The MGZ - Medical Genetics Center in Munich has implemented a comprehensive quality management system since its very founding. The lab received accreditation in accordance with the international standard DIN EN ISO15189 “Medical Laboratories: Special Requirements for Quality and Competence” in May 2000. This international standard requires not only the establishment and maintenance of a quality management system but also evidence of the highest standards in genetic testing in all areas, including pre- and post-analytics and the interpretation of test results.
Excerpt from DIN EN ISO 15189:2014:
Medical laboratory services are essential to patient care and must therefore be available such that they meet the needs of all patients and all clinical personnel responsible for patient care.
Compliance with the requirements of this international standard means that a medical laboratory fulfills the technical competency and management system requirements necessary to consistently deliver valid test results.
The DAkkS (Deutsche Akkreditierungsstelle, or German Accreditation Body) has continually renewed the MGZ’s accreditation in accordance with DIN EN ISO 15189 ever since. In 2014, the MGZ became the first laboratory in Germany to be accredited for single-cell diagnosis. In 2015, the MGZ received accreditation for the new technology of Next-Generation Sequencing (NGS).
Our high quality standard is continually evolving to fulfil the criteria laid out by international standards and regulations and comprises essential components of our quality policy:
- Detailed documentation of all lab-relevant procedures
- Exclusive use of validated test methods and qualified analytical equipment
- Technical laboratory infrastructure in accordance with international standards
- Regular participation in external quality control programs (proficiency testing)
- Regular inspection (audits) of all measures adopted to assure quality
- Extensive training and continuing education of all personnel
- Systematic management assessment and QM committee meetings
- Effective and preventative failure management
For questions and suggestions regarding quality management, please contact our QM team, Dr. rer. nat. Petra Hoffmüller and C. Keiling-Schickram, at firstname.lastname@example.org.