At the BST, quality and environment are of strategic importance for our organisation, as set out in our Quality and Environment Policy.
For this reason, in 1999 we certified our quality management system for the first time according to standard ISO 9002:1994. In 2003, we adapted our management system to standard ISO 9001:2000, and in 2009 to standard ISO 9001:2008 and in 2017 to standard ISO 9001:2015.
In the years since receiving our first certification, quality has increasingly permeated each of our organisation's processes and work centres. This is reflected in the fact that we have also been certified and accredited to standards published by different organisations, institutions and scientific societies in the BST's specific fields.
At the BST we want to promote and protect the safety and health of our workers, collaborating companies, as well as citizens by taking responsibility and promoting the integration of Occupational Risk Prevention in all the activities that we carry out and in all the decisions that we adopt. See Prevention Policy.
This certifies that our quality management system conforms to the requirements of standard ISO 9001:2015. The BST has been certified since March 1999 by Applus (formerly the Laboratorio General de Ensayos e Investigaciones / LGAI). It is renewed every 3 years and reviewed annually.
This certifies that our Environment system conforms to the requirements of standard ISO 14001:2015. The BST has been certified since April 2013 by AENOR. It is renewed every 3 years and reviewed annually.
It's the certification from the management of Security and Health at work System following the criteria from Royal Decree 39/1997 issued on January 17th
The CAT, in accordance with the 2006 CAT Accreditation Standards for Blood Transfusion (3rd edition), has accredited the quality management system, blood donation and extraction, aphaeresis, autologous transfusion, testing, production of blood components, storage, distribution and transfusion practices of the following centres: Bellvitge, Sant Pau and Vall d'Hebron in Barcelona, Germans Trias in Badalona, Mútua de Terrassa in Terrassa, Dr. Josep Trueta in Girona, Arnau de Vilanova in Lleida, Joan XXIII in Tarragona and Sant Joan in Reus.
The BST began participating in the CAT audit programme in 2005, which has allowed the quality management systems and procedure manuals of the bank's different units to be accredited according to CAT standards.
CAT accreditation is awarded individually to each audited unit, and it is renewed every 3 years and reviewed annually.
The CAT Foundation, an organisation that certifies quality in transfusion and cellular and tissue therapy, certifies that the BST Concordia Programme has been audited and meets CAT cord blood bank standards in the following areas: donation and collection of umbilical cord blood, processing, and storage and distribution of cellular products for transplantation.
We have held this certificate since 14 October 2011.
Jacie certifies that the BST meets the standards in the area of hematopoietic stem cell processing.
We have held this certificate since 10 September 2015 and it is renewed every 4 years.
The BSCU is a member of the Netcord network, a worldwide association of umbilical cord blood banks. Currently, Netcord has among its members the 15 most important banks in the world.
The aim of Netcord is to develop and use synergies between banks and create a registry of cord blood units available to hospitals who request them for transplantations.
The quality of stored units has always been one of Netcord's priorities, hence it has established quality standards that all members must abide by.
The BSCU has had the corresponding certificate since April 2005.
The Immunogenetics Immunobiology lab has held a European Federation of Immunogenetics (EFI) certificate for HLA typing since July 2002, which is renewed annually.
In the area of production, the BST Advanced Therapy Division meets the principles and guidelines of Good Manufacturing Practice established in Directive 2003/94/EC. The first inspection was in November 2011, and the certificate of GMP compliance is renewed every three years.
The department of medicinal products under research for human use of the Tissue Bank abides by the principles and guidelines of Good Manufacturing Practice established in Directive 2003/94/EC. The corporate headquarters were inspected for the first time in February 2017 and the certificate of GMP compliance is renewed every three years.