EpiDisease obtains ISO 9001:2015 quality management certification for its COVID-19 diagnostic laboratory


The biomedical company, located at the University of Valencia Science Park, has obtained recognition from the International Certification Network for its PCR assay service for the detection of the SARS-CoV-2 virus, thus becoming one of the few Spanish laboratories with this type of certification

"At EpiDisease we consider it essential to offer a quality service that generates maximum confidence and reliability in the results of SARS-CoV-2 infection detection," says José Luis García, scientific director of the spin-off of CIBER-ISCIII, the University of Valencia and INCLIVA.

The certification granted by AENOR accredits its PCR assay service at international level and, in the same way, implies "the high technical quality of the laboratory for this type of analysis, which differentiates us in terms of reliability with respect to other laboratories that offer this type of test". The new ISO 9001 2015 incorporates several new features. "The most outstanding one is the incorporation of risk management or the risk-based approach in quality management systems," the EpiDisease manager points out.

For Garcia, "health authorities and competent authorities should require this type of quality certifications as an absolutely objective criterion and synonymous with the reliability of laboratories that offer SARS-CoV-2 virus detection tests."