Our dedication to providing high quality services has led us to obtain quality management certification according to EN ISO 9001:2015.
At the same time, the laboratories participate with great success in the external quality control schemes organized by EMQN, CEQAS, UK-NEQAS and CF Network for an extensive array of genetic disorders.
Periodic and systematic quality controls are carried out by applying a combination of the following techniques, depending on the occasion:
- repeat the test every time it is performed by the same staff and the same device
- repetition of a test by varying either the staff or the device
- use reference materials with predetermined properties (reference materials or certified reference material), or controls (control samples are typically samples which are stable and available in sufficient quantity for analysis over a long period
- correlation of the results for different sample characteristics
For ach genetic test performed, at the stage of analysis, the laboratory always analyzes in parallel with the test samples a normal-negative control sample (negative control) and at least one corresponding known ‘pathological-positive control sample (positive control).
Where feasible and available, depending on the test, the known ‘pathological-positive control sample is a reference sample (reference material), with documented properties.
The results of each test are accepted only when the results of parallel analyses of the control samples (internal and reference controls) have performed within the expected limits.
The Department of Molecular Genetics and Genomics participates continuously since 2005 and with great success in the external quality control schemes organized by EMQN (and CF Network) for an extensive array of genetic disorders. These schemes evaluate and score separately both genotyping accuracy as well as the proper reporting and clinical evaluation of the results (see certificates).
The Department of Cytogenetics participated in 2015 with great success in the external quality control schemes organized by CEQAS for a number of routine tests (see certificates).
Furthermore, several of our genetic tests have been accredited according to ISO 15189 by ESYD (see certificates).