CERTIFICATES
ISO 9001
Sistemas Genómicos has been certified by the Spanish Association for Standardization and Certification (AENOR) for standard ISO 9001 (certificate No. ER0052/2005) for the activities according to the current Certificate.
ISO 13485
Sistemas Genómicos has been certified by the Spanish Association for Standardization and Certification (AENOR) for standard ISO 13485 (certificate No. GS-0001/2015) for the activities according to the current Certificate.
ISO 14001
Sistemas Genómicos has been certified by the Spanish Association for Standardization and Certification (AENOR) for standard ISO 14001 (certificate No. GA-2020/0020) for all its activities according to the current Certificate.
HEALTHCARE PRODUCT MANUFACTURER’S LICENCE
Sistemas Genómicos has the mandatory health licence for operating a laboratory as the manufacturer of healthcare products for in vitro diagnosis, approved by the Spanish Medicines and Health Products Agency. The scope of the licence covers the manufacture of genetic testing kits and software for bionformatics analysis of genetic data (licence No. 6500-PS).
ISO 15189
Sistemas Genómicos has been accredited by the Spanish National Institution for Accreditation (ENAC) for standard ISO 15189 (accreditation 313/LE1957) to carry out the tests according to the current Technical Annex.
ISO 17025
Sistemas Genómicos has been accredited by the Spanish National Institution for Accreditation (ENAC) for standard ISO 17025 (accreditation 313/LE646) to carry out the tests according to the current Technical Annex.
Healthcare Register
Sistemas Genómicos is registered as a diagnosis centre in the Autonomous Community of Valencia’s register of healthcare centres, services and establishments to clinical, genetic and preimplantation genetic diagnosis activities
VIEW CERTIFICATEPublic Healthcare Laboratory
Sistemas Genómicos is recorded in the public healthcare laboratories register of the Department of Universal Healthcare and Public Health
PUBLIC HEALTHCARE LABORATORIES REGISTER