Quality and Performance

The Icelandic Medicines Agency (IMA) proceeded in 2001 to build up a formal quality management system. Reference was made to other regulatory agencies in the field of medicinal products as well as guidelines from international agencies and organisations and changes, which were foreseen at that time, were also taken into account. It was decided to formalise the system and IMA chose the Focal Quality Handbook within the Lotus Notes Groupware application system.

Quality management has been strengthened at IMA inter alia by increasing the number of active procedures and by establishing a specific Procedures Team, which oversees the progress and implementation of quality issues at the agency.

All internal audits and self-assessments help in assessing the current status of the quality management system. A self-assessment, under the auspice of the Heads of Medicines Agencies (HMA), which initiated Benchmarking of European Medicines Agencies (BEMA), and internal audits, have taken place and there will be increased emphasis placed on them, which will benefit the management for reviewing essential functions of the agency.