Quality management systems and occupational health and safety
At the Blood and Tissue Bank, we consider quality and the environment to be strategic for the organisation. Please see the Quality and Environment Policy.
For this reason, in 1999 we certified the quality management system for the first time according to the requirements of ISO 9002:1994. In 2003, the organisation adapted the management system to ISO 9001:2000, in 2009 to ISO 9001:2008, and in 2017 to ISO 9001:2015.
Since the first certification and over the years, Quality has permeated all processes and centres of the organisation. This is reflected in the achievement of new certifications and accreditations according to standards of different organisations, institutions, or scientific societies specific to the different fields of action of the BST.
At the BST, we aim to promote and protect the safety and health of workers, collaborating companies, as well as citizens, by taking responsibility and promoting the integration of Occupational Risk Prevention in all activities we carry out and in all decisions we make as part of the BST. Please see the Prevention Policy.
Certifications and Accreditations
ISO 9001 certification
It is the certification of the Quality System according to the criteria of ISO 9001:2015. BST has the certification, granted by AENOR and has been certified since March 1999. It is renewed every 3 years and reviewed annually.
Certification of regulatory audit of occupational risk prevention
It is the certification of the Occupational Health and Safety Management System according to the criteria of Royal Decree 39/1997 of January 17.
Accreditation Standards in Blood Transfusion. Accreditation Committee in Transfusion (CAT). Spanish Foundation of Hematology and Hemotherapy. Spanish Society of Blood Transfusion
The CAT, in accordance with the Blood Transfusion Accreditation Standards (CAT), accredits the Quality Management System, blood donation and extraction, apheresis, autotransfusion, analysis, production of blood components, storage, distribution, and transfusion practice 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 initiated the CAT audit programme in 2005, resulting in the accreditation according to these Quality System standards and procedures manual of the various BST units.
The CAT accreditation corresponds to each audited unit, is renewed every 3 years, and is reviewed annually.
Standards in umbilical cord blood banks in CAT. The CAT Foundation
The CAT Foundation, the certification body for quality in transfusion, cellular therapy and tissue, certifies that the Concordia Programme of BST has been audited and complies with the standards in CAT umbilical cord blood banks 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 certification since 14th October 2011.
JACIE-FACT International Standards for Hematopoietic Cellular Therapy Product, Collection, Processing and Administration
Jacie acredita que el BST compleix els estàndards en l'àrea de processament de progenitors hematopoiètics.
Disposem d'aquesta acreditació des del 10 de setembre del 2015, es renova cada 4 anys.
NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release
The Umbilical Cord Blood Bank (UCBB) is part of the Netcord network, an association of umbilical cord blood banks worldwide. Currently, Netcord has 15 members, the most important in the world.
The objective of Netcord is to leverage synergies between banks and create a registry of umbilical cord blood units available to hospitals for transplantation purposes.
The quality of stored units has always been Netcord's top priority, which is why it has established quality standards that all its members must follow.
The UCBB has had the corresponding accreditation since April 2005.
Standards for Histocompatibility Testing. European Federation for Immunogenetics (EFI)
The Immunobiology Immunogenetics Laboratory is accredited by the EFI (European Federation of Immunogenetics) for HLA typing since July 2002 and renews this accreditation annually.
Normes de Correcta Fabricació (NCF)
The Advanced Therapies Division of the BST in the production area complies with the principles and guidelines of the Good Manufacturing Practice established in Directive 2003/94/EC. The first inspection was carried out in November 2011 and is renewed every three years.
Good Distribution Practices (GDP)
The Blood and Tissue Bank has a Drug Warehouse that complies with the principles and guidelines of Good Distribution Practice established in Directive 92/25/EEC.
The first inspection was carried out in August 2019 and is renewed every three years.