quality management
The quality management system of the Medicines Evaluation Board
(MEB) is certified on the basis of the ISO 9001-2008 standard.
The MEB is the first European authorisation agency to have its
quality management certified.
Re-assesment 2010
Certiked performed the standard inspection of the MEB's quality
management system:
"The MEB is well aware of the nature and changes
occurring in its field of operations, and acts proactively to
anticipate them. The focus is on Europe. The MEB aspires to be a
network player, and has taken steps accordingly. The goals defined
in the Strategic Business Plan have been worked on. A twofolded
approach has been taken to processing backlogs, in which in
addition to getting through the backlogs (track 1, reduce backlogs
by at least half in 2009, which was achieved), a second track is
looking for a structural solution to the problem. A major
project was initiated to achieve this goal, called DOT
(Doorlopend Op Tijd, continuously on time). The first phase
of this project, based on LEN-6 Sigma, has already been
completed.
The ‘smart working, smart building’, outlined in the U Move
project, holds a prominent position on Intranet, in the employee’s
minds, and is relevant for future business policy. The MEB is
preparing for the future, by seriously examining and working on
issues such as defining competencies and management tools required
for time- and place- independent working. A start was made defining
competencies during a recent retreat.
The cycle of central planning and decentral implementation in
SMART department plans looks solid. During the discussions
conducted during the research, we concluded that this cycle plays a
key role in the work done.
As was the case last year, the primary processes of the
departments involved in the research make professional impression.
Quality assurance is ensured by good tools, templates and aids, but
especially by dedicated employees. It was also noted that the added
value of applicable standard operating procedures is clearly felt
within the MEB. They are consulted regularly.
Tools, such as the workflow management system (ICI) and the
dashboard are clearly result-oriented. Another positive finding is
that these tools are continuously being
optimised."
These were Certiked's comments in its research report 2010 on assessment of the
quality management system of the Medicines
Evaluation Board (MEB) to meet ISO 9001:2008 requirements, based on the
Certiked Model 2009.
Certiked website: http://www.certiked.nl/