GENOMICA has national and international quality certifications that guarantee the results of its processes.
GENOMICA satisfies the requirements of its customers, employees and other interested parties, maintaining quality standards and complying with the legal requirements established both in the European Union Directive 98/79/EC concerning the CE marking of all in vitro diagnostic medical devices and in the Royal Decrees in force that are applicable.
At present, GENOMICA is immersed in the process of adaptation to the new Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices of the European Union, which will enter into force in 2022.
Operating license as manufacturer and importer
GENOMICA, S.A.U has the operating license as manufacturer and importer nº 7311-PS granted by the department of medical devices of the Spanish Agency of Medicines and Medical Devices.
TÜV Rheinland certifies the conformity of our quality management system with the requirements of ISO 9001:2015 for both the design and development, manufacture, distribution and service of in vitro diagnostic systems based on molecular biology techniques. As well as DNA genetic identification services for human and animal samples and technology transfer activities.
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TÜV Rheinland certifies the conformity of our quality management system for medical devices in the following scope: “Design and development, production, sale and distribution of in vitro diagnostic products based on molecular biology techniques”.
Clinical Analysis Diagnostic Center
GENOMICA has received the definitive health authorization to open and operate, by the General Directorate of Inspection and Management of the Ministry of Health of the Community of Madrid as a center C.2.5.6 Diagnostic Center with units of U.73 Clinical Analysis , registered in the Register with number CS14383.
Download Document License C.2.5.6 Diagnostic center with units of U.73 Clinical analysis
GENOMICA is the first Spanish private laboratory accredited by the National Accreditation Body (ENAC) for the “Identification and genetic-forensic analysis of human tissues and fluids”, and having recently received a Scope of Accreditation for the “analysis of stem cells, adipocytes, and cells in suspension”, according to ISO 17025.
This accreditation guarantees the technical competence and reliability of results in laboratories performing DNA and genetic identification testing.
National Commission for the Forensic Use of DNA (CNUFADN)
Since 2010, GENOMICA is in possession of the certificate issued annually by the National Commission for the Forensic Use of DNA (CNUFADN). This document, granted and regulated by the Ministry of Justice, accredits laboratories that perform DNA analysis while providing legal certainty to the results obtained.
Download CNUFADN Certificate Document