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ERA-GUI-100.pdf - Europa

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Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011<br />

on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0<br />

Initial<br />

audit<br />

Initial Assessment<br />

On-site<br />

audit<br />

ECM Certification Scheme<br />

On-site<br />

inspections<br />

On-site<br />

audit<br />

Granting of ECM<br />

certificate<br />

Surveillance activities<br />

On-site inspections<br />

Specific ECM certification process<br />

Initial Assessment CSM CA<br />

Initial audit<br />

CSM Surveillance Supervision activities<br />

On-site audit and inspections<br />

Granting of ECM<br />

certificate<br />

Targeting of surveillance<br />

activities based on<br />

safety risks<br />

This picture shows a possible adaptation of ECM Certification Scheme NSAs assessing the<br />

application for an ECM certificate.<br />

The NSAs have the possibility to undertake on-site audit and inspections (initially planned in<br />

the ECM Certification Scheme prior to the delivery of the ECM certificate) together with their<br />

intended purposes at the early stage of their surveillance activities. In that sense, the NSAs<br />

may deliver ECM certificate to the applicant after the completion of the initial audit<br />

(documentary review) on the maintenance system of the ECM and then, based on safety<br />

risks and their knowledge of the applicant, target their surveillance activities (on-site audit<br />

and inspections) on existing competences related to (selected) processes relevant to the<br />

main procedures of annex III of the ECM Regulation (See 3.2.2.1 of ECM Certification<br />

Scheme), coherence between the inputs and outputs of the selected processes and also on<br />

activities affecting safety.<br />

The NSAs should also observe transparency in their decision-making process by setting out<br />

and publishing their decision-making criteria.<br />

In any case, the NSA may always perform the on-site audits and the inspections required in<br />

the ECM certifcation scheme before granting the certificate. It would then be perfectly<br />

aligned with the certification scheme.<br />

Nevertheless one target of the Network of Cooperation of Certification Bodies is to achieve<br />

a harmonised implementation of the ECM Regulation in the NSAs acting as certification<br />

bodies.<br />

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