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The monitoring of the bodies aims to check that competence is maintained, the level and
quality of activity and observance of the undertakings made.
Where accreditation exists, any decision taken by COFRAC following monitoring or
auditing activity is taken into consideration by the notifying authorities. If the decision by
COFRAC calls into the question the conditions for obtaining accreditation, the authorities
reserve the right to decide whether or not to maintain authorisation.
Furthermore, the notifying authorities regularly monitor the bodies' activities:
? they receive an annual activity report which makes it possible to assess the nature,
quality and volume of the conformity assessments made. An analysis of this report
makes it possible in particular to check the quality of the technical dossiers and the
maintenance of activity in the field of competence for which the body was
authorised, and to check sub-contracting. The authorities consider theses two
points to be of prime importance and monitor them closely;
? they are informed occasionally of the difficulties which the body may encounter
when carrying out certain assessments; sometimes even, for certain directives (e.g.
medical devices), they are informed each time an attestation of conformity is
drawn up according to a pre-established model;
? they monitor the measures taken by the bodies to improve harmonisation of their
practices by regularly taking part in meetings of national coordination groups. In
this way they are informed of the actual problems which arise in applying the
directives and can be sure that their difficulties have been shared, and they can
check up on how they participate in European coordination groups;
? following litigation resulting from differences in interpretation of directives or
inspections relating to market surveillance, they can carry out investigations of the
notified bodies concerned.
In order to participate at meetings and analyse and interpret the data and information
received, the ministerial departments responsible for the application of the directives have
set up appropriate structures and systems. To consolidate these structures, national
coordination of the ministerial departments concerned is carried out by the Interministerial
Standards Group, set up by the Inter-ministerial Representative for Standards.
Furthermore, by participating in all the national accreditation system bodies
(Administrative Board, section committees organised according to the EN 45000
standards and the permanent accreditation sectoral committees of COFRAC) the
authorities can keep informed and contribute to accreditation developments in the fields
related to the New Approach Directives.
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