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ISO 9001:2008 certification of Quality Management System to NANBIOSIS U20

The Area of Functional Validation & Preclinical Research of CIBBIM-Nanomedicine has recently obtained the ISO 9001:2008 certification of Quality Management System.

Functional Validation & Preclinical Research (FVPR), led by Dr. Ibane Abasolo, Scientific Coordinator of Unit 20 of NANBIOSIS “In Vivo experimental Platform“,  was created in 2007 as part of the  CIBBIM-Nanomedicine’s technological offer. 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 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.

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

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