Since its establishment as a separate entity in September 2011, Sunstar Europe SA continuously worked at implementing good quality practices regarding the design, the development, the manufacturing and the distribution of oral care products in Europe, Middle East and Africa. The quality management system of Sunstar Europe SA is now certified against ISO 9001:2008 and ISO 13485:2003 by an independent and well-known certification body:
-Its ISO 9001 certification (Quality management system – Requirements) covers activities related to the design, development, manufacturing and distribution of oral care products, including medical purpose products;
-Its ISO 13485 certification (Medical devices – Quality management systems – Requirements for regulatory purposes) covers activities related to the design, development, manufacturing and distribution of non-active medical devices for topical use in the field of oral care, as well as active medical devices intended to monitor and manage sleep bruxism, in addition to the distribution of oral care medical devices.
The incorporation within Sunstar Europe SA’s management system of the requirements of the new version of the standards (ISO 9001:2015 and ISO 13485:2016) is in progress.
Beyond the external recognition of the conformity of Sunstar Europe SA’s quality management system to standards requirements, these certifications enhance the ability of the organization to meet customers and regulatory requirements, while supporting the capability to address product safety and effectiveness. It is a tangible acknowledgement of the continuous and passionate customer-focus of all Sunstar Europe SA members.