations regarding the potential benefits from the ISO 9000 system and the influential measures. Small corporations focus on motivational issues and implementation procedures during the preparation for registration stage. In the case of medium size companies, motivational aspects, implementation procedures, maintenance activities, and previous/existent quality measures are all emphasized. Large corporations, similar to medium corporations, focus on the four independent variables, emphasizing the significance of employees' involvement and understanding, MIS, and Six Sigma. Our findings suggest that the integration of the influential issues within the organizational system allows the organization effectively to improve quality, minimize cost, develop international markets, and optimize profits through ISO 9000. [ABSTRACT FROM AUTHOR]