F1ANNEX IModules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability
F1 MODULES FOR CONFORMITY ASSESSMENT OF INTEROPERABILITY CONSTITUENTS
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F1 Module CA. Internal production control
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F11.
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F12.Technical documentation
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F13.Manufacturing
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F14.EC declaration of conformity
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F14.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F14.2.
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F15.Authorised representative
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F1 Module CA1. Internal production control plus product verification by individual examination
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F11.
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F12.Technical documentation
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F13.Manufacturing
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F14.Product checks
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F15.EC certificate of conformity
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F16.EC declaration of conformity
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F16.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F16.2.
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F17.Authorised representative
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F1 Module CA2. Internal production control plus product verification at random intervals
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F11.
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F12.Technical documentation
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F13.Manufacturing
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F14.Product checks
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F14.1.
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F14.2.
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F14.3.
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F15.EC certificate of conformity
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F16.EC declaration of conformity
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F16.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F16.2.
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F17.Authorised representative
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F1 Module CB. EC-type examination
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F11.
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F12.EC-type examination may be carried out in either of the following manners:
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F13.The manufacturer shall lodge an application for EC-type examination with a notified body of his choice.
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F14.The notified body shall:
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F15.
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F16.Where the type meets the requirements of the TSI that apply to the interoperability constituent concerned, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.
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F17.
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F18.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.
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F19.
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F110.
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F1 Module CC. Conformity to type based on internal production control
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F11.
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F12.Manufacturing
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F13.EC declaration of conformity
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F13.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F13.2.The EC declaration of conformity shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F14.Authorised representative
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F1 Module CD. Conformity to type based on quality management system of the production process
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F11.
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F12.Manufacturing
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F13.Quality management system
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F13.1.The manufacturer shall lodge an application for assessment of his quality management system with the notified body of his choice, for the interoperability constituents concerned.
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F13.2.The quality management system shall ensure that the interoperability constituents are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the TSI that apply to them.
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F13.3.The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The manufacturer shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the interoperability constituent, including changes of quality management system certificate.
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F14.Surveillance under the responsibility of the notified body
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F14.1.
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F14.2.The manufacturer shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
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F14.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality management system and shall provide the manufacturer with an audit report.
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F14.4.
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F15.EC declaration of conformity
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F15.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F15.2.The EC declaration of conformity shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F16.
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F17.
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F18.Authorised representative
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F1 Module CF. Conformity to type based on product verification
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F11.
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F12.Manufacturing
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F13.Verification
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F14.Verification of conformity by examination and testing of every interoperability constituent.
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F14.1.
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F14.2.The notified body shall issue an EC certificate of conformity in respect of the examinations and tests carried out.
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F15.Statistical verification of conformity
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F15.1.
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F15.2.
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F15.3.If a lot is accepted, all interoperability constituents of the lot shall be considered approved, except for those interoperability constituents from the sample that have been found not to satisfy the tests.
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F15.4.
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F16.EC declaration of conformity
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F16.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities, for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F16.2.The EC declaration of conformity shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F17.Authorised representative
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F1 Module CH. Conformity based on full quality management system
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F11.
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F12.Manufacturing
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F13.Quality management system
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F13.1.The manufacturer shall lodge an application for assessment of his quality management system with the notified body of his choice, for the interoperability constituents concerned.
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F13.2.The quality management system shall ensure compliance of the interoperability constituents with the requirements of the TSI that apply to them.
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F13.3.The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The manufacturer shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the interoperability constituent, including changes of quality management system certificate.
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F14.Surveillance under the responsibility of the notified body
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F14.1.
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F14.2.The manufacturer shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
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F14.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality management system and shall provide the manufacturer with an audit report.
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F14.4.
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F15.EC declaration of conformity
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F15.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
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F15.2.The EC declaration of conformity shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F16.
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F17.
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F18.Authorised representative
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F1 Module CH1. Conformity based on full quality management system plus design examination
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F11.
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F12.Manufacturing
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F13.Quality management system
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F13.1.The manufacturer shall lodge an application for assessment of his quality management system with the notified body of his choice, for the interoperability constituents concerned.
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F13.2.The quality management system shall ensure compliance of the interoperability constituents with the requirements of the TSI that apply to them.
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F13.3.The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The manufacturer shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the interoperability constituent, including changes of quality management system certificate.
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F13.6.Each notified body shall inform its notifying authorities of quality management system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality management system approvals refused, suspended or otherwise restricted.
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F14.Design examination
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F14.1.
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F14.2.The application shall make it possible to understand the design, manufacture, maintenance and operation of the interoperability constituent, and to assess the conformity with the requirements of the TSI that apply to it. It shall include:
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F14.3.The notified body shall examine the application, and where the design meets the requirements of the TSI that apply to the interoperability constituent it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design and if relevant, a description of the product’s functioning. The certificate may have one or more annexes attached.
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F14.4.
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F14.5.Each notified body shall inform its notifying authorities of the EC design 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.
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F14.6.
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F15.Surveillance under the responsibility of the notified body
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F15.1.
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F15.2.The manufacturer shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
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F15.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality management system and shall provide the manufacturer with an audit report.
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F15.4.
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F16.EC declaration of conformity
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F16.1.The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up and shall mention the number of the design examination certificate.
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F16.2.The EC declaration of conformity shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F17.
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F18.Authorised representative
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F1 MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS
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F1 Module CV. Type validation by in-service experience (suitability for use)
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F11.
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F12.
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F13.
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F14.
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F15.Type validation by in-service experience
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F16.
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F17.
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F18.
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F19.
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F110.
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F111.EC declaration of suitability for use
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F111.1.The manufacturer shall draw up a written EC declaration of suitability for use for an interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of suitability for use shall identify the interoperability constituent for which it has been drawn up.
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F111.2.The EC declaration of suitability for use shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
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F111.3.The interoperability constituent may be placed on the market only after the following EC declarations have been drawn up:
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F112.Authorised representative
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F1 MODULES FOR EC VERIFICATION OF SUBSYSTEMS
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F1 Module SB. EC-type examination
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F11.
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F12.EC-type examination shall be carried out by:
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F13.The applicant shall lodge an application for EC-type examination with a notified body of his choice.
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F14.The notified body shall
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F15.When the subsystem referred to in point 3 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
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F16.
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F17.Where the type meets the requirements of the relevant TSI(s) that apply to the subsystem concerned, the notified body shall issue an EC-type examination certificate to the applicant. The certificate shall contain the name and address of the applicant, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.
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F18.
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F19.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.
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F110.
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F111.
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F1 Module SD. EC verification based on quality management system of the production process
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F11.
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F12.Manufacturing
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F13.Quality management system
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F13.1.The applicant shall lodge an application for assessment of the quality management system with the notified body of his choice, for the subsystem concerned.
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F13.2.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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F13.3.The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The applicant shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the subsystem design, manufacture and final inspection, testing and operation, as well as of any changes of quality management system certificate.
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F14.
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F15.EC verification
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F15.1.The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
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F15.2.The notified body chosen by the applicant shall first examine the application concerning the validity of the EC type examination certificate and its annexes.
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F16.
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F17.Surveillance under the responsibility of the notified body
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F17.1.
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F17.2.The applicant shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
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F17.3.The notified body shall carry out periodic audits to make sure that the applicant maintains and applies the quality management system and shall provide the applicant with an audit report.
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F17.4.
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F17.5.The notified body responsible for the EC verification of the subsystem, if not carrying out the surveillance of all the quality management systems concerned as under point 3, shall coordinate the surveillance activities of any other notified bodies responsible for that task, in order:
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F18.EC certificate of verification and EC declaration of verification
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F18.1.Where the subsystem meets the requirements of the relevant TSI(s), the notified body shall issue an EC certificate of verification in compliance with point 3 of Annex VI to Directive 2008/57/EC.
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F18.2.The applicant shall draw up a written EC declaration of verification for the subsystem and keep it at the disposal of the national authorities throughout the service life of the subsystem. The EC declaration of verification shall identify the subsystem for which it has been drawn up.
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F18.3.
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F19.The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
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F110.
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F111.Authorised representative
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F1 Module SF. EC verification based on product verification
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F11.
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F12.Manufacturing
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F13.The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
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F14.EC verification
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F14.1.The notified body chosen by the applicant shall first examine the application concerning the validity of the EC type examination certificate.
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F14.2.
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F14.3.The notified body shall agree with the applicant the locations where the tests will be carried out and shall agree that final testing of the subsystem and, whenever required in the relevant TSI(s), tests or validation under full operating conditions, are carried out by the applicant under direct supervision and attendance of the notified body.
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F14.4.When the subsystem referred to in point 3 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
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F14.5.The notified body shall issue an EC certificate of verification in respect of the examinations and tests carried out.
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F15.EC declaration of verification
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F15.1.The applicant shall draw up a written EC declaration of verification for the subsystem and keep it at the disposal of the national authorities, throughout the service life of the subsystem. The EC declaration of verification shall identify the subsystem for which it has been drawn up.
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F15.2.
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F16.
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F17.Authorised representative
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F1 Module SG. EC verification based on unit verification
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F11.
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F12.The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
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F13.Technical documentation
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F14.Manufacturing
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F15.EC verification
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F15.1.A notified body chosen by the applicant shall carry out appropriate examinations and tests, set out in the relevant TSI(s), harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the subsystem with the requirements of the relevant TSI(s), or have them carried out. In the absence of such a harmonised standard and/or technical specification the appropriate tests to be carried out shall be decided between the applicant and the notified body concerned.
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F15.2.The notified body shall examine:
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F15.3.
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F15.4.When the subsystem referred to in point 2 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
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F16.EC declaration of verification
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F16.1.Where the subsystem meets the requirements of the relevant TSI(s), the notified body shall issue an EC certificate of verification in compliance with point 3 of Annex VI to Directive 2008/57/EC.
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F16.2.The applicant shall draw up a written EC declaration of verification for the subsystem and keep it at the disposal of the national authorities throughout the service life of the subsystem. The EC declaration of verification shall identify the subsystem for which it has been drawn up.
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F16.3.
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F16.4.The technical file accompanying the EC certificate of verification shall be lodged with the applicant. A copy of the EC certificate of verification and the technical file shall be made available to the Commission, the Member States and the relevant authorities upon request.
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F17.
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F18.Authorised representative
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F1 Module SH1. EC verification based on full quality management system plus design examination
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F11.
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F12.Manufacturing
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F13.Quality management system
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F13.1.The applicant shall lodge an application for assessment of the quality management system with the notified body of his choice, for the subsystem concerned.
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F13.2.The quality management system shall ensure compliance of the subsystem with the requirements of the relevant TSI(s) that apply to it.
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F13.3.The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The applicant shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the subsystem design, manufacture and final inspection, testing and operation, as well as of any changes of quality management system certificate.
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F13.6.Each notified body shall inform its notifying authorities of quality management system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality management system approvals refused, suspended or otherwise restricted.
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F14.EC verification
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F14.1.
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F14.2.The application shall make it possible to understand the design, manufacture, maintenance and operation of the subsystem, and to assess the conformity with the requirements of the TSI(s) that apply to it. It shall include:
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F14.3.When the subsystem referred to in point 4.1 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
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F14.4.The notified body shall examine the application, and where the design meets the requirements of the relevant TSI(s) that apply to the subsystem it shall issue an EC design examination certificate to the applicant. The certificate shall give the name and address of the applicant, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.
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F14.5.
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F14.6.Each notified body shall inform its notifying authorities of the EC design 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.
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F14.7.
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F15.Surveillance under the responsibility of the notified body
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F15.1.
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F15.2.The applicant shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
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F15.3.The notified body shall carry out periodic audits to make sure that the applicant maintains and applies the quality management system and shall provide the applicant with an audit report.
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F15.4.
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F15.5.The notified body responsible for the EC verification of the subsystem, if not carrying out the surveillance of all the quality management systems concerned as under point 3, shall coordinate the surveillance activities of any other notified bodies responsible for that task, in order:
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F16.EC certificate of verification and EC declaration of verification
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F16.1.Where the subsystem meets the requirements of the relevant TSI(s), the notified body shall issue an EC certificate of verification in compliance with point 3 of Annex VI to Directive 2008/57/EC.
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F16.2.The applicant shall draw up a written EC declaration of verification for the subsystem and keep it at the disposal of the national authorities throughout the service life of the subsystem. The EC declaration of verification shall identify the subsystem for which it has been drawn up and shall mention the number of the design examination certificate.
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F16.3.
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F17.The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
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F18.
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F19.Authorised representative
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F1ANNEX II
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F1ANNEX III
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Decision revoked (31.12.2020) by The Railways (Interoperability) (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2020 (S.I. 2020/318), reg. 1(2)(c), Sch. 2