The Medical Genetics Center has had a quality management system in place since its very founding. The lab received accreditation in accordance with the international standard DIN EN ISO15189 “Medical Laboratories: Particular Requirements for Quality and Competence” in May 2000. This international standard is the basis for ISO/IEC 17025 and ISO 9001 and lays out the guidelines for quality and competence in medical laboratories.
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 of 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 quality management system encompasses (but is not limited to) the following duties and responsibilities:
- Detailed documentation of all lab-relevant procedures in the quality management handbook and in the standard operating procedures (SOPs).
- Exclusive use of professional methods of analysis (validation)
- Regular participation in external quality control programs (interlaboratory round-robins)
- Adequate space and technical equipment
- Comprehensive monitoring of all analytical equipment (maintenance, internal quality control)
- Intensive basic and continuing education of all lab personnel
- Regular inspection of all measures adopted to assure quality (audits)
- Systematic managerial assessment
- Efficient and prophylactic error-prevention
- Systematic quality inspection of our suppliers
- Optimal interface (e.g. the route of samples from practice to laboratory)