ISO Certification

Bioanalytic GmbH is fully certified in accordance with ISO 9001 (quality management) and ISO 13485 (quality management medical devices) in all areas:

• Development
• Manufacturing
• Distribution

There is no certification for ISO 14001. However, Bioanalytic GmbH operates internally an environmental management system oriented according to ISO 14001.

Below are the certificates for ISO 9001 and ISO 13485 as well as information on the supplier evaluation.