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The main requirement lies in assessing the applicant's abilities to carry out not only the
necessary technical tasks (equipment, reference data, working method, staff training, etc.)
to assess conformity with the main requirements of the directive concerned, but also to
provide quality organisation which successfully completes these tasks and allows them to
be monitored.
To carry out this assessment, particularly as regards organisational quality, the notifying
authorities use the accreditation obtained from the national accrediting body, the Comité
Français d’Accréditation (COFRAC), for the field of activity concerned regarding the
relevant EN 45000 standard. Where accreditation exists in the body’s field of action, it is
requested, but it is not considered sufficient to assess the body's competence and ability.
Where it does not exist for the activity concerned, the authorities may themselves carry
out, or request COFRAC or any other relevant body to carry out, investigations to assess
the applicant body’s abilities.
In all cases, accreditation alone is considered insufficient to assess not only the
competence of the applicant to be authorised, but also the provisions taken to maintain its
competence; this is why the public authorities attach particular importance to certain
criteria, which they themselves assess directly and which the applicants must show proof
of observing:
➣ they must have genuine experience of the necessary tests and examinations,
which can be testified to, for instance, by their volume of activity,
references and experience in product certification;
➣ they must clearly specify what conformity assessment tasks they wish to
carry out regarding technical specifications and indicate the methods of
conformity assessment applicable to the products that are to receive the
CE marking provided for under the directive concerned;
➣ they must prove their involvement in the standardisation work covering
their field of technical activity for the purposes of CE marking;
➣ they must undertake to participate in the national and European bodies for
the coordination of notified bodies (public authorities have helped set up a
national coordination body for each of the directives). The structure of
national coordination makes it possible to reduce participation at European
level by delegating one or more representatives who will act as spokesmen
and rapporteurs. This promotes the sharing and harmonisation of practices
and interpretations;
➣ they must guarantee separation of the activities carried out in relation to
their designation under the directives from those concerning voluntary
certification, auditing and consultancy work. However, this question must
be examined realistically, particularly by COFRAC. A certain level of
activity outside the regulatory field may be necessary for the notified
bodies to maintain their financial equilibrium and by the same token a
certain level of competence;
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