Appendix ANNEX F PROCEDURES FOR ASSESSMENT OF CONFORMITY AND SUITABILITY FOR USE

United Kingdom

MODULE A (INTERNAL PRODUCTION CONTROL)

Conformity assessment of interoperability constituents

This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who discharges the obligations laid down in point 2, ensures and declares that the interoperability constituent concerned satisfies the requirements of the TSI that apply to it.

The manufacturer must prepare the technical documentation described in point 3.

The technical documentation must enable the conformity of the interoperability constituent with the requirements of this TSI to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the interoperability constituent. So far as relevant for the assessment, the documentation must contain:

a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the interoperability constituent,
a list of the technical specifications (relevant TSI and/or European specifications with relevant clauses, referred to in the TSI), applied in full or in part,
descriptions of the solutions adopted to meet the requirements of this TSI, where the European specifications referred to in the TSI have not been applied in full,
results of design calculations made, examinations carried out, etc.,
test reports.

The manufacturer must take all the measures necessary in order that the manufacturing process ensures compliance of the manufactured interoperability constituent with the technical documentation referred to in point 2 and with the requirements of the TSI that apply to it.

The manufacturer or his authorised representative established within the Community must draw up a written declaration of conformity. The content of this declaration has to include at least the information, indicated in Directive 96/48/EC, Annex IV(3) and in Article 13(3). The EC declaration of conformity and the accompanying documents must be dated and signed.

The declaration shall be written in the same language as the technical file and include the following:

the Directive reference (Directive 96/48/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 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 the relevant descriptions met by the interoperability constituent and in particular its conditions of use,
reference to this TSI and to any other applicable TSI, and where appropriate reference to European specifications,
identification of the signatory having received authority to engage the manufacturer or his authorised representative established within the Community.

The manufacturer or his authorised representative must 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.

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 in the Community market.

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

MODULE B (TYPE-EXAMINATION)

Conformity assessment of interoperability constituents

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 manufacturer, or his authorised representative established within the Community, must lodge the application for the type-examination with a notified body of his choice.

The application must include:

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition,
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 (see point 4.4), 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 their disposal.

The technical documentation must enable the conformity of the interoperability constituent with the provisions of the TSI to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the product.

The technical documentation must contain:

a general type-description,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
conditions of integration of the interoperability constituent in its system environment (subassembly, 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 list of the technical specifications, against which the conformity of the interoperability constituent is to be assessed (relevant TSI and/or European specifications with relevant clauses),
descriptions of the solutions adopted to meet the requirements of the TSI in cases where the European specifications referred to in the TSI have not been applied in full,
results of design calculations made, examinations carried out, etc.,
test reports.

The notified body must:

4.1.

examine the technical documentation,

4.2.

if 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,

4.3.

if 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,

4.4.

if type tests are requested in the TSI, verify that the specimen(s) 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 European Specifications referred to in the TSI,

4.5.

identify the elements which have been designed in accordance with the relevant provisions of the TSI and the European Specifications referred to in the TSI, as well as the elements which have been designed without applying the relevant provisions of those European Specifications,

4.6.

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 appropriate European specifications referred to in the TSI have not been applied, the solutions adopted by the manufacturer meet the requirements of the TSI,

4.7.

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,

4.8.

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

Where the type meets the provisions of the TSI, the notified body must issue a typeexamination certificate to the applicant. The certificate must 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.

The time period of validity shall be no longer than three 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 an EC 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 EC 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. This additional approval is given in the form of an addition to the original typeexamination certificate, or a new certificate will be issued after withdrawal of the old certificate.

If no modifications as under 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 it has withdrawn or refused.

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

10.

The manufacturer or his authorised representative established within the Community must keep with the technical documentation copies of the EC type-examination certificates and their additions for a period of 10 years after the last product 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 product on the Community market.

MODULE D (PRODUCTION QUALITY ASSURANCE)

Conformity assessment of interoperability constituents

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 EC type-examination certificate and satisfies the requirements of the Directive 96/48/EC and of the TSI that apply to it.

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

Quality system

3.1.

3.1.The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice, for the interoperability constituents concerned.

The application must include:

all relevant information for the product category representative for the interoperability constituents envisaged,
the documentation concerning the quality system,
the technical documentation of the approved type and a copy of the type-examination certificate.

3.2.

The quality system must ensure compliance of the interoperability constituents with the type as described in the EC type-examination certificate and with the requirements of the Directive 96/48/EC and 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 system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records.

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 assurance techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, 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.,
the means to monitor the achievement of the required product quality and the effective operation of the quality system.

3.3.

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It presumes conformity with these requirements in respect of quality systems that implement the relevant harmonised standard. This harmonised standard shall be EN ISO 9001 — December 2000, completed if necessary to take into consideration the specificity of the interoperability constituent for which it is implemented.

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.

3.4.

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

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

The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

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

3.5.

Each notified body must communicate to the other notified bodies the relevant information concerning the quality system approvals that it has withdrawn or refused.

3.6.

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

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

4.1.

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

4.2.

The manufacturer must allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:

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

4.3.

The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.

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

4.4.

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 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 manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

the documentation referred to in the second indent of point 3.1,
the updating referred to in the second paragraph of point 3.4,
the decisions and reports from the notified body which are referred to in the final paragraph of point 3.4, points 4.3 and 4.4.

The manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration has to include at least the information, indicated in Directive 96/48/EC, Annex IV(3) and Article 13(3). The EC declaration of conformity 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 the following:

the Directive references (Directive 96/48/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 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 its conditions of use,
name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of examination certificates together with the duration and conditions of validity of the certificate,
reference to this TSI and any other applicable TSI and where appropriate reference to European specifications,
identification of signatory having received power to engage the manufacturer or his authorised representative established within the Community.

The certificates to be referred to are:

the quality system approval and surveillance reports indicated in points 3 and 4,
the type-examination certificate and its additions,

The manufacturer or his authorised representative established within the Community must keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

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.

MODULE F (PRODUCT VERIFICATION)

Conformity assessment of interoperability constituents

This module describes that part of the procedure whereby a manufacturer or his authorised representative established within the Community checks and attests that the interoperability constituent concerned, 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 Directive 96/48/EC and of the TSI that apply to it.

The manufacturer must take all measures necessary in order that the manufacturing process ensures conformity of the interoperability constituents with the type as described in the EC type-examination certificate and with the requirements of Directive 96/48/EC and of the TSI that apply to them.

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 Directive 96/48/EC and of the TSI either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of interoperability constituents on a statistical basis, as specified in point 5, at the choice of the manufacturer.

Verification by examination and testing of every interoperability constituent

4.1.

All products must be individually examined and appropriate tests as set out in the relevant European specifications referred to in Article 10 or equivalent tests shall be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of Directive 96/48/EC and of the TSI that apply to them.

4.2.

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

4.3.

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

5.1.

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.

5.2.

All interoperability constituents must be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Interoperability constituents in a sample shall be individually examined and appropriate tests as set out in the relevant European specifications referred to in Article 10, or equivalent tests, shall be carried out to ensure their conformity with the requirements of Directive 96/48/EC and of the TSI which apply to them and to determine whether the lot is accepted or rejected.

5.3.

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

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 put on the market except those interoperability constituents from the sample which were found not to be in conformity.

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

5.5.

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 manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.

The declaration must be written in the same language of the technical file and must contain the following:

the Directive references (Directive 96/48/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 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 its conditions of use,
name and address of notified body (bodies) involved in the procedure followed in respect of conformity and date of examination certificates together with the duration and conditions of validity of the certificate,
reference to this TSI and any other applicable TSI and where appropriate reference to European specifications,
identification of signatory having received power to engage the manufacturer or his authorised representative established within the Community.

The certificates to be referred to are:

the EC type-examination certificate and its additions,
the certificate of conformity as mentioned under point 4 or 5.

MODULE H2 (FULL QUALITY ASSURANCE WITH DESIGN EXAMINATION)

Conformity assessment of interoperability constituents

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 Directive 96/48/EC and of the TSI that apply to it.

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

Quality system

3.1.

The manufacturer must lodge an application for assessment of his quality system with a notified body.

The application must include:

all relevant information for the product category representative for the interoperability constituent envisaged,
the quality system's documentation.

3.2.

The quality system must ensure compliance of the interoperability constituent with the requirements of Directive 96/48/EC and of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality 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 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, that will be applied, and, where the European specifications referred to in Article 10 will not be applied in full, the means that will be used to ensure that the requirements of Directive 96/48/EC and 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 assurance techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, 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.,
the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.

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

3.3.

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard. This harmonised standard shall be EN ISO 9001 — December 2000, completed if necessary to take into consideration the specificity of the interoperability constituent for which it is implemented.

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 examination and the reasoned assessment decision.

3.4.

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

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

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

4.1.

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

4.2.

The manufacturer must 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, in particular:

the quality system documentation,
the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3.

The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

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

4.4.

Additionally the notified body may pay unscheduled 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 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 manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

the documentation referred to in the second indent of the second subparagraph of point 3.1,
the updating referred to in the second subparagraph of point 3.4,
the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, points 4.3 and 4.4.

Design examination

6.1.

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

6.2.

The application must enable the design, manufacture and operation of the interoperability constituent to be understood, and shall enable conformity with the requirements of Directive 96/48/EC and of the TSI to be assessed.

It must include:

the technical design specifications, including European specifications, that have been applied,
the necessary supporting evidence for their adequacy, in particular where the European specifications referred to in Article 10 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.

6.3.

The notified body must examine the application and where the design meets the provisions of the TSI that apply to it must issue a 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 three years.

6.4.

The applicant must keep the notified body that has issued the 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 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. This additional approval is given in the form of an addition to the original design examination certificate.

6.5.

If no modifications as under 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.

Each notified body must communicate to the other notified bodies the relevant information concerning the quality system approvals and the design examination certificates which it has withdrawn or refused.

The other notified bodies will receive copies of:

the quality system approvals and additional approvals issued, and
the design examination certificates and additions issued

on request.

The manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.

The content of this declaration has to include at least the information, indicated in Directive 96/48/EC, Annex IV(3) and in Article 13(3). The EC declaration of conformity and its accompanying documents must be dated and signed.

The declaration must be written in the same language of the technical file and must contain the following:

the Directive references (Directive 96/48/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 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 its conditions of use,
name and address of notified body(ies) involved in the procedure followed in respect of conformity and date of examination certificates together with the duration and conditions of validity of the certificate,
reference to this TSI and other applicable TSI and where appropriate to European specifications,
identification of the signatory having received power to engage the manufacturer or his authorised representative established within the Community.

The certificates to be referred to are:

the quality system approval and surveillance reports indicated in points 3 and 4,
the design examination certificate and its additions.

The manufacturer, or his authorised representative established within the Community, must keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.

10.

MODULE V (EC TYPE-VALIDATION BY IN SERVICE EXPERIENCE)

Suitability for use assessment of interoperability constituents

This module describes that part of the procedure by which a notified body ascertains and attests that a specimen, representative of the production envisaged, meets the provisions of Directive 96/48/EC and of the TSI that apply to it for suitability for use, to be demonstrated by type validation by in service experience.

The application for the type-validation by in service experience must be lodged by the manufacturer, or his authorised representative established within the Community, with a notified body of his choice.

The application must include:

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition,
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 programme for validation by in service experience, as described in point 4,
the name and address of the company (infrastructure manager or railway enterprise), with which the applicant has obtained an agreement to contribute to a suitability for use assessment by in service experience
- by operating the interoperability constituent in service,
- by monitoring the in service behaviour and
- by issuing a report about in service experience,
the name and the address of the company, undertaking the maintenance of the interoperability constituent during the time period or running distance, required for in service experience,
an EC declaration of conformity for the interoperability constituent and,
- if Module B is required in the TSI, an EC type-examination certificate,
- if Module H2 is required in the TSI, an EC design examination certificate.

The applicant must place at the disposal of the company, undertaking the operation of the interoperability constituent in service, a specimen or a sufficient number of specimens, 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 are all covered by EC declarations of conformity and certificates as mentioned above.

The notified body may request further specimens if needed for carrying out the validation by in service experience to be put in service.

The technical documentation must enable the assessment of the product with the requirements of Directive 96/48/EC and of the TSI. It must cover the operation of the interoperability constituent, and, as far as relevant for such assessment, cover also the design and manufacture.

The technical documentation must contain:

a general type-description,
the technical specification(s), against which the performance and in service behaviour of the interoperability constituent is to be assessed (relevant TSI and/or European specifications with relevant clauses),
schemes of components, subassemblies, circuits, etc.,
conditions of integration of the interoperability constituent in its system environment (subassembly, 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.),
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the interoperability constituent,

and, as far as is relevant for assessment,

conceptual design and manufacturing drawings,
results of design calculations made and examinations carried out,
test reports.

If the TSI is requiring further information for the technical documentation, this has to be included.

A list of the European specifications referred to in the technical documentation, applied in full or in part, has to be attached.

The programme for the validation by in service experience must include:

the required performance or behaviour in service of the interoperability constituent under trial,
the installation arrangements,
the duration of the programme, either time or distance,
the operating conditions and the service programme expected,
the maintenance programme,
the special in service tests, if any, to be performed,
the batch size of the specimens, if more than one,
the inspection programme (nature, number and frequency of inspections, documentation),
criteria for tolerable defects and their impact on the programme,
the information to be included in the report of the company operating the interoperability constituent in service (see point 2).

The notified body must:

5.1.

examine the technical documentation and the programme for validation by in-service experience,

5.2.

verify that the type is representative and has been manufactured in conformity with the technical documentation,

5.3.

verify that the programme for validation by in-service experience is well adapted to assess the required performance and in service behaviour of the interoperability constituent,

5.4.

agree with the applicant about the programme and the location where the inspections and necessary tests will be carried out and about the body performing the tests (notified body or other competent laboratory),

5.5.

monitor and inspect the progress of in service running, operation and maintenance of the interoperability constituent,

5.6.

evaluate the report, to be issued by the company (infrastructure manager or railway enterprise) operating the interoperability constituent, and all other documentation and information, gained during the procedure (test reports, maintenance experience, etc.),

5.7.

assess, if the in-service behaviour meets the requirements of Directive 96/48/EC and of the TSI.

Where the type meets the provisions of the TSI, the notified body must issue a suitability for use certificate to the applicant. The certificate must 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.

The time period of validity shall be no longer than three 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 applicant is denied a suitability for use 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 suitability for use certificate of all modifications to the approved product which must receive additional approval where such changes may affect the suitability for use or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original suitability for use certificate, or a new certificate will be issued after withdrawal of the old certificate.

If no modifications as under point 7 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 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 suitability for use certificates it has withdrawn or refused.

10.

The other notified bodies will receive copies of the suitability for use certificates issued and/or their additions on request. The annexes to the certificates must be kept at the disposal of the other notified bodies.

11.

The manufacturer or his authorised representative established within the Community must keep with the technical documentation copies of suitability for use certificates and their additions for a period of 10 years after the last product has been manufactured.

12.

The manufacturer or his authorised representative established within the Community must draw up the EC declaration of suitability for use of the interoperability constituent.

The content of this declaration has to include at least the information, indicated in Directive 96/48/EC, Annex IV(3) and in Article 13(3). The EC declaration of suitability for use 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 the following:

the Directive references (Directive 96/48/EC),
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 authorised representative also give the trade name of the manufacturer or constructor),
description of interoperability constituent (make, type, etc.),
all of the relevant descriptions met by the interoperability constituent and in particular its conditions of use,
name and address of notified body (bodies) involved in the procedure followed in respect of suitability for use and date of suitability for use certificate together with the duration and conditions of validity of the certificate,
reference to this TSI and to any other applicable TSI, and where appropriate reference to European specifications,
identification of the signatory having received power to engage the manufacturer or his authorised representative established within the Community.

13.

The manufacturer or his authorised representative established within the Community must 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.

MODULE SB (EC TYPE-EXAMINATION)

EC verification of rolling stock subsystem

This module describes part of the EC verification procedure whereby a notified body checks and certifies at the request of an adjudicating entity or its authorised representative established within the Community, that a type of a rolling stock subsystem, representative for the production envisaged,

complies with this TSI and any other applicable TSI, which demonstrates that the essential requirements of Directive 96/48/EC have been met,
complies with the other regulations deriving from the Treaty.

The adjudicating entity or its authorised representative established within the Community must lodge an application for EC verification (through type-examination) of the subsystem with a notified body of his choice.

The application includes:

name and address of the adjudicating entity or its authorised representative
the technical documentation, as described in point 3.

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

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 specifications referred to in Article 10, also a specimen or specimens of a subassembly or assembly or a specimen of the subsystem in a preassembled condition has to be delivered.

The technical documentation must enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity with the provisions of Directive 96/48/EC and of the TSI to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the subsystem.

It must include:

a general description of the subsystem, overall design and structure,
the register of rolling stock, including all indications as specified in the TSI
conceptual design and manufacturing drawings and schemes of components, subassemblies, assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
the technical design specifications, including European specifications, that have been applied,
the necessary supporting evidence for their adequacy, in particular where European specifications referred to in the TSI and the relevant clauses have not been applied in full,
a list of the interoperability constituents, to be incorporated into the subsystem,
technical documentation as regards the manufacturing and the assembling of the subsystem,
a list of manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,
conditions for use and maintenance of the subsystem (restrictions of running time or distance, wear limits, etc.),
a list of the European specifications referred to in Article 10 or in the technical design specification,
results of design calculations made, examinations carried out, etc.,
test reports.

If the TSI is requiring further information for the technical documentation, this has to be included.

The notified body must:

4.1.

examine the technical documentation,

4.2.

4.3.

if type tests are requested in the TSI, verify that the specimen(s) of the subsystem or of assemblies or subassemblies of the subsystem, required for carrying out type tests, 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 European specifications concerned,

4.4.

identify the elements which have been designed in accordance with the relevant provisions of the TSI and the European specifications referred to in Article 10, as well as the elements which have been designed without applying the relevant provisions of those European specifications,

4.5.

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

4.6.

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

4.7.

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

Where the type meets the provisions of Directive 96/48 /EC and of the TSI, the notified body must issue a type-examination certificate to the applicant. The certificate must contain the name and address of the adjudicating entity and the manufacturer(s), conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.

The time period of validity shall be no longer than three 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 adjudicating entity or its 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 EC type-examination certificate of all modifications to the approved subsystem which must receive additional approval where such changes may affect the conformity with the requirements of Directive 96/48/EC and of the TSI or the prescribed conditions for use of the subsystem. This additional approval is given in the form of an addition to the original type-examination certificate, or a new certificate will be issued after withdrawal of the old certificate.

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

10.

The adjudicating entity or its authorised representative established within the Community must keep with the technical documentation copies of type-examination certificates and their additions throughout the service life of the subsystem, it must be sent to any other Member State who so requests.

MODULE SD (PRODUCTION QUALITY ASSURANCE)

EC verification of rolling stock subsystem

This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an adjudicating entity or its authorised representative established within the Community, that a rolling stock subsystem, for which an EC type-examination certificate has already been issued by a notified body,

complies with this TSI and any other applicable TSI, which demonstrates that the essential requirements of Directive 96/48/EC have been met,
complies with the other regulations deriving from the Treaty and may be put into service.

The notified body carries out the procedure, under the condition that the adjudicating entity and the manufacturers involved satisfy the obligations of point 2.

For the subsystem, which is the subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (manufacturing, assembling, installation) are subject to an approved quality system for manufacture and final product inspection and testing as specified in point 3 and subject to surveillance as specified in point 4.

The term ‘manufacturer’ also includes companies:

responsible for the whole subsystem project (including in particular responsibility for subsystem integration (main contractor),
performing assembling (assemblers) and installation of the subsystem.

The main contractor responsible for the whole subsystem project (including in particular responsibility for subsystem integration), must operate in any case an approved quality system for manufacture and final product inspection and testing, as specified in point 3 and which shall be subject to surveillance as specified in point 4.

In the case, that the adjudicating entity is directly involved in the production (including assembling and installation), or that the adjudicating entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), it has to operate an approved quality system for those activities, as specified in point 3 and subject to surveillance as specified in point 4.

Quality system

3.1.

The manufacturer(s) involved and, if involved the adjudicating entity must lodge an application for assessment of their quality system with a notified body of their choice.

The application must include:

all relevant information for the subsystem envisaged,
the quality system's 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.

For manufacturers, only involved in a part of the subsystem project, the information is only requested for that specific relevant part.

3.2.

For the main contractor the quality system must ensure overall compliance of the subsystem with the type as described in the type-examination certificate and overall compliance of the subsystem with the requirements of the TSI. For other manufacturers (subsuppliers) the quality system has to ensure compliance of their relevant contribution to the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI.

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 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 applicants:

the quality objectives and the organisational structure,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
the examinations, the checking and tests that will be carried out before, during and after manufacture, assembling 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 for the main contractor:

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.

3.3.

The notified body referred to in point 3.1 must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard. This harmonised standard shall be EN ISO 9001 — December 2000, completed if necessary to take into consideration the specificity of the subsystem for which it is implemented.

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.

3.4.

The manufacturer(s) and if involved the adjudicating entity must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

They must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

It 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 system(s) under the responsibility of the notified body(ies)

4.1.

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

4.2.

The notified body as referred to under point 3.1 must have permanent access for inspection purposes to the locations of building sites, production workshops, locations of assembling 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.

4.3.

The manufacturer(s) and, if involved, the adjudicating entity or its authorised representative established within the Community must send the notified body referred to under point 3.1 (or have sent it) 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), in particular:

the quality system documentation, including the particular means implemented to ensure that:
- (for the main contractor) overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,
- the quality systems of each manufacturer are correctly managed for achieving integration at subsystem level,
the quality records as foreseen by the manufacturing part (including assembling and installation) of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.4.

The notified body(ies) must periodically carry out audits to make sure that the manufacturer(s) and, if involved the adjudicating entity maintain and apply the quality system and must provide an audit report to them.

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, assembling or installation) for the subsystem being the subject of the EC verification procedure mentioned under point 6.

4.5.

Additionally the notified body(ies) may pay unexpected visits to the sites mentioned under point 4.2. 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 system where necessary. It must provide the applicant(s) with an inspection report and also, if an audit has been carried out, with an audit report, and, if a test has been carried out with a test report.

The manufacturer(s) and, if involved the adjudicating entity must, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:

the documentation referred to in the second indent of the second subparagraph of point 3.1,
the updating referred to in the second subparagraph of point 3.4,
the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, points 4.4 and 4.5.

EC verification procedure

6.1.

The adjudicating entity or its authorised representative established within the Community must lodge an application for EC verification of the subsystem (through production quality assurance), including coordination of the surveillance of the quality systems as under point 6.5., with a notified body of its choice. The adjudicating entity or his authorised representative within the Community must inform the manufacturers involved of this choice and of the application.

6.2.

The application must enable the design, manufacture, assembling, installation and operation of the subsystem to be understood, and shall enable conformity with the requirements of Directive 96/48/EC and of the TSI to be assessed.

It 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,

and, if not included in this documentation,
- the technical design specifications, including European specifications, that have been applied,
- the necessary supporting evidence for their adequacy, in particular where the European specifications referred to in Article 10 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.
F1. . . . .
the technical documentation as regards the manufacturing and the assembling of the subsystem,
a list of the interoperability constituents, to be incorporated into the subsystem,
a list of all manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,
the demonstration, that all stages, as mentioned under point 3.2, are covered by quality systems of the manufacturers and/or of the adjudicating entity involved and the evidence of their effectiveness,
indication of the notified body(ies), responsible for the approval and surveillance of these quality systems.

6.3.

The notified body must examine the application concerning the validity of the typeexamination and the typeexamination certificate.

6.4.

The notified body must then examine if the approval and surveillance of the quality system(s) of the applicant(s) as mentioned in the last subparagraph of point 3.2 sufficiently and properly cover all stages of the subsystem.

If the conformity of the subsystem with the type as described in the EC type-examination certificate and the compliance of the subsystem with the requirements of Directive 96/48/EC and the TSI is based on more than one quality system, it has to examine in particular,

if the relations and interfaces between the quality systems are clearly documented,
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.

6.5.

The notified body responsible for the EC verification, if not carrying out the surveillance of the quality system(s) concerned as under point 4, must coordinate the surveillance activities of any other notified body responsible for that task, in order to be ensured that correct management of interfaces between the different quality systems in view of subsystem integration has been performed. This coordination includes the right of the notified body responsible for the EC verification,

to receive all documentation (approval and surveillance), issued by the other notified body(ies),
to witness the surveillance audits as under point 4.4,
to initiate additional audits as under point 4.5 under its responsibility and together with the other notified body(ies).

6.6.

Where the subsystem meets the requirements of the TSI, the notified body must then, based on the type-examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

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 to Directive 96/48/EC.

6.7.

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 Directive 96/48/EC, Article 18(3), and in particular as follows:

all necessary documents relating to the characteristics of the subsystem,
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 system approval and surveillance documents) issued by the notified bodies on the basis of the TSI,
all elements relating to the conditions and limits for use,
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,
certificate of EC verification of the notified body as mentioned under point 6.5, 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 under points 4.4 and 4.5F2. and in particular:
. . . . .

The complete records accompanying the certificate of EC verification must be lodged with the adjudicating entity or its authorised representative in support of the certificate of EC verification issued by the notified body and must be attached to the EC declaration of verification drawn up by the adjudicating entity intended for the supervisory authority.

The adjudicating entity or its authorised representative within the Community must keep a copy of the records throughout the service life of the subsystem; it must be sent to any other Member State who so requests.

MODULE SF (PRODUCT VERIFICATION)

EC verification of a rolling stock subsystem

This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an adjudicating entity or its authorised representative established within the Community, that a rolling stock subsystem, for which an EC type-examination certificate has already been issued by a notified body,

complies with this TSI and any other applicable TSI, which demonstrates that the essential requirements of Directive 96/48/EC have been met,
complies with the other regulations deriving from the Treaty and may be put into service.

The adjudicating entity or its authorised representative established within the Community must lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice.

The application includes:

name and address of the adjudicating entity or its authorised representative,
the technical documentation.

Within that part of the procedure the adjudicating entity or his authorised representative established within the Community checks and attests that the subsystem concerned is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of Directive 96/48/EC and of the TSI that apply to them.

The adjudicating entity must take all measures necessary in order that the manufacturing process (including assembling and integration of interoperability constituents) ensures conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements that apply to them.

The technical documentation must enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity with the type as described in the type-examination certificate and the requirements of the Directive and the TSI to be assessed.

It must include:

the type-examination certificate and its accompanying documents and additions, and, as far as not included in the documents accompanying the EC type-examination certificate,
a general description of the subsystem, overall design and structure,
. . . . .
conceptual design and manufacturing drawings and schemes of subassemblies, circuits, etc.,
technical documentation as regards the manufacturing and the assembling of the subsystem,
the technical design specifications, including European specifications, that have been applied,
the necessary supporting evidence for their adequacy, in particular where European specifications have not been applied in full,
a list of the interoperability constituents to be incorporated into the subsystem,
a list of manufacturers involved in the subsystem's design, manufacturing, assembling and installation,
a list of the European specifications. If the TSI requires further information for the technical documentation, this has to be included.

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 EC type-examination certificate and with the requirements of the TSI by examination and testing of every subsystem, manufactured as a serial product, as specified under point 4.

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

7.1.

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

structure of subsystem, including constituent assembly and overall adjustments,
final testing of the subsystem,
and, whenever specified in the TSI, the validation under full operational conditions.

7.2.

All subsystems (as serial products) must be individually examined and appropriate tests and verifications as set out in the TSI and in the relevant European specifications (or equivalent tests) shall be carried out in order to verify their conformity with the type as described in the type-examination certificate and the requirements of the TSI that apply to them.

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

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

10.

Where the subsystem meets the requirements of the Directive 96/48/EC and of the TSI, the notified body must then, based on the tests, verifications and checking carried out on all serial products as indicated in point 7 and required in the TSI and in the European specifications referred to in Article 10, draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority inthe Member State where the subsystem is located and/or operates. 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 to Directive 96/48/EC.

11.

all necessary documents relating to the characteristics of the subsystem,
. . . . .
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 system approval and surveillance documents) issued by the notified bodies on the basis of the TSI,
all elements relating to conditions and limits of use,
all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,
EC type-examination certificate and accompanying technical documentation,
certificate of EC verification of the notified body as mentioned under point 10, 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.

12.

The complete records accompanying the certificate of EC verification must be lodged with the adjudicating entity, or its authorised representative, in support of the certificate of EC verification issued by the notified body and must be attached to the EC declaration of verification drawn up by the adjudicating entity intended for the supervisory authority.

13.

MODULE SH2 (FULL QUALITY ASSURANCE WITH DESIGN EXAMINATION)

EC verification of rolling stock subsystem

complies with this TSI and any other applicable TSI, which demonstrates that the essential requirements of Directive 96/48/EC have been met,
complies with the other regulations deriving from the Treaty and may be put into service.

The notified body carries out the procedure, including a design examination of the subsystem under the condition, that the adjudicating entity and the manufacturers involved satisfies the obligations of point 2.

For the subsystem, subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (design, manufacturing, assembling, installation) are subject to an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and which shall be subject to surveillance as specified in point 4.

The term ‘manufacturer’ also includes companies:

responsible for the whole subsystem project (including in particular responsibility for subsystem integration (main contractor),
performing design services or studies (e.g. consultants),
performing assembling (assemblers) and installation of the subsystem. For manufacturers, performing only assembling and installation, a quality system for manufacture and final product inspection and testing is sufficient.

The main contractor responsible for the whole subsystem project (including in particular responsibility for subsystem integration), must operate in any case an approved quality system for design, manufacture and final product inspection and testing, as specified in point 3 and which shall be subject to surveillance as specified in point 4.

Where the adjudicating entity is directly involved in the design and/or production (including assembling and installation), or that the adjudicating entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), it has to operate an approved quality system for those activities, as specified in point 3 and subject to surveillance as specified in point 4.

Quality system

3.1.

The manufacturer(s) involved and, if involved, the adjudicating entity must lodge an application for assessment of their quality system with a notified body of their choice.

The application must include:

all relevant information for the subsystem envisaged,
the quality system's documentation.

For manufacturers, only involved in a part of the subsystem project, the information is only requested for that specific relevant part.

3.2.

For the main contractor the quality system must ensure overall compliance of the subsystem with the requirements of the Directive 96/48/EC and of the TSI. For other manufacturers (subsuppliers) the quality system has to ensure compliance of their relevant contribution to the subsystem with the requirements of the TSI.

It 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 assurance techniques, processes and systematic actions that will be used,
the examinations, the checking and tests that will be carried out before, during and after manufacture, assembling 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 contractor and for the subsuppliers (only as far as relevant for their specific contribution to the subsystem project):

the technical design specifications, including European specifications, that will be applied and, where the European specifications referred to in the TSI 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 system,

and for the main contractor:

responsibilities and powers of the management with regard to overall design and 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 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.

3.3.

For applicants, which are only involved in assembling and installation, the harmonised standard shall be EN 29002, completed if necessary to take into consideration the specificity of the subsystem for which it is implemented.

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

3.4.

The manufacturer(s) and, if involved the adjudicating entity must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

They must keep the notified body that has approved their quality system informed of any intended updating of the quality system.

It 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 system(s) under the responsibility of the notified body(ies)

4.1.

The purpose of surveillance is to make sure that the manufacturer(s) and if involved the adjudicating entity duly fulfil the obligations arising out of the approved quality system.

4.2.

The notified body(ies) as referred to under point 3.1 must have permanent access for inspection purposes to the locations of design, building sites, production workshops, locations of assembling 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.

4.3.

The manufacturer(s) and, if involved the adjudicating entity or its authorised representative established within the Community must send the notified body referred to under point 3.1 (or have sent it) 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), in particular:

the quality system documentation, including the particular means implemented to ensure that:
- (for the main contractor) overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,
- the quality systems of each manufacturer are correctly managed for achieving integration at subsystem level,
the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
the quality records as foreseen by the manufacturing part (including assembling and installation) of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.4.

The frequency of the audits shall be at least once a year, with at least one audit during the period of performing relevant activities (design, manufacture, assembling or installation) for the subsystem being the subject of the EC verification procedure mentioned under point 6.

4.5.

Additionally the notified body(ies) may pay unscheduled visits to the sites mentioned under point 4.2 of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits. in order to check the proper functioning of the quality system where necessary; it must provide the applicant(s) with an inspection report and, if an audit has been carried out, with an audit report.

The manufacturer(s) and, if involved the adjudicating entity must, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:

the documentation referred to in the second indent of the second subparagraph of point 3.1,
the updating referred to in the second subparagraph of point 3.4,
the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, points 4.4 and 4.5.

EC verification procedure

6.1.

The adjudicating entity or its authorised representative established within the Community must lodge an application for EC verification of the subsystem (through full quality assurance with design examination), including coordination of surveillance of the quality systems as under points 4.4 and 4.5, with a notified body of its choice. The adjudicating entity or its authorised representative established within the Community must inform the manufacturers involved of his choice and of the application.

6.2.

The application must enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity with the requirements of the TSI to be assessed.

It must include:

the technical design specifications, including European specifications, that have been applied,
the necessary supporting evidence for their adequacy, in particular where the European specifications referred to in the TSI 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 rolling stock, including all indications as specified in the TSI,
the technical documentation as regards the manufacturing and the assembling of the subsystem,
a list of the interoperability constituents, to be incorporated into the subsystem,
a list of all manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,
the demonstration, that all stages, as mentioned under point 3.2, are covered by quality systems of the manufacturer(s) and/or of the adjudicating entity involved, and the evidence of their effectiveness,
indication of the notified body(ies), responsible for the approval and surveillance of these quality systems.

6.3.

The notified body must examine the application concerning the design examination and where the design meets the provisions of Directive 96/48/EC and of the TSI that apply to it must issue a design examination report to the applicant. The report 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.

6.4.

The notified body must, concerning the other stages of the EC verification examine, if all stages of the subsystem as mentioned under point 3.2 are sufficiently and properly covered by the approval and surveillance of quality system(s).

If the compliance of the subsystem with the requirements of the TSI is based on more than one quality system, it has to examine in particular,

if the relations and interfaces between the quality 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.

6.5.

to receive all documentation (approval and surveillance), issued by the other notified body(ies),
to witness the surveillance audits as under point 4.4,
to initiate additional audits as under point 4.5 under its responsibility and together with the other notified body(ies).

6.6.

Where the subsystem meets the requirements of the TSI, the notified body must then, based on the design examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

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 to Directive 96/48/EC.

6.7.

The notified body shall be responsible for compiling the technical file to accompany the EC declaration of verification. The technical file has to include at least the information indicated in Directive 96/48/EC, Article 18(3), and in particular:

all necessary documents relating to the characteristics of the subsystem,
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 system approval and surveillance documents) issued by the notified bodies on the basis of the TSI,
all elements relating to the conditions and limits for use,
all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance
certificate of EC verification of the notified body as mentioned under point 6.6, 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 under points 4.4 and 4.5F3.
. . . . .

Annotations

Textual amendments

F1: Deleted by Commission Decision of 23 July 2012 amending Decisions 2002/731/EC, 2002/732/EC, 2002/733/EC, 2002/735/EC and 2006/66/EC and repealing Decision 2002/730/EC concerning technical specifications for interoperability (notified under document C(2012) 4982) (Text with EEA relevance) (2012/462/EU).
F2: Inserted by Commission Decision of 23 July 2012 amending Decisions 2002/731/EC, 2002/732/EC, 2002/733/EC, 2002/735/EC and 2006/66/EC and repealing Decision 2002/730/EC concerning technical specifications for interoperability (notified under document C(2012) 4982) (Text with EEA relevance) (2012/462/EU).
F3: Substituted by Commission Decision of 23 July 2012 amending Decisions 2002/731/EC, 2002/732/EC, 2002/733/EC, 2002/735/EC and 2006/66/EC and repealing Decision 2002/730/EC concerning technical specifications for interoperability (notified under document C(2012) 4982) (Text with EEA relevance) (2012/462/EU).