Quality Statement

BÜHLMANN is ISO 9001 and ISO 13485 certified!

BÜHLMANN Laboratories AG is proud to announce the achievement of ISO 9001:2008 and EN ISO 13485:2012 + AC:2012 re-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 9001 and 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 ISO 13485:2003 CMDCAS, as well as the applicable GMP requirements.

Certification is a 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 9001:2008:

The ISO 9000 family of standards is related to “quality management”, and what a particular organization does to enhance customer satisfaction by meeting customer requirements and to continually improve the corresponding performance.

What is EN ISO 13485:2012 + AC:2012:

ISO 13485:2012 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 9001 or ISO 13485, visit the International Organization for Standardization’s website (www.iso.org).

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