CERTIF 2015-02 REV3Consultancy
CERTIF 2015-02 REV3Consultancy
CERTIF 2015-02 REV3Consultancy
NOTE TO THE EXPERT GROUP ON THE INTERNAL MARKET FOR PRODUCTS (IMP)
Status:
Abstract:
This paper aims to seek a common approach to Article R17(4) of Decision (EC) No.
768/2008 concerning consultancy and impartiality of notified bodies.
Following comments from the experts group the paper has been revised (Rev 3)
Brussels,
CERTIF 2015-02 REV3
1. OBJECTIVE
Decision (EC) No. 768/2008 (the Decision) aimed, among other things, at ensuring
a uniformly high level of performance of notified bodies across the Union and
specified the requirements for notified bodies. The provisions of the Decision have
been inserted into a large number of Directives. It is therefore necessary to come to
a joint understanding of these provisions across sectors to safeguard the aim of the
legislators in terms of the impartiality of notified bodies.
2. BACKGROUND
Article R17(4) of the Decision specifies the requirements that a notified body needs
to meet in terms of independence. Its aim is to avoid any conflict of interest that
would prejudice their “independence of judgement or integrity in relation to
conformity assessment activities for which they are notified. This shall in particular
apply to consultancy services”. It specifically refers also to the top level
management of the conformity assessment body as well as subsidiaries and
subcontractors.
3. COMMON APPROACH
The aim of the provision is thus on the one hand to ensure that the activities of a
notified body are compatible with its status as an independent and impartial third
party and that consultancy services provided do not compromise this independence
and impartiality while allowing for a presumption of conformity with the relevant
harmonised conformity assessment body standard. The approach taken should thus
not differ substantially from that taken in the voluntary area and be inspired by those
harmonised standards.
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Along those lines, consultancy in this context should thus be understood to cover the
participation in the design, implementation, operation or maintenance of the product
to be assessed by a notified body under given EU legislation.
Given that Article R17(4) refers to the activity for which a body is notified, this
means that the notified body may not provide consultancy services (such as
technical assistance or provide advice on how to pass conformity assessment
procedures) to manufacturers of the products it assesses.
Conformity Assessment Bodies must have the appropriate means to counteract these
risks and safeguard impartiality. They are supposed to have documented policies
and procedures safeguarding impartiality.