Appendix ANNEX E

This module describes that part of the procedure by which a notified body ascertains and attests that a type, representative of the production envisaged, meets the provisions of the TSI that apply to it.

The application must include:

• the name and address of the manufacturer and also, if the application is lodged by the authorised representative, his name and address,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation, as described in point 3.

The applicant must place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called ‘type’.

A type may cover several versions of the Interoperability Constituent provided that the differences between the versions do not affect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme.

If no type tests are requested within the type examination procedure, and the type is sufficiently defined by the technical documentation, as described in point 3, the notified body may agree, that no specimens are placed at its disposal.

The technical documentation must contain:

• a general type-description,

• conceptual design and manufacturing information, for example drawings and schemes of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information, maintenance and the operation of the interoperability constituent,

• conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),

• the technical specifications, including European specifications^f1 with relevant clauses, applied in full or in part,

• descriptions of the solutions adopted to meet the requirements of the TSI in cases where the European specifications have not been applied in full,

• results of design calculations made, examinations carried out, etc.,

• test reports.

The notified body must:

examine the technical documentation,

verify that any specimen(s) required for test has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and/or the relevant European specifications,

where a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the interoperability constituent at the completion of the design process,

where a review of the manufacturing process is requested in the TSI, perform an examination of the manufacturing process devised for manufacturing the interoperability constituent, to evaluate its contribution to product conformity, and/or examine the review carried out by the manufacturer at the completion of the design process,

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;

perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2., 4.3. and 4.4 to establish whether, where the manufacturer has chosen to apply the relevant European specifications, these have actually been applied;

perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2., 4.3. and 4.4. to establish whether, where the relevant European specifications have not been applied, the solutions adopted by the manufacturer meet the requirements of the TSI;

agree with the applicant the location where the examinations and necessary tests will be carried out.

The time period of validity shall be no longer than 5 years.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the manufacturer or his authorised representative established within the Community is denied a type-examination certificate, the notified body must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

The applicant must inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications to the approved product which must receive additional approval where such changes may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In this case the notified body shall perform only those examinations and tests that are relevant and necessary to the change(s).This additional approval may be given either in the form of an addition to the original type-examination certificate, or, by the issue of a new certificate after withdrawal of the old one.

If no modifications as in point 6 have been made, the validity of an expiring certificate can be extended for another period of validity. The applicant will apply for such a prolongation by a written confirmation that no such modifications have been made, and the notified body issues a prolongation for another period of validity as in point 5, if no contrary information exists. This procedure can be reiterated.

Each notified body must communicate to the other notified bodies the relevant information concerning the type-examination certificates and additions issued, withdrawn or refused.

The other notified bodies may receive, on request, copies of the type-examination certificates issued and/or their additions. The annexes to the certificates (see § 5) must be kept at the disposal of the other notified bodies.

The manufacturer or his authorised representative established within the Community must keep with the technical documentation copies of type-examination certificates and their additions for a period of 10 years after the last interoperability constituent has been manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

This module describes the procedure whereby the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2 ensures and declares that the interoperability constituent 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.

The manufacturer must operate an approved quality management system for production, final product inspection and testing as specified in point 3 and is subject to monitoring as specified in point. 4.

Quality management system

The application must include:

• all relevant information for the product category representative for the interoperability constituents envisaged,

• the documentation concerning the quality management system,

• the technical documentation of the approved type and a copy of the type-examination certificate, issued after the completion of the type examination procedure of Module B (type examination).

• a written declaration that the same application has not been lodged with any other notified body,

It must contain in particular an adequate description of:

• the quality objectives and the organisational structure,

• responsibilities and powers of the management with regard to product quality,

• the manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required product quality and the effective operation of the quality management system.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit must be specific for the product category, which is representative for the interoperability constituent. The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality management system informed of any intended updating of the quality management system.

The notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Surveillance of the quality management system under the responsibility of the notified body.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

• the quality management system documentation,

• the quality records such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

The frequency of the audits shall be at least once a year.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.

Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality management system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

The other notified bodies may receive on request copies of the quality management system approvals issued.

• the documentation referenced to in the second indent of point 3.1,

• the updating referenced to in the second paragraph of point 3.4,

• the decisions and reports from the notified body in the final paragraph of points 3.4, 4.3 and 4.4.

The declaration must be written in the same language as the technical documentation and must contain the following:

• the Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of the interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other relevant TSI and where appropriate reference to European specification^f2,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the quality management system approval indicated in point 3,

• the type-examination certificate and its additions,

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

This module describes the procedure whereby a manufacturer or his authorised representative established within the Community checks and attests that the interoperability constituent concerned and subject to the provisions of point 3 is in conformity with the type as described in the EC type examination certificate and satisfies the requirements of the TSI that apply to it.

The manufacturer must take all measures necessary in order that the manufacturing process ensures conformity of each interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the EC type examination certificate and with the requirements of the TSI. The manufacturer^f3 can choose either an examination and testing of every interoperability constituent as specified in point 4 or an examination and testing of interoperability constituents on a statistical basis, as specified in point 5.

Verification by examination and testing of every interoperability constituent

Each product shall be individually examined and appropriate tests shall be carried out in order to verify the product conformity with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it. When a test is not set out in the TSI, (or in an European Standard quoted in the TSI), the relevant European Specifications^f4, or equivalent tests are to be used.

The notified body must draw up a written certificate of conformity for the approved products relating to the tests carried out.

The manufacturer or his authorised representative must ensure that he is able to supply the notified body's certificates of conformity on request.

Statistical verification

The manufacturer must present his interoperability constituents in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.

All interoperability constituents must be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Each interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type as described in the type-examination certificate and with the requirements of the TSI which apply to it and to determine whether the lot is accepted or rejected. When a test is not set out in the TSI (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are to be used.

The statistical procedure must use appropriate elements (statistical method, sampling plan etc), depending on the characteristics to be assessed, as specified in the TSI.

If a lot is rejected, the notified body or the competent authority must take appropriate measures to prevent placing of that lot on the market. In the event of frequent rejection of lots the notified body may suspend the statistical verification.

The manufacturer or his authorised representative established within the Community must ensure that he is able to supply the notified body's certificates of conformity on request.

The content of this declaration shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed.

The declaration must be written in the same language as the technical documentation and must contain the following:

• the Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other relevant TSI and where appropriate reference to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the type-examination certificate and its additions,

• the certificate of conformity as mentioned in points 4 or 5.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

This module describes the procedure whereby a notified body carries out an examination of the design of an interoperability constituent and the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2 ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

The manufacturer must operate an approved quality management system for design, production and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point. 4.

Quality management system.

The application must include:

• all relevant information for the product category representative for the interoperability constituent envisaged,

• the quality management system's documentation.

• a written declaration that the same application has not been lodged with any other notified body,

It must contain in particular an adequate description of:

• the quality objectives and the organisational structure,

• responsibilities and powers of the management with regard to design and product quality,

• the technical design specifications, including European specifications^f5, that will be applied, and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the interoperability constituent will be met,

• the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,

• the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required design and product quality and the effective operation of the quality management system.

The quality policies and procedures shall cover in particular the assessment phases, such as design review, review of manufacturing processes and type tests, as they are specified in the TSI, for different characteristics and performances of the interoperability constituent.

When the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit must be specific for the product category, which is representative for the interoperability constituent. The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality management system informed of any intended updating of the quality management system.

The notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.

It must notify its decision to the manufacturer. The notification shall contain the conclusions of the evaluation and the reasoned assessment decision.

Surveillance of the quality management system under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

• the quality management system documentation,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

The frequency of the audits shall be at least once a year.

Additionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality management system where necessary. It must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

• the documentation referenced in the second indent of the second subparagraph of point 3.1,

• the updating referenced to in the second subparagraph of point 3.4,

• the decisions and reports from the notified body in the final subparagraph of points 3.4, 4.3 and 4.4.

Design examination

The manufacturer must lodge an application for examination of the design of the interoperability constituent with a notified body of his choice

It must include:

• a general type-description,

• the technical design specifications, including European specifications, with relevant clauses, that have been applied in full or in part,

• any necessary supporting evidence for their adequacy, in particular where the European specifications and the relevant clauses have not been applied.

• the test programme

• conditions for integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),

• a written declaration that the same application has not been lodged with any other notified body.

The applicant shall present the results of tests^f6, including type tests when required, carried out by its appropriate laboratory or on their behalf.

The notified body must 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 must 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. The time period of validity shall be no longer than 5 years.

The applicant must keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design examination certificate where such changes may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In this case the notified body shall perform only those examinations and tests that are relevant and necessary to the change(s). This additional approval shall be given in the form of an addition to the original EC design examination certificate.

If no modifications as in point 6.4. have been made, the validity of an expiring certificate can be extended for another period of validity. The applicant will apply for such a prolongation by a written confirmation that no such modifications have been made, and the notified body issues a prolongation for another period of validity as in point 6.3. if no contrary information exists. This procedure can be reiterated.

The other notified bodies may receive on request copies of:

• the quality management system approvals and additional approvals issued and

• the EC design examination certificates and additions issued

The content of this declaration shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and its accompanying documents must be dated and signed.

The declaration must be written in the same language as the technical documentation and must contain the following:

• the Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),

• the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of an authorised representative also give the trade name of the manufacturer or constructor),

• description of interoperability constituent (make, type, etc)

• description of the procedure (module) followed in order to declare conformity,

• all of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,

• name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of certificates together with the duration and conditions of validity of the certificates,

• reference to the TSI and any other relevant TSI and where appropriate to European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

The certificates to be referred to are:

• the quality management system approval and surveillance reports indicated in point 3 and 4,

• the EC design examination certificate and its additions.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.

If additional to the EC declaration of conformity an EC declaration of suitability for use for the interoperability constituent is requested in the TSI, this declaration has to be added, after being issued by the manufacturer under the conditions of Module V.

• complies with this TSI and any other relevant TSI, which demonstrate that the essential requirements^f7 of Directive 01/16/EC^f8 have been met

• complies with the other regulations deriving from the Treaty.

The type examination defined by this module could include specific assessment phases — design review, type test or review of manufacturing process, which are specified in the relevant TSI.

The application must include:

• name and address of the contracting entity or its authorised representative

• the technical documentation, as described in point 3.

A type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme. If so required for specific test or examination methods and specified in the TSI or in the European specification^f11 referenced to in the TSI, a specimen or specimens of a subassembly or assembly or a specimen of the subsystem in a pre-assembled condition shall to be provided.

The technical documentation and specimen(s) must enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the provisions of the TSI to be assessed.

The technical documentation must include:

• a general description of the subsystem, overall design and structure,

• F1The European register of authorised types of vehicle, including all information as specified in the TSI,

• conceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information, the maintenance and the operation of the subsystem,

• the technical specifications, including European specifications, that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use of interoperability constituents and all the necessary elements defined in annex VI of the directives,

• evidence of conformity with regulations deriving from the treaty (including certificates)

• technical documentation regarding the manufacture and the assembly of the subsystem,

• a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem

• any technical requirement that must be taken into account during production, maintenance or operation of the subsystem

• results of design calculations made, examinations carried out, etc.,

• test reports.

If the TSI requires further information for the technical documentation, this shall be included.

The notified body must:

Examine the technical documentation.

Verify that the specimen(s) of the subsystem or of assemblies or subassemblies of the subsystem, has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and the appropriate European specifications. Such manufacture shall be verified using an appropriate assessment module.

Where a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at the completion of the design process

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;

Perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2. and 4.3 to establish where the relevant European specifications have been chosen, these have actually been applied;

Perform or have performed the appropriate examinations and necessary tests in accordance with point 4.2. and 4.3. to establish whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied.

Agree with the applicant the location where the examinations and necessary tests will be carried out.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the contracting entity is denied a type-examination certificate, the notified body must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

Each notified body must communicate to the other notified bodies the relevant information concerning the type-examination certificates issued, withdrawn or refused.

The other notified bodies may receive on request copies of the type-examination certificates issued and/or their additions. The annexes to the certificates must be kept at the disposal of the other notified bodies.

The contracting entity must keep with the technical documentation copies of type-examination certificates and any additions throughout the service life of the subsystem. It must be sent to any other Member State which so requests.

The applicant must inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the subsystem. The subsystem must receive additional approval in such cases. This additional approval may be given either in the form of an addition to the original type-examination certificate, or by issue of a new certificate after withdrawal of the old certificate.

• complies with this TSI and any other relevant TSI, which demonstrate that the essential requirements^f12 of Directive 01/16/EC^f13 have been met

• complies with the other regulations deriving from the Treaty,

and may be placed in service.

• the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application,

• the contracting entity^f14 and the main contractors involved are satisfying the obligations of point 3.

• The ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns:

  • the company responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

  • other companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem).

• It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

When the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), or the contracting entity is directly involved in the production (including assembly and installation), it has to operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.

If a main contractor is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), it must operate in any case an approved quality management system for manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.

EC verification procedure

The contracting entity must 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 must inform the manufacturers involved of this choice and of the application.

The application must include:

• name and address of the contracting entity or its authorised representative

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in Module SB (type-examination),

and, if not included in this documentation,

• a general description of the subsystem, its overall design and structure,

• the technical specifications, including European specifications, that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where these European specifications, and the relevant clauses have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf.

• the Register of Infrastructure, including all information as specified in the TSI,

• the technical documentation regarding the manufacture and the assembly of the subsystem,

• evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which the constituents must be provided, and all the necessary elements defined in annex VI of the directives,

• a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• the demonstration, that all stages, as mentioned under point 5.2, are covered by quality management systems of the contracting entity, if involved, and/or of the main contractors, and the evidence of their effectiveness,

• indication of the notified body, responsible for the approval and surveillance of these quality management systems.

If the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.

Quality management system

The application must include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

• the technical documentation of the approved type and a copy of the type examination certificate, issued after the completion of the type examination procedure of Module SB (type-examination).

For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

All the elements, requirements and provisions adopted by the applicant(s) must 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.

It must contain in particular an adequate description of the following items for all applicant(s):

• the quality objectives and the organisational structure,

• the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, assembly and installation, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• and also for the contracting entity or the main contractor responsible for the whole subsystem project:

• responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

• structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

If the conformity of the subsystem with the type as described in the type-examination certificate and the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,

• if the relations and interfaces between the quality management systems are clearly documented

• and if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractors are sufficiently and properly defined.

When an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team must have at least one member experienced as an assessor in the subsystem technology concerned.

The evaluation procedure shall include an assessment visit to the applicant's premises.

The decision must be notified to the applicant. The notification must contain the conclusions of the examination and the reasoned assessment decision.

They must keep the notified body that has approved the quality management system, informed of any significant change that will affect the fulfilment of the TSI requirements by the subsystem.

The notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements referenced in point 5.2 or whether a re-assessment is required.

lt must notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance of the quality management system(s) under the responsibility of the notified body

The purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractors, duly fulfil the obligations arising out of the approved quality management system.

• the quality management system documentation, including the particular means implemented to ensure that:

  • for the contracting entity or main contractor, responsible for the whole subsystem project, overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,

  • for each applicant, the quality management system is correctly managed for achieving integration at subsystem level,

• the quality records as foreseen by the manufacturing part (including assembly and installation) of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

The frequency of the audits shall be at least once a year, with at least one audit during the time period of performing relevant activities (manufacture, assembly or installation) of the subsystem being the subject of the EC verification procedure mentioned under point 8.

Additionally the notified body may pay unexpected visits to the relevant sites of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests, in order to check the proper functioning of the quality management system where necessary. It must provide the applicant(s) with an inspection report and also, audit and/or test reports, as appropriate.

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed,

• to collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.

This co ordination includes the rights of the notified body:

• to receive all documentation (approval and surveillance), issued by the other notified bodies,

• to witness the surveillance audits in point 6.3,

• to initiate additional audits as in point 6.4 under its responsibility and together with the other notified bodies.

The notified body as referenced in point 5.1. must have entrance for inspection purposes, audit and surveillance to the locations of building sites, production workshops, locations of assembly and installations, storage areas and where appropriate, prefabrication and testing facilities and, more general, to all premises which it considers necessary in order to carry out its tasks, in accordance with the applicant's specific contribution to the subsystem project.

• the documentation referenced in the second indent of the second subparagraph of point 5.1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body, which are, referenced in points 5.4, 5.5 and 6.4.

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

• all necessary documents relating to the characteristics of the subsystem,

• a list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which said constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and the accompanying technical documentation as defined in the Module SB (type-examination),

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• certificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.3 and 6.4 and in particular:

• the Register of Infrastructure, including all information as specified in the TSI.

The other notified bodies may receive on request copies of the quality management system approvals issued

The contracting entity within the Community must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.

• complies with this TSI and any other relevant TSI, which demonstrate that the essential requirements^f16 of Directive 01/16/EC^f17 have been met

• complies with the other regulations deriving from the Treaty

and may be placed into service

The application shall include:

• The name and address of the contracting entity or its authorised representative

• the technical documentation.

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. The notified body shall carrying out the procedure under the condition that the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application

The contracting entity must take all measures necessary in order that the manufacturing process (including assembly and integration of interoperability constituents by main contractors^f19 when employed) ensures conformity of the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.

The application must include:

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in Module SB (type-examination),

and, if not included in this documentation,

• a general description of the subsystem, overall design and structure,

• the Register of Infrastructure, including all information as specified in the TSI,

• conceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,

• the technical documentation regarding the manufacture and the assembly of the subsystem,

• the technical specifications, including European specification, that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where these European specification and the relevant clauses have not been applied in full,

• evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

• a list of the Interoperability Constituents, to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which said constituents must be provided and all the necessary elements defined in annex VI of the directives,

• a list of manufacturers involved in the subsystem's design, manufacture, assembly and installation,

If the TSI requires further information for the technical documentation, this shall be included.

If the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type, as described in the type examination certificate and with the requirements of the TSI. The notified body shall examine and testing of every subsystem manufactured as a serial product, as specified in point 4

Verification by examination and testing of every subsystem (as a serial product)

The notified body must carry out the tests, examinations and verifications, to ensure conformity of the subsystems, as serial products as provided for in the TSI. The examinations, tests and checking shall extend to the stages as provided for in the TSI:

Each subsystem (as serial product) must be individually examined, tested and verified^f20 in order to verify its conformity with the type as described in the type-examination certificate and the requirements of the TSI that apply to it. When a test is not set out in the TSI, (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are to be used.

The notified body shall have entrance for testing and verification purposes to production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

These NB activities shall be based on the type examination and the tests, verifications and checks carried out on all serial products as indicated in point 7 and required in the TSI and/or in the relevant European specification,

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

• all necessary documents relating to the characteristics of the subsystem

• the Register of Infrastructure, including all information as specified in the TSI,

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and accompanying technical documentation, as defined in the Module SB (type-examination)

• certificate of conformity of the notified body as mentioned in point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn. The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification.

The contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.

• complies with this TSI and any other relevant TSI, ,which demonstrate that the essential requirements^f21 of Directive 01/16/EC^f22 have been met

• complies with the other regulations deriving from the Treaty.

and may be placed in service.

The ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns the company:

• responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

• other companies only involved only in a part of the subsystem project (performing for example design, assembly or installation of the subsystem).

It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

The main contractor responsible for the whole subsystem project (including in particular responsibility for subsystem integration), must operate in any case an approved quality management system for design, manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.

In the case that the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration) or that the contracting entity is directly involved in the design and/or production (including assembly and installation), it shall operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.

Applicants which are only involved in assembly and installation, may operate only an approved quality management system for manufacture and final product inspection and testing

EC verification procedure

The contracting entity must lodge an application for EC verification of the subsystem (through full quality management system with design examination), including co ordination of surveillance of the quality management systems as in points 5.4. and 6.6., with a notified body of its choice. The contracting entity must inform the manufacturers involved of his choice and of the application.

The application must include:

• name and address of the contracting entity or its authorised representative,

• the technical documentation including:

  • a general description of the subsystem, overall design and structure,

  • the technical design specifications, including European specifications, that have been applied,

  • any necessary supporting evidence for the use of the above specifications, in particular where the European specifications and the relevant clauses have not been applied in full.

  • the test programme

  • the Infrastructure and/or Rolling Stock (subsystem) register, including all information as specified in the TSI,

  • the technical documentation regarding the manufacture, the assembly of the subsystem,

  • a list of the interoperability constituents to be incorporated into the subsystem,

  • copies of the EC declarations of conformity or suitability for use with which the constituents must be provided and all the necessary elements defined in annex VI of the directives,

  • evidence of conformity to other regulations deriving from the treaty (including certificates)

  • a list of all manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

  • conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

  • conditions for maintenance and technical documentation regarding the maintenance of the subsystem

  • any technical requirement that must be taken into account during production, maintenance or operation of the subsystem

  • the explanation, of how all stages, as mentioned in point 5.2, are covered by quality management systems of the mains contractor(s) and/or of the contracting entity, if involved, and the evidence of their effectiveness,

  • indication of the notified body (ies) responsible for the approval and surveillance of these quality management systems.

The contracting entity shall present the results of examinations, checking and tests^f24, including type tests when required, carried out by its appropriate laboratory or on their behalf.

If the contracting entity is denied a design examination report, the notified body must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

Quality management system

The application must include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

The quality management system(s), for other main contractor(s), has (have) to ensure compliance of their relevant contribution to the subsystem, with the requirements of the TSI.

All the elements, requirements and provisions adopted by the applicants must 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.

The system must contain in particular an adequate description of the following items:

• for all applicants:

  • the quality objectives and the organisational structure,

  • the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

  • the examinations, checking and tests that will be carried out before, during and after design, manufacture, assembly and installation and the frequency with which they will be carried out,

  • the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• for the main contractors, as far as relevant for their contribution to the design of the subsystem:

  • the technical design specifications, including European specifications^f25, that will be applied and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the subsystem will be met,

  • the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystem,

  • the means to monitor the achievement of the required design and subsystem quality and the effective operation of the quality management systems in all phases including production.

  • and also for the contracting entity or the main contractor responsible for the whole subsystem project:

  • responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

• overall design,

• structure of the subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

If the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,

• if the relations and interfaces between the quality management systems are clearly documented

and if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractor are sufficiently and properly defined.

When an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team must have at least one member experienced as an assessor in the subsystem technology concerned.

The evaluation procedure shall include an assessment visit to the applicant's premises.

The decision must be notified to the applicant. The notification must contain the conclusions of the examination and the reasoned assessment decision.

They must keep the notified body that has approved their quality management system informed of any significant change that will affect the fulfilment of the requirements by the subsystem.

The notified body must evaluate any modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 5.2 or whether a re-assessment is required.

It shall notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance of the quality management system(s) under the responsibility of the notified body

The purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractors duly fulfil the obligations arising out of the approved quality management system(s).

• the quality management system documentation, including the particular means implemented to ensure that

  • for the contracting entity or the main contractor, responsible for the whole subsystem project, overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,

  • for each applicant, the quality management system is correctly managed for achieving integration at subsystem level,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part (including assembly, installation and integration) of the quality management system, such as inspection reports and test data, calibration data, competency records of the personnel concerned, etc.

The frequency of the audits shall be at least once a year, with at least one audit during the time period of performing the relevant activities (design, manufacture, assembly or installation) for the subsystem being the subject of the EC verification procedure mentioned in point 7.

Additionally the notified body may pay unexpected visits to the sites mentioned in point 5.2 of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests in order to check the proper functioning of the quality management system where necessary. It must provide the applicant(s) with an inspection report and, audit and/or test reports as appropriate

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed.

• to collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.

This co ordination includes the right of the notified body

• to receive all documentation (approval and surveillance), issued by the other notified body(s),

• to witness the surveillance audits as in point 5.4.,

• to initiate additional audits as in point 5.5. under its responsibility and together with the other notified body(s).

The notified body as referenced under point 5.1. must have entrance for inspection purposes, audit and surveillance to the locations of design, building sites, production workshops, locations of assembly and installation, storage areas and. where appropriate, prefabrication or testing facilities and, more general, to all premises which it considers necessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

• the documentation referenced in the second indent of the second subparagraph of point 5.1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body which are referenced in the points 5.4, 5.5 and 6.4

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

• all necessary documents relating to the characteristics of the subsystem

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified,

• evidence of conformity to other regulations deriving from the treaty (including certificates)

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance

• certificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.4. and 6.5.;

• the Register of Infrastructure, including all information as specified in the TSI.

The other notified bodies may receive on request copies of:

• the quality management system approvals and additional approvals issued and

• the EC design examination reports and additions issued

The contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.

• complies with this TSI and any other relevant TSI, which demonstrate that the essential requirements^f27 of Directive 01/16/EC^f28 have been met

• complies with the other regulations deriving from the Treaty,

and may be placed in service.

The application shall include:

• name and address of the contracting entity or its authorised representative

• the technical documentation.

The technical documentation must include:

• a general description of the subsystem, its overall design and structure,

• the Register of Infrastructure, including all information as specified in the TSI,

• conceptual design and manufacturing information, for example drawings, schemes of components, sub-assemblies, assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the design and manufacturing information and the operation of the subsystem,

• the technical specifications, including European specifications^f30, that have been applied,

• any necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies of the EC declarations of conformity or suitability for use with which said constituents must be provided and all the necessary elements defined in annex VI of the directives,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• technical documentation regarding the manufacture and the assembly of the subsystem,

• a list of manufacturers involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem

• any technical requirement that must be taken into account during production, maintenance or operation of the subsystem

• results of design calculations made, examinations carried out, etc.,

• all other appropriate technical evidences, which can demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by independent and competent bodies

• all other appropriate technical evidences, which can demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by independent and competent bodies

If the TSI requires further information for the technical documentation, this shall be included.

The notified body must examine the subsystem and perform (or participate to) the appropriate and necessary tests to establish whether, where the relevant European specifications have been chosen, these have actually been applied or whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied;

The examinations, tests and checks shall extend to the following stages as provided for in the TSI:

• overall design

• structure of the subsystem, including, in particular and when relevant, civil-engineering activities, constituent assembly, overall adjustments

• final testing of the subsystem

• and, whenever specified in the TSI, the validation under full operational conditions.

The notified body shall take into account previous checking or tests that have been successfully performed, under comparable conditions by other independent and competent bodies^f31. The notified body will then decide as to whether it shall use the results of these checks or tests. If it accepts, then the notified body shall investigate the evidences of these previous checking or test and shall establish the conformity of their results with the requirement of the TSI. In all case the notified body keeps the final responsibility of them.

The notified body may agree with the contracting entity the locations where the tests will be carried out and may agree that final subsystem tests and, whenever required in the TSI, tests in full operating conditions, are carried out by the contracting entity under direct supervision and attendance of the notified body.

The notified body must have entrance for testing and verification purposes to the locations of design, building sites, production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language as the technical file and must contain at least the information included in Annex V of the Directive.

• all necessary documents relating to the characteristics of the subsystem

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• certificate of conformity of the notified body as mentioned in point 7, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn; the certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• the Register of Infrastructure, including all information as specified in the TSI.

The records accompanying the certificate of conformity must be lodged with the contracting entity. The contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.