GenómicaCERTIFICATIONS AND CE MARK

CE MARK - DIAGNOSTIC PRODUCTS


GENOMICA, in accordance with the current legislation, fulfils all the requirements of the European Directive 98/79/CE with reference to the CE mark for all its commercialized in vitro diagnostic products.



ISO 13485


GENOMICA has established and applies a quality management system for medical devices for the following scope: "Design/development, manufacture, sales and distribution for in vitro diagnostic test systems based on molecular biology techniques"


 

ISO 9001 


Our quality management system is certified by TÜV Rheinland.


TÜV Rheinland certifies the conformity of our quality management system with the ISO 9001:2015 covering the design, production and commercialisation of our in vitro diagnostic kits as well as the rest of activities developed for the company such as Technology Transfer and the Genetic Identification Laboratory.

 


ISO 17025


GENOMICA is the first Spanish private laboratory in Spain accredited for the National de Accreditation Entity (ENAC) for the "Identification and Genetic-Forensic Analysis of human tissues and fluids", and the only one further accredited for "stem cells, adipocytes and suspension cells" according to the norm UNE-EN ISO / IEC 17025: 2005.


 

GENOMICA is a Clinical Analyses Diagnostic Center, with License Nº of CONSEJERÍA DE SANIDAD Y CONSUMO: CS 12753.


National Commission for the Forensic Use of DNA (CNUFDNA)


Since 2010 GENOMICA holds the certificate issued annually by the National Commission for the Forensic Use of DNA (CNUFDNA). This document, issued and regulated by the Ministry of Justice, accredits laboratories performing DNA analysis while providing legal certainty to the obtained results.

Being in possession of the accreditation certificate issued by the National Accreditation Entity (ENAC) as described in Article 8 of the "Royal Decree 1977/2008 for the procedure assessment of DNA testing laboratories", is one of the prerequisites to achieve this accreditation.

The regulations applied for the establishment of this commission are based on the following conditions:

 

  • Article 8 of Royal Decree 1977/2008 regulating the procedure for evaluation of DNA testing laboratories.
  • The CNUFADN agreement on accreditation and quality control for laboratories approved by the CNUFADN plenary on the 21/07/2009.
  • The 2009/905/JAI FRAMEWORK DECISION OF THE EUROPEAN COUNCIL on accreditation of forensic service providers who perform laboratory activities.

 

 

           

Certifications