Quality Assurance & QMS

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Quality Assurance

We strive to provide highest quality products, which can be deployed with confidence in scientific research, clinics and in the process and quality control of the biopharmaceutical industry.

All clients, submitting samples to Minerva Biolabs can be assured that we adhere to the highest standards for quality control activities with regard to your samples.

Our commitment to excellence is reflected in continued investments in manufacturing, quality and customer service. The continuous monitoring of all processes, our strict quality management system, the exclusive use of certified reagents and a final quality check guarantee the highest possible quality and consistency of each product.

Our Quality Management System - Your Safety

To fulfill highest standards and requirements on a continuing basis, we have designed a quality management system that meets all requirements of the worldwide accepted quality standard ISO 9001:2008 and ISO 13485:2003 + AC:2007. Additionally, we are working in accordance with GLP standards, ISO 17025 standards for testing laboratories, and the European Pharmacopoeia established guidelines.

DIN EN ISO 9001:2008 

Minerva Biolabs quality management system (QMS) had been introduced in November 2000. The transition to a quality management system (QMS) in accordance with ISO 9001:2008 has been made in December 2008.

Minerva Biolabs GmbH obtained the ISO 9001:2008 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 + AC:2007  

The transition to a quality management system in accordance with ISO 13485:2003 + AC:2007 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 + AC:2007 is a discrete standard, but with a cross reference to the DIN EN ISO 9001:2008. The content of the DIN EN ISO 9001:2008 has been absorbed to a large extend but amended by the specific requirements for medical products, such that the DIN EN ISO 13485:2003 + AC:2007 is significantly more comprehensive in comparison to the DIN EN ISO 9001:2008. The objective of the DIN EN ISO 13485:2003 + AC:2007 is the compliance with statutory requirements, whereas the objective of the DIN EN ISO 9001:2008 is the improvement of the productive efficiency.