VHIO understands Quality as a transversal value that extends across all areas of the organization’s activity. Our policy is not limited to the formal compliance with requirements, but is based on the principles of scientific excellence, social responsibility, sustainability, information security and continuous improvement, providing a solid reference framework for the development of our activities.
We work with the commitment to meet the needs and expectations of our interested parties, both internal and external, including patients, researchers, institutional collaborators, funding bodies and society as a whole. We guarantee the quality and technical competence of our laboratories, ensuring the reliability, validity, metrological traceability and confidentiality of the clinical results generated within the framework of biomedical research.
At the same time, we develop and maintain an integrated and effective management system, aligned with ISO 9001, ISO 15189 and ISO 27001 standards, which promotes innovation, efficiency and the continuous improvement of our processes, and ensures the management of risks and opportunities within the organizational context.
The organization operates in full compliance with the legal, technical-health, regulatory, ethical and data protection requirements applicable to its activity, especially with regard to clinical research and the management of sensitive information, ensuring compliance at all times. This commitment is accompanied by the allocation of the necessary resources (infrastructure, technology, training and qualified personnel) to guarantee the proper development of our activities.
We are committed to the protection of information—clinical, scientific and organizational—ensuring its confidentiality, integrity and availability, through the implementation of appropriate security measures and controls, staff awareness and the systematic management of information security risks.
We promote an organizational culture based on shared responsibility, teamwork and open communication, encouraging the active involvement of all staff in the continuous improvement of the management system. Likewise, we integrate relevant environmental considerations into our strategic and operational planning, including challenges associated with climate change, thereby contributing through our activity to responsible and sustainable research.
Finally, VHIO Management firmly commits to the continuous improvement of its processes and activities, setting specific objectives, systematically measuring their progress and applying the results obtained to review and adapt the integrated management system, processes and, where appropriate, this Quality Policy itself, thus ensuring its permanent suitability to the organizational context and future challenges.
VHIO Management leads, supports and guarantees the dissemination, understanding and effective application of this policy throughout the organization, as well as its periodic review to ensure its relevance and validity.
Recognition through certification/accreditation
ISO 9001:2015 certification of the quality system for the Management of biomedical research projects in oncology.
ISO 15189:2022 accreditation for the activities defined in the TECHNICAL ANNEX nº1052/LE2022 of the laboratories of:
- Cancer genomics
- Molecular Oncology
- Historical milestones
- QMS approach
Recognition through Accreditation
Audit of Clinical Trials Units, Generalitat de Catalunya
ENETs Cancer of Excellence
Severo Ochoa Excellence Program
CERCA: A rating
AECC Excellence Program
OECI ACCREDITATION AS AN COMPREHENSIVE CANCER CENTRE
Regardless of the supplier selection that a principal Investigator may make in the context of a project for which he/she is responsible, and which is explained in previous sections of this procedure, VHIO establishes a supplier evaluation system on an annual basis.
The criteria adopted by VHIO for the acceptance of a supplier are:
- Degree of compliance with delivery deadlines.
- Acceptance of VHIO’s conditions for receiving orders.
- Adaptation of the supplier’s product catalogue to the VHIO standard.
- Having made at least one purchase from the supplier in a period not exceeding one year. If this requirement is not met, the IQAS system removes the supplier from the database.
- Not having detected any quality deficiencies in the products/services purchased from the supplier, nor any applicable legal non-compliance.
- Initial review of satisfactory products/services at the time of delivery.
With regard to the quality criteria required of suppliers, these can be:
- Quality of the products: degree of adequacy of the characteristics and technical specifications to the requirements provided by VHIO.
- Warranty periods.
- User training, if appropriate.
- Existence and level of after-sales service.
- Existence and level of customer service.
- Legal/regulatory quality compliance: possessing applicable accreditations, certifications, CE marking, etc.
When selecting a supplier, the most important point is the quality of the items ordered. For this purpose, if necessary, the supplier’s proposal will be subjected to a detailed comparative study of the technical characteristics, sample analysis, etc.
This will be the priority criterion when what is most important is a minimum level of quality required, from the researcher’s point of view (compliance with certain technical characteristics).
In the event that more than one supplier is available that meets the quality requirements, the most economical option will be chosen, provided that the researcher has no explicit preference for one of them as best suiting his/her needs.
In certain circumstances, the selection of a supplier may be based on quality criteria not closely related to the product, such as, for example, after-sales service, warranty periods, image of the product/supplier in the market, existence of customer services, etc.
Whenever possible, we try to ensure that orders for the same product are spread across more than one supplier. The reasons for this are:
- Firstly, to accommodate the preferences of different researchers.
- Secondly, to guarantee the supply in the event of failure by any of the suppliers, guaranteeing that the VHIO is not left without the supply, with the consequent economic and scientific damage that this could cause in the development of the research. The disadvantage of this strategy is that, by dividing the quantity needed among several suppliers, the wholesale discount is lower.
When preparing the Annual Quality Report, the VHIO quality manager collects information from the IQAS system on suppliers and the Excel of non-conformities in order to analyze the suitability of VHIO suppliers.
VHIO’s Quality Department is made up of the following team:
- Sergi Cuadrado – Deputy Manager and Head of the Quality Program
- Javier Fonts – Quality Assurance (Clinical Trials)
- José Jimenez – Molecular Oncology Laboratory Quality Manager
- Deborah Grazia lo Giacco – Cancer Genomics Laboratory Quality Manager
- Miriam Artigas – Quality Assurance (Clinical Trials)
- Gemma Sala – Clinical Trials Quality and Processes Unit Director
