QUALITY MANAGEMENT

Central to our success is the high quality of our services. We follow the continuous improvement principle. Monitoring and optimising all processes permanently and train our team regularly to meet the exceptionally high demands of all our customers.

Our high quality is certified by DIN EN ISO 9001: 2008 in terms of quality management. All our services are based on GCP / GCLP and GLP guidelines.

Central to our success is the high quality of our services. To meet the exceptionally high demands of all our customers all processes are monitored and optimized permanently. We follow the continuous improvement principle and regularly train our team.

Our high quality is certified by DIN EN ISO 9001: 2015 in terms of quality management. All our services are based on GCP / GCLP, GCDP and GLP guidelines.

 

Success factors

  • Highest service quality available
  • Extremely high customers satisfaction based on flexibility and reliable implementation of requests
  • Zero error principle
  • Continuous monitoring and optimization of all processes
  • Own quality assurance department
  • Regular functional training of all our employees regarding quality, occupational safety and environment protection

 

Certificates

2018:

  • Certification according to DIN EN ISO 9001:2015
  • Audit certification: Review of the quality management system according to the requirements of ISO/IEC 17025:2018
  • GCP-trained Team (S2 Laboratory, Logistics, Study Monitoring, Project Management, Quality Management, Quality Assurance)
  • GDP-qualified Team of Logistics
  • certified Auditor according to DIN ISO/IEC 17025:2017

2017:

  • Certified member of BVMA (Federal Association of Contract Research Organisations)
  • GCLP-trained Team (S2 Laboratory, Logistics, Study Monitoring, Project Management, Quality Management, Quality Assurance)
  • GLP-qualification of quality manager

 

Realization of our services is based on the following guidelines:

  • GCP / GCLP / GLP/ GDP
  • EU Medical Device Directive (93/42/EEC)
  • Directive on in vitro diagnostic medical devices (98/79/EC)
  • DIN EN ISO 14155 – Clinical testing of medical devices
  • Clinical & Laboratory Standards Institute Guidelines
  • IVDR- and MDR-Regulations (Mai 2017)