Quality Management System
We have a Quality Management System certified according to EN ISO 13485:2016 "Medical Devices - Quality Management systems - Requirements for regulatory purpose" by TÜV Product Service, Munich, Germany.
The scope of the certificate is "Design and development, production and distribution of products, reagents, and instruments for in-vitro diagnostic use".
EN ISO 13485:2016 DiaMed GmbH (EN)
EN ISO 13485:2016 Bio-Rad Medical Diagnostics GmbH (EN)
EN ISO 13485:2016 Bio-Rad Medical Diagnostics GmbH (DE)
The ISO 13485:2016 is an internationally recognized standard for organizations involved in the medical device industry. This standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Hence the ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. Therefore, the decision was taken to not renew ISO9001 certification.
Our quality management system implements the relevant national and international guidelines and laws and meets the requirements of IVDD 98/79 / EG, Regulation (EU) 2017/746 (IVDR), the FDA regulations and the Medical Device Single Audit Program.
IVDD 98/79/EG (EN) MDSAP 2024 Bio-Rad Medical Diagnostics GmbH MDSAP 2021 DiaMed GmbH
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