Appendix ANNEX F MODULES FOR THE EC VERIFICATION OF SUBSYSTEMSF1
United Kingdom Repealed
F.1.
List of the modules
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F.2.
Modules for Interoperability Constituents
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F.3.
Modules for the EC Verification of Subsystems
F.3.1.
Module SB: Type Examination
1.
This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a type of an infrastructure, energy, control-command or rolling stock subsystem, representative of the production envisaged,
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2.
The contracting entity shall lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice.
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3.
The applicant shall place at the disposal of the notified body a specimen of the subsystem, representative of the production envisaged and hereinafter called ‘type’.
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4.
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4.1.
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4.2.
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4.3.
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4.4.
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4.5.
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4.6.
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4.7.
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5.
Where the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the contracting entity and the manufacturer(s) indicated in the technical documentation, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.
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6.
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7.
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8.
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9.
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F.3.2.
Module SD: Production Quality Management System
1.
This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy or rolling stock subsystem, for which already a type-examination certificate has been issued by a notified body,
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2.
The notified body carries out the procedure, under the condition, that:
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3.
For the subsystem that is subject of the EC verification procedure, the contracting entity, or the main contractor when employed, shall operate an approved quality management system for manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6.
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4.1.
The contracting entity shall lodge an application for EC verification of the subsystem (through production quality management system), including co-ordination of the surveillance of the quality management systems, as under point 5.3 and 6.5. with a notified body of its choice. The contracting entity shall inform the manufacturers involved of this choice and of the application.
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4.3.
The notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate.
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Quality management system
5.1.
The contracting entity, if involved, and the main contractor, when employed, shall lodge an application for assessment of their quality management systems with a notified body of their choice.
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5.2.
For the contracting entity or the main contractor responsible for the whole subsystem project, the quality management systems shall ensure overall compliance of the subsystem with the type as described in the type-examination certificate and overall compliance of the subsystem with the requirements of the TSI. For other contractors, their quality management system(s) has (have) to ensure compliance of their relevant contribution to the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI.
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5.3.
The notified body chosen by the contracting entity shall examine, if all stages of the subsystem as mentioned under point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s).
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5.4.
The notified body referenced to in point 5.1. shall assess the quality management system to determine whether it satisfies the requirements referenced in point 5.2. It presumes compliance with these requirements if the applicant implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which takes into consideration the specificity of the subsystem for which it is implemented.
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5.5.
The contracting entity, if involved, and the main contractor shall undertake to fulfil the obligations arising out of the quality management system as approved and to uphold it so that it remains adequate and efficient.
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6.
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6.1.
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6.2.
The contracting entity, if involved, and the main contractor shall send to the notified body referenced in point 5.1 (or have sent) all the documents needed for that purpose including the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicants to the subsystem), in particular:
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6.3.
The notified body shall periodically carry out audits to make sure that the contracting entity, if involved, and the main contractor, maintain and apply the quality management system and shall provide an audit report to them. When those operate a certified quality management system, the notified body shall take this into account in the surveillance.
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6.4.
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6.5.
The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned, shall co ordinate the surveillance activities of any other notified body responsible for that task, in order:
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7.
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8.
The contracting entity, if involved, and the main contractor shall, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:
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9.
Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the type examination and the approval and surveillance of the quality management system(s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.
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10.
The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in the Art 18 (3) of the Directive, and in particular as follows:
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11.
Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused.
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12.
The records accompanying the certificate of conformity shall be lodged with the contracting entity.
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F.3.3.
Module SF: Product Verification
1.
This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy or rolling stock subsystem, for which a type-examination certificate has already been issued by a notified body,
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2.
The contracting entity shall lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice.
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3.
Within that part of the procedure the contracting entity checks and attests that the subsystem concerned is in conformity with the type as described in the type examination certificate and satisfies the requirements of the TSI that apply to it.
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4.
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5.
The application shall enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the type as described in the type-examination certificate and the requirements of the TSI to be assessed.
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6.
The notified body shall first examine the application concerning the validity of the type examination and the type examination certificate.
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7.
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7.1.
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7.2.
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8.
The notified body shall agree with the contracting entity (and the main contractor) the locations where the tests will be carried out and shall agree that final testing of the subsystem and, whenever required in the TSI, tests or validation under full operating conditions, are carried out by the contracting entity under direct supervision and attendance of the notified body.
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9.
Where the subsystem meets the requirements of the TSI, the notified body shall draw up the certificate of conformity intended for the contracting entity, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates.
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10.
The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art.18 (3) of the Directives, and in particular as follows:
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11.
The records accompanying the certificate of conformity shall be lodged with the contracting entity.
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F.3.4.
Module SG: Unit verification
1.
This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy, control-command or rolling stock subsystem
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2.
The contracting entity shall lodge an application for EC verification (through unit verification) of the subsystem with a notified body of his choice.
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3.
The technical documentation shall enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity assessment with the requirements of the TSI.
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4.
The notified body shall examine the application and the technical documentation, and identify the elements which have been designed in accordance with the relevant provisions of the TSI and the European specifications, as well as the elements which have been designed without applying the relevant provisions of those European specifications.
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5.
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6.
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7.
Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the tests, verifications and checks carried out as required in the TSI and/or in the relevant European specifications, draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates.
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8.
The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file has to include at least the information indicated in Art.18 (3) of the Directive, and in particular as follows:
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9.
The records accompanying the certificate of conformity shall be lodged with the contracting entity
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F.3.5.
Module SH2: Full Quality Management System with Design Examination
1.
This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that an infrastructure, energy, control-command or rolling stock subsystem
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2.
The notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity and the main contractor involved are satisfying the obligations of point 3.
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3.
For the subsystem that is subject of the EC verification procedure, the contracting entity or the main contractor, when employed, shall operate an approved quality management system for design, manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6
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4.
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4.1.
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4.2.
The application shall enable the design, manufacture, assembly, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the requirements of the TSI to be assessed.
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4.3.
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4.4.
The notified body shall examine the application concerning the design examination and assess the results of the tests. Where the design meets the provisions of the Directive and of the TSI that apply to it shall issue a design examination certificate to the applicant. The certificate shall contain the conclusions of the design examination, conditions for its validity, the necessary data for identification of the design examined and, if relevant, a description of the subsystem's functioning.
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4.5.
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5.
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5.1.
The contracting entity, if involved, and the main contractor, when employed, shall lodge an application for assessment of their quality management systems with a notified body of their choice.
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5.2.
For the contracting entity or the main contractor responsible for the whole subsystem project, the quality management system shall ensure overall compliance of the subsystem with the requirements of the TSI.
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5.3.
The notified body chosen by the contracting entity shall examine, if all stages of the subsystem as mentioned in point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s).
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5.4.
The notified body referenced in point 5.1. shall assess the quality management system to determine whether it satisfies the requirements of point 5.2. It presumes compliance with these requirements if the applicant implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which takes into consideration the specificity of the subsystem for which it is implemented.
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5.5.
The contracting entity, if involved, and the main contractor shall undertake to fulfil the obligations arising out of the quality management system as approved and to uphold it so that it remains adequate and efficient.
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6.
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6.1.
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6.2.
The contracting entity, if involved, and the main contractor shall send the notified body referenced in point 5.1. (or have sent) all the documents needed for that purpose and in particular the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicant to the subsystem), including:
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6.3.
The notified body shall periodically carry out audits to make sure that the contracting entity, if involved, and the main contractor maintain and apply the quality management system and shall provide an audit report to them. When they operate a certified quality management system, the notified body shall take this into account in the surveillance.
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6.4.
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6.5.
The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned as under point 5, shall co ordinate the surveillance activities of any other notified bodies responsible for that task, in order:
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7.
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8.
The contracting entity, if involved, and the main contractor shall, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:
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9.
Where the subsystem meets the requirements of the TSI, the notified body shall then, based on the design examination and the approval and surveillance of the quality management system (s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.
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10.
The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art. 18 (3) of The Directive, and in particular as follows:
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11.
Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals and the EC design examination certificates, which it has issued, withdrawn or refused.
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12.
The records accompanying the certificate of conformity shall be lodged with the contracting entity
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F.4.
Assessment of Maintenance Arrangements: Conformity Assessment Procedure
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