Quality Statement – Buhlmann Diagnostics Corp

Quality Statement

BÜHLMANN is ISO 13485 certified!

BÜHLMANN Laboratories AG is proud to announce the achievement of EN ISO 13485:2016 and MDSAP certification for our Quality Management System, demonstrating our commitment to the quality of our IVD products.

Our process controls, documentation, and quality standards meet or exceed all ISO 13485 requirements. By this, our customers can expect a constant and high level of reliability and transparency from our work. The quality of our products and services is supported by every employee.

The Quality Management System is additionally based on the requirements of US Quality Systems Regulations (21 CFR 820), and the Canadian Regulations (SOR/98-282), as well as the applicable GMP requirements.

Certification is proof of quality. It also provides an advantage for you, our customers. Because of certifications, you can easily distinguish between higher quality and lower quality suppliers of IVD products.

What is EN ISO 13485:2016 + MDSAP:

ISO 13485:2016 and MDSAP certification specifies 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 requirements and regulatory requirements applicable to medical devices and related services.

For more information on ISO 13485, visit the International Organization for Standardization’s website (www.iso.org).

ISO 13485:2016
CERTIFICATE
MDSAP 2018
CERTIFICATE
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