AIBILI-Association for Innovation and Biomedical Research on Light and Image

ABOUT UGQ

AIBILI is ISO 9001 certified for the activities of: Performance of Clinical Research; Planning, Coordination, Monitoring of Clinical Research Activities, Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics, Grading of Eye Exams, Research and development in new technologies for medicine in the areas of Imaging, Optics and Photobiology and Data Centre activities.

SERVICES

QMS effective maintainance
Internal auditing
Improvement oportunities
External consultancy services

The Quality Management Unit (QMU) is responsible for the Quality Management System (QMS), which is in accordance with ISO 9001:2015, Principles of Good Clinical Practices, requirements for Certification of ECRIN Data Centre and General Data Protection Regulation (EU) 2016/679, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, Regulation (EU) 2017/745 on medical devices as well as other regulatory requirements applicable to AIBILI activities, to ensure continual improvement through regular support to Unit´s activities and internal audits.

Internal auditing is a guarantee that procedures are followed and the QMS is in continual improvement to enhance Client’s satisfaction by meeting Clients´ requirements. This year an information security internal audit was also performed by QMU to assess the employees´ behaviour regarding security issues and their compliance with the internal Policies, as well as, to prepare them for the current implementation of stricter procedures. AIBILI is incorporating in AIBILI´s Quality Management System the ISO 27001 Information security management systems — Requirements and other ISO 27000 family of standards to improve its information security, cybersecurity, and privacy protection.

The QMU assures that the Quality Management System (QMS) is maintained effective and efficient permitting continual improvement and has the necessary resources to provide the services and meet the needs of its Clients and interested parties. AIBILI QMS is in digital format streamlining approvals, records and archiving as well as giving permanent access to all information.

AIBILI is ISO 9001 certified for all its main activities. AIBILI Data Centre is certified by ECRIN Data Centre requirements (https://ecrin.org/data-centre-certification).

The QMU performs external Quality Assurance (QA) services. The QMU also performs internal
and external training on quality and regulatory requirements applicable to clinical research activities.

The QMU, as Personal Data Privacy Committee, is responsible for promoting compliance and awareness of applicable personal data protection laws, advising on the implementation of data protection standards and monitoring compliance in AIBILI. The QMU has also a Compliance Committee, since June 2022, which is responsible for managing and processing whistleblower breach reports in a work-related context submitted through an internal channel available at AIBILI website.