Os aglomerados de pequenas e médias empresas têm recebido grande atenção devido ao potencial de desenvolvimento econômico e social que eles representam. Percebe-se que, ao aproveitar as semelhanças existentes entre as empresas de um aglomerado, a aplicação de ferramentas de melhoria organizacional pode ser potencializada. Da mesma forma, a necessidade de aumentar a competitividade das empresas pela implantação dessas ferramentas pode estimular o desenvolvimento de ações conjuntas. Nesse sentido, este trabalho teve por objetivo propor um processo de implementação de um Sistema de Gestão da Qualidade (SGQ) para grupos de empresas. O trabalho consistiu em um levantamento bibliográfico, além do desenvolvimento da proposta e de uma pesquisa de campo. As etapas de pesquisa de campo envolveram a identificação, a escolha e a caracterização do aglomerado e das empresas típicas do aglomerado. Com o levantamento dessas informações, foi elaborada uma estrutura para implantação do SGQ, delineada com base no estudo de caso do aglomerado de empresas de máquinas e equipamentos da cidade de Sertãozinho. A partir deste estudo, propôs-se uma estrutura documental e um processo de implementação conjunta de um SGQ baseado nos requisitos da ISO 9001:2000. Foi possível constatar que as similaridades existentes entre as pequenas empresas, aliadas à necessidade e ao tipo de relacionamento da cadeia local, facilitam o desenvolvimento de um processo de implementação conjunta. A proposta foi avaliada por meio de entrevistas com representantes de empresas e entidades do aglomerado de Sertãozinho. A partir dessa avaliação, foi possível perceber que a proposta é viável, no entanto, dependerá da preparação das empresas e também do apoio de instituições e empresas que exercem a governança na região. / Small and medium-sized entrerprise clusters have received great attention due to their potential for promoting the economic and social development of the companies they represent. Upon exploiting the similarities among companies from the same cluster, the application of continuous improvement tools is facilitated. Following this line of thinking, the necessity of increasing companies\' competitiveness through the deployment of these tools may stimulate the development of collaborative initiatives. Therefore, the objective of this research is to propose a process for deploying a Quality Management System (QMS) for groups of companies. This work consists of a literature review, the proposal development and a field research. The stages of the field research included the identification, choice and characterization of the cluster and its typical companies. Based on this data, which was obtained by means of a case study undertook in Sertãozinho industrial machine and equipment cluster, a structure for deploying the QMS was built. Later, a document structure and a join action process for the QMS based on the requirements from ISO 9001:2000 was proposed. Interviews with the representatives of some companies from this cluster were used to assess the proposal. These interviews showed that this proposal is viable, but its success will depend on the companies\' preparation and also on the support of the institutions which govern the region.

Orientador: Iris Bento da Silva / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Engenharia Mecânica / Made available in DSpace on 2018-08-16T17:09:45Z (GMT). No. of bitstreams: 1 Santos_JadirPerpetuodos_D.pdf: 5968712 bytes, checksum: b9996fe6c706dab0901d54ec6a53c1ca (MD5) Previous issue date: 2010 / Resumo: Em momentos de pressões crescentes, empresas se veem compelidas a modificar suas estratégias e ajustarem-se às oportunidades e ameaças que se transformam rapidamente, o que as fazem depender de um processo contínuo de aprendizado. O objetivo central deste trabalho é desenvolver um método que permite identificar e avaliar as dificuldades encontradas pelas empresas, que foram certificadas pela Norma ISO 9001: 1994 e que migraram para a versão ano 2000 e, ainda, foram recertificadas na versão ano 2008 dessa Norma que passou da ênfase em requisitos para o enfoque em processos e seus resultados. Para alcançar tal objetivo, iniciou-se com a metodologia de survey em empresas do setor metal mecânico. Posteriormente, foi desenvolvido um modelo para se alcançar a excelência e, por fim, elaborou-se a técnica de múltiplos casos. A partir da survey, dos múltiplos casos e da construção de um modelo, foi possível identificar os principais dificultadores de implementação dos Sistemas de Gestão da Qualidade, possibilitando, assim, potencializar a implementação de um Sistema de Gestão, com riscos minimizados e resultados duradouros através da excelência / Abstract: In times of increasing demand, companies feel compelled to change their strategies and to adjust themselves to opportunities and threats which have been rapidly converted, making them depend on a continuous learning process. The objective of this work is to develop a method to identify and go into the difficulties found by companies certified with "ISO 9001: 1994" and also with the "2000" version and even with the one in "2008". It has moved from simple emphasis on requirements to the focus on processes and outcomes. To achieve this goal, we had begun with the methodology of company survey in the metal mechanic sector. Afterward a model was developed to achieve excellence and to develop the technique for multiple cases. From the survey on the multiple cases and the construction of a model, it was possible to identify the main hinderer for the implementation of Quality Management Systems, allowing the implement of a way to minimize risks and mall results last through excellence / Doutorado / Materiais e Processos de Fabricação / Doutor em Engenharia Mecânica

The basic objective of the quality management systems either based on the requirements of the NBR ISO 9001:2008 norms of management, either based on the criteria that give support to the National Foundation of Quality (FNQ), is to improve the indexes of quality, productivity and trustworthiness of the products and services of the organizations, as well as promoting guarantees for the customer. Based on these facts this work has as objective: to propose an alignment of NBR ISO 9001/2008 requirements with the criteria of excellency of the National Foundation of Quality (FNQ) - Commitment with the excellency, in companies with the intention to develop a system of management looking toward organizations in incipient managemental stage. For this the criteria of excellency of the FNQ had been interpreted - Commitment with the excellency and the requirements of NBR ISO 9001:2008, observing the methodological practices, using the exploratory, descriptive and clarifying research. Therefore at a first moment a bibliographical revision was made, looking for to have subsidies for the descriptive studies, that it aims at to characterize the evolution of the management concepts until the current days of the companies as well as the scene where these companies are inserted. Later was analyzed the compatibility of the criteria of the FNQ and the requirements of NBR ISO 9001:2008, through bibliographical research and multicriteria study in what it refers to the intention of this work aiming to establish a relationship between these systems of management improving the administration of the organizations in clarifying form. It was observed that both the programs are accurate its proposals of implantation, however with some proper peculiarities, the requirements of norm NBR ISO 9001:2008, are focused basically in the control of the processes and the attendance of the requirements of product defined for the customer, already the criteria of the FNQ are directed toward the results and establish practices for philosophical and mannering actions. The union of the culture of the organizacional quality spread by the FNQ lined up with the requirements of the guarantee of the quality of norm NBR ISO 9001:2008 will be able to create a positioning favorable to the organization that to follow this way. The result of this integration will create organizations that in fact will provide products and services in the market with quality, reduced costs, improved processes and increase of yield. / O objetivo básico dos sistemas de gestão da qualidade seja embasado nos requisitos das normas de gestão NBR ISO 9001:2008, seja fundamentado nos critérios que dão suporte à Fundação Nacional da Qualidade (FNQ), é melhorar os índices de qualidade, produtividade e confiabilidade dos produtos e serviços das organizações, assim como promover garantias para o cliente. Ciente destes fatos este trabalho tem como objetivo: Propor um alinhamento dos requisitos NBR ISO 9001/2008 com os critérios de excelência da Fundação Nacional da Qualidade (FNQ) - Compromisso com a excelência, em empresas com o propósito de desenvolver um sistema de gestão voltado para organizações em estágio incipiente gerencial. Para isto foram interpretados os critérios de excelência da FNQ - Compromisso com a excelência e os requisitos da NBR ISO 9001:2008, observando os discernimentos metodológicos, usando a pesquisa de natureza exploratória, descritiva e explicativa, pois num primeiro momento foi feita uma revisão bibliográfica, procurando ter subsídios para os estudos descritivos, que visa caracterizar a evolução dos conceitos de gestão até os dias atuais das empresas bem como o cenário em que estas empresas estão inseridas, posteriormente foi analisada a compatibilidade entre os critérios da FNQ e os requisitos da NBR ISO 9001:2008, através de pesquisa bibliográfica e estudo criterioso no que tange o propósito deste trabalho com a intenção de estabelecer um relacionamento entre estes sistemas de gestão de maneira que fortaleça o aprimoramento da administração das organizações de forma explicativa. Foi observado que ambos os programas são criteriosos e pontuais em suas propostas de implantação, porém com algumas peculiaridades próprias, os requisitos da norma NBR ISO 9001:2008, estão focados basicamente no controle dos processos e no atendimento dos requisitos de produto definido pelo cliente, já os critérios da FNQ estão voltados para os resultados e estabelecem práticas para ações de cunho filosóficos e comportamentais. A união da cultura da qualidade organizacional disseminada pela FNQ alinhada com os requisitos da garantia da qualidade da norma NBR ISO 9001:2008 poderá criar um posicionamento favorável à organização que seguir este caminho. O resultado desta integração criará organizações que de fato disponibilizaram produtos e serviços no mercado com qualidade, custos reduzidos, processos melhorados e aumento de rentabilidade.

This thesis deals with a detailed analysis of the systems of quality management in a particular company according to EN ISO 9001:2000. The aim of this work is to analyse the system deeply and then focus on how the system could become more effective. In this case the topic was the system of measurement of the customers´satisfaction. In the theoretical part there is the overall view of quality from the historical point of view up to the present. For better understanding of the problem the principles of ISO standards, maintenance of the systems and improvement instruments are mentioned. In the practical part there is the analysis of the particular system of quality management and the process of application of improvement procedures.

Detta kandidatexamensarbete, som genomförts på uppdrag av medicinteknisk chef på Södersjukhuset Git Eliasson, hade som mål att analysera vilken standard av ISO 9001:2015 och SS-EN ISO 13485:2016 som var lämpligast för Södersjukhusets medicintekniska verksamhet. ISO 9001:2015 och ISO 13485:2016 är internationella standarder framtagna av EU kommissionen för att hjälpa organisationer att bygga upp kvalitetsledningssystem som uppfyller de krav som ställs på dessa organisationer. För att ta reda på vad som var lämpligast för Södersjukhuset MTA så gjordes en litteraturstudie där djupgående kunskaper om ISO 9001:2015 och SS-EN ISO 13485:2016 erhölls. Vid oklarheter så kontaktades projektledare och experter för att tydliggöra regelverk. Därefter gjordes verksamhetsbesök där Södersjukhusets medicintekniska verksamhet studeras för att förstå var de befinner sig i dagsläget samt för att kunna göra en GAP-analys. Även företag som erbjuder ackreditering kontaktades. Detta för att få en inblick på kostnadsfrågan då även den var utav intresse. Den lämpligaste standarden visade sig vara ISO 13485:2016, och för att hjälpa Södersjukhusets MTA med att uppnå kraven i standarden föreslogs en del förslag såsom att bygga upp ett kvalitetsledningssystem gentemot kraven i ISO 13485. För att upprätta en sådant system skulle MTA kunna anställa en verksamhetsutvecklare, alternativt utnyttja redan anställd personal till att göra det arbetet. / This bachelor's thesis, which was carried out on behalf of the medical technical director at Södersjukhuset Git Eliasson, aimed to analyze which standard among ISO 9001:2015 and SSEN ISO 13485:2016 was most suitable for Södersjukhuset's operations. ISO 9001:2015 and ISO13485:2016 are international standards constructed by the EU Commission to help organizations build quality management systems that meet the requirements set on these organizations. To find out what was most suitable for Södersjukhuset, a literature study was conducted where in-depth knowledge of ISO 9001:2015 and SS-EN ISO 13485:2016 was obtained. In case of ambiguity and vagueness, project managers and experts were contacted to clarify regulations.Thereafter, hospital visits were made where the Södersjukhusets medical technology operations were studied to understand where they are at the present and to subsequently attain the knowledge needed to make a thorough GAP analysis. With the intention to elucidate costs that come with accreditation, companies that offer accreditation were also contacted. The most suitable standard proved to be ISO 13485:2016. The GAP analysis, and thus the methods needed to reach certification, consisted of setting up a QMS system which met the requirements in ISO 13485. Such a QMS could be set up by a business developer, or by already hired personnel with the right expertise. / Nej

Företag ställs inför höga krav att ständigt leverera produkter med hög kvalitet. Ett kvalitetsledningssystem med en ISO 9001:2015 (ISO 9001) certifiering är generellt fördelaktigt för att öka företags konkurrenskraft. Eftersom kvalitetsledningssystem och Enterprise Resource Planning-system (ERP-system) har olika fokus och funktioner, är det nödvändigt att undersöka hur de kompletterar varandra för att förbättra företags prestanda.    Syftet med detta examensarbete är att undersöka om och hur ett SME (Small Medium Enterprises) med erfarenhet av ett ERP-system kan effektivt bli ISO 9001 certifierade. Studien har genomförts på ett fallföretag som har många års erfarenhet av ett ERP-system och har som avsikt att ansöka om en ISO 9001 certifiering. Arbetet började med en analys och identifiering av hinder och utmaningar som små och medelstora företag kan möta när kvalitetsledningssystemet implementeras med ERP-system som stöd.   En litteraturgenomgång genomfördes först för att få en större inblick av de olika ISO 9001 krav som ställs på företag som ska certifieras. Litteraturgenomgången gav också en bättre förståelse för vad och hur ett ERP-system kan fungera i olika sammanhang. Med litteraturgenomgången som utgångspunkt utfördes intervjuer och observationer för att förstå nuläget hos företaget och de olika funktioner som finns i ett ERP-system. En certifieringsmodell skapades för att vägleda företaget att bli ISO 9001 certifierade med stöd av ERP-system. Den föreslagna modellen kan tillämpas på andra liknande små och medelstora företag även om studien genomfördes på ett fallföretag. De viktiga resultaten av denna studie indikerar att dokumentation, spårbarhet och kontroll är huvudelementen i ett ERP-system för att stödja företag att bli ISO 9001 certifierade. Men det finns också hinder och svårigheter som resulterar i att ERP-system inte fullt ut kan stödja små och medelstora företag att bli certifierade eftersom deras egen planering och beslut krävs under certifieringsprocessen. / Companies are facing high demands to constantly deliver products with high quality. A quality management system with an ISO 9001:2015 (ISO 9001) certification is generally thought to be beneficial for increasing the company's competitiveness. Since Quality management systems and Enterprise Resource Planning systems (ERP systems) have different focuses and functions to play, it is necessary to examine how they complement to each other to improve the company performance.    The purpose of this thesis work is to investigate if and how a SME (Small Medium Enterprises) with experience of an ERP system can effectively become ISO 9001 certified. The study has been carried out at a case company that has had many years’ experiences of an ERP system and has the intention to apply for an ISO9001 certification. The research started with an analysis and identification of obstacles and challenges that SMEs may face when the quality management system is implemented under the support of an ERP systems.   A literature review was first carried out to gain a greater insight into the various ISO 9001 requirements that are placed on the company to be certified. The literature review also provided a better understanding of what and how an ERP system can function in different contexts. With the literature review as a starting point, interviews and observations were taken to understand the current situation at the company and the functions of an ERP system. A certification model was created to guide the company to become ISO 9001 certified under the support of ERP. The proposed model can be applicable to other similar SMEs though the study is implemented at one case company. The important results of this study indicate that documentation, traceability and control are the main elements of an ERP system to support companies becoming ISO 9001 certified. However, there are also barriers and difficulties that ERP systems cannot fully support SMEs to become certified because their own planning and decisions are required during the certification process.

Bakgrund: Offensiv kvalitetsutveckling innebär att ständigt sträva efter att möta och helst överträffa kundförväntningar. Små till medelstora organisationer kan med hjälp av en ISO 9001-certifiering öka sin konkurrenskraft och få ökade affärsvinster, men de stöter på flera svårigheter. Fallgropar är bland annat brist på resurser, processkunskap och förståelse för kvalitetsförbättringsverktyg.  Metod: En undersökning genomfördes i tre steg. Dels undersöktes processkraven i ISO 9001 och handbok för att kartlägga brister i det praktiska stödet, dels identifierades faktorer inom litteraturen som kan ge stöd för små till medelstora företag för att uppnå processkraven i ISO 9001. Studien har genomförts som en fallstudie med en aktionsforskningsstrategi där en huvudprocess hos en fallorganisation har kartlagts för att identifiera det pågående processarbetet. Dessa sammanställda data utgjorde grunden för ett stöd för fallorganisationens framtida processarbete i ISO 9001:2015. Dataanalys innefattar metoder och verktyg bland annat tematiska analyser, tabeller och diagram.   Resultat: Bristen på praktiskt stöd i ISO 9001-standarden och dess handbok visade sig vara liten. Istället framhävs vikten av förkunskap hos organisationen och ledningens engagemang som betydande faktorer för att införa processledning, uppfylla processkrav och upprätthålla en certifiering. Fallorganisationen uppvisade få av de positiva faktorer för processledning som identifierats i litteraturen. Stödet lyfter ett systematiskt processarbete och en systemsyn som centrala punkter.    Slutsatser: Fallorganisationens brister i processledning visar sig inte kunna överbryggas genom operativa verktyg. Snarare beror de på otillräckliga kunskaper och förberedelser, vilket kräver prioritering att införskaffa förståelse för processteori och engagemang från ledningen för att framgångsrikt uppnå en ISO 9001-certifiering. / Background: The backbone of Total Quality Management is to constantly strive to meet customer needs and exceed their expectations. By obtaining an ISO 9001 certificate small to medium-sized organizations can enhance their competitive position and increase business profit, but they encounter difficulties in doing so. Pitfalls include lack of resources, process knowledge and understanding of quality improvement tools.  Method: The study was conducted in three stages. First, the process requirements in ISO 9001 and its handbook were examined to map the lack of practical support. Next, practical support factors for business process management in small to medium-sized enterprises were identified in the literature. The study employs a case study approach with an action research strategy. Therefore, a main process at a case organization was mapped to identify the current process work. This compiled data serves as the foundation for the support created for the case organization. Data analysis methods and tools include thematic analyses, tables and diagrams.  Results: The lack of practical support in the ISO 9001 standard and its handbook was relatively minor. Instead, the importance of process know-how and management commitment are highlighted as significant factors. The case organization exhibited few of the favorable factors identified in the literature. The support created emphasizes systematic process work and system view as focal points.  Conclusion: The case organization’s deficiencies in process management cannot be remedied by operative tools. Rather, they are due to insufficient knowledge and inadequate preparation for ISO 9001. Preparation should include acquiring the necessary understanding of process management theory and increased management engagement.

La investigación posee contenidos referidos a la búsqueda constante de mejorar de manera continua la rentabilidad a través de una mejor gestión en la entidad Casa Junio E.I.R.L. dedicada al rubro de hospedaje en la provincia de Chota. Por ende, esta investigación iniciará por describir el mercado del servicio de hospedaje de Chota, luego de esto, se tendrá la selección de una entidad, que hará posible la elaboración del diseño de la guía de gestión que está basada en el estándar ISO 9001 del año 2015 que se utiliza en esta investigación y al finalizar se analizará los resultados y ver el efecto positivo o negativo en dicha entidad. El propósito fundamental de esta investigación es diseñar de una guía de gestión operativa fundada en la ISO 9001 – 2015 que permita incrementar la rentabilidad en el hotel tres estrellas Casa Junio EIRL Chota 2022, este estudio emplea un enfoque mixto, combinando elementos descriptivos y analíticos, con un diseño no experimental de corte transversal. La población de interés se centra en la empresa de servicio de hospedaje Casa Junio EIRL, mientras que la muestra está compuesta por los procesos operativos específicos del hotel de tres estrellas Casa Junio EIRL, utilizando un muestreo no probabilístico. Para recopilar información, se utilizaron técnicas como el análisis de entrevistas, de instrumento, la entrevista; así como la guía de análisis documental y la ficha de análisis documental. Los efectos obtenidos al describir el sector de las empresas de hospedaje en la provincia de Chota se centran en ofrecer una visión detallada del mercado y los movimientos de gestión que se llevan a cabo en estas organizaciones. Por otro lado, la evaluación de la gestión en este sector revela de manera directa las deficiencias que presentan estas entidades en su gestión. A partir de esto, se han establecido pautas y estrategias basadas en el estándar ISO 9001-2015 con la finalidad de mejorar la rentabilidad de estas organizaciones. Estas pautas y estrategias sirven como una guía de mejora para las empresas, ya su vez, están alineadas con el objetivo final de la investigación / The research has contents related to the constant search to continuously improve profitability through better management in the entity Casa Junio E.I.R.L. dedicated to the field of lodging in the province of Chota. Therefore, this investigation will begin by describing the hosting service market of Chota, after this, the selection of an entity will be made, which will make possible the elaboration of the design of the management guide that is based on the ISO 9001 standard of the year 2015 that is used in this investigation and at the end the results will be analyzed and see the positive or negative effect on said entity. The fundamental purpose of this research is to design an operational management guide based on ISO 9001 - 2015 that allows increasing profitability in the three-star hotel Casa Junio EIRL Chota 2022, this study uses a mixed approach, combining descriptive and analytical elements, with a non-experimental cross-sectional design. The population of interest is focused on the hosting service company Casa Junio EIRL, while the sample is made up of the specific operational processes of the three-star hotel Casa Junio EIRL, using non-probabilistic sampling. To collect information, techniques such as interview analysis, instrument, interview were used; as well as the document analysis guide and the document analysis sheet. The results obtained when describing the sector of hosting companies in the province of Chota are mainly focused on offering a detailed vision of the market and the management movements that are carried out in these organizations. On the other hand, the evaluation of the management in this sector directly reveals the deficiencies that these entities present in their management. From this, guidelines and strategies based on the ISO 9001-2015 standard have been established with the aim of improving the profitability of these organizations. These guidelines and strategies serve as an improvement guide for companies, and in turn, are aligned with the final objective of the research.

Submitted in fulfilment of the requirements of the degree of Master of Technology: Quality, Durban University of Technology, 2010. / Over the years, organisations have been criticised for implementing the ISO 9000 Quality Management Standards purely as a marketing strategy without any commitment to improving quality and customer satisfaction. This study aimed to investigate the effectiveness of the ISO 9001:2000 quality management standard on performance and customer satisfaction. The objectives of the study included determining the level of effectiveness of the ISO 9001:2000 quality management with respect to enhanced leadership, continuous improvement and customer satisfaction; ascertaining the extent to which ISO 9004 and other business improvement approaches that were used to improve the performance of the organisation and determining the level of customer complaints before and after ISO 9001:2000 certification. This research investigation involved the case study approach which utilised both the qualitative and quantitative methodologies. The latter involved the analysis of the organisation’s production and customer complaints data pre- and post ISO 9001:2000 certification as well as the responses to the closed-ended questions in the questionnaire, while the former entailed an analysis of the responses to the open-ended questions in the questionnaire and a search of the literature to corroborate the findings of this study. Thirty-one of the fiftytwo employees of the organisation completed and returned the questionnaire that was administered. This represented a 60% response rate. The responses to the questionnaire were influenced by the employees’ level of training, knowledge and experience of the ISO 9001 quality management standard. Thus, the results cannot be generalised to other ISO 9001 certified organisations. The pre- and post study revealed that the level of customer complaints decreased following ISO 9001:2000 certification. Analysis of the responses to the questionnaire indicated that the ISO 9001:2000 quality management standard was, in most instances, perceived to be effective in ensuring customer satisfaction, leadership and continuous improvement. For future research, it is recommended that researchers investigate the impact of continuous improvement teams and the introduction of appropriate business improvement approaches on organisational performance and customer satisfaction in ISO 9001 certified organisations.

The main topic of the thesis is "The creating of a quality manual at Represent Ltd. company". The theoretical part describes the quality management system and documentation structure, especially the requirements according to ISO 9001:2008. The second part focuses on a specific analysis of the documentation structure at the manufacturing and trading company Represent Ltd. Consequently, the quality manual is developed and designed the new documentation system according to ISO 9001:2008 Quality Management Systems - Requirements.