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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 and integrity 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 Biobanks sector is a requirement inherent to the activity carried out as set out in Royal Decree 1716/2011. 

In addition, we have internal quality controls at the key points of each process and participate in external quality control programs organized by national and international institutions that allow us to standardize and standardize procedures used.