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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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Audit of process management
Vostatková, Adéla ; Kala, Václav (advisor) ; Pavel, Pavel (referee)
The thesis focuses on Audit of process management. In a section Current issue, the basic terms related to the topic of thesis are defined, for example audit and its purpose in enterprise, procedural audit, process and process management with applied methods included. Furthermore, the theoretical part gives an explanation about terms connected to quality and relevant standards of ISO. Selected and monitored enterprise for this thesis is a construction company XY which deliveres turnkey constructions. The company is certificated with ISO norms 9001. In analytical part the author will provide a procedural analysis which is base on conversation and cooperation with liable employees. In these analyses the up to date process will be identified as well as evaluated. Then the author will evaluate the current process of output product´s quality by chosen analysis. The author will also make a review of economic performance of the company in relation to up to date process that are currently taking place in the company. Afterwards, the comparison of adjusted process with ISO 9001 requirements will be made. From acquired findings which will come out from previous analysis the author of thesis will make a proposal to leading which contains simplification of the process, the aim is to increase performance. The author will bring a statement in every single section and refers to prevention. The author suggests to perceive a quality as the most important factor of success to achieve customer´s satisfaction which brings higher profit at the end.
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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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Quality management in the selected company
TURKOVÁ, Jana
This thesis deals with quality management in the selected company. The aim of this thesis is to evaluate the quality management system and suggest possible changes. Thesis is focused primarily on training, education and motivation of the employees affecting the quality.
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Management quality - The customer view of a product audit
BUCHLOVIČOVÁ, Kateřina
This graduation theses deals with quality, quality control system, ISO rules and audit of product. Chosen firm is characterized in the practical part of the document, there is explanation of the implementation ISO rules in company. Then I occupy by creation of instruction: quality monitoring in the workroom. Other part of document deals with characteristic of monitored product parameters and using FMEA method. I get at product values of customer and I design methodics for finding customers satisfaction in the ending of document.
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