Quality Assurance & QMS

Quality Assurance

We strive to provide highest quality products, which can be applied with confidence in scientific research, clinics and in the process and quality control of the biopharmaceutical industry.
We constantly meet these high quality standards.
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.
The continuous staff training and further education combined with accurate financial planning, costs management and a clear market focus ensures superior products at economical prices for our customers.

Our Quality Management System – Your Safety

We have implemented the requirements of ISO 13485:2016 and ISO 9001:2015 in every area of our company.

We introduced ISO 9001 in 2000 and then ISO 13485 in 2004 to give our support to sustainable development, thereby enhancing the company value and contributing to the safeguard of the future.

Since then, the QMS Quality Management System (QMS) has been adapted in accordance with the revisions of ISO 9001 and ISO 13485.

Minerva Biolabs GmbH has the following scope of application for:

-ISO 9001:2015:

“Development, production and marketing as well as contact manufacturing of reagents for applications in molecular biology.”

-ISO 13485:2016:

“Contract development and contract manufacturing of various molecular biological NAAT-based in vitro diagnostic reagents for disease detection.”

Note:

DIN EN ISO 13485 is an independent standard, but refers to DIN EN ISO 9001. The aim of DIN EN ISO 13485 is to meet the requirements for regulatory purposes. It deals with the requirements for the medical device industry that manufacturers and suppliers of medical devices must meet when developing, implementing and maintaining management systems.

The goal of DIN EN ISO 9001 is the continuous improvement and productivity with a focus on customer orientation. It ensures that the numerous interlinked activities are identified, managed and directed.

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