EUROPEAN COMMISSION

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

Single Market Policy, Regulation and Implementation

Single Market Policy, Mutual Recognition and Surveillance

NOTE TO THE EXPERT GROUP ON THE INTERNAL MARKET FOR PRODUCTS (IMP)

Title: CERTIF 2015-02 – Notified bodies - consultancy

DG Internal Market, Industry, Entrepreneurship and SMEs, Unit B1

GROW-B1@ec.europa.eu

Doc. N.: CERTIF 2015-02 REV3 Issue Date: 2016-11

Version: Rev 3 Meeting: 2016-12-01

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)

Keywords: Notified Bodies, notification, consultancy, aligned legislation

References: Regulation (EC) No. 765/2008, Decision (No.) 768/2008/EC

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

 EUROPEAN COMMISSION
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

Single Market for goods

Internal Market for Goods and Market Surveillance

Brussels,
CERTIF 2015-02 REV3

NANDO – Notified bodies – consultancy

1. OBJECTIVE

This paper aims to propose a common approach to the independence of notified

bodies and the issue of consultancy services that these bodies may wish to provide
in other fields.

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.

This Article reflects the requirements of the international conformity assessment

body standards of the EN ISO/IEC 17000 series and summarises the general
requirements that a notified body needs to meet, not least in terms of independence.
For this reason Article R18 introduces a presumption of conformity with the
relevant harmonised standards in this respect.

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.
2
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.

Otherwise, the independence provisions of Article R17(4) would be undermined as

providing or having provided consultancy to its own clients on products or type of
products the notified body is assessing would result in a conflict of interest for the
notified body.

In some particular sectors, it may be relevant to introduce complementary criteria in

order to ensure that conflicts of interest are avoided. Such specific aspects should be
discussed among relevant sectorial groups (committees, expert groups etc.).

Concerning the reference to subsidiaries and subcontractors in Article R17(4), this

would imply that a notified body :may have a conflict of interest and cannot perform
conformity assessment on items where e.g. a related (to the notified body) company
(i.e. subsidiary or subcontractor) has been involved with the manufacturer by means
of consultancy or has participated directly or indirectly in the in the design,
manufacturing, installation etc. of the product or type of product. To avoid such a
conflict of interests the notified body should identify the risks coming from e.g. the
subsidiaries/subcontractors companies or persons offering those services, make this
information available and state that if these companies provided services to a
manufacturer for a specific product the notified body is unable to provide
conformity assessment to that manufacturer for the concerned items.

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.

It is useful to note that the above topic is addressed by relevant harmonised

standards. ISO/IEC 17065 (chapter 5.2) lays down "a mechanism for safeguarding
impartiality" and ISO/IEC 17021 (chapter 6.2) provides for a "Committee for
safeguarding impartiality". Furthermore ISO/IEC 17020 (clauses 4.1.3-4.1.4 and
A1d), ISO/IEC 17021-1 (clauses 5.2.3-5.2.11) and ISO/IEC 17065 (clauses 4.2.6-
4.2.9) lay down provisions for avoiding conflict of interests.