Certification According to DIN EN ISO 9001:2015

gempex has also successfully passed the 5th follow-up audit for certification according to DIN EN ISO 9001:2015 without any deviations. Thus, the quality management system of gempex has been consistently and reliably certified since 2006.

Again, there were several aspects that were positively highlighted. This year it was the training planning, the onboarding of new employees, the planning of internal audits and again the knowledge management.

gempex is considered a recognized expert in the field of Compliance Consulting on GMP, GDP, MDR as well as comparable quality standards and supports leading companies in the Chemical, Pharmaceutical and Medical Device Industries in the safe implementation of these quality requirements. 

"We constantly focus on the quality of our processes and services," says Peter Bappert, Managing Director and responsible for the Quality Management at gempex. "Quality, safety, trust - these are fundamental criteria for gempex's services for our customers. And the basis for this is continuously kept up-to-date, broadly positioned knowledge of our team." Knowledge management and training are central topics for gempex, and we work on both continuously. 

The certification was carried out by TÜV SÜD Management Service GmbH and covers the German gempex sites in Karlsruhe and Mannheim as well as the Swiss site of the GMP Consulting company in Sisseln. 
The ISO 9001 is nationally and internationally the self-evident standard in the area of Quality Management (QM). 

The gempex certificate is available at Portrait.