CEN/CLC Guide 15:2009

SLOVENSKI STANDARD
01-september-2009
Naloge in odgovornosti svetovalca za "novi pristop"
Tasks and responsibilities of the New Approach consultants
Ta slovenski standard je istoveten z: CEN/CLC Guide 15:2009
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN/CENELEC Guide 15
Tasks and responsibilities
of the New Approach consultants

The present guide provides guidance on the tasks and responsibilities of the New Approach consultants working with
CEN and CENELEC. It was approved by CENELEC BT decision D134/C056 and by CEN Resolution BT C072/2008.

Edition 1 / April 2009
European Committee for European Committee for
Standardization Electrotechnical
Standardization
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CEN/CENELEC Guide 15 Tasks and responsibilities of the New Approach Consultants

Tasks and responsibilities
of the New Approach consultants

1 Scope
This document is the CEN/CENELEC guide on the tasks and responsibilities of the New
Approach consultants working with CEN and CENELEC.
It deals with the:
• Role and profile of the consultant
• Main tasks and responsibilities of the consultant
• Consultant’s involvement in the development of standards
o Involvement from the time of the creation of the NWI
o Comments at enquiry stage
o Advice and comments following the enquiry stage
o Formal assessment prior to formal vote/UAP
o Resolution of disputes
• Selection of a new consultant
• Induction and introduction of a new consultant
• Handover from previous consultant
• Reporting and evaluation of consultant's work
• Treatment of complaints
2 Background
European Directives (hereinafter called directives) contain essential requirements. These
essential requirements shall be fulfilled by the product before it may be placed on the
market.
Standardisation work related to directives is described in Mandates to the ESO’s.
European Standards provide a means for manufacturers to demonstrate conformity to the
essential requirements of directives. Such European Standards are referenced as
harmonised standards.
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The relevant technical body of CEN or CENELEC is responsible for deciding which
technical requirements will be included in a European Standard.
The references and titles of harmonised European Standards are published by the
European Commission in the Official Journal of the European Union (OJEU).
The European Commission and EFTA request that CEN and CENELEC assess the
conformity of all candidate harmonised standards to the relevant essential requirements of
relevant directives.
CEN, CENELEC and the European Commission/EFTA appoint independent consultants
to carry out this assessment and to provide assistance and guidance to the technical
bodies developing these European Standards in relation to the relevant directives and
their respective essential requirements. Mandates can influence this work in particular
ways. Consultants may also explain some elements of the relevant Mandates.
Many harmonised European Standards are based on international standardization
according to the Vienna or Dresden Agreements. In such cases the consultant shall also
be consulted with the development of such standards.
3 Role and profile of the consultant
3.1 Role of the consultant
The consultant is responsible for assisting experts to prepare harmonised standards and
provides the necessary recommendations, explanation and support in relation to the
relevant directive(s) and the respective essential requirements.
The consultant shall be involved with the technical bodies from the earliest possible stage in
the development of a European Standard at the latest when a working draft is available in
order that his/her comments may be taken into account from the beginning.
When requested by a technical body, the consultant shall obtain clarification on the scope
of the directive or mandate from the Commission.
The consultant shall examine if the work programme of the relevant technical bodies
covers all aspects indicated in the related directives and mandates (i.e. essential
requirements, product families…) and identify any gaps which may be bridged by
standards.
The consultant is not responsible for deciding or choosing which technical requirements will
be included in a European Standard. This is the responsibility of the technical bodies.
The consultant informs the technical body on the compliance of a draft standard with the
1)
provisions of the relevant directive ; during development of the draft from the creation of the
work item, through the preparation of the draft standard, during the public enquiry and
before the Formal Vote or UAP.

1)
Directive has to be understood in its broad sense (e.g. TSI’s in case of Railway Interoperability,
RID/ADR/AND agreements in the case of dangerous goods, …).

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3.2 Competence of the consultant
A consultant is required to be impartial and independent.
In order to fulfil his/her tasks, the consultant shall have:
• a deep technical understanding of the field of work of the relevant technical bodies
and a recent state of the art experience of the subject;
• extensive knowledge and experience of relevant directives;
• experience of developing and implementing standards;
• knowledge of the main rules (e.g. CEN/CLC Internal Regulations, ISO/IEC Directives,
different timeframes within the drafting process);
• knowledge of the Vienna Agreement, Dresden Agreement;
• social competence/interpersonal skills.
4 Main tasks and responsibilities of the consultant
The consultant's main tasks and responsibilities are:
• to explain to the technical bodies the different elements of the relevant directive(s)
and mandate(s), especially the essential requirements, as far as necessary;
• to give recommendations to the technical bodies during the development of a
standard with the consistency of the draft standard to the relevant directive(s);
• to identify shortcomings in the technical requirements chosen by the technical body in
relation to the essential requirements in the relevant directive(s), and where possible
suggest remedies, noting that the responsibility for the choice of technical
requirement remains with the technical body;
• to advise whether the work programme of the technical body covers all aspects
indicated in the relevant directive(s) (i.e. essential requirements, product families,
risks…);
• to provide formal assessments on draft standards prior to formal vote/UAP in relation
to the relevant directive(s) as requested and strictly by the deadline requested by the
2)
central secretariat ;
• to keep up to date with the latest developments of the directive(s) they are contracted
for;
• to identify new standardization needs and check for duplication of work.

2)
In this document “central secretariat” refers to CEN Management Centre (CMC) and/or CENELEC Central
Secretariat (CLC/CS).
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In particular, the consultant shall:
• ensure that candidate harmonised standards comply with the relevant essential
requirements laid down by the relevant directive(s). This activity is to be maintained
for the entire duration of the development of the standard, at the latest starting with
the first working draft, during the enquiry (prEN) and before the formal vote/UAP;
• comment on all draft standards under his/her responsibility during the Enquiry Stage;
• give a formal assessment to all final drafts prior to the Formal Vote/UAP under his
responsibility;
• check each draft standard, that is under his/her responsibility and that is in support of
directive(s), for the existence and the contents of an annex (Annex Z) giving the
relation between the standard and the essential requirements in the relevant
directive(s);
• by mutual agreement attend meetings of technical bodies;
• be available to the European Commission (usually DG Enterprise and Industry) and
the relevant Standing Committee(s) for questions related to the preparation of the
standards;
• co-operate and co-ordinate with other consultants who are advising the technical
body in relation to other directives or aspects of directives;
• co-operate and co-ordinate with the central secretariat for the setting of work and
priorities;
• identify the need for formal assessment of draft standards by consultants responsible
for other sectors.
Additionally the consultant may:
• help the technical body to identify new harmonised standards to be prepared;
• give recommendations to technical bodies in the light of what standards are being
prepared or are planned in other technical bodies in order to avoid duplication of work
and contradictions;
• be asked to support the central secretariat in tasks related to standardization in the
field of his/her competence;
5 Consultant’s involvement in the development of standards
A flowchart in Annex A is outlining the procedures described in this clause.
Each time a standard is drafted in the framework of the Vienna Agreement, the guidelines
for the implementation of the Vienna Agreement apply for the involvement of the
consultant.
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For standards drafted in the framework of the Dresden Agreement:
• CENELEC/CS asks for the formal assessment from the consultant at CDV and FDIS
stage for all projects associated with directives;
• In order to allow possible "corrective" action at IEC level, it is recommended that
CENELEC should also ask an informal advice from the consultant on the CD;
• When there is a CENELEC technical body mirroring the IEC activities, it is the
responsibility of this body to manage the alignment of their (upcoming) standards to
the ERs of the directive. This includes possible requests for informal advice (e.g. on
CD) from the consultant;
• When there is no CENELEC technical body mirroring the IEC activities - and as a
support to the Reporting Secretariat – CENELEC/CS would in the future also ask for
3)
the informal advice from the consultant on the CD .
5.1 Involvement from the time of the creation of the NWI
The consultant shall be involved with the technical body , e.g. by giving written comments or
attending meetings, from the earliest possible stage in the development of a European
Standard and at the latest when a working draft is available in order to provide advice to the
technical body in relation to the essential requirements of the directive(s).
5.2 Comments at enquiry stage
The central secretariat ensures that all relevant draft standards that are submitted to the
4)
enquiry are given to the respective consultant(s).
The consultant(s) shall provide comments to the relevant technical bodies on all draft
standards submitted to enquiry under his/her responsibility.
The technical body shall then take into account the consultant’s comments along with all
comments made as a result of the enquiry in order to further develop and consolidate the
technical requirements contained in the draft standard.
5.3 Advice and comments following the enquiry stage
Following the closure of the enquiry the technical body reviews all comments received,
including those from the consultant, and revises the draft standard accordingly.
If agreed by the technical body the consultant receives the resulting revised draft standard
and further versions as necessary and provides additional comments and guidance to the
technical body.
The goal of both the consultant and the technical body should be to achieve a final draft
standard that when presented for formal vote or UAP will receive a positive assessment
from the consultant.
3)
EMC issues are exempted, as these are duly coordinated through installed provisions by CLC/TC 210.
4)
For standards being developed in parallel by IEC/CENELEC under the Dresden Agreement commenting at
the CD stage might be appropriate.

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It is important that the technical body and the consultant work together efficiently at this
stage to avoid introducing delays into the development timeframe for the standard.
To support this aim the technical body is advised to provide the final draft standard to the
consultant for ‘informal assessment’ and take into account the consultant comments
before submitting revised final draft to the central secretariat to launch the formal vote or
UAP.
5.4 Formal assessment prior to formal vote/UAP
When the technical body decides that a draft standard is sufficiently mature and that there
is consensus within the technical body on its technical content, it sends the draft standard
to the central secretariat for submission to formal vote or UAP.
The rules require that all relevant consultants formally
...