Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation intended for the technical file submitted by the applicant, until the expiry of the validity of the certificate.
10.
The applicant shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities throughout the service life of the subsystem.
11.
The applicant’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 5, 8 and 10, provided that they are specified in the mandate.
Module SD.
EC verification based on quality management system of the production process
1. EC verification based on quality management system of the production process is the part of a EC verification procedure whereby the applicant fulfils the obligations laid down in points 2 and 8, and ensures and declares on his sole responsibility that the subsystem concerned is in conformity with the type described in the EC-type examination certificate and satisfies the requirements of the relevant TSI(s) as well as any other regulations deriving from the Treaty that apply to it.
2. Manufacturing
The production, final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system(s) as specified in point 3, and shall be subject to surveillance as specified in point 7.
3. Quality management system
3.1.
The applicant shall lodge an application for assessment of the quality management system with the notified body of his choice, for the subsystem concerned.
The application shall include:
— the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
— a written declaration that the same application has not been lodged with any other notified body,
— the breakdown structure of the project management and the name and address of each involved entity,
— all relevant information for the subsystem envisaged,
— the documentation concerning the quality management system,
— copy of EC ISV declaration(s) issued for the subsystem, if any,
— the technical documentation of the approved type and a copy of the EC-type examination certificate and its annexes.
3.2.
The quality management system shall ensure that the subsystem is in conformity with the type described in the EC-type examination certificate and comply with the requirements of the relevant TSI(s) that apply to it.
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