The PHSA Biobank guarantees the quality of the services that it offers. The Biobank has established a Quality Policy with the aim of satisfying the needs and expectations of all interested parties.
Our Quality Policy is based on the following objectives:
- Remain consistent with the mission, vision, and values of the PHSA Biobank.
- Comply with all ethical, legal, and regulatory requirements whilst prioritizing the rights of donors.
- Guarantee a suitable system of traceability, service, and improved performance, including the performance of risk assessment and the provision of the necessary resources.
- Ensure the continuous improvement of our processes by periodic reviews and external evaluations.
- Involve staff members in achieving and analysing established objectives.
- Improve the effectiveness and efficiency of the system to find solutions to health problems and provide improved services to clinical and research teams.
- Provide requested services in a timely manner thereby satisfying the expectations of the user.
- Offer a validated portfolio of services.
- Facilitate citizen participation and partnerships with patient associations.
The Coordinating Centre of the Biobank and the provincial centres in Almería, Córdoba, Granada, Huelva, Jaén, Málaga, and Seville have certified their Quality Management System by ISO 9001:2015 an international standard that certifies quality management systems.
The ISO 9001 Standard certifies that all of the procedures and processes which samples are subjected to at the Biobank are in compliance with the standard, including the general management of the Biobank. The scope of the Quality Management System that is followed by the Biobank’s Coordinating Centre includes the following:
- Services for the provision, safekeeping, and processing of blood or blood-derived products, tissues, substances, or biological samples of human origin, including human pluripotent stem cell lines, for use in research and teaching.
- Coordination of the Biobank in its research area.
- Technical advice regarding the management of human samples 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 that is implemented in the provincial centres includes:
- Services for the provision, safekeeping, and processing of blood or blood-derivative products, tissues, substances, or biological samples of human origin, including embryonic and adult human stem cell lines, for use in research and teaching.
The quality of the work that is performed in the Biobank sector is a technical requirement that is determined by Royal Decree 1716/2011.
In addition to the above, we perform internal quality controls at key points in each of our work processes. We also participate in external quality control programs that are organized by national and international institutions that inform how we standardize our work and the procedures that we use.