Quality

The SSPA Biobank guarantees the quality of the services it offers, establishing a Quality Policy with the aim of meeting the needs and expectations of the interested parties.

This Quality Policy is based on the following objectives:

  • Be consistent with the mission, vision and values of the SSPA Biobank.
  • Comply with ethical, legal and regulatory requirements, mainly attending to the rights of the source subjects or donors.
  • Ensure an adequate system of traceability, monitoring and bio-surveillance.
  • Ensure quality in all processes, thus ensuring a better service and better services, carrying out a risk assessment and providing the necessary resources.
  • Ensure continuous improvement of processes with periodic reviews and promote external evaluation.
  • Involve all personnel in the achievement and analysis of the established objectives.
  • Promote improved effectiveness and efficiency to find responses to health problems and provide a better service to clinical teams, research teams and therefore society.
  • Provide the required service in a timely manner and in accordance with the user's expectations.
  • Offer a validated portfolio of services.
  • Facilitate citizen participation and alliances with patients.
  • Ensure the impartiality, independence, integrity and confidentiality of its activity, as well as the technical competence of its actions in biomedical research, establishing in turn the necessary mechanisms for equity in access to its services.

The Biobank Coordinator Node and its Provincial Nodes have certified their Biobank Management System quality by the ISO 9001:2015 standard, which is the international certifiable standard that regulates quality management systems.

This Standard certifies compliance with all the procedures and processes to which the samples are subjected as well as the general management of the Biobank. The scope of the quality management system implanted in the Biobank Coordinator Node is:

  • The provision of services for the provision, custody and processing of blood products or derivatives, tissues, substances or biological samples of human origin, and human pluripotent stem cell lines, for use in research and teaching.
  • Coordination of the Biobank of the Public Health System of Andalusia in your area of research.
  • Technical advice on human sample management for research.
  • Design and delivery of training in the area of biomedical research.
  • Registration of donors of biological samples for biomedical research.

 

The scope of the quality management system implemented in the provincial nodes of the Biobank is:

  • The provision of services for the provision, custody and processing of blood products or derivatives, tissues, substances or biological samples of human origin, and embryonic and adult human stem cell lines, for use in research and teaching.

In addition, the Biobank of the Public Health System of Andalusia is accredited by ENAC with accreditation No. 2/BB003 according to the UNE-EN ISO 20387: 2020 standard, for the scope of the acquisition, preparation and conservation, quality control, storage, distribution and transport of human pluripotent cell lines, both of embryonic and induced origin, activity that is carried out as a Granada Node of the National Bank of Cell Lines.

Quality in the Biobank sector is an inherent technical requirement of the activity it performs, as set forth in Real Decreto 1716/2011. 

Furthermore, as part of the strategy to ensure the quality of samples and the services provided, the SSPA Biobank participates in various national and international external quality assessment programs. This supports the technical competence of the processing, preservation, and quality control procedures for biological samples carried out at the Biobank, contributing to the standardization and normalization of the procedures used.

During the year 2025, the Biobank participated in international programs such as the “Proficiency Testing" program organized by the Integrated BioBank of Luxembourg (IBBL) and endorsed by ISBER, and the “Proficiency test for bodily fluids 2025" program organized by the German Biobank Node integrated into the Jena Biobank. At the national level, the Biobank participated in the external quality control program organized by the Carlos III National DNA Bank. The following table shows the processes evaluated in each of the programs.

Quality Program

EVALUATED PROCESS

IBBL Proficiency testing, ISBER 

IBBL Proficiency testing, ISBER Seal

 

“DNA Quantification and Purity Scheme” |LS|DNAQ25|RS|

“RNA Integrity” Scheme |LS|RNAI25|RS|

“Cell viability” Scheme |LS|CELL25|RS|

 

Proficiency test for bodily fluids 2025 German Biobank Node/ Integrated Biobank Jena 

Logos of the German Biobank Network and the Integrated Biobank Jena

 

  • Testing the homogeneity and volume accuracy of plasma aliquots
  • Evaluation of inspection upon sample receipt and corresponding documentation
  • Process assessment of sample shipment by checking shipping documents and packing according to ADR (UN3373) packing instruction P650
  • Temperature monitoring and analysis of samples during shipment
  • Testing for contamination in plasma aliquots using NMR
  • Optional: Conformity check of the sample report in accordance with ISO 20387 und DIN/TS 13283

 

Carlos III National DNA Bank 

Logo of the Carlos III National DNA Bank

 

Determination of concentration and purity of RNA samples by spectrophotometry

DNA extraction from whole blood

 

 

External quality controls in which the Biobank participated during 2025, indicating the evaluated procedure