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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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Revitalizace krajiny po těžbě
Moravcová, Zdeňka
The diploma thesis called Revitalization of the Landscape after Mining deals with the current topic of recultivation of the area affected by mining, namely the deep mining of black coal in the territory of Karviná. The aim of the diploma thesis is to characterize the progress of one of the largest reclamation projects in the CR, the Karviná Sea, and to evaluate its success on the basis of a comparison of the ecological stability of the area before starting the mining and after the recultivation work. In order to determine the stability of the territory, two methods of calculation were used, namely a simpler calculation of the ecological stability coefficient according to Míchal, and a more precise calculation of Miklós ecological stability coefficient, which also takes into account the ecological significance of individual landscape elements. The results show an unambiguous increase in ecological stability of the area of interest after recultivation, compared to very low ecological stability in 1950.
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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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