ERA-GUI-100.pdf - Europa

Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011
on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0
Regarding specifically to the accreditation of the certification bodies to perform the certification of
ECMs, ERA has developed, with the sector, the corresponding accreditation scheme [17]. This
accreditation scheme shall be used in the same way for the recognition body.
Recognised certification bodies meaning certification bodies according to art 6 and 10 of the ECM
Regulation 445/2011/EU and selected by Member States through a specific process of verification
of competence ( described in the accreditation scheme) put in place by public national authorities.
To assure this, the accreditation scheme remains a reference also for the recognition process (and
also for the NSAs acting as ECM certification body) in order to ensure the recognised certification
body is sufficiently competent for the tasks it must perform. The member states selecting other
schemas than the accreditation scheme must justify their decision and ensure that their alternative
system meets the requirements of the Regulation 445/20110EU and the accreditation scheme. In
the cooperation network of certification bodies the NSAs and the recognised certification bodies
can collaborate with accredited certification bodies to harmonise the implementation of the
certification system having the accreditation scheme as a reference.
7.9 I would like to become a recognised certification body for ECM. To
whom have I to apply for recognition?
The use of an alternative to the accreditation is allowed by Article 5(2) of regulation 765/2008 which
states that “when a Member State decides not to use accreditation, it shall provide the Commission
and the other Member States with all the documentary evidence necessary for the verification of
the competence of the conformity assessment bodies it selects for the implementation of the
Community harmonisation legislation in question”.
In the case of ECM certification, two possible alternatives are identified by the legislator
(safety directive, art 14a): recognition or designation of NSA as ECM certification body.
ECM case
The regulation 445/2011 details the requirements and criteria related to the competence of each
certification body: the art 6 introducing the accreditation scheme and the annex II. Therefore
whenever the certification body is accredited, recognized or is a NSA, this certification body shall
comply with the annex II and the art 6 of Regulation 445/2011 and consequently shall comply with
the accreditation scheme.
The accreditation scheme has to be used for the accreditation (by the national accreditation
body) or the recognition (by the recognition body put in place by the Member State) or by
the Member states to provide assurance that the NSA designated as certification body is
competent.
Either the Member States will use recognition or designate NSA as certification body. For these two
choices, they shall provide to the Commission and the other Member states all the documentary
evidence necessary for the competence of the conformity assessment bodies it selects for the
implementation of the regulation 445. (point 2 of article 5 of the regulation 765/2008)
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