Då konkurrensen blir allt hårdare bland företag, har kvalitet blivit ett allt viktigare konkurrensmedel. För att kunna ge hög kvalitet till sina kunder, måste företaget ha hög kvalitet internt. Allt fler företag inför därför ett kvalitetssystem som hjälpmedel för att styra kvaliteten åt rätt håll. Ett av de vanligaste kvalitetssystemen är ISO 9000. Detta examensarbete behandlar de förändringar som sker efter införandet av ISO 9000 i IT-företag. I undersökningen har fyra kvalitetsansvariga på fyra olika IT-företag intervjuats om vilka förändringar som har skett i deras företag. Förändringarna har varit ganska likartade mellan de olika företagen. Resultatet visar att de förändringar som sker är att företaget får ett bättre kvalitetsmedvetande, mer fokus på kvalitet till kund, bättre ordning och reda i företaget och fler revisioner.

Submitted by Priscila Nascimento (pnascimento@icict.fiocruz.br) on 2012-11-21T16:17:01Z No. of bitstreams: 1 carla-franca-wolanski-de-almeida.pdf: 1099876 bytes, checksum: e454fb4f1e8e4f2a5e837e602abcf47e (MD5) / Made available in DSpace on 2012-11-21T16:17:01Z (GMT). No. of bitstreams: 1 carla-franca-wolanski-de-almeida.pdf: 1099876 bytes, checksum: e454fb4f1e8e4f2a5e837e602abcf47e (MD5) Previous issue date: 2009 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil. / Controle em processo é parte das ações para garantia da qualidade dos produtos a fim de que eles atendam aos requisitos mínimos estabelecidos para seu uso. Os resultados obtidos nos ensaios orientam na tomada de decisões, bem como em ajustes ao processo de produção. Muitas vezes tais resultados são condições imperativas para as etapas subsequentes. O monitoramento do processo produtivo se dá a partir do estabelecimento dos pontos críticos de controle, que precisam ser verificados a cada lote, pois interferem diretamente na qualidade e rendimentos da produção. Portanto, a confiabilidade e agilidade deresposta são fundamentais para correta tomada de decisão e/ou ajuste. O objetivo deste trabalho é propor um modelo de laboratório de controle em processo nos aspectos gerenciais e principalmente nos aspectos técnicos aplicados ao processo de produção do biofármaco Interferon alfa 2b humano recombinante. Este produto, oferecido no portfólio de Bio-Manguinhos encontra-se em processode transferência de tecnologia com o Instituto cubano CIGB. Com base nos dados da literatura foram estabelecidas as principais etapas do processo produtivo a para expressão de proteínas heterólogas, em sistema recombinante utilizando-se a bactéria Escherichia coli. Os pontos críticos de controle foram estabelecidos utilizando-se a metodologia de análise de riscos HACCP (Hazard Analisys Critical Control Point). Para as análises de controle foram propostas metodologias analíticas que proporcionem a consistência de resultados e que possam garantir a qualidade final do processo de manufatura do produto. O modelo proposto também enfatiza a conduta de ações rotineiras de forma que qualquer desvio possa ser imediatamente identificado e suas causas apuradas além de executar as análises com segurança. Os critérios gerenciais e técnicos abordados foram avaliados criticamente, utilizando-se os procedimentos do sistema de garantia da qualidade vigentes no Instituto, bem como na estrutura do laboratório de controle em processodestinado à vacina contra Hib, que foi adotado como premissa básica, fruto da transferência de tecnologia bem sucedida em Bio-Manguinhos. A proposta elaborada poderá ser utilizada em outros laboratórios destinados ao controle em processo de novos produtos em Bio-Manguinhos e enfatiza os critérios técnicos como condicionais para confiabilidade de medição. / In-process control is a part of the actions to guarantee the quality for final products in order to attend the minimum requirements established for their using. The results obtained from analytical assays guide on decision-making as well as production process adjustments. Often, these results are conditioned to the follow the subsequent stages. The process monitoring occurs from the establishment of critical control points to verify in each batch because theydeterminate product quality and process yield. Therefore, the reliability and speedof response are critical for correct decision-making and adjustment. The objective of this work is to propose a model in process control laboratory in management aspects and especially the technical aspects applied to the production of human recombinant interferon alpha 2b biopharmaceutical, object of this study. Bio-Manguinhos supplies this product in its portfolio, which production technology is being transferred from the CIGB, a Cuban Institution. Based on literature data the main steps were established for a production process of heterologous proteins expressed using a recombinant system with the Escherichia colibacteria. The critical control points were established using the risk assessment methodology HACCP, Hazard analysis Critical Control, HACCP. Analytical methodologies were proposed to improve results consistency and assure the final quality of production process. The proposed model emphasizes the routine actions, so that, any deviation could be immediately identified, their causes verified and activities performed reliably. The management and technical criteria described have been critically evaluated using the Bio-Manguinhos institute quality assurance procedures as well as compared to the structure of the in-process control laboratory for Hib vaccine. This laboratory, adopted as basic premise, resulted from a successful technology transfer in Bio-Manguinhos. The proposal drawn up can be used in other laboratories for in- process control in new products in Bio-Manguinhos and emphasizes the technical criteria for conditional measurement reliability.

Die Dissertation hat drei Teilziele: - eine Auseinandersetzung mit den theoretischen Ansätzen, - eine Kriterien- und Modellanalyse hinsichtlich der Praktikabilität und Tauglichkeit der Qualitätssicherung und -entwicklung für Weiterbildungseinrichtungen, - Erarbeitung eines auf die Selbstevaluation orientierten Qualitätsrahmens für berufliche Weiterbildungseinrichtungen, in dem das erfolgreiche Lernen und die dafür zu schaffenden Rahmenbedingungen einen großen Stellenwert einnehmen. Dabei wird die Qualitätsentwicklung und nicht die Qualitätssicherung im Mittelpunkt stehen.

Descreve e analisa a participação do Profissional da Informação no Sistema da Qualidade nas Empresas, com ênfase no controle de documentos e registros da Qualidade. Os objetivos do estudo são: Colaborar para o enriquecimento teórico do tema, através da realização de uma revisão de literatura; Contribuir para a conscientização dos Profissionais da Informação nas Empresas quanto à sua atuação no gerenciamento da informação do Sistema da Qualidade; Apresentar conceitos básicos para a implantação do Controle de Documentos baseado na ISO 9000, com o objetivo de apoiar a efetiva participação do Profissional da Informação nos Sistemas da Qualidade; e Analisar uma experiência prática de atuação de Profissionais da Informação em Sistemas da Qualidade, por intermédio de Estudo de Caso, realizado no Serviço de Informação da COPENE. Com esta pesquisa, conclui-se que o Profissional da Informação tem capacidade profissional para atuar em Sistemas da Qualidade, principalmente tendo em vista sua similaridade com Sistemas de Informação, área de atuação deste profissional. É feita uma análise sobre o perfil básico esperado deste Profissional, relacionado a fatores comportamentais, situacionais, técnicos e intelectuais. / Describes and analyses the participation of the Information Professional in the Quality System, with a special focus on document Control and Quality records. The objectives of the study are: to contribute to the theorethical strenghtening of the theme, by a literatura review; to contribute to Information Professionals working in companies, enlightening them about their roles in the Quality System Information Management; to present the basic concepts for the introduction of Document Control based on ISO-9000, with the objective of giving support to the effective participation of the Information Professionals in the Quality Systems; and, by a case study of COPENE’s Information Service, analyse a practical experience of Information Professionals working in Quality Systems. By this research, it is possible to conclude that the Information Professional has the ability to work in Quality Systems, principally due to its similarity to the Information Systems. Furthermore, an analysis of the basic profile of this professional is proposed, relating it to behavioral, environmental, technical and intellectual factors.

Diese Dissertation stellt ein strukturelles ökonometrisches Modell der Nachfrage mit direkten Netzwerkeffekten vor. Der strukturelle Ansatz ermöglicht es, den Umfang von Netzwerkeffekten and Netwerkkompatibilität zu identifizieren. Nach unserem Wissen ist es das erste Modell, das diese Identifikation im Falle von direkten Netzwerkeffekten ermöglicht. Gleichzeitig ist es der erste Versuch, den Umfang von Netzwerkkompatibilität mit ökonometrischen Methoden zu bestimmen. Das Modell wird dann angewandt, um die Nachfrage von Mobilfunkdienstleistungen, als auch den Zusammenhang zwischen ISO 9000 Normierung und internationalem Handel zu untersuchen. Die Schätzungsergebnisse führen zu interessanten wirtschaftspolitischen Folgerungen. / This thesis introduces a structural econometric model of demand exhibiting direct network effects. The structural approach we follow allows us to identify the extent of network effects and compatibility between competing networks. To the best of our knowledge, this is the first model that facilitates the identification in the case of direct network effects. At the same time, it is the first attempt to assess the degree of compatibility in an econometric framework. The model is then applied to investigate demand for mobile telecommunications service and the link between adoptions of ISO 9000 standard and international trade. The estimation results allow us to formulate some interesting policy conclusions.

本研究是以組織發展的部份觀點來探討影響一般企業成功推行 ISO9000系列品保制度之組織面因素。因為申請此一國際性的品保認證是一個強調品質的企業必然的選擇，也是世界的潮流。而國內有為數不少的廠商都已成功地導入合乎自己體質的品保制度，但也有許多企業目前正著手進行或考慮導入中，本研究採「定性研究」的個案探討，選擇四家資訊電子產業的個案公司對他們推動的歷程作深入的報導；四家公司皆已順利取得商檢局或其它國外機構的認證，其中兩家屬於集團企業下的公司或分廠，另兩家則為典型的中小企業。目的是期待藉由已成功導入的企業為例，發掘出影響推動的組織面因素，並發展出相關的假設命題，並提供建議目前 正著手進行或考慮導入的企業作為參考之用。

<p>The purpose of this thesis has been to investigate the effect of introducing the qualitystandard ISO 9001:2000 at Metso Paper Service in Sundsvall. The investigation has been focused on implementation of the new method of work, Continuous improvements. The implementation has been studied in a case study with both a qualitative and quantitative method. </p><p>Continuous Improvements is a way of working focused on continuously increasing the efficiency and having the purpose of achieving the formulated goals. This is often accomplished by the organisation carrying out the changing process to a great extent in small but efficient teams. </p><p>The effects of Metso’s introduction of the system are many. Above all the possibility of influence on the changing process has increased. This study also shows significant increase of the motivation and engagement of the employees as well as the number of ideas of improvements. This documentation ends with recommendations for further improvements of the system.</p>

The purpose of this thesis has been to investigate the effect of introducing the qualitystandard ISO 9001:2000 at Metso Paper Service in Sundsvall. The investigation has been focused on implementation of the new method of work, Continuous improvements. The implementation has been studied in a case study with both a qualitative and quantitative method. Continuous Improvements is a way of working focused on continuously increasing the efficiency and having the purpose of achieving the formulated goals. This is often accomplished by the organisation carrying out the changing process to a great extent in small but efficient teams. The effects of Metso’s introduction of the system are many. Above all the possibility of influence on the changing process has increased. This study also shows significant increase of the motivation and engagement of the employees as well as the number of ideas of improvements. This documentation ends with recommendations for further improvements of the system.

Today's industries are constantly evolving and the demands according to quality for products and services produced and performed are becoming more and higher. ISO 9001 is a standard that serves as a tool for organizations who wants to effectively control and manage their quality workforce on business different processes. A background to the introduction of a quality managementsystem towards Skärås svets och mekaniska in Västerås are that more and more customers demand this from a company to enable it to obtain an order of production. Efforts to introduce a quality system such as ISO 9001-2008 all begin with to carry out a situationanalysis of the business. Skärås svets och mekaniska currently has no existing quality management system so therefore there is no current directives regarding who is responsible, for a future certification in the business. By structuring a situation analysis of the business. You get a good overview of the business and how it is conducted today. This analysis can be performed in separate ways, but this thesis has chosen to perform it using the process mapping. Process mapping is a powerful tool for an organization, not just as a situation analysis, but as a tool for future efficiencies and improvements. Process mapping has been done in accordance with walk-trough concept where you go through the tasks that are within the business itself and see what the people involved in the making are doing in there tasks. To compile this to the process maps later on. An Analysis of the process and the mapping of them compered to the requirements of ISO 9001-2008. Is explaining where Skärås svets och mekaniska really are today in the work towards a future certification. Against what the standard requires. What do you need to implement in their business or change for a future certification will be possible?. This is one of the main issues reguarding this thesis. The results of this thesis is a comprehensive situation analysis consisting of process maps for Skärås svets och mekaniska, and an analysis of these against the requirements of ISO 9001-2008 standard. That are requiered for a business lika Skärås svets och mekaniska in order to be able to certify against the ISO 9001 Series.

20% d’une classe d’âge sort du système éducatif sans qualification. Est-ce la non-qualité d’un processus qui dysfonctionne ? Peut-on appliquer dans l’Ecole la gestion de la qualité, qui est aujourd’hui un modèle organisationnel de la culture managériale commune. L’émergence d’un nouveau type de contrat social, caractérisé par un nouvel ordre du travail (New Work Order), semble concomitante du New Public Management qui voit une importation des concepts généralement liés au monde des entreprises dans la sphère des institutions. Ces transpositions ne sont pas sans poser des problèmes notamment dans la traduction deprincipes dans un contexte qui peut s’avérer différent, et dont les parties prenantes ne sont pas en demande ou en refusent les paradigmes tout autant que leur application. Il nous a donc paru intéressant d’analyser les conditions d’applicabilité de la norme ISO 9000 aux établissements éducatifs, en nous focalisant plus particulièrement sur les lycées professionnels qui présentent des caractéristiques originales permettant d’appréhender la question de la finalité d’insertion vers l’emploi du système scolaire. A partir d’entretiens semi-directifs, nous proposons une modélisation des processus mis en oeuvre ainsi que des recommandations sur les conditions d’applicabilité d’une démarche qualité dans une institution scolaire. Au-delà de l’analyse des impacts organisationnels de l’application de l’ISO 9000 dans un contexte éducatif, faisant notamment apparaître un système complexe de voix de clients parfois contradictoires, ou de parties prenantes jouant plusieurs rôles dans le processus, nousnous sommes attachés à mettre au point un outil de pilotage de la relation individu/organisation ou élève/institution. Pour ce faire, nous avons adapté le Psychological Contract Index de Rousseau, à la fois au public et au contexte de cette relation. Une étudequantitative nous a permis de distinguer les facteurs influençant la dynamique du contrat implicite et explicite qui est en oeuvre dans l’éducation et l’apprentissage. Une procédure, ce n’est pas nécessairement une suite de réponses mais cela peut être unefaçon de poser les questions. / 20% of an age group comes out of the educational system without qualification. Should this non-quality of the educational process be questioned? Quality management is now a widely accepted an organizational framework of managerial culture. The emergence of a new social contract, characterized by the New Work Order seems concomitant of New Public Management which promotes organizational concepts taken from the business culture and applied to institutions. These transfers can nonetheless cause problems. For example, translating principles in a different context, and also when stakeholders are not receptive or even refusing both the paradigms and their implementation. We analyze the applicability conditions of the ISO 9000 norm to educative institutions, focusing on vocational education which contains special features that allow us to understand the aim of the educational system as the preparation to a first professional position. Based on a field-work of semi-structured interviews, we propose a modelization of the process as well as recommendations about applicability conditions of a quality management course of actions in an educative institution. We also try to go beyond the impact analysis of organizational issues when applying ISO 9000 in an educative context. We unveil a complex system of sometimes contradictory customer voices, or stakeholders taking up different roles and functions in the process. We have tried to set up an analytic tool to monitor the relation between an individual and an organization, or a student and an institution. To do so, we adapted Rousseau’s Psychological Contract Index both to the public target population and to the context of the relation. A set of collected data quantitative study allowed us to isolate a series of factors influencing implicit and explicit dynamics at work in education and professional training. A procedure is not necessarily a continuation of answers but it can be a means of asking questions.