932 resultados para ISO 9001 elements


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My bowl es un proyecto que nace a partir de la búsqueda de nuevas y mejores formas de alimentación, sin necesidad de pertenecer a un estilo de vida fitness, sino que al contrario, se basa en el interés por encontrar y ofrecer una opción de alimentación de forma balanceada, práctica, rápida, personalizada, fresca y funcional, enfocado en los smoothies de fruta, con el propósito de lograr un bienestar general.

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L'elaborato riguarda l'analisi tra lo stato as-is e lo stato to-be in riferimento ai processi interni ad un'organizzazione. Il focus del trattato è la descrizione delle fasi di lavoro che si susseguono nella ricostruzione di un processo, in questo caso specifico la rintracciabilità del flusso materiali inerenti al caso di Rosetti Marino Sp.a (Ravenna, Italia), nell'evidenziare quali sono le criticità attuali e le risorse coinvolte nel processo. Una volta individuati i punti critici, si passa all'analisi del to-be, ovvero allo studio delle possibili aree ed opportunità di miglioramento sia in termini di processo che di attori coinvolti. E' di fondamentale importanza comprendere nella fase finale momenti di formazione dei propri dipendenti con la sponsorship dei prorpi responsabili di funzione. In conclusione, l'elaborato attraversa sia le fasi operative del processo, di costruzione del nuovo flusso di attività ottimizzato, ma pone l'attenzione anche sulle fasi di formazione e di coinvolgimento di tutti i partecipanti necessari, affinchè il processo sia compreso, metabolizzato e messo a frutto.

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Il settore farmaceutico è regolato da numerose norme e linee guida al fine di tutelare la salute del consumatore. Infatti, il principio generale che governa lo sviluppo e l’operabilità di un impianto farmaceutico prevede che l’utilizzatore debba fornire l’evidenza documentale che il sistema sia “qualificato” e che il processo produttivo che in esso risiede sia “convalidato” e mantenuto in tale stato. Sulla base di quanto detto risulta essenziale, prima dell'accettazione alla produzione di un nuovo farmaco, che venga confermata una valutazione esatta e affidabile per la sua realizzazione e per la sicurezza degli utilizzatori, garantendone la qualità. Tale elaborato è volto ad analizzare suddetta gestione delle richieste normative in ambito di qualifica dei sistemi farmaceutici, come frutto di un’esperienza formativa svolta presso lo stabilimento di Termoli (CB) della F.I.S. – Fabbrica Italiana Sintetici S.p.A. Il processo di qualifica è stato messo in atto per l’installazione di una nuova centrifuga e per la mappatura termo-igrometrica del nuovo magazzino automatizzato dello stabilimento. Nello specifico, i due casi studio esaminati sono stati individuati grazia ad una prima presentazione del sistema inquadrato nella produzione di principi attivi farmaceutici, seguita dall’analisi dei protocolli (standard e non) di qualifica da compilare nella fase esecutiva. Nell’elaborato sono stata presentate e comparate le normative e le linee guide vigenti del settore, quali EU GMP Guidelines, ISPE Baseline Guide e UNI EN ISO 9001:2015 per la gestione della qualità, e le procedure aziendali, nell’ottica delle norme di buona documentazione e del rispetto del data integrity. L’esecuzione dei due progetti ha permesso l’avvio e la messa in esercizio di sistemi critici per la produzione di principi attivi farmaceutici, garantendo il miglioramento delle prestazioni complessive dell’impianto.

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The focus of this dissertation is to develop finite elements based on the absolute nodal coordinate formulation. The absolute nodal coordinate formulation is a nonlinear finite element formulation, which is introduced for special requirements in the field of flexible multibody dynamics. In this formulation, a special definition for the rotation of elements is employed to ensure the formulation will not suffer from singularities due to large rotations. The absolute nodal coordinate formulation can be used for analyzing the dynamics of beam, plate and shell type structures. The improvements of the formulation are mainly concentrated towards the description of transverse shear deformation. Additionally, the formulation is verified by using conventional iso-parametric solid finite element and geometrically exact beam theory. Previous claims about especially high eigenfrequencies are studied by introducing beam elements based on the absolute nodal coordinate formulation in the framework of the large rotation vector approach. Additionally, the same high eigenfrequency problem is studied by using constraints for transverse deformation. It was determined that the improvements for shear deformation in the transverse direction lead to clear improvements in computational efficiency. This was especially true when comparative stress must be defined, for example when using elasto-plastic material. Furthermore, the developed plate element can be used to avoid certain numerical problems, such as shear and curvature lockings. In addition, it was shown that when compared to conventional solid elements, or elements based on nonlinear beam theory, elements based on the absolute nodal coordinate formulation do not lead to an especially stiff system for the equations of motion.

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Este documento contiene el Diseño de Aplicación de la Norma internacional ISO 26000:2010 Modelo de Gestión de Responsabilidad Social en la Fundación Hospital San Carlos, Bogotá - Colombia, en el que se incluye la herramienta que se diseñó para el desarrollo del estudio con base en los requisitos aplicables de la norma que orientan a un comportamiento socialmente responsable; así como el diagnóstico inicial que se realizó en la organización objeto de estudio desde una perspectiva cualicuantitativa, frente a los lineamientos que la norma presenta como elementos esenciales: Principios y Materias Fundamentales. De igual manera y acorde a la metodología que se definió para el estudio que fue observacional de corte descriptivo cualitativo interpretativo, se muestra la matriz DOFA de la institución según el diagnóstico, con el respectivo análisis e interpretación derivados de los hallazgos evidenciados en el proceso de evaluación; en el cual se identificó que la Fundación Hospital San Carlos cumple con un 47,97% de los requerimientos de responsabilidad social según la norma ISO 26000:2010, con el logro de 71 criterios de los 148 evaluados y aplicables a la organización, observándose especial fragilidad en los componentes Fortalecimiento de la Comunidad, Prácticas Laborales, y Transparencia, con un cumplimiento que estuvo por debajo del 50%. Por otra parte y como propósito fundamental del estudio se presenta el diseño propuesto para la aplicación de la norma ISO 26000:2010 en la IPS Fundación Hospital San Carlos, en el cual se registran estrategias y mecanismos que los autores sugieren y recomiendan se deben trabajar para que la implementación de este modelo internacional de Responsabilidad Social, se haga de una manera pragmática y sencilla, que lo conviertan además en un diseño de aplicación de la norma que pueda ser referenciado por organizaciones del sector salud o no, interesadas en trabajar en responsabilidad social empresarial. Para la estructura del diseño de aplicación de la norma y conforme el estudio realizado, se plantean 7 pasos que deben seguir las organizaciones de manera sistemática, metódica y ordenada: comprender la responsabilidad social; reconocer su Responsabilidad Social; levantar una matriz DOFA con base en un diagnóstico institucional; planificar; estructurar y definir de la Responsabilidad Social dentro de la organización; sensibilizar, divulgar y capacitar los estándares de la Norma ISO 26000:2010; documentar el Modelo de Responsabilidad Social; Implementar el modelo de Responsabilidad Social; y monitorear el modelo mediante un mecanismo que integre un sistema de auditoría integral y la revisión de gerencia.

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As a result of increasing global awareness about the importance of the environment, depletion of natural resources and legal pressures for companies to manage their processes in a sustainable manner, ISO 14001 systems have been gaining increasingly more importance in the organizational scenario. These elements are even more critical in emerging nations due to less awareness and fewer demands by governments and the population in relation to environmental issues. Therefore, the main objective of this study is to verify the benefits and difficulties of Environmental Management Systems based on ISO 14001 at industries in the state of São Paulo - Brazil (an emerging country) by conducting a survey to subsidize the proposal for actions in the public, academic and private sectors to promote the use of this standard of reference and strengthen its results in Brazil. A questionnaire was sent to 194 companies from the National Institute of Metrology, Standardization and Industrial Quality database. 69 answered, representing a return rate of 35.36%. The main benefits identified are related to the development of preventive environmental actions, reduction in the consumption of power, water, gas and fuel oil, and a positive influence on other internal management processes. The main difficulties are related to cost increases from ISO 14001 management systems and the constant changes in environmental legislation in Brazil. Some actions are proposed at the end of the analyses to intensify the use and improve the results of this standard, such as changes in government legislation and its collective development and implementation in industries. (C) 2010 Elsevier Ltd. All rights reserved.

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This study deals with the seasonal distribution of Al, Ca, Cu, Fe, K, Mg, Na, Pb and Zn and water soluble ions (Cl-, PO4(3-), NO3-, SO4(2-), HCOO-, CH3COO-, oxalate, succinate, Na+, NH4+, K+, Mg2+ and Ca2+) found in PM10 samples (particulate matter less than 10 mm in diameter) São Paulo City, Brazil, (April 2003-May 2004). Higher atmospheric levels were found for SO4(2-), NO3-, Cl- and PO4(3-) while the main organic anions were oxalate and formate. Atmospheric levels for elements were: Fe > Al > Ca > K > Na > Mg > Zn > Cu > Pb. Some sources were predominant for some species: (i) fuel burning and/or biomass burning (NO3-, HCOO-, C2O4(2-), K+, Mg2+, Ca2+, Fe, Pb, Zn, Al, Ca, K and Mg), (ii) gas-to-particle conversion (SO4(2-) and NH4+) and (iii) sea salt spray (Cl-, Na+ and Na).

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This study deals with the reduction of the stiffness in precast concrete structural elements of multi-storey buildings to analyze global stability. Having reviewed the technical literature, this paper present indications of stiffness reduction in different codes, standards, and recommendations and compare these to the values found in the present study. The structural model analyzed in this study was constructed with finite elements using ANSYS® software. Physical Non-Linearity (PNL) was considered in relation to the diagrams M x N x 1/r, and Geometric Non-Linearity (GNL) was calculated following the Newton-Raphson method. Using a typical precast concrete structure with multiple floors and a semi-rigid beam-to-column connection, expressions for a stiffness reduction coefficient are presented. The main conclusions of the study are as follows: the reduction coefficients obtained from the diagram M x N x 1/r differ from standards that use a simplified consideration of PNL; the stiffness reduction coefficient for columns in the arrangements analyzed were approximately 0.5 to 0.6; and the variation of values found for stiffness reduction coefficient in concrete beams, which were subjected to the effects of creep with linear coefficients from 0 to 3, ranged from 0.45 to 0.2 for positive bending moments and 0.3 to 0.2 for negative bending moments.

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Reinforced concrete beam elements are submitted to applicable loads along their life cycle that cause shear and torsion. These elements may be subject to only shear, pure torsion or both, torsion and shear combined. The Brazilian Standard Code ABNT NBR 6118:2007 [1] fixes conditions to calculate the transverse reinforcement area in beam reinforced concrete elements, using two design models, based on the strut and tie analogy model, first studied by Mörsch [2]. The strut angle θ (theta) can be considered constant and equal to 45º (Model I), or varying between 30º and 45º (Model II). In the case of transversal ties (stirrups), the variation of angle α (alpha) is between 45º and 90º. When the equilibrium torsion is required, a resistant model based on space truss with hollow section is considered. The space truss admits an inclination angle θ between 30º and 45º, in accordance with beam elements subjected to shear. This paper presents a theoretical study of models I and II for combined shear and torsion, in which ranges the geometry and intensity of action in reinforced concrete beams, aimed to verify the consumption of transverse reinforcement in accordance with the calculation model adopted As the strut angle on model II ranges from 30º to 45º, transverse reinforcement area (Asw) decreases, and total reinforcement area, which includes longitudinal torsion reinforcement (Asℓ), increases. It appears that, when considering model II with strut angle above 40º, under shear only, transverse reinforcement area increases 22% compared to values obtained using model I.

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El apartado <4.2 Altavoz> de la Norma Internacional UNE-EN ISO 140-5 [1] especifica que la directividad del altavoz usado en el ensayo debe asegurar en todas las bandas de frecuencias de interés, unas diferencias de nivel locales inferiores a 5dB (o a 10 dB para fachadas de dimensiones mayores a 5m), medidas en campo libre, sobre una superficie del mismo tamaño y orientación que la pared o elemento a ensayar. Este requisito debe verificarse en unas bandas de frecuencia de interés que sean como mínimo los tercios de octava desde 100Hz hasta 3150Hz, y preferiblemente desde 50Hz hasta 5kHz. Desde hace unos años, en el Laboratorio de sonido de la EUIT de Telecomunicación de la Universidad Politécnica de Madrid, los autores han implementado un método en el que, a partir de las medidas de directividad en cámara anecoica de la fuente sonora a ensayar, se calcula el campo sonoro directo sobre una superficie ficticia que representa un elemento de fachada en la misma disposición que se indica en la norma ICO 140-5 y con unas dimensiones según se requieran en el procedimiento. También se estima la dimensión horizontal máxima ΔXmax de una fachada rectangular en relación de aspecto fija que permite verificar la norma con los criterios de 5dB y 10dB de diferencias máximas de niveles directos en dicha fachada. En esta ponencia se detalla el procedimiento anterior. ABSTRACT. The Section "4.2 loudspeaker" of the UNE-EN ISO 140-5 International Standard: "Field measurements of airborne sound insulation of façade elements and façades", specifies that the directivity of the loudspeaker used in the test must ensure in all frequency bands of interest, local level differences less than 5dB (or 10dB for façade dimensions greater than 5m), measured in free field over an area of the same size and orientation as the wall or element to be tested. This requirement must be verified in the frequency bands of interest which are, at least, the third octave bands from 100Hz to 3150Hz, preferably from 50Hz to 5kHz. In recent years, in the Laboratory of Sound of the EUIT Telecomunicación (Universidad Politécnica de Madrid), the authors have implemented a method that, from directivity measurements of loudspeakers performed in the anechoic room, the direct sound field on a surface in the same layout as indicated in the ISO standard is calculated. It is also estimated the maximum horizontal dimension Δxmax of a rectangular façade for each aspect ratio which verify the standard criteria of either 5dB or 10dB for the maximum differences of direct levels in the façade. This paper details the procedure above introduced.

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Tese de mestrado integrado em Engenharia da Energia e do Ambiente, apresentada à Universidade de Lisboa, através da Faculdade de Ciências, 2016

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Geospatial data have become a crucial input for the scientific community for understanding the environment and developing environmental management policies. The Global Earth Observation System of Systems (GEOSS) Clearinghouse is a catalogue and search engine that provides access to the Earth Observation metadata. However, metadata are often not easily understood by users, especially when presented in ISO XML encoding. Data quality included in the metadata is basic for users to select datasets suitable for them. This work aims to help users to understand the quality information held in metadata records and to provide the results to geospatial users in an understandable and comparable way. Thus, we have developed an enhanced tool (Rubric-Q) for visually assessing the metadata quality information and quantifying the degree of metadata population. Rubric-Q is an extension of a previous NOAA Rubric tool used as a metadata training and improvement instrument. The paper also presents a thorough assessment of the quality information by applying the Rubric-Q to all dataset metadata records available in the GEOSS Clearinghouse. The results reveal that just 8.7% of the datasets have some quality element described in the metadata, 63.4% have some lineage element documented, and merely 1.2% has some usage element described. © 2013 IEEE.

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The present dissertation aims to analyze the evaluation process of environmental performance inside an organization from the building construction section of civil construction based on the NBR ISO 14031 guidelines, which provide orientation regarding the implementation of this project towards the internal organizational management. The theoretical research has addressed concepts and historical development of environmental management inside organizations, from the emergence of the first models to the strengthening of environmental management through the standardization of the Environmental Management System caused by the publication of ISO 14001. It has also addressed the evaluation of environmental performance, the NBR ISO 14031 (concepts, types of indicators of evaluation of environmental performance, the elaboration process of such indicators, as well as its use and evaluation by the high administration). The research has an applied character, with exploratory and descriptive goals, and a qualitative approach based on case study. The data collection will be made through questionnaires, interviews, and documental analysis. Through the present research project, one expects to learn the elements taken into consideration by the organization for the elaboration and selection of indicators; to identify which interested parties contribute in the aforementioned process; to discover which sources are taken into consideration by the organization while establishing its environmental performance goals; to learn how the different kinds of environmental indicators are handled by organizations on daily basis, considering the existence of interferences on the decision making process, whether or not the interested parties are integrated, and if there is an periodical evaluation of environmental performance and how it is handled. One also expects to identify the opportunities for improvement regarding the organization that is object of study.

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Dissertação de Mestrado em Gestão Integrada da Qualidade, Ambiente e Segurança

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Cancer is a multistep process that begins with the transformation of normal epithelial cells and continues with tumor growth, stromal invasion and metastasis. The remodeling of the peritumoral environment is decisive for the onset of tumor invasiveness. This event is dependent on epithelial-stromal interactions, degradation of extracellular matrix components and reorganization of fibrillar components. Our research group has studied in a new proposed rodent model the participation of cellular and molecular components in the prostate microenvironment that contributes to cancer progression. Our group adopted the gerbil Meriones unguiculatus as an alternative experimental model for prostate cancer study. This model has presented significant responses to hormonal treatments and to development of spontaneous and induced neoplasias. The data obtained indicate reorganization of type I collagen fibers and reticular fibers, synthesis of new components such as tenascin and proteoglycans, degradation of basement membrane components and elastic fibers and increased expression of metalloproteinases. Fibroblasts that border the region, apparently participate in the stromal reaction. The roles of each of these events, as well as some signaling molecules, participants of neoplastic progression and factors that promote genetic reprogramming during epithelial-stromal transition are also discussed.