The role of the quality manager has evolved from being a quality controller to work with a more global business. Within many organizations in Sweden, however, the traditional role of the quality manager's remains and the tasks categorized as quality control still takes up most of the quality manager's time. The survey conducted as part of this master thesis shows that the quality manager in most businesses has multiple roles in addition to the role of quality manager, which can create a role conflict. One consequence of this is that each improvement is not given priority due to time constraints. Although the importance of a clear and committed leadership is the key for succeeding as the quality manager. The quality manager’s educational background can vary between different activities. Most quality managers have a basic training in business development and quality, but many do not have deep expertise in the area. The quality manager wants more education and is looking for deeper skills for living in a constantly learning. The master thesis identifies the quality manager's role, tasks and education. It is hoped that in the long run from this study could support the quality manager's role and future development in the debate.

För att   lyckas med kvalitetsarbetet är kvalitetschefens roll och kompetens av   betydelse. Samtidigt visar studier att kvalitetschefens roll är otydlig och   att relativt få har utbildning på universitetsnivå. Denna studie syftade till   att bidra med ökad kunskap och förståelse för framgångsfaktorer och   utveckling av kvalitetschefens roll och kompetens det senaste decenniet. I   syfte att utforska kvalitetschefens roll och kompetens valdes kvalitetschefer   som idag arbetar som kvalitetschef inom offentlig, privat eller ideell   sektor. Arbetsprocessen bestod av sex faser: litteraturgenomgång,   pilotstudie, enkätutformning, enkäthantering och datainsamling samt analys.   Analysmetoden har varit multipel stegvis regressionsanalys och   släktskapsdiagram. Resultatet visar att kvalitetschefens kompetens finns inom   de 12 identifierade kompetensområden för kvalitetschefens roll. Vidare har   rollen identifierats arbeta inom fem identifierade hörnstenar samt inom   hörnstenar för offensiv kvalitetsutveckling. Rollen upplevs som tydligare i   organisationer med färre anställda där det finns en engagerad ledning,   möjlighet till kompetensutveckling och en samverkan med kunder och   leverantörer. För att lyckas i rollen är ledningens engagemang och   kvalitetschefens personliga egenskaper viktiga. Att Leda för hållbar   utveckling är ytterligare ett arbetsområde som har identifierats i   kvalitetschefens roll, där området EHS (Environment, Health and Safety)   ingår. Fler än majoriteten av kvalitetscheferna sitter i ledningsgruppen där   faktorer som bidrar till om kvalitetschefen påverkar strategiska beslut och   mål i organisationer är om de sitter i ledningsgruppen, där de kan påverka   beslut. De senaste   åren har utbildningsnivån hos kvalitetschefer inte ökat markant och   slutsatsen av denna studie är att kvalitetschefen besitter den kompetens som   behövs. Kompetensen utgörs av såväl kunskap och erfarenhet som formell och   icke formell utbildning. Utbildning, kompetens och engagemang hos ledningen   är faktorer som hänger samman och påverkar varandra. / In successful quality management, the role and competence of the quality manager is of importance. Previous studies show that the role is ambiguous and relatively few are educated on a university level. This study seeks to contribute to the knowledge and understanding of the success factors and the development of role and competence of the quality manager the last decade. Quality managers in public-, private- and non-profit sector was selected that as of today works as a quality manager. The working procedure remained of six phases: literature review, pilot study, questionnaire design, survey management and data collection and analysis. To analyze the result, a method of a multiple stepwise regression analysis and affinity diagram was used. The result shows that the competence of the quality manager lays within 12 identified areas and the role operates within five areas of a quality manager and quality management. The role appears as clear in smaller organizations where there is a committed leadership, possibilities for competence development and a collaboration with customers and suppliers. To succeed, the management's commitment and personal capacity are important. Leading for sustainable development, is a field of work that has been identified as part of the role. Most of the quality managers sit in the management group, where factors that contribute to whether the quality manager influences strategic decisions and goals in organizations are whether they are in the management group where they can influence decisions. The education level of the quality manager has not increased significantly the past few years which leads to the conclusion that quality managers holds the required skills for the work. The competence consists of knowledge and experience and of formal and non-formal education. Education, competence and commitment within the management are factors that stick together and affect each other. / <p>2019-06-27</p>

This diploma thesis deals with a quality management system of a small construction company. The aim is to analyse the existing baseline system and propose specific measures leading to compliance with the ČSN EN ISO 9001:2009 standard specification. The first three chapters focus on general description and concepts of quality management systems. The next chapter identifies and maps the main processes in the studied construction company and proposes a new quality management system. The last chapter presents general guidelines for creation of management documentation.

This diploma thesis deals with a quality management system of a small construction company. The aim is to analyse the existing baseline system and propose specific measures leading to compliance with the ČSN EN ISO 9001:2009 standard specification. The first three chapters focus on general description and concepts of quality management systems. The next chapter identifies and maps the main processes in the studied construction company and proposes a new quality management system. The last chapter presents general guidelines for creation of management documentation.

Centros de pesquisa clínica (CPC) devem ter infraestrutura adequada, equipe treinada e gerenciamento de processos bem definidos, para atender as particularidades dos projetos científicos, as Boas Práticas Clínicas (BPC), e as diretrizes e normas nacionais e internacionais que regem este ambiente. Um sistema de gestão da qualidade é fator primordial para o sucesso de um CPC durante a condução de ensaios clínicos. Neste contexto, a ANVISA instituiu em 2009 a Instrução Normativa nº 4 (IN4) que dispõe sobre o guia de Inspeção em BPC. O objetivo deste estudo foi desenvolver e validar um questionário eletrônico capaz de medir o desempenho dos centros participantes da Rede Nacional de Pesquisa Clínica (RNPC) em uma auditoria de qualidade baseada nas BPC. Avaliamos a correlação do nosso instrumento com o guia de inspeção em BPC disposto na IN4 ANVISA e estudamos a influência de um gerente de qualidade em relação ao cumprimento aos requisitos. Foi realizado um estudo transversal nos 32 centros participantes da RNPC, por meio da aplicação de um questionário eletrônico, legitimado por uma validação de conteúdo. As questões foram agrupadas em três domínios (infraestrutura, estrutura organizacional (EO) e processos). Os dados foram pontuados de acordo com o cumprimento (1) ou não cumprimento (0) em BPC. As questões do nosso questionário foram arbitrariamente correlacionadas aos itens da IN Nº 4, atribuímos (0) ponto às questões conformes e (1) para não conforme. Esta correlação foi realizado por meio de coeficiente de correlação de postos de Spearman. O índice de cumprimento para atendimento aos itens críticos e maiores (ICCM) foi calculado para cada domínio usando a equação ICCM = -1 * (Escore IN4) + valor total escore para dado domínio e comparado usando ANOVA não-paramétrica. Os dados foram agrupados de acordo com a presença ou ausência de um gerente de qualidade no centro de pesquisa e os escores foram comparados usando o teste de Mann-Whitney, com P valor <0.05. 27 centros responderam ao questionário (84,4%). Nosso instrumento representa aproximadamente 40% dos itens do roteiro de inspeção da IN4 ANVISA. A pontuação obtida com o questionário correlaciona-se significativamente ao escore correspondente à IN4/ANVISA (r-=0,95, -0,89 a -0,98, CI95%, P<0.0001). A mediana do ICCM foi menor que 75% em todos os domínios estudados. Apenas 14,81% dos centros contam com a presença de um gerente de qualidade. A presença de um gerente de qualidade foi associada ao melhor desempenho nos domínios infraestrutura e estrutura organizacional (P<0.05). O instrumento desenvolvido para medir o desempenho em BPC apresenta alta correlação com a Instrução Normativa Nº 4 ANVISA e poderia ser utilizado para auditoria interna de qualidade. A IN4/ANVISA mostrou ser muito rigorosa e todos os centros participantes da RNPC apresentaram pelo menos uma não conformidade em itens críticos ou maiores. A presença de um gerente de qualidade pode ajudar a melhorar o desempenho em qualidade em centros de pesquisa clínica / Clinical research centers (CRC) must have an adequate infrastructure, trained staff and well defined management process in order to conduct scientific clinical research protocols with distinct demands and to fulfill the regulatory rules including good clinical practices (GCP) and national or international additional regulatory rules. A quality management system plays a significant role in the success or failure of a CRC in conducting clinical trials. In this context, the Brazilian Health Surveillance Agency (ANVISA), published in 2009 a guide regarding quality audits in the CRC (The Normative Statute #4 of the Agência Nacional de Vigilância Sanitária - IN4 ANVISA). The aim of this study was to develop and validate an electronic questionnaire to measure how CRC that is part of the National Clinical Research Network (Rede Nacional de Pesquisa Clínica/RNPC) performed in a quality audit, using as a source document the GCP. We also evaluated the correlation between our instrument and IN4/ANVISA guide and studied the influence of a quality manager on the level of compliance with quality requirements. It was a transversal study that evaluated 32 CRC of the RNPC. They fulfilled an electronic questionnaire, validated by contend valid index. The questions were divided into tree domains (infrastructure (I), organization structure (OS), focused on human resources and process (P)). Data were scored according compliance (1) or non-compliance (0) with GCP. The questions between our questionnaire where arbitrary related to IN4/ANVISA guide and scored as non-conformity (1) or conformity (0). The correlation of the two measurements above was done using a Spearman rank method. The critical and major non-conformities index (ICCM) obtained with IN4/ANVISA score was calculated for each study domain using the equation ICCM=-1*score + maximal domain score and compared using non-parametric ANOVA. Data were grouped according the presence or absence of a CRC quality manager and the scores compared using Mann-Whitney rank test. The P valor was set to <0.05. Results: 27 CRCs answered the questionnaire (84,4%). Our instrument covered around 40% of all items checked by IN4/ANVISA inspection quality guide. The score obtained with our questionnaire significantly correlates with IN4/ANVISA score (r-=0,95, -0,89 to -0,98, CI95%, P<0.0001). The median of ICCM was lesser than 75% for all domain studied. Only 14,8 % of CRCs had a quality manager. The presence of a quality manager was associated with best performance in infrastructure and OS scores studied (P<0.05). The instrument designed to measure performance GCP showed high correlation with IN4/ANVISA guide and could be used to perform the internal quality audit. The IN4/ANVISA guide showed to be very strict and all CRC presented at least one critical or major quality non-conformities. The presence of quality manager could help CRC improve quality performance

<p>When a new building is constructed, or some changes are taking place in the already existing building, it is required according to PBL  chapter 8 that the developer applies for planning permissions at the building committee in that municipality where the real estate is located. In the planning permission, the documents of the current building are examined.<strong></strong></p><p> </p><p>The developer will appoint a quality manager that helps the developer to ensure that all necessary controls are done and that the requirements in these are met. The developer has the final responsibility to ensure that the building is built according to all requirements and rules. The building committee establishes a control plan that shows which controls have to be carried out and which certificates and documents have to be sent in during the time of the construction.</p><p>This study aims to finding out which documents that will be submitted at the construction of a new building, according to the laws found in PBL, if these documents are required and if they are examined of the municipalities before the building is approved.</p>

When a new building is constructed, or some changes are taking place in the already existing building, it is required according to PBL  chapter 8 that the developer applies for planning permissions at the building committee in that municipality where the real estate is located. In the planning permission, the documents of the current building are examined.   The developer will appoint a quality manager that helps the developer to ensure that all necessary controls are done and that the requirements in these are met. The developer has the final responsibility to ensure that the building is built according to all requirements and rules. The building committee establishes a control plan that shows which controls have to be carried out and which certificates and documents have to be sent in during the time of the construction. This study aims to finding out which documents that will be submitted at the construction of a new building, according to the laws found in PBL, if these documents are required and if they are examined of the municipalities before the building is approved.

Centros de pesquisa clínica (CPC) devem ter infraestrutura adequada, equipe treinada e gerenciamento de processos bem definidos, para atender as particularidades dos projetos científicos, as Boas Práticas Clínicas (BPC), e as diretrizes e normas nacionais e internacionais que regem este ambiente. Um sistema de gestão da qualidade é fator primordial para o sucesso de um CPC durante a condução de ensaios clínicos. Neste contexto, a ANVISA instituiu em 2009 a Instrução Normativa nº 4 (IN4) que dispõe sobre o guia de Inspeção em BPC. O objetivo deste estudo foi desenvolver e validar um questionário eletrônico capaz de medir o desempenho dos centros participantes da Rede Nacional de Pesquisa Clínica (RNPC) em uma auditoria de qualidade baseada nas BPC. Avaliamos a correlação do nosso instrumento com o guia de inspeção em BPC disposto na IN4 ANVISA e estudamos a influência de um gerente de qualidade em relação ao cumprimento aos requisitos. Foi realizado um estudo transversal nos 32 centros participantes da RNPC, por meio da aplicação de um questionário eletrônico, legitimado por uma validação de conteúdo. As questões foram agrupadas em três domínios (infraestrutura, estrutura organizacional (EO) e processos). Os dados foram pontuados de acordo com o cumprimento (1) ou não cumprimento (0) em BPC. As questões do nosso questionário foram arbitrariamente correlacionadas aos itens da IN Nº 4, atribuímos (0) ponto às questões conformes e (1) para não conforme. Esta correlação foi realizado por meio de coeficiente de correlação de postos de Spearman. O índice de cumprimento para atendimento aos itens críticos e maiores (ICCM) foi calculado para cada domínio usando a equação ICCM = -1 * (Escore IN4) + valor total escore para dado domínio e comparado usando ANOVA não-paramétrica. Os dados foram agrupados de acordo com a presença ou ausência de um gerente de qualidade no centro de pesquisa e os escores foram comparados usando o teste de Mann-Whitney, com P valor <0.05. 27 centros responderam ao questionário (84,4%). Nosso instrumento representa aproximadamente 40% dos itens do roteiro de inspeção da IN4 ANVISA. A pontuação obtida com o questionário correlaciona-se significativamente ao escore correspondente à IN4/ANVISA (r-=0,95, -0,89 a -0,98, CI95%, P<0.0001). A mediana do ICCM foi menor que 75% em todos os domínios estudados. Apenas 14,81% dos centros contam com a presença de um gerente de qualidade. A presença de um gerente de qualidade foi associada ao melhor desempenho nos domínios infraestrutura e estrutura organizacional (P<0.05). O instrumento desenvolvido para medir o desempenho em BPC apresenta alta correlação com a Instrução Normativa Nº 4 ANVISA e poderia ser utilizado para auditoria interna de qualidade. A IN4/ANVISA mostrou ser muito rigorosa e todos os centros participantes da RNPC apresentaram pelo menos uma não conformidade em itens críticos ou maiores. A presença de um gerente de qualidade pode ajudar a melhorar o desempenho em qualidade em centros de pesquisa clínica / Clinical research centers (CRC) must have an adequate infrastructure, trained staff and well defined management process in order to conduct scientific clinical research protocols with distinct demands and to fulfill the regulatory rules including good clinical practices (GCP) and national or international additional regulatory rules. A quality management system plays a significant role in the success or failure of a CRC in conducting clinical trials. In this context, the Brazilian Health Surveillance Agency (ANVISA), published in 2009 a guide regarding quality audits in the CRC (The Normative Statute #4 of the Agência Nacional de Vigilância Sanitária - IN4 ANVISA). The aim of this study was to develop and validate an electronic questionnaire to measure how CRC that is part of the National Clinical Research Network (Rede Nacional de Pesquisa Clínica/RNPC) performed in a quality audit, using as a source document the GCP. We also evaluated the correlation between our instrument and IN4/ANVISA guide and studied the influence of a quality manager on the level of compliance with quality requirements. It was a transversal study that evaluated 32 CRC of the RNPC. They fulfilled an electronic questionnaire, validated by contend valid index. The questions were divided into tree domains (infrastructure (I), organization structure (OS), focused on human resources and process (P)). Data were scored according compliance (1) or non-compliance (0) with GCP. The questions between our questionnaire where arbitrary related to IN4/ANVISA guide and scored as non-conformity (1) or conformity (0). The correlation of the two measurements above was done using a Spearman rank method. The critical and major non-conformities index (ICCM) obtained with IN4/ANVISA score was calculated for each study domain using the equation ICCM=-1*score + maximal domain score and compared using non-parametric ANOVA. Data were grouped according the presence or absence of a CRC quality manager and the scores compared using Mann-Whitney rank test. The P valor was set to <0.05. Results: 27 CRCs answered the questionnaire (84,4%). Our instrument covered around 40% of all items checked by IN4/ANVISA inspection quality guide. The score obtained with our questionnaire significantly correlates with IN4/ANVISA score (r-=0,95, -0,89 to -0,98, CI95%, P<0.0001). The median of ICCM was lesser than 75% for all domain studied. Only 14,8 % of CRCs had a quality manager. The presence of a quality manager was associated with best performance in infrastructure and OS scores studied (P<0.05). The instrument designed to measure performance GCP showed high correlation with IN4/ANVISA guide and could be used to perform the internal quality audit. The IN4/ANVISA guide showed to be very strict and all CRC presented at least one critical or major quality non-conformities. The presence of quality manager could help CRC improve quality performance

Bibliografický záznam WINZBERGEROVÁ, Alžběta. 2015. Odborný a osobnostní profil manažerů kvality fakultních nemocnic v České republice. Praha: Univerzita Karlova, Fakulta humanitních studií, Katedra řízení a supervize v sociálních a zdravotnických organizacích. 85 stran. Vedoucí diplomové práce Mgr. Petr Vrzáček. Abstract The thesis is focused on the quality management in the healthcare organizations. Quality management is perceived as a process or a set of processes, which are coordinated by a responsible person - a quality manager. The thesis summarizes the expert theoretical knowledge about the historical development of the quality requirements, about the quality management systems in healthcare and it introduces the institutional framework of quality and safety in healthcare organizations in the Czech Republic. The emphasis is especially given to the profile and job description of quality managers. The objective of this thesis is to create a professional and personal profile of quality managers working at the Czech university hospitals. The method of data collection used is semi structured interview. The results from the analysis show that quality managers were educated in different fields, but still they have similar personal characteristics. They perceive their job as exhausting, but they keep being...

This diploma thesis deals with the role, position and profession development of quality managers in the social service of personal assistance. It describes the emergence of this role in the context of the development of legislation in the Czech Republic and its changes after the entry into force of Act No. 108/2006 Coll. on social services, which regulates their provision. It reveals the importance of the quality manager's role in the personal assistance service from the point of view of its directors, social and management staff and quality managers, in context with the requirements for its fulfilment. Based on interviews with participants, the research identifies the role of the quality manager as a "quality teacher", a "motivator" and a "protector". The author also briefly deals with the stories of quality managers and their experience from methodological practice. Furthermore, the research shows the possibilities of grasping the quality manager's position in the organization, the preconditions for its fulfilment and aspects of the organization's culture, which have an influence on the fulfilment on the role of quality manager. Based on the research, the author further identifies problems which the participants face practice, namely: setting the position of the quality manager, introducing...