This January, the Area of Functional Validation & Preclinical Research (FVPR) of CIBBIM-Nanomedicine has obtained the ISO 9001:2008 certification of Quality Management Systems for functional validation, preclinical development and/or histological processing services for agents with therapeutic or diagnostic activity, especially those with a nanotechnology base.
The certification audit was carried out in May 2017 by the certification company TÜV Rheinland and the compliance with the standard was reviewed and that a Quality Management System based on continuous improvement was implemented. The certificate has been issued after the certification process already had been reviewed and approved by the head of the certification body. Now, FVPR is already implementing the transition from this ISO9001:2008 to ISO9001:2015, which will be audited in June of this year.
Functional Validation & Preclinical Research
Functional Validation & Preclinical Research (FVPR), led by Dr. Ibane Abasolo, was created in 2007 as part of the CIBBIM-Nanomedicine’s technological offer. Currently, it is part as the U20 of the singular technical scientific infrastructure (ICTS) Nanbiosis. This ICTS is formed by technological units of CIBER in Biotechnology, Bioengineering, and Nanomedicine (CIBER-BBN) and several sections of the Minimally Invasive Surgery Centre Jesús Usón (CCMIJU) of Cáceres.
The objective of FVPR is to provide services to the different research groups of the mother institutions (VHIR and CIBER), as well as to external companies or groups, to evaluate the effectiveness and toxicity of new therapeutic agents or targets, whether they are nanotechnology-based or not. To this end, it has an “in vivo Experimentation Platform with three differentiated sections (i) Experimental Animal Models, (ii) Molecular Imaging, and (iii) Preclinical Histology) and an “in vitro Experimentation Platform.”
The ISO 9001 Standard
The ISO 9001 Standard is the most widespread Quality Management tool worldwide, with over one million certificates in 175 countries. The main objective of the standard is to increase customer satisfaction through continuous improvement processes. It is designed so that the organizations that apply it can guarantee their ability to offer services that meet the requirements of their customers. This international standard promotes the adoption of a process-based approach when the effectiveness of a quality management system is developed, implemented and improved, based in turn on the PDCA (Plan, Do, Check, Act) continuous improvement cycle.
The main benefits derived from ISO 9001 certification for organizations are: systematization of operations, improvement of internal organization, generation of a higher level of confidence in the internal and external environment, increased competitiveness, guarantee of compliance with legislation and regulations related to products and services, among others.