In the SEE region only DPA, the Albanian national accreditation body, has experience in accrediting of management systems certification bodies for medical devices management systems. Therefore the training focused on the additional mandatory requirements of the International Accreditation Forum (IAF) to the accreditation bodies and the accreditation process and to the certification bodies and the certification process to support DPA to further develop and the other accreditation bodies (in the future) to establish accreditation in this field.
The training was provided by Francesco Soro from the Italian Accreditation Body (ACCREDIA) and was moderated by Rózsa Ring.
There were 25 participants from 4 SEE countries. The trainer provided comprehensive interpretation of IAF MD8 Application of ISO/IEC 17011 in the field of medical device quality management systems and of IAF MD9 Application of ISO/IEC 17021-1 in the field of medical device quality management systems) with several examples taken from ACCREDIA’s practices. Special attention was paid to the scope of accreditation and the scope of certification, the competence requirements of accreditation assessors and certification auditors, and to the witnessing of certification activities. In addition, the related mandatory standards (e.g. ISO 14971, CEN/TR 17223), regulatory requirements (e.g. EU Regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices), guidance documents (e.g. GHTF guidelines, ACCREDIA’s guide of DT-02) and useful databases to obtain information from (e.g. EUDAMED database, ACCREDIA Databank) were also briefly presented to provide the accreditation bodies with full picture. The participants raised several questions related to the implementation of the specific requirements by the accreditation bodies.
The feedback of the participants of the virtual training was positive, they found the virtual training very informative and useful for supporting the establishment or the further development of their accreditation service in the field of medical device quality management systems.