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Certificações no setor sucroenergético brasileiro: analise dos efeitos da ISO 9001 e Bonsucro / Certifications in the Brazilian sugar and ethanol industry: analysis of the effects of ISO 9001 and BonsucroGioia, Henrique Raymundo 20 September 2017 (has links)
O setor sucroenergético é um dos mais dinâmicos do país. Sua importância na economia brasileira é evidente, sendo um grande empregador, gerador de divisas externas, contribuindo para o crescimento econômico. Com o aumento da disponibilidade de informações e da conscientização da sociedade, as causas sociais e ambientais ganharam mais destaque. As certificações surgem como uma resposta para a sociedade, além de promover melhorias de acordo com seus requisitos. Através de estudos anteriores, constatou-se que certificações podem gerar vantagens competitivas para as empresas. Entre as certificações presentes no setor, os selos ISO 9001 e Bonsucro mereceram ser mais detalhadas. A ISO 9001 por ser tradicional, e estar presente em todos os setores da economia. E a Bonsucro, uma certificação socioambiental diretamente relacionada com o setor sucroenergético, além de estar presente nas principais usinas do país. Objetivou-se realizar um levantamento das certificações no setor sucroenergético, e foram identificadas aproximadamente 16 certificações distintas no setor, entre elas, ficou evidente a presença dos selos ISO 9001 e Bonsucro. As certificações podem ser caracterizadas de acordo com suas finalidades, de acordo com o levantamento realizado, observou-se que elas apresentam reconhecimento por práticas de gestão, qualidade, ética, ambiental e social. Por meio de métodos estatísticos de análise de variância (ANOVA), foram realizadas comparações entre as usinas certificadas e não certificadas, está análise contemplou apenas as certificações ISO 9001 e Bonsucro. Objetivou-se também encontrar as particularidades da ISO 9001 e Bonsucro, por meio de aplicação de questionários junto as usinas certificadas, a partir disto, foram mensurados os motivos de obtenção, impactos e dificuldades relacionadas a essas certificações. A certificação ISO 9001 apresentou boa notoriedade com reconhecimento de seus impactos operacionais e de mercado, entre eles, aumento da produtividade, melhoria da qualidade, redução de reclamações. Já a certificação Bonsucro por ter características socioambientais, obteve pouco destaque entre as motivações listadas, porém as usinas concordaram que ela possui impacto de mercado, entre eles, aumento da competitividade e aumento das exportações. Em relação as dificuldades para obtenção das certificações, as usinas relataram que as certificações ISO 9001 e Bonsucro não possuem grandes obstáculos, porém foi constatado que as usinas encontram mais burocracias para obtenção da certificação ISO 9001. / The sugar-energy sector is one of the most dynamic in the country. Its importance in the Brazilian economy is evident, being a great employer, generator of foreign exchange, contributing to economic growth. With increasing availability of information and awareness of society, social and environmental causes have gained more prominence. The certifications emerge as a response to society, as well as promoting improvements according to their requirements. Through previous studies, it has been found that certifications can generate competitive advantages for companies. Among the certifications present in the sector, the ISO 9001 and Bonsucro seals deserved to be more detailed. ISO 9001 for being traditional, and to be present in all sectors of the economy. And Bonsucro, a socio-environmental certification directly related to the sugar-energy sector, besides being present in the main plants of the country. The objective was to conduct a survey of certifications in the sugar-energy sector, and identified approximately 16 different certifications in the sector, among them, the presence of the ISO 9001 and Bonsucro seals was evident. The certifications can be characterized according to their purposes, according to the survey carried out, it was observed that they are recognized by management practices, quality, ethics, environmental and social. Using statistical methods of analysis of variance (ANOVA), comparisons were made between certified and non-certified plants, this analysis included only ISO 9001 and Bonsucro certifications. It was also aimed to find the particularities of ISO 9001 and Bonsucro, through the application of questionnaires to the certified plants, from which, the reasons for obtaining, impacts and difficulties related to these certifications were measured. ISO 9001 certification was well-known with recognition of its operational and market impacts, among them, increasing productivity, improving quality, reducing complaints. The Bonsucro certification, due to its socioenvironmental characteristics, obtained little prominence among the motivations listed, but the mills agreed that it has a market impact, among them, increased competitiveness and increased exports. Regarding the difficulties in obtaining the certifications, the mills reported that ISO 9001 and Bonsucro certifications do not have great obstacles, but it was verified that the mills find more bureaucracies to obtain ISO 9001 certification.
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Avaliação do processo de implantação e validação de um sistema de gestão da qualidade conforme a norma NBR ISO 9001:2000Cadorin, Marcos Lindomar January 2003 (has links)
Dissertação (mestrado) - Universidade Federal de Santa Catarina, Centro Tecnológico. Programa de Pós-Graduação em Engenharia de Produção. / Made available in DSpace on 2012-10-20T21:22:43Z (GMT). No. of bitstreams: 1
228750.pdf: 1301005 bytes, checksum: 6299502000850f2bbb43ba828cb584d4 (MD5) / Este trabalho tem como objetivo, disponibilizar as empresas uma metodologia para implantação e avaliação de um sistema de gestão da qualidade conforme a norma NBR ISO 9001:2000. A metodologia esta fundamentada na aplicação inicial de um diagnóstico a fim de estabelecer a estrutura da documentação do sistema de gestão da qualidade, a partir daí, um planejamento inicial garante a elaboração, implementação e manutenção através de auditorias do sistema proposto.
Após a implantação do sistema de gestão da qualidade, foi possível evidenciar melhoria organizacional em todos os departamentos da empresa, seus processos suas atividades apresentaram maior confiabilidade devido aos padrões estabelecido pelo sistema. A confiabilidade metrológica garantiu qualidade dos processos e produtos, foi verificada também melhoria da qualidade das atividades dos funcionários devido à aplicação de procedimentos operacionais para todo processo que impactava com os requisitos dos clientes, bem como melhoria nas questões comportamentais individualmente e em grupo.
Para os clientes, podemos constatar através de baixo índice de reclamações e também através de pesquisas de satisfação que, conforme o sistema se estruturava, maior era a satisfação e a confiança .
Diante destas observações, podemos concluir que um processo que tem como proposta a melhoria organizacional através da implantação de um sistema que gestão a qualidade dos processos operacionais resultará na melhoria da qualidade, na garantia do atendimento aos requisitos regulamentares, estatutários e dos clientes, bem como em sua plena satisfação.
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Certificações no setor sucroenergético brasileiro: analise dos efeitos da ISO 9001 e Bonsucro / Certifications in the Brazilian sugar and ethanol industry: analysis of the effects of ISO 9001 and BonsucroHenrique Raymundo Gioia 20 September 2017 (has links)
O setor sucroenergético é um dos mais dinâmicos do país. Sua importância na economia brasileira é evidente, sendo um grande empregador, gerador de divisas externas, contribuindo para o crescimento econômico. Com o aumento da disponibilidade de informações e da conscientização da sociedade, as causas sociais e ambientais ganharam mais destaque. As certificações surgem como uma resposta para a sociedade, além de promover melhorias de acordo com seus requisitos. Através de estudos anteriores, constatou-se que certificações podem gerar vantagens competitivas para as empresas. Entre as certificações presentes no setor, os selos ISO 9001 e Bonsucro mereceram ser mais detalhadas. A ISO 9001 por ser tradicional, e estar presente em todos os setores da economia. E a Bonsucro, uma certificação socioambiental diretamente relacionada com o setor sucroenergético, além de estar presente nas principais usinas do país. Objetivou-se realizar um levantamento das certificações no setor sucroenergético, e foram identificadas aproximadamente 16 certificações distintas no setor, entre elas, ficou evidente a presença dos selos ISO 9001 e Bonsucro. As certificações podem ser caracterizadas de acordo com suas finalidades, de acordo com o levantamento realizado, observou-se que elas apresentam reconhecimento por práticas de gestão, qualidade, ética, ambiental e social. Por meio de métodos estatísticos de análise de variância (ANOVA), foram realizadas comparações entre as usinas certificadas e não certificadas, está análise contemplou apenas as certificações ISO 9001 e Bonsucro. Objetivou-se também encontrar as particularidades da ISO 9001 e Bonsucro, por meio de aplicação de questionários junto as usinas certificadas, a partir disto, foram mensurados os motivos de obtenção, impactos e dificuldades relacionadas a essas certificações. A certificação ISO 9001 apresentou boa notoriedade com reconhecimento de seus impactos operacionais e de mercado, entre eles, aumento da produtividade, melhoria da qualidade, redução de reclamações. Já a certificação Bonsucro por ter características socioambientais, obteve pouco destaque entre as motivações listadas, porém as usinas concordaram que ela possui impacto de mercado, entre eles, aumento da competitividade e aumento das exportações. Em relação as dificuldades para obtenção das certificações, as usinas relataram que as certificações ISO 9001 e Bonsucro não possuem grandes obstáculos, porém foi constatado que as usinas encontram mais burocracias para obtenção da certificação ISO 9001. / The sugar-energy sector is one of the most dynamic in the country. Its importance in the Brazilian economy is evident, being a great employer, generator of foreign exchange, contributing to economic growth. With increasing availability of information and awareness of society, social and environmental causes have gained more prominence. The certifications emerge as a response to society, as well as promoting improvements according to their requirements. Through previous studies, it has been found that certifications can generate competitive advantages for companies. Among the certifications present in the sector, the ISO 9001 and Bonsucro seals deserved to be more detailed. ISO 9001 for being traditional, and to be present in all sectors of the economy. And Bonsucro, a socio-environmental certification directly related to the sugar-energy sector, besides being present in the main plants of the country. The objective was to conduct a survey of certifications in the sugar-energy sector, and identified approximately 16 different certifications in the sector, among them, the presence of the ISO 9001 and Bonsucro seals was evident. The certifications can be characterized according to their purposes, according to the survey carried out, it was observed that they are recognized by management practices, quality, ethics, environmental and social. Using statistical methods of analysis of variance (ANOVA), comparisons were made between certified and non-certified plants, this analysis included only ISO 9001 and Bonsucro certifications. It was also aimed to find the particularities of ISO 9001 and Bonsucro, through the application of questionnaires to the certified plants, from which, the reasons for obtaining, impacts and difficulties related to these certifications were measured. ISO 9001 certification was well-known with recognition of its operational and market impacts, among them, increasing productivity, improving quality, reducing complaints. The Bonsucro certification, due to its socioenvironmental characteristics, obtained little prominence among the motivations listed, but the mills agreed that it has a market impact, among them, increased competitiveness and increased exports. Regarding the difficulties in obtaining the certifications, the mills reported that ISO 9001 and Bonsucro certifications do not have great obstacles, but it was verified that the mills find more bureaucracies to obtain ISO 9001 certification.
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Gestão da qualidade em serviços de informação no Brasil: estabelecimento de um modelo de referência baseado nas diretrizes da NBR ISO 9001 / Quality management on information services in Brazil: a reference model based on the NBR ISO 9001Valéria Martin Valls 22 September 2005 (has links)
Este trabalho descreve a implantação da Gestão da Qualidade em Serviços de Informação no Brasil, com base na NBR ISO 9001, através de revisão de literatura nacional e internacional e da realização de pesquisa de campo (estudos de caso) em três Serviços de Informação brasileiros: Supremo Tribunal Federal, Clube Paineiras do Morumby e Instituto de Pesquisa Tecnológicas do Estado de São Paulo. A abordagem teórica contempla o estudo da Gestão da Qualidade, seus fundamentos e conceitos e sua perspectiva histórica, a implantação e certificação de Sistemas de Gestão da Qualidade com base na NBR ISO 9001, a Qualidade em Serviços, a Gestão da Qualidade em Serviços de Informação no Brasil e a Gestão da Qualidade em Serviços de Informação com base na série ISO 9000. A abordagem prática contempla o estudo da Metodologia de Pesquisa que descreve os objetivos da pesquisa de campo, os métodos e instrumentos utilizados e os critérios empregados para seleção dos casos, incluindo a apresentação dos três Serviços de Informação analisados. O principal objetivo da pesquisa é desenvolver e disponibilizar aos dirigentes de Serviços de Informação um modelo de referência, baseado na NBR ISO 9001, visando a apoiar o planejamento, a implantação e a melhoria de seus processos, principalmente no que se refere à elevação dos níveis de satisfação de seus usuários, fornecendo parâmetros para a implantação da Gestão da Qualidade em qualquer tipo de Serviço de Informação, independente de sua natureza, tipo ou porte. Além disso, o modelo prevê a apresentação de um planejamento padrão comentado, com as fases básicas de um projeto de implantação de Gestão da Qualidade com base na NBR 9001 em Serviços de Informação. / This paper describes the implementation of Quality Management on Information Services in Brazil based on the NBR ISO 9001, through both national and international literature review and through practical research (case studies) in three Brazilian Information Services: Supremo Tribunal Federal (Federal Supreme Court), Clube Paineiras do Morumby (Morumby Paineiras Club) and Instituto de Pesquisas Tecnológicas do Estado de São Paulo (São Paulo Technological Research Institute). The theoretical approach contemplates the study of Quality Management on those meaning: the fundamentals; concepts and its historical perspective; Quality Managements implementation and NBR ISO 9001 certification; Services Quality; Brazilian Information Services Quality Management and the Quality Management on Information Services based on ISO 9000 series. The practical approach contemplates the study of research methodology, describing the field research objectives, the methods and tools utilized and the criteria employed for cases selection, including the presentation of three Information Services analysed. The main objective of this research is to develop and make available to Information Services managers a reference model, based on the NBR ISO 9001, supporting the planning, the implementation and improvement of these processes, mainly regarding the increase in the users satisfaction levels by offering parameters that can support the Quality Management implementation in any Information Service, independently of its nature or size. Besides that, the model aims at the presentation of a common planning including comments with the basic phases of a Quality Management implementation project based on the NBR ISO 9001 in Information Services.
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Analýza systému managementu vybrané společnosti a návrhy na zlepšení / Analysis of the Management System of the Selected Company and Proposals for the ImprovementKvarda, Tomáš January 2021 (has links)
This diploma thesis focuses on the analysis and improvement of quality management in chosen company. The theoretical part of the thesis describes several methodological analyzes evaluating the company's management. As main analysis was chosen the standard ČSN EN ISO 9001 and to whose requirements the company is assessed. In thesis’s conclusion are for selected identified insufficiencies created solutions for their fulfillmentt.
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Vilken påverkan har kvalitetskulturen vid införandet av ISO? / What impact does quality culture have on the implementation of ISO?Ekman, David January 2020 (has links)
Bröderna Axelssons är ett plåtslageri beläget i Karlskoga. Detta examensarbete har syftat till att undersöka kvalitetskulturen vid två olika ISO-införanden på företaget. Företaget har även fått hjälp med att skriva nya rutiner och instruktioner till processen Beredning/Produktion/Leverans. För att undersöka kvalitetskulturen har metoder använts från Cronemyr P, Bäckström I och Rönnbäck Å (2016). Vid undersökning av kvalitetskulturen har intervjuer genomförts med VD, administratör, produktionstekniker och en enkät om beteenden på företaget. Svaren används sedan till analys för att se vilka värderingar som hindrar/stödjer kvalitetskulturen. Resultatet visade att den dåvarande kvalitetskulturen på företaget till stor del var hindrande, medan dagens kvalitetskultur är av blandad karaktär, alltså både stödjande och hindrande. Vid skapandet av de nya rutinerna och instruktionerna inspirerades strukturen och innehållet av material från Bergman B och Klefsjö B (2012). De färdiga rutinerna och instruktioner lämnades vid arbetets slut över till företaget som ska användas till deras nya ledningssystem som är ISO 9001:2015 integrerat med ISO 14001:2015. Resultatet visade att rutiner och instruktioner från det gamla ledningssystemet var felaktigt skrivna för de gjordes av en utomstående part. Dagens rutiner och instruktioner är gjorda tillsammans med dem som arbetar i processen. Utöver det följer allt material i det nya ledningssystemet samma dokumentationsstruktur, vilket de ej gjorde i det gamla ledningssystemet. För ett fortsatt arbete rekommenderas att vidare undersöka kvalitetskulturen samt ge de ISO-ansvariga på företaget dedikerad arbetstid för att få möjlighet att skriva klart det nya ledningssystemet. Utöver det minimera de värderingar som hindrar kvalitetskulturen. / Bröderna Axelssons is a sheet metal part producing company located in Karlskoga. This thesis aim has been to investigate the quality culture at the company at two different ISO implementation occasions. The company has also received guided help to write new routines and instructions for their process Preparation/Production/Delivery. To investigate the quality culture, methods from Cronemyr P, Bäckström I and Rönnbäck Å (2016) have been used. In the investigation of the quality culture, interviews were conducted with the CEO, administrator, manufacturing engineer and a survey was conducted regarding the existing behaviours in the company. The responses from the interviews and survey were then used to analyse which values obstruct or support the quality culture. The results show that the former quality culture was for the most part obstructive, while the current quality culture is of mixed nature, i.e. both supportive and obstructive. The creation of the new routines and instructions, structure and content were inspired by materials from Bergman B and Klefsjö B (2012). The completed routines and instructions were handed over to the company to be used in their new management system containing ISO 9001:2015 integrated with ISO 14001:2015. The result showed that routines and instructions from the old management system were written incorrectly because they were created by a third party. The new routines and instructions are made together with those who work in the process. In addition, all material in the new management system follows the same documentation structure, which they did not do in the old management system. For continued work it is recommended to further investigate the quality culture and give the responsible for ISO implementation at the company dedicated time to complete the new management system. In addition, the company should minimize the values that obstruct the quality culture.
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Prediction of Time, Cost and Effort needed for software organizations to transit from ISO 9001:2008 to ISO 9001:2015. : A SurveySomaraju, Dilip January 2016 (has links)
Context. Several quality standards have been developed over the years in order to define quality metrics for an organization’s product and even processes. One of the famous standards among them is the ISO 9000 standards which started several years ago. Since its beginning, ISO standards have seen several upgrades. Currently ISO 9001:2008 is in use which is being upgraded to ISO 9001: 2015. Companies have to migrate to the new scheme within three years of the prescribed time in order to retain certification to the ISO 9001 standards. The present thesis is targeted at finding the expected changes and the work improvements in the context of software engineering. Objectives. The main aim of the study is to find the expected changes and work improvements needed to migrate to the new version. This is done by fulfilling the following objectives, they are: analyze the expected changes and motivations for the changes in the new ISO 9001 version. Understand the required work and improvements needed for a software organization to successfully upgrade their certification to the new ISO 9001:2015 version. Predict the estimated cost/time /effort that could be incurred for organization to get certified to the forthcoming ISO version. Methods. In order to meet the objectives, a literature review was done and the changes incorporated in the new scheme are identified. A survey was conducted in order to predict the impact of cost, time and effort on the new changes in moving to ISO 9001:2008 to ISO 9001:2015. The survey was sent only to software organizations as the context of this study is only restricted to quality in software engineering. The collected data was analyzed using bi-variate analysis and Friedman test on SPSS tool. Results. From the literature review, the changes brought about in the new scheme were identified. These changes made were used in the survey questionnaire designed. The survey questionnaire was designed to investigate the expectations of the organizations on the time taken, cost incurred and the effort needed to implement these changes. A total of 63 responses were recorded from the survey. Conclusions. From the analysis it was found that several key changes were identified in the new scheme when compared to the old one. From the survey responses, the cost needed for implementing the changes is expected to be moderate, the time needed is predicted as less than 1 year and the effort needed for implementing the changes was estimated to be more. Along with this, the document also holds clear results about clause by clause expected time, cost and effort estimates and the reasons for these assumptions.
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Desarrollo del Sistema de Gestión de la Calidad ISO 9001:2008 para Empresa de Tecnología y Servicios Industriales, InduamericanaVillarroel Navarro, Fabiola Andrea January 2016 (has links)
Memoria para optar al título de Ingeniera en Alimentos / El presente trabajo que fue realizado, en la sección de Proyectos de Ingeniería de la empresa de servicios industriales Induamericana, para determinar el grado de cumplimiento de los requisitos de la norma internacional ISO 9001:2008 y diseñar el sistema de gestión de la calidad (SGC) según dicha norma.
En la etapa de investigación se reunió toda la información y documentación existente hasta el año 2011. Se elaboró una lista de chequeo para realizar el diagnóstico inicial y final de la empresa y determinar el número de no conformidades antes y después de la realización de este trabajo.
Para subsanar las no conformidades diagnosticadas en la situación inicial y las no conformidades determinadas por Bureau Veritas en su visita a la empresa en el año 2011 (primer intento de implementación de sistema de gestión de la calidad), entre las que se cuentan falta del manual y la política de la calidad, objetivos de la calidad que no son medibles, falta de registros de revisiones por parte de la dirección, entre otras, se diseñó el sistema de gestión de la calidad, comenzando por elaboración de la documentación que dio forma al sistema de gestión de la calidad del presente trabajo.
En la elaboración de la documentación se buscó realizar procedimientos y registros fáciles de usar para que sean verdaderas herramientas de apoyo al trabajo. Toda la documentación elaborada se encuentra disponible en el Anexo 1 de la presente memoria que incluye el manual de la calidad, procedimientos y formularios de registros.
La evaluación final del SGC indicó que se logró solucionar las no conformidades correspondientes a la parte de documentación, con la elaboración del manual de la calidad, los procedimientos y los registros necesarios para su aplicación. Las no conformidades correspondientes a la implementación del sistema quedan como trabajo para la empresa cuando dicho proceso comience.
Finalmente se logró el objetivo de desarrollar el sistema de gestión de la calidad con documentación útil para la empresa, que facilite su aplicación / The present study was done at the Engineering Projects section of an industrial services company Induamericana to determine the degree of accomplishment with the requirements of the international standard ISO 9001: 2008.
In the research stage was gathered all the existing information and documentation in the year 2011 a checklist was developed for initial and final diagnosis of the company and determine the number of non-conformities met.
To remedy nonconformities diagnosed at baseline and non-conformities determined by Bureau Veritas on a visit to the company in 2011 (first attempt to implement quality management system), including lack of a quality manual and a quality policy, quality objectives that are not measurable, absence of records of reviews by the management, among others, the quality management system was designed, starting with development of documentation that shaped the quality management system of the present study.
In the documentation developing it was sought the production of easy to use procedures and records to be real tools to support their work. All documentation is made available in Annex 1 of this title memory it includes the quality manual, procedures, and record forms.
The QMS final evaluation indicated that it achived to solve the nonconformities relating to the part of documentation, with the preparation of a quality manual, procedures and records necessary for application. Non-conformities relating to the implementation of the system stays as work for the company when that process begins. Finally was achieved the objective of develop the quality management system with useful documentation for the company to facilitate its application
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Diseño de un sistema de gestión en base a la norma ISO 9001:2008 para una organización que realiza la distribución de gas natural por red de ductos en el PerúRodríguez Olivares, Moisés Santos January 2016 (has links)
Diseña un sistema de Gestión de Calidad en base a la norma ISO 9001:2008 para una organización que realiza la distribución de gas natural por red de ductos en el Perú.
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Diseño de un manual y procedimientos para la implementación de un sistema de gestión de la calidad ISO 9001:2008 en farmacia o boticaAngulo Alvarado, Pedro José January 2010 (has links)
En el Perú, existe una proliferación significativa de apertura de Farmacias y Boticas las cuales no garantizan el almacenamiento y la dispensación de medicamentos de calidad. Por esta razón, nos propusimos conocer los requisitos legales y voluntarios del servicio de dispensación, expendio y comercialización de productos farmacéuticos, dispositivos médicos y productos sanitarios para un Sistema de Gestión de la Calidad (SGC) ISO 9001:2008 en una Farmacia o Botica. La ISO 9001:2008 es una Norma Internacional voluntaria que especifica los requisitos para un SGC. La presente monografía tiene por objetivo diseñar los manuales y procedimientos para dicha implementación, integrando los sistemas de calidad de Buenas Prácticas de Dispensación (BPD) y las Buenas Prácticas de Almacenamiento (BPA). La metodología del trabajo consistió en determinar cinco fases consecutivas, identificando inicialmente las normas legales aplicables al servicio, la interacción de los procesos, la correspondencia de las BPD y BPA con la ISO 9001:2008; la identificación del alcance, los clientes, los proveedores, las exclusiones, la Política de la Calidad, los programas de gestión y las competencias del personal; para finalmente elaborar la documentación. Nuestros resultados indican el diseño de dos Manuales de Gestión, catorce Procedimientos de Gestión y una serie de documentos. Esto apertura un espacio de discusión para que a partir de trabajos adicionales se pueda identificar la correspondencia de las Buenas Prácticas de Almacenamiento, Dispensación, Laboratorio, Distribución y de Seguimiento Farmacoterapéutico; así como, adelantarse a los cambios significativos de un SGC por cumplimiento de requisitos legales volubles en nuestro país. Todo lo anterior nos lleva a proponer que la implementación de los Manuales de Gestión y los Procedimientos de Gestión permitirán establecer, documentar, implementar, mantener y mejorar continuamente el SGC del establecimiento; así como, cumplir con los requisitos legales establecidos por las instituciones reguladores, DIGEMID e INDECOPI, para evitar multas, cierres temporales e inclusive el deterioro de la imagen del establecimiento a la sociedad.
Palabras clave: Sistema de Gestión de la Calidad, Farmacia, Botica, ISO 9001:2008, manual de gestión, procedimiento de gestión, implementación. / In Peru, there is a significant proliferation drugstores openings which doesn’t guarantee the storage and dispensation of quality drugs. For this reason, we decided to know the legal requirements and voluntary of service dispensing, sale and commercialization of pharmaceutical products, medical devices y health care products for a quality management system (QMS) ISO 9001:2008 in drugstores. ISO 9001:2008 is a voluntary international standard that specifies requirements for a QMS. The objective is to design manuals and procedures for implementation of the QMS – ISO 9001:2008 in the drugstores integrating quality system of Good Dispensing Practice (GDP) and Good Storage Practice (GSP). The methodology is to identify five consecutive stages, initially identified legal standards applicable to the service; interaction between the processes; correspondence between GDP, GSP and ISO 9001:2008, identify the scope, the customers, suppliers, exclusions, Quality policy, programs management and competence of personnel; finally produced the documents. Our results indicate the design of two Management Manuals, fourteen Management Procedures and a number of documents. This opened a space for discussion for additional works to identify the correspondence of Good Storage Practices, Dispensing, Distribution, Pharmacotherapeutic Plan; as well as, anticipate significant changes of QMS for compliance with legal requirements fickle in our country. All this leads us to propose that the implementation of the Management Manuals and Procedures Management will establish, document, implement, maintain and continuously improve the QMS of the organization; as well as, meet the legal requirements established by regulatory institutions, INDECOPI and DIGEMID, to avoid fines, temporary closure and even the deterioration of the organization image to society.
Keywords: Quality management system, Drugstore, ISO 9001:2008, Management Manual, Management Procedure, implementation.
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