Commission Decision of 21 December 2007 concerning the technical specification of interoperability relating to ‘persons with reduced mobility’ in the trans-European conventional and high-speed rail system (notified under document C(2007) 6633) (Text with EEA relevance) (2008/164/EC) (repealed) (c. 164)

ANNEXES (TO THE TSI) Scope: Whole Subsystems Aspect: Accessibility for Persons with Reduced Mobility

ANNEX F Procedures for assessment of conformity and suitability for use

F.2. Modules for Interoperability Constituents

F.2.1. Module A: Internal production control

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out 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.

2. The manufacturer shall establish the technical documentation described in point 3.

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

• a general description of the interoperability constituent

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

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

• the technical specifications including European specifications(1) with relevant clauses, applied in full or in part,

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

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

• test reports.

4. The manufacturer shall take all the measures necessary in order that the manufacturing process ensures compliance of each manufactured interoperability constituent with the technical documentation referenced in point 3 and with the requirements of the TSI that apply to it.

5. The manufacturer or his authorised representative established within the Community shall draw up a written declaration of conformity for the interoperability constituent. The content of this declaration has to include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directives 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directives 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 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 empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.

6. The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.

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.

7. If additional 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.

F.2.2. Module A1: Internal Design Control with Production Verification

1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out 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.

2. The manufacturer shall establish the technical documentation described in point 3.

3. The technical documentation shall enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed.

The technical documentation shall also give evidence that the design of the interoperability constituent, already accepted before the implementation of the present TSI, is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use.

It shall, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent. So far as relevant for the assessment, the documentation shall contain:

• a general description of the interoperability constituent and its conditions of use,

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

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

• the technical specifications including European specifications(2) with relevant clauses, applied in full or in part,

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

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

• test reports,

4. The manufacturer shall take all the measures necessary in order that the manufacturing process ensures compliance of each manufactured interoperability constituent with the technical documentation referenced in point 3 and with the requirements of the TSI that apply to it.

5. The notified body, chosen by the manufacturer, shall carry out the appropriate examinations and tests in order to verify the conformity of the manufactured interoperability constituents with the type described in the technical documentation referenced in point 3 and with the requirement of the TSI. The manufacturer(3) can choose one of the following procedures:

5.1. Verification by examination and testing of every product

5.1.1. Each product shall be individually examined and appropriate tests shall be carried out in order to verify the product conformity with the type described in the technical documentation 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 applicable

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

5.2. Statistical verification

5.2.1. The manufacturer shall present his products 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.

5.2.2. All interoperability constituents shall 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 described in the technical documentation and 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 applicable

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

5.2.4. In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.

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

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

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directives 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 applicable 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 certificate to be referred to is the certificate of conformity as mentioned in point 5. The manufacturer or his authorised representative established within the Community shall ensure that he is able to supply the notified body's certificates of conformity on request

7. The manufacturer or his authorised representative shall keep a copy of the EC declaration of conformity with the technical documentation for a period of 10 years after the last interoperability constituent has been manufactured.

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.

8. If additional 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.

F.2.3. Module B: Type Examination

1. 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.

2. The application for the EC type-examination shall be lodged by the manufacturer or his authorised representative established within the Community.

The application shall 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 shall 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 shall agree that no specimens are placed at its disposal.

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

The technical documentation shall contain:

• a general type-description,

• conceptual design and manufacturing information, for example drawings, 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(4) with relevant clauses, applied in full or in part,

• description 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,

4. The notified body shall:

4.1. examine the technical documentation,

4.2. verify that any specimen(s) required for 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/or the relevant European specifications,

4.3. 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,

4.4. 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,

4.5. 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;

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 manufacturer has chosen to apply the relevant European specifications, these have actually been applied;

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 relevant European specifications have not been applied, the solutions adopted by the manufacturer meet the requirements of the TSI;

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

5. Where the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.

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

A list of the relevant parts of the technical documentation shall 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 shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

6. The applicant shall inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications to the approved product which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In such cases the interoperability constituent shall receive additional approval from the notified body that issued the EC type examination certificate. In this case, the notified body shall perform only those examinations and tests that are relevant and necessary to the changes. The additional approval shall 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.

7. 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.

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

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

10. The manufacturer or his authorised representative established within the Community shall 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.

F.2.4. Module C: Conformity to Type

1. This module describes that part of the procedure whereby the manufacturer or his authorised representative established within the Community 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.

2. The manufacturer shall take all measures necessary to ensure that the manufacturing process ensures compliance of each manufactured interoperability constituent with the type as described in the EC type examination certificate and with the requirements of the TSI that apply to it.

3. The manufacturer or his authorised representative established within the Community shall draw up an EC declaration of conformity for the interoperability constituent.

The content of this declaration has to include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directive 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 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 type examination conformity and date of the EC type examination certificate (and its additions) together with the duration and conditions of validity of the certificate,

• reference to the TSI and to any other applicable TSI, and where appropriate reference to European specifications(5),

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

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

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.

5. If additional to the EC declaration of conformity an EC declaration of 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.

F.2.5. Module D: Production Quality Management System

1. 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.

2. The manufacturer shall 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.

3. Quality management system

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

The application shall 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.

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

3.2. The quality management system shall ensure compliance of the interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plan, manuals and records.

It shall 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.

3.3. The notified body assesses the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.

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

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

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

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

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

4. Surveillance of the quality management 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 management system.

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

• the quality management system documentation,

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

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

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

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

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 management system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals, issued, withdrawn or refused.

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

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

• 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.

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

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directive 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 applicable TSI and where appropriate reference to European specification(6),

• 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,

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

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.

9. 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.

F.2.6. Module F: Product Verification

1. 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.

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

3. The notified body shall 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(7) 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.

4. Verification by examination and testing of every interoperability constituent

4.1. 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(8), or equivalent tests are applicable.

4.2. The notified body shall 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 shall ensure that he is able to supply the notified body's certificates of conformity on request.

5. Statistical verification

5.1. The manufacturer shall 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 shall 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 applicable.

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

5.4. In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.

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

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

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

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directive 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 applicable 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.

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

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.

8. 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.

F.2.7. Module H1: Full Quality Management System

1. 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 satisfies the requirements of the TSI that apply to it.

2. The manufacturer shall 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.

3. Quality management system

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

The application shall 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,

3.2. The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall 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(9), 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 as design review, review of manufacturing process and type tests, as they are specified in the TSI, for the different characteristics and performances of the interoperability constituent.

3.3. The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.

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

The audit shall be specific for the product category, which is representative for the interoperability constituent. The auditing team shall 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 shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

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

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

4. Surveillance of the quality management 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 management system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including particular:

• 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.

4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.

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. 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 shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

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

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

• the updating referenced 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.

6. Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused.

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

7. The manufacturer or its authorised representative established within the Community shall draw up the EC Declaration of conformity of the interoperability constituent.

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and the accompanying documents shall be dated and signed.

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

• the Directive references (Directive 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 its conditions of use,

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

• reference to the TSI and to any other applicable 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 certificate to be referred to is:

• the Quality management system approvals indicated in point 3.

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

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.

9. 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.

F.2.8. Module H2: Full Quality Management System With Design Examination

1. 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.

2. The manufacturer shall 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.

3. Quality management system

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

The application shall 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,

3.2. The quality management system shall ensure compliance of the interoperability constituent with the requirements of the TSI that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall 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(10), 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.

3.3. The notified body shall assess the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for design, production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which takes into consideration the specificity of the interoperability constituent for which it is implemented.

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

The audit shall be specific for the product category, which is representative for the interoperability constituent. The auditing team shall 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 shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

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

4. Surveillance of the quality management 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 management system.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including:

• 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.

4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer. When the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.

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. 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 shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

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

• 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.

6. Design examination

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

6.2. The application shall enable the design, manufacture, maintenance and operation of the interoperability constituent to be understood, and shall enable conformity with the requirements of the TSI to be assessed.

It shall 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,

6.3. The applicant shall present the results of tests(11), including type tests when required, carried out by its appropriate laboratory or on their behalf.

6.4. The notified body shall examine the application and assess the results of the tests. Where the design meets the provisions of the TSI that apply to it, the notified body shall issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the product's functioning.

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

6.5. The applicant shall keep the notified body that has issued the EC design examination certificate informed of all modifications to the approved design, which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the interoperability constituent. In such cases the interoperability constituent shall receive additional approval from the notified body that issued the EC design examination certificate. In this case, the notified body shall perform only those examinations and tests that are relevant and necessary to the changes. The additional approval shall be given in the form of an addition to the original EC design examination certificate.

6.6. 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.

7. Each notified body shall communicate to the other notified bodies the relevant information concerning the quality management system approvals and the EC design examination certificates, which it has issued, withdrawn or refused.

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.

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

The content of this declaration shall include at least the information indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of conformity and its accompanying documents shall be dated and signed.

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

• the Directive references (Directive 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 applicable 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.

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

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.

10. 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.

F.2.9. Module V: Type-Validation By In Service Experience (Suitability For Use)

1. 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 the TSI that apply to it for suitability for use, by type validation as demonstrated through in service experience(12).

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

The application shall 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 programme for validation by in service experience, as described in point 4,

• the name and address of the company(ies) (infrastructure managers and/or railway enterprises), 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 shall place at the disposal of the company(ies), 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.

3. The technical documentation shall enable the assessment of the product with the requirements of the TSI. The documentation shall cover the operation of the interoperability constituent, and, as far as relevant for such assessment, cover also the design, manufacture and maintenance.

The technical documentation shall contain

• a general type-description,

• the technical specification, 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),

• 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),

• descriptions and explanations necessary for the understanding of the design, manufacture and 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 requires further information for the technical documentation, this shall be included.

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

4. The programme for the validation by in service experience shall 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).

5. The notified body shall:

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 the programme and the location where the inspections and necessary tests will be carried out and 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 (ies) (infrastructure managers and/or railway enterprises) 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 the TSI.

6. Where the type meets the provisions of the TSI, the notified body shall issue a suitability for use certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the validation, conditions for its validity and the necessary data for identification of the approved type.

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

A list of the relevant parts of the technical documentation shall 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 shall provide detailed reasons for such denial.

Provision shall be made for an appeals procedure.

7. The applicant shall inform the notified body that holds the technical documentation concerning the suitability for use certificate of all modifications to the approved product which shall receive additional approval where such changes may affect the suitability for use 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 changes. The additional approval shall be given in the form of an addition to the original suitability for use certificate, or by issue of a new certificate issued after withdrawal of the old certificate.

8. If no modifications as in 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.

9. Each notified body shall communicate to the other notified bodies the relevant information concerning the suitability for use certificates issued, withdrawn or refused.

10. The other notified bodies shall be provided on request with copies of the suitability for use certificates issued and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.

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

The content of this declaration shall include at least the information, indicated in Annex IV (3) and in Article 13 -3 of Directive 01/16/EC. The EC declaration of suitability for use and the accompanying documents shall be dated and signed.

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

• the Directive references (Directive 01/16/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 an 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 any 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 specification,

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

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

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.

(1)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(2)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(3)

When necessary, the manufacturer's discretion may be limited for specific constituents. In this case, the relevant verification process required for the interoperability constituent is specified in the TSI (or in its annexes).

(4)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(5)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(6)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(7)

The manufacturer's discretion may be limited in specific TSIs.

(8)

The definition of an European specification is indicated in the directives 96/48/EEC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(9)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(10)

The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC. The guide for application of HS TSIs explains the way to use the European Specifications.

(11)

The presentation of the results of the tests can be at the same time as the application or later.

(12)

During the time of in service experience, the IC is not placed on the market.