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Wagner, Marcel Vila

Anpassung des Dokumentenmanagements der Firma CRS medical GmbH an DIN EN ISO 13485:2016, LSE BS BMT 0185

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Kurzfassung in Deutsch

Kein deutschsprachiges Abstract.

Kurzfassung in Englisch

This bachelor thesis is based on the newly structured risk-based approach of the German Institute for Standardization, EN ISO 13485:2016 (referred hereafter as “ISO 13485”). The goal of this thesis is to use the new risk-based method for document management, ISO 13485, and implement it at CRS medical GmbH. This is done through newly formed processes that show the required changes to ISO 13485 and a restructured document management approach. The risk-based approach is a weakened version of risk management. Therefore, all relevant risk factors must be clearly defined and then adapted to CRS medical GmbH. In order to show this process clearly, a flowchart was developed with identified risk factors. This flowchart visualizes the restructured procedure of the document management process. As with all new process developments, a new standard Operation Procedure (SOP) and a form (FM) were created. New forms are always needed when a SOP is developed so it can be properly classified. The results show that the developed method is an easy way to classify documents. Now every document can get a quick classification in its risk classes. Finally there is a clear link to ISO 13485 and the result demonstrates a significant improvement of the document management.

Studiengang / zentr. Einrichtung: Biomedizinische Technik Bachelor
Dokumentart: Bachelor-Arbeiten
Sprache: Deutsch
Erstellungsjahr: 2017
Publikationsdatum: 19.11.2018

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