Quality Assurance & QMS

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DIN EN ISO 9001:2000  

The transition to a quality management system (QMS) in accordance with ISO 9001:2000 has been made in November 2000.

Minerva Biolabs GmbH obtained the ISO 9001:2000 (newly certified in 2004) quality system certificate for the following scope:
"Development, Production and Commercialization of Diagnostics, Reagents and Services in the field of Cell Culture Technology, Water Testing and Clinical Application".

DIN EN ISO 13485:2003  

The transition to a quality management system in accordance with ISO 13485:2003 has been made in July 2004.

Minerva Biolabs GmbH has established and applied a quality management system for medical devices for the following scope:
"Development, Production and Commercialization of Molecular Diagnostics and Reagents for the Detection of Infectious Diseases".

Note:

The DIN EN ISO 13485:2003 is a discrete standard, but with a cross reference to the DIN EN ISO 9001:2000. The content of the DIN EN ISO 9001:2000 has been absorbed to a large extend but amended by the specific requirements for medical products, such that the DIN EN ISO 13485:2003 is significantly more comprehensive in comparison to the DIN EN ISO 9001:2000. The objective of the DIN EN ISO 13485:2003 is the compliance with statutory requirements, whereas the objective of the DIN EN ISO 9001:2000 is the improvement of the productive efficiency.