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Mise en place d'un nouveau guide de management de la qualité pharmaceutique, l'ICH Q10, au Laboratoire Français du Fractionnement et des BiotechnologiesFourel, Céline Daniel-Gautier, Hélène. January 2009 (has links)
Reproduction de : Thèse d'exercice : Pharmacie : Nantes : 2009. / Bibliogr.
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Bassett mechanical a case study of implementation of ISO-9001:2000 /Bassett, Kimberley S. January 2002 (has links) (PDF)
Thesis--PlanB (M.S.)--University of Wisconsin--Stout, 2002. / Includes bibliographical references.
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La pratique d'intervention ergonomique mise en oeuvre dans le cadre d'un projet de certification à la norme ISO 9001 /Viau-Guay, Anabelle. January 2002 (has links)
Thèse (de maîtrise)--Université Laval, 2002. / Bibliogr.: f. [148]-156. Publié aussi en version électronique.
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Implementace ISO 9001 na Ústavu pro informační systém MZLU v BrněRůžičková, Petra January 2008 (has links)
No description available.
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Návrh systému managementu kvality v antikvariátu Vysoké školy ekonomické v Praze / Concept of Quality Management System in Antikvariát VŠESnopková, Lenka January 2008 (has links)
Graduation Theses describes Management System of Quality (QMS) according to Needs of Standard Specifications ISO 9001:2000 in Antikvariát VŠE. Target was designed funktional QMS and implemented Survey of customer's Satisfaction with proposition of Quality Manual. This work is designed like Interpretation of single points ISO - Standards and with practical Solutions for Antikvariát VŠE.
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ISO 9001:2015 implementation at a manufacturing companyJönsson, Anna, Berglund, Magnus January 2016 (has links)
Martin Ivarsson, manager and part owner at Landeryd’s Mechanical Workshop (LMW), Landeryd, Sweden, initiated this project. This because of a new released ISO 9001 version that LMW has to implement before the 15th of September 2018 to remain certified. Since LMW is ISO 9001:2008 certified the project members only needed to identify the differences among the 2015 and 2008 version to see what LMW has to do to get certified. There are approximately 1.1 million ISO 9001 certificates issued worldwide. An ISO 9001 certification increase organizations ability to satisfy customer needs and customers can rely on that the products and services provided are of consistently good quality. ISO 9001 can also work as a tool to streamline the organization’s processes and make them more efficient. Since the ISO 9001 is reviewed every five year it helps organizations to keep current in an ever- changing world. Landeryd’s Mechanical Workshop has been ISO 9001 certified since 2002 and the “ISO- think” is deeply rooted within the company. LMW is a small owner-controlled company with only 18 employees. ISO 9001:2015 is applicable on different kinds of organizations in various scales. Comparing to previous versions of ISO 9001 the new version is more adaptable. This makes it more beneficial for the organizations but harder for the auditors that certifies. One major conclusion is that LMW will have more freedom of document handling with the new ISO version. This report highlights LMW’s status today in accordance to the new ISO 9001 version, and estimates how much effort that is needed for a successful revision. Readers of this report will benefit from the results, since much is applicable on all types of organizations or companies.
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Quality management system developmentHodder, Carl Alexander January 2013 (has links)
With Chiptech’s current growth rate and size it has become necessary to develop a Quality Management System to enable repeatability, meet customer demands, and protect Chiptech from staff turnover. ISO 9001 was identified as a base for development, with the imperative that the system identified and developed must deliver value for Chiptech. Several frameworks were investigated, along with journal articles and discussions with industry members in order to determine the aspects that would deliver value, and determine the key success factors. Two factors were identified as critical: employee involvement, and the utilisation of metrics – both of which were leveraged for the project results and recommendations.
The systems developed have already proved they offer benefits, however, in order to maintain performance Chiptech must a) keep evaluating the measured results, b) ensure that quality forms an integral part of the organisational culture and, c) continue the systematic approach of continual improvement.
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Diseño de un manual de calidad y procedimiento para la implementación del sistema de gestión de calidad ISO 9001:2008 en laboratorio de fármacos veterinariosJimenez Limay, Paula Alexandra, Huamán León, Alvaro Noé January 2015 (has links)
Durante los últimos años hemos evidenciado la importancia de conducir las organizaciones en base a un sistema de gestión de calidad que permita definir la interacción y establezca los controles de cada uno de sus procesos involucrados, la búsqueda de la satisfacción del cliente y difundir la búsqueda de la mejora continua, que le permita adaptarse rápidamente en un mercado que cambia constantemente. El objetivo de realizar este análisis prospectivodescriptivo es diseñar un manual de calidad y procedimientos que permitan estandarizar la documentación de todos los procesos en una organización, en base a una norma internacional certificable como es el caso de la ISO 9001:2008. Es por este motivo que la norma en mención exige, para mantener un sistema de gestión de calidad, un procedimiento que dé las directivas para el control de documentos que sirvan de medio de difusión sobre las actividades que se realizan en cada proceso dentro de la organización, un procedimiento que dé las directivas para el control de los registros generados en cada actividad de la organización, un procedimiento que explique el tratamiento que se le da a cada producto que esté fuera de sus especificaciones, un procedimiento que explique el tratamiento que se le dará a cualquier no conformidad o potencial no conformidad respecto con la norma en mención o a la documentación generada en el sistema y, un procedimiento que de los lineamientos para auditar el sistema de gestión de calidad con la finalidad de comprobar su eficacia y mejora continua. De igual manera, mostrar la importancia de contar con un Manual de Calidad que permita comunicar a la organización la política y objetivos de calidad que la alta dirección desea difundir a cada uno de los colaboradores, los procesos que forman parte del alcance del sistema y de la interacción de cada uno de ellos, además de la mención de los procedimientos complementarios que la organización ha decidido implementar. / --- Over the past years has shown the importance of organizations leads to a quality management system to define the interaction and set controls for each process involved, looking for customer satisfaction and promote the pursuit of continuous improvement, enabling it to adapt quickly in a market which is constantly changing. The aim of this analysis prospective-descriptive is to design a quality manual and procedures which allows standardize documentation for all process in an organization, based on a Certifiable International Standard as ISO 9001:2008. For this reason the norm requires to maintain a quality management system. The norm requires a procedure which gives directives for the control of documents to serve as a means of diffusion on activities that take place in every process within the Organization, also requires to include a procedure that gives directives for the control of records generated in each activity of the Organization, call for a procedure that explain the treatment given to each product that is out of its specifications, requires a procedure that explains the treatment that is given to any non-conformance or potential non- conformance in regards or documentation generated by the system and, call for a procedure to give guidelines to audit the quality management systems in order to check effectiveness and continuous improvement. Similarly, show the importance of having a Quality Manual that allows communicate to the Organization, the quality policy and objectives which was established by the senior management and communicated to each one of the partners, and the processes that are part of the scope of the system and the interaction of each of them, besides the mention of complementary procedures that the Organization has decided to implement.
Keywords: System, procedures, manual, processes.
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Gestión del cumplimiento de los requisitos de la norma ISO 9001:2008 en la empresa Arcor Dos en Uno y el cumplimiento de requisitos de documentación de esta norma en el área de gestión de calidadContreras Moreno, Viviana Andrea 07 1900 (has links)
Memoria para optar al título profesional de Ingeniero en Alimentos / Autorizada por el autor, pero con restricción para ser publicada a texto completo en el Portal de Tesis Electrónicas, hasta diciembre de 2015. / En Chile el grupo Arcor se ve representado por Dos en Uno. Para efecto de
esta memoria de título, la implementación de la norma internacional ISO
9001:2008 se realiza en la Planta 2 ubicada en la comuna de Cerrillos. La norma
ISO 9001:2008 es una norma internacional de gestión de la calidad, cuyo objetivo
es establecer los requisitos aplicables a todo tipo de organización de cualquier
sector o actividad y se basa en los ochos principios de gestión de la calidad
fundamentales para una buena gestión empresarial. Todas las empresas que
conforman el grupo Arcor poseen como modelo un Sistema de Gestión Integral
(SGI) que involucra diversas normas y herramientas, dentro de las cuales se
encuentra la norma ISO 9001. El área de gestión de calidad es la encargada de
revisar la relación que existe entre el SGI y lo respectivo a la norma ISO 9001,
para luego entregar a las diversas áreas de la organización la responsabilidad de
cumplir con los requisitos asignados. Posteriormente, respecto a lo que le compete
al área de gestión de calidad, se establecen los documentos obligatorios y los que
la organización estime conveniente, para cumplir con los requisitos 4.2.1 c y d.
Finalmente para dar cumplimiento con cada uno de los requisitos sobre
documentación en el área de gestión de calidad, se revisan los documentos
existentes y se elaboran todos aquellos que sean necesarios, los que una vez
aprobados, se cargan en la base de datos del grupo Arcor, llamado Loyal ISO, con
el propósito de llevar un control y manejo de los documentos de la organización.
Se concluye que el área de gestión de calidad identificó y entregó adecuadamente
los requisitos de la ISO 9001:2008 a cada encargado de área de la organización.
El porcentaje de avance inicial de la Planta 2 fue de un 50%, siendo el área menos
preparada para la implementación, el área de Compras y aquella más apta fue el
área de Producción. El área de gestión de calidad logró el cumplimiento de los
requisitos sobre documentación de la ISO 9001:2008, a través del sistema
computacional, Loyal ISO. La Planta 2 de la empresa Arcor Dos en Uno se
certificó por la norma ISO 9001:2008 en el tercer trimestre del año 2012 / In Chile, Arcor group is represented by Dos en Uno. For purposes of this
thesis work, the implementation of the international standard ISO 9001:2008 is
done at the Plant 2 located in area of Cerrillos. The standard ISO 9001:2008 is an
international standard of quality management, which establishes requirements for
all types of organization in any sector or activity and is based on the eight
principles of quality management critical to good corporate governance. All
companies in the Arcor group have modeled Arcor Integrated Management System
(SGI in Spanish) that involves various rules and tools, among which is the standard
ISO 9001. The quality management area is responsible for reviewing the
relationship between SGI and all related to ISO 9001, and deliver to the various
areas of the organization, the compliance of responsibilities assigned.
Subsequently, on what the area is responsible for quality management,
establishing the required documents and the organization consider appropriate, to
accomplish requirement 4.2.1 c and d. Finally to comply with each of the
documentation requirements in the area of quality management, review existing
documents and are elaborated all necessary in them, so their shall be loaded, once
approved, to the Arcor group database, Loyal ISO to thus take control and
management of organizational documents. It is concluded that the area of quality
management, identify and deliver properly the requirements of the standard ISO
9001:2008 to each area of the organization. The initial advance percentage of the
Plant 2 was 50%, being the area less prepared to implementation, Purchasing
Department, while the area better prepared was Production Department. The
quality management area achieved the compliance with the documentation
requirements of ISO 9001:2008, through Loyal ISO computer system. Plant 2 Arcor
Dos en Uno was certified by ISO 9001:2008 in third quarter 2012.
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Modelo de diagnóstico para avaliação de Sistemas de Gestão da Qualidade em PMESSoares, Eduardo José Oenning 31 January 2010 (has links)
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Previous issue date: 2010 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / No atual ambiente competitivo é importante que existam métodos que garantam vantagem
competitiva a organizações, principalmente para Pequenas e Médias Empresas (PMEs), por
serem desprovidas de recursos de diversas naturezas. A certificação ISO 9001:2008, é um
Sistema de Gestão da Qualidade (SGQ) que oferece diretrizes que proporcionam vantagens
para as empresas, tanto no seu ambiente interno quanto externo, entretanto, uma ineficaz
implementação não garante tais benefícios. Assim, um diagnóstico que seja capaz de auxiliar
a efetiva e eficaz implementação deste Sistema de Gestão da Qualidade seria útil às
organizações. Entretanto, na literatura não foi encontrado nenhum método específico a PMEs.
Assim, este trabalho de pesquisa teve como objetivo elaborar um modelo de diagnóstico para
avaliação de Sistemas de Gestão da Qualidade que levasse em consideração as características
e particularidades das PMEs. Para tanto, foi utilizada pesquisa bibliográfica para
levantamento de dados secundários de caráter exploratório no intuito de elaborar o modelo e
também fora realizado um estudo de caso para testar o modelo proposto em um caso real. Ao
final da pesquisa, foi possível apresentar um modelo que atendesse ao objetivo proposto neste
trabalho, que é capaz de identificar pontos críticos previamente à implementação de tal
Sistema de Gestão da Qualidade, assim, oferecendo informações importantes aos gestores na
tomada de decisão quanto à intensidade de recursos necessários a cada ponto crítico, deixando
a cargo do gestor a natureza do recurso. Apesar de algumas limitações do modelo, uma grande
contribuição deste estudo é a adequação a PMEs, recomendando-se para estudos posteriores
uma amostragem estatística para testar algumas considerações feitas pelo autor
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