The UNE 166002:2014 standard provides a frame of reference for systematizing R+D+I activities and ensuring effective and efficient management. Therefore, the regulation provides guidelines and requirements for the implementation and maintenance of an R+D+I Management System. It applies to all types of organizations, public or private, independently of sector or size. Nowadays, it has become a model in the promotion, management, and improvement of R+D+I activities.
In the case of IDIBELL, the certificate confirms that the Institute has an R+D+I management system for research, development, and innovation of drugs, biomarkers, medical devices, and clinical software within the fields of oncology, neuroscience, translational and regenerative medicine.
Certification process
The certification is obtained when an authorized verifying agent, in our case AENOR, issues a document that corroborates compliance with the regulation, by which it performs the appropriate checks through an audit process in which it verifies the proper implementation and operation of the system. Certification, in this sense, would be the final goal of the project to implement this standard and is only achieved if all requirements are met satisfactorily.
This certificate corroborates that “the Organization is able to generate and manage innovation projects, to systematize R+D+I activities and ensure that they are carried out effectively and efficiently.”
According to the AENOR audit report, the audit was carried out without detecting any non-compliance. The strengths of IDIBEL’s Innovation Unit were highlighted: project evaluation procedures, project management from portfolio to the market, enhancement of partners attraction and investors to projects.
The achievement of the certificate supposes the recognition of the work developed by the Units of Innovation and Quality to adapt his processes to the requirements of the normative.
The Bellvitge Biomedical Research Institute (IDIBELL) is a biomedical research center created in 2004. It is participated by the Bellvitge University Hospital and the Viladecans Hospital of the Catalan Institute of Health, the Catalan Institute of Oncology, the University of Barcelona and the City Council of L’Hospitalet de Llobregat.
IDIBELL is a member of the Campus of International Excellence of the University of Barcelona HUBc and is part of the CERCA institution of the Generalitat de Catalunya. In 2009 it became one of the first five Spanish research centers accredited as a health research institute by the Carlos III Health Institute. In addition, it is part of the “HR Excellence in Research” program of the European Union and is a member of EATRIS and REGIC. Since 2018, IDIBELL has been an Accredited Center of the AECC Scientific Foundation (FCAECC).