International Norms

ISO 9001:2008. Quality Management Systems.

ISO 13485:2003; EN ISO 13485:2012. Health Products. Quality Management Systems. Requisites for regulation purposes, encompassing good manufacturing practices.

Legislation:
European:
Directive 98/79/EC, 27October, concerning health products for in vitro diagnosis.
Spanish:
Royal Decree 1662/2000, 29 September, HEALTH PRODUCTS FOR "IN VITRO" DIAGNOSIS

System Quality Management

1.-* ISO 9001:2008 Quality health products. Design, manufacture and distribution of in vitro diagnostic reagents and diagnostic kits based on antibodies and recombinant antigens for use in flow cytometry, ELISA and spectrophotometry.

   


2.- * ISO 13485:2003; EN ISO 13485:2012. Health Products. Quality management systems. Requirements for regulatory purposes.