Quality Management

Hyglos prides itself on providing customers with products and solutions of the highest quality. We are committed to pursuing compliance and registration to relevant International Standards Organization (ISO) standards. Hyglos is certified according to EN ISO 9001:2015 and EN ISO 13485:2012 + AC:2012.

EN ISO 9001:2015 applies to organizations involved in the design and development, manufacturing, installation, and servicing of products. To be certified to this standard, companies must implement a comprehensive quality management system that addresses all areas of operations - from internal staff training to product design, manufacturing, delivery, and service.

EN ISO 13485:2012 + AC:2012 relates to the requirements for a comprehensive management system for the design and manufacture of medical devices.

To view Hyglos ISO 9001:2015 and EN ISO 13485:2012 + AC:2012 certificates, please click on the links below:

>> Certificate Hyglos GmbH ISO 9001:2015

>> Certificate Hyglos GmbH EN ISO 13485:2012 + AC:2012