![]() ![]() ![]() This QM System has to meet the requirements of the ISO 13485 A Quality Management System has to be adopted, recorded and implemeted and the efficiency of this system has to be maintained.This means, among other things, that the following requirements have to be fulfilled: Minimum requirements for the certification according to ISO 13485Īn organisation that wants to be certified has to fully and demonstrably meet all the requirements of the applicable standards.
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