AIBILI is ISO 9001 certified for the activities of: Performance of Clinical Research; Planning, Coordination, Monitoring of Clinical Research Activities, Health Technology Assessment, Grading of Eye Exams, Research and development in new technologies for medicine in the areas of Imaging, Optics and Photobiology and Data Centre activities.
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.
Rita Sousa Fernandes