In 1992 DOTTIKON EXCLUSIVE SYNTHESIS decided to implement a Quality System according to ISO 9001. The subsequent project was successfully completed with the certification according to ISO 9001:1994 in 1994.

ISO 9001 is a general quality system which is not especially designed for the chemical or pharmaceutical industry. The quality system according to ISO 9001 defines the frame and has the advantage that a company can define within this frame their own procedures. This advantage became even larger with the process approach of
ISO 9001:2008. DOTTIKON ES has used cGMP as well as Safety, Health and Environmental Protection (SHE) requirements to define their procedures within the flexible ISO-frame. Thus DOTTIKON ES integrated cGMP as well as SHE into their ISO Quality Management System.

Within this integrated Quality System ISO has the benefit that it covers all business areas of the company and ensures effectiveness and efficiency of the whole organization. 

The most recent recertification according to ISO 9001:2000 was in December 2006, which was updated in the recent intermediate inspection to ISO 9001:2008.

By the Quality Management System according to ISO 9001:2008 including cGMP as well as SHE requirements DOTTIKON ES ensures that the high quality, safety and environmental requirements of the authorities and customers are met.