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CERTIFICATIONS AND CE MARK

CE MARK - DIAGNOSTIC PRODUCTS

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

• Doc. Declaration of Conformity CE: CLART® HPV 2
• Doc. Declaration of Conformity CE: CLART® MetaBone
• Doc. Declaration of Conformity CE: CLART® PneumoVir
• Doc. Declaration of Conformity CE: CLART® ENTHERPEX
• Doc. Declaration of Conformity CE: CLART® SeptiBac
• Doc. Declaration of Conformity CE: CLART® EnteroBac
• Doc. Declaration of Conformity CE: CAR
• Doc. Declaration of Conformity CE: CAP

Norma ISO 9001 : 2008

Our quality management system is certified by  SGS (Société Générale de Surveillance, SA).

SGS certifies the conformity of our quality management system with the ISO 9001:2008 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.

 

• Certificate SGS ISO 9001

Norma ISO 17025

GENOMICA is the first private laboratory in Spain accredited for the National de Accreditation Body (ENAC) for the "Identification and Genetic-Forensic Analysis of human tissues and fluids", and it has been recently accredited for the analysis of "stem cells", in agreement with the normative ISO 17025. This warrantees the technical competence and reliability of the results in those laboratories performing DNA tests and genetic identification.

• Accreditation ENAC - ISO 17025
• Schedule of Accreditation - ISO 17025

Norma ISO 13485

GENOMICA has establised and applies a quality managment 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"

• Certificate SGS ISO 13485

 

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.

 

• DNA Commission 2011