Purpose: The ISO 9000 family of standards is the most noted standard concerning quality management and its realisation. Over one million organisations are certified according to the requirements of ...ISO 9001 worldwide. Especially in Europe, this standard has an outstanding status. An ISO certification creates trust between customers, partners and suppliers. In addition, it drives the companies to improve continuously in order to get a recertification.
For September 2015, a revision of the ISO 9001:2008 was published. It shows many differences compared to the version of 2008. These changes mean various challenges to companies, which want to get a recertification. A main modification is the risk-based approach, which requires that the companies plan and realise measures to treat risks and chances. Particularly in Europe, the ISO 9001 revision is one of the main topics of discussion in quality management. To investigate the current status how companies in Germany fulfil the additional requirements, and especially the challenge of risk consideration, the division for quality management of the Fraunhofer IPK conducted a study with 1175 participants. The paper will firstly address the changes mentioned and the associated challenges to give a good overview and show that the new ISO 9001:2015 offers the chance to improve for organisations. The main focus of the paper will be to present the results of the study and thereby to show the status of preparation for the new ISO 9001 of German companies of all sizes.
Design/methodology/approach: After an introduction to the ISO 9001:2015 and its changes and challenges, the paper follows the same structure as the survey itself. It gives an overview of the demography and results of the study and ends with a conclusion.
Findings: Most German companies neither consider themselves well prepared nor do they claim to possess sufficient knowledge about the new requirements included in the revised ISO 9001 standard. The need for action is especially great regarding the new requirements subsumed under the classification of risk-based thinking. The aforementioned applies to small and medium-sized enterprises as well as to large companies. Most organisations define risk as the effect of uncertainty with solely negative effects. Therefore, only a minority evaluates both risks and chances instead of only risks.
Furthermore, enterprises mostly neglect planning of actions to address identified risks. Only in a few cases, companies do implement trainings to improve their employees' capabilities regarding risk management. The afore-cited applies even though companies consider a lack of experience the main challenge related to the analysis and assessment of risks. Additionally, other newly established requirements of the ISO 9001:2015 are also only fulfilled by a minority of participants. These new requirements include the need for measures to determine the expectations of interested parties and the necessity that modi operandi are implemented which ensure that knowledge is maintained and made available to the extent necessary.
Originality/value: The paper considers the study results from different angles and shows the changes and challenges of the ISO 9001:2015.
Introdução: A gestão da qualidade é um mecanismo de destaque no contexto gerencial, firmando-se como espaço teórico e prático de produção de conhecimento e influenciando a execução e o controle nos ...processos de trabalho nas organizações. Objetivo: Identificar a aplicação de práticas de gestão da qualidade, por meio de autoavaliação, em órgãos de Vigilância Sanitária. Método: Estudo exploratório descritivo, de autoavaliação, com uso de formulário eletrônico para a coleta de dados. Foram selecionados e aplicados requisitos considerados iniciais em um modelo de Sistema de Gestão da Qualidade, a partir da norma ABNT NBR ISO 9001:2015. Com o intuito de consultar órgãos de Vigilância Sanitária que exercessem ações envolvendo atividades de alto risco sanitário, foram considerados municípios e estados em cujos territórios houvesse concentração de, pelo menos, três unidades industriais fabricantes de medicamentos, insumos farmacêuticos ativos e produtos para a saúde classes de risco III e IV. Assim, o universo do estudo compreendeu sete estados e 32 municípios, nos quais estavam instalados, respectivamente, 94,0% e 63,0% do parque industrial brasileiro das referidas indústrias, no ano de 2018. Resultados: Observou-se que, nos órgãos de Vigilância Sanitária estudados, existem práticas de gestão da qualidade sendo executadas, sendo que as práticas de planejamento e apoio são as mais difundidas, enquanto as voltadas à avaliação de desempenho são as menos presentes. Conclusões: Conhecer o grau em que os órgãos de Vigilância Sanitária atendem aos requisitos iniciais de cada uma das seções de um modelo de Sistema de Gestão da Qualidade contribui para confirmar o potencial para implantação de princípios da Gestão da Qualidade nos entes que compõem o Sistema Nacional de Vigilância Sanitária, para que esses estejam em sintonia com as exigências de melhoria de gestão impostas pelo ambiente regulatório nacional e internacional.
More than one million certified companies must choose, every three years, whether to renew or to withdraw from ISO 9001 certification. This paper investigates whether ISO 9001 decertification ...decision is driven by economic motivations. Using standard event-study methods, the paper looks into this question by comparing the abnormal performance of a sample of Portuguese firms that lose their certification with that of similar, non-event, firms. The paper finds no statistically significant differences in the economic performance of these two sets of firms in their post-ISO certification period. Such evidence suggests that economic underperformance is not the reason why companies are ISO decertifying and further suggests that the decision to decertify is economically irrelevant. The study advances possible explanations for this (ir)relevancy and puts forwards implications for theory and for the ISO 9001 governance system. The governance system must change in order to increase the economic benefits that organisations can expect to gain from ISO (re)certification. This is the first study assessing the impact of ISO 9001 certification on firms that subsequently lost the certificate.
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.
Purpose: The purpose of this paper is to determine the similarities and differences between the benefits derived from implementing the ISO 9001 and the ISO 14001 standards. Methodology/Approach: The ...paper reviews the literature using an electronic search in the ScienceDirect, ABI/Inform, Emerald databases to identify papers focusing on the adoption of the ISO 9001 and 14001 standards and the benefits derived from implementing them. Findings: The paper identifies 82 articles about ISO 9001 and 29 about ISO 14001. Although some differences can be observed between the benefits considered by ISO 9001 and 14001, there is a great degree of coincidence in the benefits studied. The review suggests 13 benefits as the most usually analyzed (including environmental performance for the case of the ISO 14001 standard) by scholars. It is suggested that both standards have clear benefits on operational, people and customer results and that the effects on financial performance are inconclusive. Limitations/implications: One limitation of this paper is that the works identified are conditioned by the search strategy used. In addition, other key words could be included in future studies such as operational, market, quality, financial performance, and customer satisfaction in order to expand this search. Originality/Value: The main contribution is that the paper identifies the literature gap and future research proposals with regard to the benefits of the ISO 9001 and ISO 14001 standards.
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.
Gastronomy management Bernardo, Merce; Escalante, Raúl; Roca, Joan ...
The International journal of quality & reliability management,
01/2017, Letnik:
34, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Purpose The purpose of this paper is to analyze and compare the existing management system standards in the gastronomy sector. Design/methodology/approach On the basis of secondary data, the most ...implemented management system standards within this sector are analyzed, namely, the ISO 9001 focusing on the sector of “hotels and restaurants,” the ISO 22000, the “Q” Spanish tourism-specific standard, and the Michelin stars system. Findings The results, although descriptive, show the differences among them. Regarding the content, the main difference between the documented management system standards and the Michelin stars system is in the evaluation and certification process, as it is known and planned in the former group but not in the latter. The scope is also different, as the former group refers mainly to the process and the latter to results. The diffusion results confirm the increase in sectoral management system standards. Originality/value Although studies analyzing the importance of sectoral standards have been published, this study is one of the first focusing on four different management system standards in the gastronomy sector. Implications for both practitioners and academia are also discussed.
We hypothesize a model where domestic and international institutional pressures lead to the successful implementation of ISO 9000 and can in turn lead to the successful implementation of ...environmental management systems such as ISO 14001 environmental certification systems or total quality environmental management (TQEM) systems. Using appropriate tests for mediation with dichotomous mediators and outcomes, we find that the model holds for a sample of 377 Chinese manufacturers in six major industrial groups in Suzhou, Dalian, and Tianjin. Our findings are consistent with the theory linking internal capabilities to heterogeneous external (in this case, institutional) pressures on organizations for environmentally proactive efforts. Our findings suggest that institutions in developing countries with significant environmental concerns such as China as well as foreign suppliers and partners to firms in these countries should encourage and support ISO 9000 implementations by local firms. These findings may influence other developing nations' adoption of quality and environmental process systems.
► We examine the effect of ISO 9000 for environmental management systems adoption. ► Empirical evaluation from 377 Chinese manufacturing firms using a robust logistic regression approach. ► ISO 9000 is helpful for ISO 14001 and other EMS adoption given various institutional pressures. ► International organizations may justify ISO 9000 as a supportive tool for implementation of broader systems.
Considering the importance of small and medium-sized businesses in the economy and that the majority of quality management systems (QMS) implemented in SMEs are based on the requirements of the ISO ...9001 standard, with this work our focus is on studying the influence of ISO 9001 standard certification on performance in SMEs. The data was collected through interviews in two SMEs. The study showed that the implementation of an ISO 9001-based QMS has distinct effects on the performance of the SMEs studied. While the implementation of such QMS had significantly improved the performance in one of the companies, in the other, the few changes brought by certification were in terms of external image and organization of documentation and may not be deemed to affect performance significantly.
Small and medium-sized enterprises (SMEs) stand out in the economy of countries, since they act as a source of income and employment for the population, social cohesion, market diversification, in ...addition to contributing to poverty reduction. Currently, companies around the world have faced the consequences of the economic crisis caused by the Covid-19 pandemic, mainly SMEs. The demand for initiatives that contribute to increasing the productivity of SMEs is related to their importance for the countries' economy. One of the factors to increase the competitive capacity of SMEs is to encourage quality and compliance certification through the ISO 9001. This paper proposes a methodology for assessing the main difficulties faced by SMEs in implementing ISO 9001:2015 requirements. This research is exploratory and qualitative. A case study was carried out in two Brazilian enterprises. The results indicate that the barriers associated with the implementation of the requirements are mainly associated with leadership, engagement of people, process approach, improvement, evidence-based decision making and risk management. This study provides important conclusions for managers of SMEs in implementing the requirements of the ISO 9001:2015.
PDF
