Corporate information

Management and Quality Assurance Systems

The Banc de Sang i Teixits (Blood and Tissue Bank, BST) has earned the European Seal of Excellence (500+) awarded by the European Foundation for Quality Management (EFQM). We are one of only seven Catalan companies to boast this rating, which certifies the excellence of our management model.

This certification, which can be downloaded in PDF via this link, was obtained four years after we implemented the EFQM model in our business management system, and it represents an important acknowledgment of our efforts to manage public resources responsibly and our ongoing quest for efficiency.

The keys to achieving this recognition were the involvement and commitment of all our professionals, our emphasis on continuous improvement and review, and on designing and implementing new projects and initiatives. Our objective is and always has been to constantly increase our efficiency and ability to satisfy people, whether they are donors or customers.

The auditors underscored the quality of the BST's report, corporate strategy and systematic analysis of indicators for better decision-making. In 2010, the BST received the EFQM Seal of Excellence with a score of +400.

Now, having achieved the 500+ rating, we are more motivated than ever to continue our pursuit of excellence with the commitment and participation of the entire team.

For further information on the EFQM model, visit: www.efqm.org

Quality Assurance at the Banc de Sang i Teixits

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.

Certifications and Accreditations

ISO 9001 Certification

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.

ISO 14001 Certification

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.

ISO 18001 Certification

This is the Occupational Health and Safety Management System certificate based on the criteria of the OHSAS 18001:2007 standard. The BST has held the AENOR-granted certificate since August 2015. It is renewed every 3 years and reviewed on a yearly basis.

Blood Transfusion Accreditation Standards. Transfusion Accreditation Committee (CAT). Spanish Haematology and Haemotherapy Foundation. Spanish Society of Blood Transfusion

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.

CAT STANDARDS FOR UMBILICAL CORD BLOOD BANKS THE CAT FOUNDATION

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. 

FACT-JACIE INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT, COLLECTION, PROCESSING AND ADMINISTRATION

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.

NETCORD-FACT INTERNATIONAL STANDARDS FOR CORD BLOOD COLLECTION, PROCESSING, TESTING, BANKING, SELECTION AND RELEASE

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.

STANDARDS FOR HISTOCOMPATIBILITY TESTING. EUROPEAN FEDERATION FOR IMMUNOGENETICS (EFI)

The Immunogenetics Immunobiology lab has held a European Federation of Immunogenetics (EFI) certificate for HLA typing since July 2002, which is renewed annually.

GOOD MANUFACTURING PRACTICE (GMP)

In the area of production, the BST Advanced Therapy Division (Xcella) 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.

GOOD MANUFACTURING PRACTICE (GMP)

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.