# Commission Decision of 20 December 2007 concerning a technical specification for interoperability relating to the ‘infrastructure’ sub-system of the trans-European high-speed rail system (notified under document number C(2007) 6440) (Text with EEA relevance) (2008/217/EC) (repealed), Appendix ANNEX C: Assessment procedures

Extent: E+W+S+N.I.
Status: repealed

Modules for Interoperability Constituents
Module A: Internal Production Control
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2.
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3.
The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent. So far as relevant for the assessment, the documentation shall contain:
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4.
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5.
The manufacturer or his authorised representative established within the Community shall draw up a written declaration of conformity for the interoperability constituent. The content of this declaration has to include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directives 96/48/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.
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6.
The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.
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7.
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Module A1: Internal Design Control with Production Verification
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2.
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3.
The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed.
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4.
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5.
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5.1
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5.1.1
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5.1.2
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5.2
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5.2.1
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5.2.2
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5.2.3
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5.2.4
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5.2.5
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6.
The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.
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7.
The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.
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8.
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Module B: Type Examination
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2.
The application for the EC type-examination shall be lodged by the manufacturer or his authorised representative established within the Community.
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3.
The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent.
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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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4.8
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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 manufacturer, 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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10.
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Module D: Production Quality Management System
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2.
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3.
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3.1
The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.
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3.2
The quality management system shall ensure compliance of the interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plan, manuals and records.
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3.3
The notified body assesses the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.
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3.4
The manufacturer 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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4.
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4.1
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4.2
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and shall provide it with all necessary information, in particular:
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4.3
The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer.
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4.4
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5.
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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6.
The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
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7.
The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.
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8.
The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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9.
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Module F: Product Verification
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2.
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3.
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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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5.
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5.1
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5.2
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5.3
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5.4
In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.
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5.5
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6.
The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.
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7.
The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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8.
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Module H 1: Full Quality Management System
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2.
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3.
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3.1.
The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.
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3.2.
The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
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3.3.
The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.
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3.4.
The manufacturer 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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4.
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4.1.
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4.2.
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including particular:
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4.3.
The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.
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4.4.
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5.
The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
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6.
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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7.
The manufacturer or its authorised representative established within the Community shall draw up the EC Declaration of conformity of the interoperability constituent.
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8.
The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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9.
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Module H2: Full Quality Management System With Design Examination
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2.
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3.
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3.1.
The manufacturer shall lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.
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3.2.
The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
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3.3.
The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer 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 interoperability constituent for which it is implemented.
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3.4.
The manufacturer 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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4.
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4.1.
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4.2.
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including:
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4.3.
The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.
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4.4.
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5.
The manufacturer shall, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
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6.
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6.1.
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6.2.
The application shall enable the design, manufacture, maintenance and operation of the interoperability constituent to be understood, and shall enable conformity with the requirements of the TSI to be assessed.
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6.3
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6.4.
The notified body shall examine the application and assess the results of the tests. Where the design meets the provisions of the TSI that apply to it, the notified body shall issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the product's functioning.
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6.5.
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6.6.
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7.
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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8.
The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of conformity of the interoperability constituent.
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9.
The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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10.
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Module V: Type-Validation By In Service Experience (Suitability For Use)
1.
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2.
The manufacturer, or his authorised representative established within the Community, shall lodge the application for the type-validation by in service experience with a notified body of his choice.
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3.
The technical documentation shall enable the assessment of the product with the requirements of the TSI. The documentation shall cover the operation of the interoperability constituent, and, as far as relevant for such assessment, cover also the design, manufacture and maintenance.
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4.
The programme for the validation by in service experience shall include:
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5.
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5.1.
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5.2.
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5.3.
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5.4.
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5.5.
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5.6.
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5.7.
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6.
Where the type meets the provisions of the TSI, the notified body shall issue a suitability for use certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the validation, conditions for its validity and the necessary data for identification of the approved type.
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7.
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8.
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9.
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10.
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11.
The manufacturer or his authorised representative established within the Community shall draw up the EC declaration of suitability for use of the interoperability constituent.
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12.
The manufacturer or his authorised representative established within the Community shall keep a copy of the EC declaration of suitability for use for a period of 10 years after the last interoperability constituent has been manufactured.
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Modules for the EC Verification of Subsystems
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 the infrastructure 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 fulfill 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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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 the infrastructure 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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Source: https://www.legislation.gov.uk/eudn/2008/217/annex/annex/C (the official version)
Page: https://openlegislation.uk/eu-decision-2008-217/annex/annex-C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.