Quality and certification
Our laboratory is the very definition of high-quality laboratory analytics. We achieve this by being committed to a quality policy that is universally recognised by our management team and our employees. In addition to continually monitoring our workflows, we also regularly adapt our processes in line with specific requirements. Our analytics are always based on the state of the art.
Our laboratory is certified in accordance with ISO 9001:2015 Quality Management and 14001:2015 Environmental Management.
In addition to the laboratory management being granted the right to work as an independent entity by the Canton of Zurich, medica has FOPH approval to carry out molecular genetic testing on humans and Swissmedic approval to perform diagnostic or epidemiological testing in the field of transmissible human diseases.
We undertake to participate regularly in external interlaboratory trials and internal quality controls in accordance with the requirements set out by QUALAB and Art. 58 of the Swiss Federal Law on Health Insurance (KVG) and Art. 77 of the Swiss Health Insurance Ordinance (KVV). Further information and certificates can be obtained upon request.
We monitor the measuring accuracy of our methods through internal quality controls and external round robin tests. To this end, we apply the requirements set out by QUALAB and have defined corresponding error margins, which are determined using the characteristic values for methodology bias (for validity) and for the coefficient of variation of the relative standard deviation (for precision). For the purposes of clarity, we do not include these characteristic values in the diagnostic reports. We will be happy to provide these to you at any time upon request. The laboratory is recognised as a category B FAMH advanced training centre for haematology, clinical chemistry, clinical immunology, medical genetics and medical microbiology. Zurich Pathology Centre is also recognised as a category C SIWF advanced training centre for pathology and category A centre for cytology and molecular pathology.
All subcontracted analyses are carried out by partner laboratories that are accredited or meet the legal requirements for carrying out the analyses (e.g. Swissmedic approval to perform microbiological testing to identify or rule out transmissible diseases, FOPH approval to carry out genetic testing on humans, participation in interlaboratory trials). We undertake regular testing of these requirements and will be happy to provide you with more detailed information upon request.
We attach the highest importance to quality. As part of our quality management, we maintain a system for continuous improvement. Please send any questions or concerns to qm@medica.ch and we will provide you with feedback in due course.
Your contact person
Andrea Klausner
Certified Quality Manager NDS HF
Head Quality Management