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Home / Organisation / About Us / Quality Management

Quality Management

Quality Management

A Quality Management System (QMS) was set up by the Medicines Authority in 2004 during accession period as part of project with another European medicines competent authority. The Medicines Authority is committed towards the continuous improvement of the quality management system.  The Quality Management System was improved continuously through internal audits and internal and external assessments performed as part of the three-year Benchmarking of European Medicines Agencies (BEMA) cycle in which the Medicines Authority participated since 2004. 

ISO Certification

The Quality Management System covers all activities (core and support) and is based on ISO principles.  The quality management system of the Medicines Authority has been certified on the basis of the MSA EN ISO9001-2008 in January 2014.  Objective evidence collected during the audit has showed that the organization's QMS is implemented and maintained effectively.

Benchmarking

The objective of the Benchmarking exercise is 'to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards.'  It is in its third cycle and the Medicines Authority was last visited in April 2013.  The Medicines Authority notes its strengths and best practices identified which are shared with other agencies.  Also, it identifies opportunities for improvement which are considered for improving the operations.