{
  "url": "https://openlegislation.uk/eu-decision-2006-860/annex/annex-E",
  "json_url": "https://openlegislation.uk/eu-decision-2006-860/annex/annex-E.json",
  "legislation": "eudn/2006/860",
  "legislation_title": "Commission Decision of 7 November 2006 concerning a technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European high speed rail system and modifying Annex A to Decision 2006/679/EC concerning the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system (notified under document number C(2006) 5211) (Text with EEA relevance) (2006/860/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2006-860",
  "path": "annex/annex/E",
  "kind": "appendix",
  "number": "ANNEX E",
  "heading": null,
  "text": "MODULES FOR INTEROPERABILITY CONSTITUENTS\nModule B: Type Examination\n1.\nThis 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.\n2.\nThe application for the EC type-examination must be lodged by the manufacturer or his authorised representative established within the Community.\nThe application must include:\nthe name and address of the manufacturer and also, if the application is lodged by the authorised representative, his name and address,\na written declaration that the same application has not been lodged with any other notified body,\nthe technical documentation, as described in point 3.\nThe applicant must place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called ‘type’.\nA type may cover several versions of the Interoperability Constituent provided that the differences between the versions do not affect the provisions of the TSI.\nThe notified body may request further specimens if needed for carrying out the test programme.\nIf no type tests are requested within the type examination procedure, and the type is sufficiently defined by the technical documentation, as described in point 3, the notified body may agree, that no specimens are placed at its disposal.\n3.\nThe technical documentation must enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent.\nThe technical documentation must contain:\na general type-description,\nconceptual design and manufacturing information, for example drawings and schemes of components, sub-assemblies, circuits, etc.,\ndescriptions and explanations necessary for the understanding of the design and manufacturing information, maintenance and the operation of the interoperability constituent,\nconditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,\nconditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),\nthe technical specifications, including European specifications with relevant clauses, applied in full or in part,\ndescriptions of the solutions adopted to meet the requirements of the TSI in cases where the European specifications have not been applied in full,\nresults of design calculations made, examinations carried out, etc.,\ntest reports.\n4.\nThe notified body must:\n4.1.\nexamine the technical documentation,\n4.2.\nverify that any specimen(s) required for test has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and/or the relevant European specifications,\n4.3.\nwhere 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,\n4.4.\nwhere 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,\n4.5.\nidentify 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;\n4.6.\nperform 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;\n4.7.\nperform 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;\n4.8.\nagree with the applicant the location where the examinations and necessary tests will be carried out.\n5.\nWhere the type meets the provisions 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 manufacturer, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.\nThe time period of validity shall be no longer than 5 years.\nA list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.\nIf the manufacturer or his authorised representative established within the Community is denied a type-examination certificate, the notified body must provide detailed reasons for such denial.\nProvision must be made for an appeals procedure.\n6.\nThe applicant must inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications to the approved product which must receive additional approval where such changes may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In this case the notified body shall perform only those examinations and tests that are relevant and necessary to the change(s).This additional approval may be given either in the form of an addition to the original type-examination certificate, or, by the issue of a new certificate after withdrawal of the old one.\n7.\nIf 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.\n8.\nEach notified body must communicate to the other notified bodies the relevant information concerning the type-examination certificates and additions issued, withdrawn or refused.\n9.\nThe other notified bodies may receive, on request, copies of the type-examination certificates issued and/or their additions. The annexes to the certificates (see § 5) must be kept at the disposal of the other notified bodies.\n10.\nThe manufacturer or his authorised representative established within the Community must keep with the technical documentation copies of type-examination certificates and their additions for a period of 10 years after the last interoperability constituent has been manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the interoperability constituent on the Community market.\nModule D: Production Quality Management System\n1.\nThis 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.\n2.\nThe manufacturer must operate an approved quality management system for production, final product inspection and testing as specified in point 3 and is subject to monitoring as specified in point. 4.\n3.\nQuality management system\n3.1.\nThe manufacturer must lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.\nThe application must include:\nall relevant information for the product category representative for the interoperability constituents envisaged,\nthe documentation concerning the quality management system,\nthe technical documentation of the approved type and a copy of the type-examination certificate, issued after the completion of the type examination procedure of Module B (type examination).\na written declaration that the same application has not been lodged with any other notified body,\n3.2.\nThe quality management system must 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 must permit a consistent interpretation of the quality programmes, plan, manuals and records.\nIt must contain in particular an adequate description of:\nthe quality objectives and the organisational structure,\nresponsibilities and powers of the management with regard to product quality,\nthe manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,\nthe examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,\nthe quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,\nthe means to monitor the achievement of the required product quality and the effective operation of the quality management system.\n3.3\nThe 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.\nWhen the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.\nThe 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.\nThe decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.\n3.4.\nThe manufacturer must 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.\nThe 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.\nThe notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.\nIt must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.\n4.\nSurveillance of the quality management system under the responsibility of the notified body.\n4.1.\nThe purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.\n4.2.\nThe 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:\nthe quality management system documentation,\nthe quality records such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.\n4.3.\nThe notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality management system and must provide an audit report to the manufacturer.\nThe frequency of the audits shall be at least once a year.\nWhen the manufacturer operates a certified quality management system, the notified body shall take this into account in the surveillance.\n4.4.\nAdditionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality management system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.\n5.\nEach notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals, issued, withdrawn or refused.\nThe other notified bodies may receive on request copies of the quality management system approvals issued.\n6.\nThe manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:\nthe documentation referenced to in the second indent of point 3.1,\nthe updating referenced to in the second paragraph of point 3.4,\nthe decisions and reports from the notified body in the final paragraph of points 3.4, 4.3 and 4.4.\n7.\nThe 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 shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed.\nThe declaration must be written in the same language as the technical documentation and must contain the following:\nthe Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),\nthe 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),\ndescription of the interoperability constituent (make, type, etc)\ndescription of the procedure (module) followed in order to declare conformity,\nall of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,\nname 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,\nreference to the TSI and any other relevant TSI and where appropriate reference to European specification,\nidentification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.\nThe certificates to be referred to are:\nthe quality management system approval indicated in point 3,\nthe type-examination certificate and its additions,\n8.\nThe 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.\nWhere 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.\n9.\nIf 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.\nModule F: Product Verification\n1.\nThis 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.\n2.\nThe manufacturer must take all measures necessary in order that the manufacturing process ensures conformity of each interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.\n3.\nThe notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the EC type examination certificate and with the requirements of the TSI. The manufacturer 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.\n4.\nVerification by examination and testing of every interoperability constituent\n4.1.\nEach 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, or equivalent tests are to be used.\n4.2.\nThe notified body must draw up a written certificate of conformity for the approved products relating to the tests carried out.\n4.3.\nThe manufacturer or his authorised representative must ensure that he is able to supply the notified body's certificates of conformity on request.\n5.\nStatistical verification\n5.1.\nThe 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.\n5.2.\nAll interoperability constituents must be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Each interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type as described in the type-examination certificate and with the requirements of the TSI which apply to it and to determine whether the lot is accepted or rejected. When a test is not set out in the TSI (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are to be used.\n5.3.\nThe statistical procedure must use appropriate elements (statistical method, sampling plan etc), depending on the characteristics to be assessed, as specified in the TSI.\n5.4.\nIn 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.\nIf a lot is rejected, the notified body or the competent authority must take appropriate measures to prevent placing of that lot on the market. In the event of frequent rejection of lots the notified body may suspend the statistical verification.\n5.5.\nThe 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.\n6.\nThe manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.\nThe content of this declaration shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed.\nThe declaration must be written in the same language as the technical documentation and must contain the following:\nthe Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),\nthe 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),\ndescription of interoperability constituent (make, type, etc)\ndescription of the procedure (module) followed in order to declare conformity,\nall of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,\nname 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,\nreference to the TSI and any other relevant TSI and where appropriate reference to European specifications,\nidentification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.\nThe certificates to be referred to are:\nthe type-examination certificate and its additions,\nthe certificate of conformity as mentioned in points 4 or 5.\n7.\nThe 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.\nWhere 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.\n8.\nIf 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.\nModule H2: Full Quality Management System With Design Examination\n1.\nThis 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.\n2.\nThe manufacturer must operate an approved quality management system for design, production and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point. 4.\n3.\nQuality management system.\n3.1.\nThe manufacturer must lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.\nThe application must include:\nall relevant information for the product category representative for the interoperability constituent envisaged,\nthe quality management system's documentation.\na written declaration that the same application has not been lodged with any other notified body,\n3.2.\nThe quality management system must 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 must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.\nIt must contain in particular an adequate description of:\nthe quality objectives and the organisational structure,\nresponsibilities and powers of the management with regard to design and product quality,\nthe technical design specifications, including European specifications, 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,\nthe 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,\nthe corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,\nthe examinations, checks and tests that will be carried out before, during and after manufacture, and the frequency with which they will be undertaken,\nthe quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,\nthe means to monitor the achievement of the required design and product quality and the effective operation of the quality management system.\nThe 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.\n3.3.\nThe notified body must 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.\nWhen the manufacturer operates a certified quality management system, the notified body shall take this into account in the assessment.\nThe 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.\nThe decision must be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.\n3.4.\nThe manufacturer must 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.\nThe 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.\nThe notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 3.2 or whether a re-assessment is required.\nIt must notify its decision to the manufacturer. The notification shall contain the conclusions of the evaluation and the reasoned assessment decision.\n4.\nSurveillance of the quality management system under the responsibility of the notified body\n4.1.\nThe purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.\n4.2.\nThe 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, including:\nthe quality management system documentation,\nthe quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,\nthe 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.\n4.3.\nThe notified body must 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.\nThe frequency of the audits shall be at least once a year.\n4.4.\nAdditionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality management system where necessary. It must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.\n5.\nThe manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:\nthe documentation referenced in the second indent of the second subparagraph of point 3.1,\nthe updating referenced to in the second subparagraph of point 3.4,\nthe decisions and reports from the notified body in the final subparagraph of points 3.4, 4.3 and 4.4.\n6.\nDesign examination\n6.1.\nThe manufacturer must lodge an application for examination of the design of the interoperability constituent with a notified body of his choice\n6.2.\nThe application must 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.\nIt must include:\na general type-description,\nthe technical design specifications, including European specifications, with relevant clauses, that have been applied in full or in part,\nany necessary supporting evidence for their adequacy, in particular where the European specifications and the relevant clauses have not been applied.\nthe test programme\nconditions for integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,\nconditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc),\na written declaration that the same application has not been lodged with any other notified body.\n6.3.\nThe applicant shall present the results of tests, including type tests when required, carried out by its appropriate laboratory or on their behalf.\n6.4.\nThe notified body must examine the application and assess the results of the tests. Where the design meets the provisions of the TSI that apply to it, the notified body must issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the product's functioning. The time period of validity shall be no longer than 5 years.\n6.5.\nThe applicant must keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design examination certificate where such changes may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the product. In this case the notified body shall perform only those examinations and tests that are relevant and necessary to the change(s). This additional approval shall be given in the form of an addition to the original EC design examination certificate.\n6.6.\nIf 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.\n7.\nEach notified body must 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.\nThe other notified bodies may receive on request copies of:\nthe quality management system approvals and additional approvals issued and\nthe EC design examination certificates and additions issued\n8.\nThe manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.\nThe content of this declaration shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and its accompanying documents must be dated and signed.\nThe declaration must be written in the same language as the technical documentation and must contain the following:\nthe Directive references (Directives 96/48/EC or 01/16/EC and other directives to which the interoperability constituent may be subject),\nthe 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),\ndescription of interoperability constituent (make, type, etc)\ndescription of the procedure (module) followed in order to declare conformity,\nall of the relevant descriptions met by the interoperability constituent and in particular any conditions of use,\nname 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,\nreference to the TSI and any other relevant TSI and where appropriate to European specifications,\nidentification of the signatory empowered to enter into commitments on behalf of the manufacturer or of his authorised representative established within the Community.\nThe certificates to be referred to are:\nthe quality management system approval and surveillance reports indicated in point 3 and 4,\nthe EC design examination certificate and its additions.\n9.\nThe 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.\nWhere 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.\n10.\nIf 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.\nMODULES FOR THE EC VERIFICATION OF SUBSYSTEMS\nModule SB: Type Examination\n1.\nThis module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a type of a Control-Command Subsystem, representative of the production envisaged,\ncomplies with this TSI and any other relevant TSI, which demonstrate that the essential requirements of Directive 01/16/EC have been met\ncomplies with the other regulations deriving from the Treaty.\nThe type examination defined by this module could include specific assessment phases — design review, type test or review of manufacturing process, which are specified in the relevant TSI.\n2.\nThe contracting entity must lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice.\nThe application must include:\nname and address of the contracting entity or its authorised representative\nthe technical documentation, as described in point 3.\n3.\nThe applicant must place at the disposal of the notified body a specimen of the subsystem, representative of the production envisaged and hereinafter called ‘type’.\nA type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the TSI.\nThe notified body may request further specimens if needed for carrying out the test programme. If so required for specific test or examination methods and specified in the TSI or in the European specification referenced to in the TSI, a specimen or specimens of a subassembly or assembly or a specimen of the subsystem in a pre-assembled condition shall to be provided.\nThe technical documentation and specimen(s) must enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the provisions of the TSI to be assessed.\nThe technical documentation must include:\na general description of the subsystem, overall design and structure,\nThe European register of authorised types of vehicle, including all information as specified in the TSI,\nconceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,\ndescriptions and explanations necessary for the understanding of the design and manufacturing information, the maintenance and the operation of the subsystem,\nthe technical specifications, including European specifications, that have been applied,\nany necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,\na list of the interoperability constituents to be incorporated into the subsystem,\ncopies of the EC declarations of conformity or suitability for use of interoperability constituents and all the necessary elements defined in annex VI of the directives,\nevidence of conformity with regulations deriving from the treaty (including certificates)\ntechnical documentation regarding the manufacture and the assembly of the subsystem,\na list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,\nconditions for use of the subsystem (restrictions of running time or distance, wear limits etc),\nconditions for maintenance and technical documentation regarding the maintenance of the subsystem\nany technical requirement that must be taken into account during production, maintenance or operation of the subsystem\nresults of design calculations made, examinations carried out, etc.,\ntest reports.\nIf the TSI requires further information for the technical documentation, this shall be included.\n4.\nThe notified body must:\n4.1.\nExamine the technical documentation.\n4.2.\nVerify that the specimen(s) of the subsystem or of assemblies or subassemblies of the subsystem, has (have) been manufactured in conformity with the technical documentation, and carry out or have carried out the type tests in accordance with the provisions of the TSI and the appropriate European specifications. Such manufacture shall be verified using an appropriate assessment module.\n4.3.\nWhere a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at the completion of the design process\n4.4.\nIdentify 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;\n4.5.\nPerform or have performed the appropriate examinations and necessary tests in accordance with points 4.2. and 4.3 to establish where the relevant European specifications have been chosen, these have actually been applied;\n4.6.\nPerform or have performed the appropriate examinations and necessary tests in accordance with point 4.2. and 4.3. to establish whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied.\n4.7.\nAgree with the applicant the location where the examinations and necessary tests will be carried out.\n5.\nWhere the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the contracting entity and the manufacturer(s) indicated in the technical documentation, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.\nA list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.\nIf the contracting entity is denied a type-examination certificate, the notified body must provide detailed reasons for such denial.\nProvision must be made for an appeals procedure.\n6.\nEach notified body must communicate to the other notified bodies the relevant information concerning the type-examination certificates issued, withdrawn or refused.\n7.\nThe other notified bodies may receive on request copies of the type-examination certificates issued and/or their additions. The annexes to the certificates must be kept at the disposal of the other notified bodies.\n8.\nThe contracting entity must keep with the technical documentation copies of type-examination certificates and any additions throughout the service life of the subsystem. It must be sent to any other Member State which so requests.\n9.\nThe applicant must inform the notified body that holds the technical documentation concerning the type-examination certificate of all modifications which may affect the conformity with the requirements of the TSI or the prescribed conditions for use of the subsystem. The subsystem must receive additional approval in such cases. This additional approval may be given either in the form of an addition to the original type-examination certificate, or by issue of a new certificate after withdrawal of the old certificate.\nModule SD: Production Quality Management System\n1.\nThis module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that a Control-Command Subsystem, for which already a type-examination certificate has been issued by a notified body,\ncomplies with this TSI and any other relevant TSI, which demonstrate that the essential requirements of Directive 01/16/EC have been met\ncomplies with the other regulations deriving from the Treaty,\nand may be placed in service.\n2.\nThe notified body carries out the procedure, under the condition, that:\nthe type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application,\nthe contracting entity and the main contractors involved are satisfying the obligations of point 3.\nThe ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns:\nthe company responsible for the whole subsystem project (including in particular responsibility for subsystem integration),\nother companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem).\nIt does not refer to manufacturer sub contractors supplying components and interoperability constituents.\n3.\nFor the subsystem that is subject of the EC verification procedure, the contracting entity, or the main contractors when employed, shall operate an approved quality management system for manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6.\nWhen the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), or the contracting entity is directly involved in the production (including assembly and installation), it has to operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.\nIf a main contractor is responsible for the whole subsystem project (including in particular responsibility for subsystem integration), it must operate in any case an approved quality management system for manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.\n4.\nEC verification procedure\n4.1\nThe contracting entity must lodge an application for EC verification of the subsystem (through production quality management system), including co-ordination of the surveillance of the quality management systems, as under point 5.3 and 6.5. with a notified body of its choice. The contracting entity must inform the manufacturers involved of this choice and of the application.\n4.2\nThe application must enable the design, manufacture, assembly, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the type as described in the type-examination certificate and the requirements of the TSI to be assessed.\nThe application must include:\nname and address of the contracting entity or its authorised representative\nthe technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in Module SB (type-examination),\nand, if not included in this documentation,\na general description of the subsystem, its overall design and structure,\nthe technical specifications, including European specifications, that have been applied,\nany necessary supporting evidence for the use of the above specifications, in particular where these European specifications, and the relevant clauses have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf.\nthe Register of Infrastructure, including all information as specified in the TSI,\nthe technical documentation regarding the manufacture and the assembly of the subsystem,\nevidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase\na list of the interoperability constituents to be incorporated into the subsystem,\ncopies of the EC declarations of conformity or suitability for use with which the constituents must be provided, and all the necessary elements defined in annex VI of the directives,\na list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,\nthe demonstration, that all stages, as mentioned under point 5.2, are covered by quality management systems of the contracting entity, if involved, and/or of the main contractors, and the evidence of their effectiveness,\nindication of the notified body, responsible for the approval and surveillance of these quality management systems.\n4.3\nThe notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate.\nIf the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.\n5\nQuality management system\n5.1\nThe contracting entity, if involved, and the main contractors, when employed, must lodge an application for assessment of their quality management systems with a notified body of their choice.\nThe application must include:\nall relevant information for the subsystem envisaged,\nthe quality management system documentation.\nthe technical documentation of the approved type and a copy of the type examination certificate, issued after the completion of the type examination procedure of Module SB (type-examination).\nFor those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.\n5.2\nFor the contracting entity or the main contractor responsible for the whole subsystem project, the quality management systems shall ensure overall compliance of the subsystem with the type as described in the type-examination certificate and overall compliance of the subsystem with the requirements of the TSI. For other main contractor, their quality management system(s) has (have) to ensure compliance of their relevant contribution to the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI.\nAll the elements, requirements and provisions adopted by the applicant(s) must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.\nIt must contain in particular an adequate description of the following items for all applicant(s):\nthe quality objectives and the organisational structure,\nthe corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,\nthe examinations, checks and tests that will be carried out before, during and after manufacture, assembly and installation, and the frequency with which they will be carried out,\nthe quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,\nand also for the contracting entity or the main contractor responsible for the whole subsystem project:\nresponsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.\nThe examinations, tests and checking shall cover all of the following stages:\nstructure of subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,\nfinal testing of the subsystem,\nand, where specified in the TSI, the validation under full operation conditions.\n5.3\nThe notified body chosen by the contracting entity must examine, if all stages of the subsystem as mentioned under point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s).\nIf the conformity of the subsystem with the type as described in the type-examination certificate and the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,\nif the relations and interfaces between the quality management systems are clearly documented\nand if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractors are sufficiently and properly defined.\n5.4.\nThe notified body referenced to in point 5.1. must assess the quality management system to determine whether it satisfies the requirements referenced in point 5.2. It presumes compliance with these requirements if the manufacturer implements a quality system for production, final product inspection and testing in respect of the standard EN/ISO 9001 — 2000, which takes into consideration the specificity of the interoperability constituent which it is implemented.\nWhen an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.\nThe 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.\nThe evaluation procedure shall include an assessment visit to the applicant's premises.\nThe decision must be notified to the applicant. The notification must contain the conclusions of the examination and the reasoned assessment decision.\n5.5.\nThe contracting entity, if involved, and the main contractors 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.\nThey must keep the notified body that has approved the quality management system, informed of any significant change that will affect the fulfilment of the TSI requirements by the subsystem.\nThe notified body must evaluate the modifications proposed and decide whether the amended quality management system will still satisfy the requirements referenced in point 5.2 or whether a re-assessment is required.\nlt must notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.\n6.\nSurveillance of the quality management system(s) under the responsibility of the notified body\n6.1.\nThe purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractors, duly fulfil the obligations arising out of the approved quality management system.\n6.2.\nThe contracting entity, if involved, and the main contractors must send to the notified body referenced in point 5.1 (or have sent) all the documents needed for that purpose including the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicants to the subsystem), in particular:\nthe quality management system documentation, including the particular means implemented to ensure that:\nfor the contracting entity or main contractor, responsible for the whole subsystem project, overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,\nfor each applicant, the quality management system is correctly managed for achieving integration at subsystem level,\nthe quality records as foreseen by the manufacturing part (including assembly and installation) of the quality management system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.\n6.3.\nThe notified body must periodically carry out audits to make sure that the contracting entity, if involved, and the main contractors, maintain and apply the quality management system and must provide an audit report to them. When those operate a certified quality management system, the notified body shall take this into account in the surveillance.\nThe frequency of the audits shall be at least once a year, with at least one audit during the time period of performing relevant activities (manufacture, assembly or installation) of the subsystem being the subject of the EC verification procedure mentioned under point 8.\n6.4.\nAdditionally the notified body may pay unexpected visits to the relevant sites of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests, in order to check the proper functioning of the quality management system where necessary. It must provide the applicant(s) with an inspection report and also, audit and/or test reports, as appropriate.\n6.5.\nThe notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned, must co ordinate the surveillance activities of any other notified body responsible for that task, in order:\nto be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed,\nto collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.\nThis co ordination includes the rights of the notified body:\nto receive all documentation (approval and surveillance), issued by the other notified bodies,\nto witness the surveillance audits in point 6.3,\nto initiate additional audits as in point 6.4 under its responsibility and together with the other notified bodies.\n7.\nThe notified body as referenced in point 5.1. must have entrance for inspection purposes, audit and surveillance to the locations of building sites, production workshops, locations of assembly and installations, storage areas and where appropriate, prefabrication and testing facilities and, more general, to all premises which it considers necessary in order to carry out its tasks, in accordance with the applicant's specific contribution to the subsystem project.\n8.\nThe contracting entity, if involved, and the main contractors must, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:\nthe documentation referenced in the second indent of the second subparagraph of point 5.1,\nthe updating referenced in the second subparagraph of point 5.5,\nthe decisions and reports from the notified body, which are, referenced in points 5.4, 5.5 and 6.4.\n9.\nWhere 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 management system(s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.\nThe EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.\n10.\nThe notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in the Art 18 (3) of the Directive, and in particular as follows:\nall necessary documents relating to the characteristics of the subsystem,\na list of interoperability constituents incorporated into the subsystem,\ncopies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which said constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,\nall elements relating to the maintenance, the conditions and limits for use of the subsystem,\nall elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,\nthe type-examination certificate for the subsystem and the accompanying technical documentation as defined in the Module SB (type-examination),\nevidence of conformity with other regulations deriving from the treaty (including certificates)\ncertificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.3 and 6.4 and in particular:\nthe Register of Infrastructure, including all information as specified in the TSI.\n11.\nEach notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused.\nThe other notified bodies may receive on request copies of the quality management system approvals issued\n12.\nThe records accompanying the certificate of conformity must be lodged with the contracting entity.\nThe contracting entity within the Community must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.\nModule SF: Product Verification\n1.\nThis module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a Control-Command Subsystem, for which a type-examination certificate has already been issued by a notified body,\ncomplies with this TSI and any other relevant TSI, which demonstrate that the essential requirements of Directive 01/16/EC have been met\ncomplies with the other regulations deriving from the Treaty\nand may be placed into service\n2.\nThe contracting entity must lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice.\nThe application shall include:\nThe name and address of the contracting entity or its authorised representative\nthe technical documentation.\n3.\nWithin that part of the procedure the contracting entity checks and attests that the subsystem concerned is in conformity with the type as described in the type examination certificate and satisfies the requirements of the TSI that apply to it. The notified body shall carrying out the procedure under the condition that the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application\n4.\nThe contracting entity must take all measures necessary in order that the manufacturing process (including assembly and integration of interoperability constituents by main contractors when employed) ensures conformity of the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI that apply to it.\n5.\nThe application must enable the design, manufacture, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the type as described in the type-examination certificate and the requirements of the TSI to be assessed\nThe application must include:\nthe technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in Module SB (type-examination),\nand, if not included in this documentation,\na general description of the subsystem, overall design and structure,\nthe Register of Infrastructure, including all information as specified in the TSI,\nconceptual design and manufacturing information, for example drawings, schemes of components, subassemblies, assemblies, circuits, etc.,\nthe technical documentation regarding the manufacture and the assembly of the subsystem,\nthe technical specifications, including European specification, that have been applied,\nany necessary supporting evidence for the use of the above specifications, in particular where these European specification and the relevant clauses have not been applied in full,\nevidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase\na list of the Interoperability Constituents, to be incorporated into the subsystem,\ncopies of the EC declarations of conformity or suitability for use with which said constituents must be provided and all the necessary elements defined in annex VI of the directives,\na list of manufacturers involved in the subsystem's design, manufacture, assembly and installation,\nIf the TSI requires further information for the technical documentation, this shall be included.\n6.\nThe notified body shall first examine the application concerning the validity of the type examination and the type examination certificate.\nIf the notified body considers the type examination certificate no longer remains valid or is not appropriate and that a new type examination is necessary, it shall justify its decision.\nThe notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type, as described in the type examination certificate and with the requirements of the TSI. The notified body shall examine and testing of every subsystem manufactured as a serial product, as specified in point 4\n7.\nVerification by examination and testing of every subsystem (as a serial product)\n7.1.\nThe notified body must carry out the tests, examinations and verifications, to ensure conformity of the subsystems, as serial products as provided for in the TSI. The examinations, tests and checking shall extend to the stages as provided for in the TSI:\n7.2.\nEach subsystem (as serial product) must be individually examined, tested and verified in order to verify its conformity with the type as described in the type-examination certificate and the requirements of the TSI that apply to it. When a test is not set out in the TSI, (or in an European Standard quoted in the TSI), the relevant European Specifications or equivalent tests are to be used.\n8.\nThe notified body may agree with the contracting entity (and the main contractors) 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 contracting entity under direct supervision and attendance of the notified body.\nThe notified body shall have entrance for testing and verification purposes to production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.\n9.\nWhere the subsystem meets the requirements of the TSI, the notified body must, draw up the certificate of conformity intended for the contracting entity, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates.\nThese NB activities shall be based on the type examination and the tests, verifications and checks carried out on all serial products as indicated in point 7 and required in the TSI and/or in the relevant European specification,\nThe EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.\n10.\nThe notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art.18 (3) of the Directives, and in particular as follows:\nall necessary documents relating to the characteristics of the subsystem\nthe Register of Infrastructure, including all information as specified in the TSI,\nthe list of interoperability constituents incorporated into the subsystem,\ncopies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,\nall elements relating to the maintenance, the conditions and limits for use of the subsystem,\nall elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,\nthe type-examination certificate for the subsystem and accompanying technical documentation, as defined in the Module SB (type-examination)\ncertificate of conformity of the notified body as mentioned in point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn. The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification.\n11.\nThe records accompanying the certificate of conformity must be lodged with the contracting entity.\nThe contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.\nModule SH2: Full Quality Management System with Design Examination\n1.\nThis module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that a Control-Command Subsystem\ncomplies with this TSI and any other relevant TSI, ,which demonstrate that the essential requirements of Directive 01/16/EC have been met\ncomplies with the other regulations deriving from the Treaty.\nand may be placed in service.\n2.\nThe notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity and the main contractors involved are satisfying the obligations of point. 3\nThe ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns the company:\nresponsible for the whole subsystem project (including in particular responsibility for subsystem integration),\nother companies only involved only in a part of the subsystem project (performing for example design, assembly or installation of the subsystem).\nIt does not refer to manufacturer sub contractors supplying components and interoperability constituents.\n3.\nFor the subsystem that is subject of the EC verification procedure, the contracting entity or the main contractors, when employed, shall operate an approved quality management system for design, manufacture and final product inspection and testing as specified in point 5 and which shall be subject to surveillance as specified in point 6.\nThe main contractor responsible for the whole subsystem project (including in particular responsibility for subsystem integration), must operate in any case an approved quality management system for design, manufacture and final product inspection and testing, which shall be subject to surveillance as specified in point 6.\nIn the case that the contracting entity itself is responsible for the whole subsystem project (including in particular responsibility for subsystem integration) or that the contracting entity is directly involved in the design and/or production (including assembly and installation), it shall operate an approved quality management system for those activities, which shall be subject to surveillance as specified in point 6.\nApplicants which are only involved in assembly and installation, may operate only an approved quality management system for manufacture and final product inspection and testing\n4.\nEC verification procedure\n4.1.\nThe contracting entity must lodge an application for EC verification of the subsystem (through full quality management system with design examination), including co ordination of surveillance of the quality management systems as in points 5.4. and 6.6., with a notified body of its choice. The contracting entity must inform the manufacturers involved of his choice and of the application.\n4.2.\nThe application must enable the design, manufacture, assembly, installation, maintenance and operation of the subsystem to be understood, and shall enable conformity with the requirements of the TSI to be assessed.\nThe application must include:\nname and address of the contracting entity or its authorised representative,\nthe technical documentation including:\na general description of the subsystem, overall design and structure,\nthe technical design specifications, including European specifications, that have been applied,\nany necessary supporting evidence for the use of the above specifications, in particular where the European specifications and the relevant clauses have not been applied in full.\nthe test programme\nthe Infrastructure and/or Rolling Stock (subsystem) register, including all information as specified in the TSI,\nthe technical documentation regarding the manufacture, the assembly of the subsystem,\na list of the interoperability constituents to be incorporated into the subsystem,\ncopies of the EC declarations of conformity or suitability for use with which the constituents must be provided and all the necessary elements defined in annex VI of the directives,\nevidence of conformity to other regulations deriving from the treaty (including certificates)\na list of all manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,\nconditions for use of the subsystem (restrictions of running time or distance, wear limits etc),\nconditions for maintenance and technical documentation regarding the maintenance of the subsystem\nany technical requirement that must be taken into account during production, maintenance or operation of the subsystem\nthe explanation, of how all stages, as mentioned in point 5.2, are covered by quality management systems of the mains contractor(s) and/or of the contracting entity, if involved, and the evidence of their effectiveness,\nindication of the notified body (ies) responsible for the approval and surveillance of these quality management systems.\n4.3\nThe contracting entity shall present the results of examinations, checking and tests, including type tests when required, carried out by its appropriate laboratory or on their behalf.\n4.4\nThe notified body must examine the application concerning the design examination and assess the results of the tests. Where the design meets the provisions of the Directive and of the TSI that apply to it 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.\nIf the contracting entity is denied a design examination report, the notified body must provide detailed reasons for such denial.\nProvision must be made for an appeals procedure.\n5.\nQuality management system\n5.1.\nThe contracting entity, if involved, and the main contractors, when employed, must lodge an application for assessment of their quality management systems with a notified body of their choice.\nThe application must include:\nall relevant information for the subsystem envisaged,\nthe quality management system documentation.\nFor those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.\n5.2.\nFor the contracting entity or the main contractor responsible for the whole subsystem project, the quality management system shall ensure overall compliance of the subsystem with the requirements of the TSI.\nThe quality management system(s), for other main contractor(s), has (have) to ensure compliance of their relevant contribution to the subsystem, with the requirements of the TSI.\nAll the elements, requirements and provisions adopted by the applicants must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.\nThe system must contain in particular an adequate description of the following items:\nfor all applicants:\nthe quality objectives and the organisational structure,\nthe corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,\nthe examinations, checking and tests that will be carried out before, during and after design, manufacture, assembly and installation and the frequency with which they will be carried out,\nthe quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,\nfor the main contractors, as far as relevant for their contribution to the design of the subsystem:\nthe technical design specifications, including European specifications, that will be applied and, where the European specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the subsystem will be met,\nthe design control and design verification techniques, processes and systematic actions that will be used when designing the subsystem,\nthe means to monitor the achievement of the required design and subsystem quality and the effective operation of the quality management systems in all phases including production.\nand also for the contracting entity or the main contractor responsible for the whole subsystem project:\nresponsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.\nThe examinations, tests and checking shall cover all of the following stages:\noverall design,\nstructure of the subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,\nfinal testing of the subsystem,\nand, where specified in the TSI, the validation under full operation conditions.\n5.3.\nThe notified body chosen by the contracting entity must examine, if all stages of the subsystem as mentioned in point 5.2 are sufficiently and properly covered by the approval and surveillance of the quality management system(s) of the applicant(s).\nIf the compliance of the subsystem with the requirements of the TSI is based on more than one quality management system, the notified body shall examine in particular,\nif the relations and interfaces between the quality management systems are clearly documented\nand 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.\n5.4.\nThe notified body referenced in point 5.1. must assess the quality management system to determine whether it satisfies the requirements of point 5.2. 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 harmonised standard EN/ISO 9001/2000, which takes into consideration the specificity of the interoperability constituent for which it is implemented.\nWhen an applicant operates a certified quality management system, the notified body shall take this into account in the assessment.\nThe 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.\nThe evaluation procedure shall include an assessment visit to the applicant's premises.\nThe decision must be notified to the applicant. The notification must contain the conclusions of the examination and the reasoned assessment decision.\n5.5.\nThe contracting entity, if involved, and the main contractors 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.\nThey must keep the notified body that has approved their quality management system informed of any significant change that will affect the fulfilment of the requirements by the subsystem.\nThe notified body must evaluate any modifications proposed and decide whether the amended quality management system will still satisfy the requirements of point 5.2 or whether a re-assessment is required.\nIt shall notify its decision to the applicant. The notification shall contain the conclusions of the examination and the reasoned assessment decision.\n6.\nSurveillance of the quality management system(s) under the responsibility of the notified body\n6.1.\nThe purpose of surveillance is to make sure that the contracting entity, if involved, and the main contractors duly fulfil the obligations arising out of the approved quality management system(s).\n6.2.\nThe contracting entity, if involved, and the main contractors must send the notified body referenced in point 5.1. (or have sent) all the documents needed for that purpose and in particular the implementation plans and technical records concerning the subsystem (as far as relevant for the specific contribution of the applicant to the subsystem), including:\nthe quality management system documentation, including the particular means implemented to ensure that\nfor the contracting entity or the main contractor, responsible for the whole subsystem project, overall responsibilities and powers of the management for the compliance of the whole entire subsystem are sufficiently and properly defined,\nfor each applicant, the quality management system is correctly managed for achieving integration at subsystem level,\nthe quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,\nthe quality records as foreseen by the manufacturing part (including assembly, installation and integration) of the quality management system, such as inspection reports and test data, calibration data, competency records of the personnel concerned, etc.\n6.3.\nThe notified body must periodically carry out audits to make sure that the contracting entity, if involved, and the main contractors maintain and apply the quality management system and shall provide an audit report to them. When they operate a certified quality management system, the notified body shall take this into account in the surveillance\nThe frequency of the audits shall be at least once a year, with at least one audit during the time period of performing the relevant activities (design, manufacture, assembly or installation) for the subsystem being the subject of the EC verification procedure mentioned in point 7.\n6.4.\nAdditionally the notified body may pay unexpected visits to the sites mentioned in point 5.2 of the applicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carry out or cause to be carried out tests in order to check the proper functioning of the quality management system where necessary. It must provide the applicant(s) with an inspection report and, audit and/or test reports as appropriate\n6.5.\nThe notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned as under point 5, must co ordinate the surveillance activities of any other notified bodies responsible for that task, in order:\nto be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed.\nto collect, in liaison with the contracting entity, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.\nThis co ordination includes the right of the notified body\nto receive all documentation (approval and surveillance), issued by the other notified body(s),\nto witness the surveillance audits as in point 5.4.,\nto initiate additional audits as in point 5.5. under its responsibility and together with the other notified body(s).\n7.\nThe notified body as referenced under point 5.1. must have entrance for inspection purposes, audit and surveillance to the locations of design, building sites, production workshops, locations of assembly and installation, storage areas and. where appropriate, prefabrication or testing facilities and, more general, to all premises which it considers necessary for its task, in accordance with the applicant's specific contribution to the subsystem project.\n8.\nThe contracting entity, if involved, and the main contractors must, for a period of 10 years after the last subsystem has been manufactured, keep at the disposal of the national authorities:\nthe documentation referenced in the second indent of the second subparagraph of point 5.1,\nthe updating referenced in the second subparagraph of point 5.5,\nthe decisions and reports from the notified body which are referenced in the points 5.4, 5.5 and 6.4\n9.\nWhere 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 management system (s), draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.\nThe EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.\n10.\nThe notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art 18 (3) of The Directive, and in particular as follows:\nall necessary documents relating to the characteristics of the subsystem\nthe list of interoperability constituents incorporated into the subsystem,\ncopies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified,\nevidence of conformity to other regulations deriving from the treaty (including certificates)\nall elements relating to the maintenance, the conditions and limits for use of the subsystem,\nall elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance\ncertificate of conformity of the notified body as mentioned under point 9, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification, as mentioned in points 6.4. and 6.5.;\nthe Register of Infrastructure, including all information as specified in the TSI.\n11.\nEach notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals and the EC design examination reports, which it has issued, withdrawn or refused.\nThe other notified bodies may receive on request copies of:\nthe quality management system approvals and additional approvals issued and\nthe EC design examination reports and additions issued\n12.\nThe records accompanying the certificate of conformity must be lodged with the contracting entity\nThe contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.\nModule SG: Unit Verification\n1.\nThis module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that a Control-Command Subsystem\ncomplies with this TSI and any other relevant TSI, which demonstrate that the essential requirements of Directive 01/16/EC have been met\ncomplies with the other regulations deriving from the Treaty,\nand may be placed in service.\n2.\nThe contracting entity must lodge an application for EC verification (through unit verification) of the subsystem with a notified body of his choice.\nThe application shall include:\nname and address of the contracting entity or its authorised representative\nthe technical documentation.\n3.\nThe technical documentation must enable the design, manufacture, installation and operation of the subsystem to be understood, and shall enable conformity assessment with the requirements of the TSI.\nThe technical documentation must include:\na general description of the subsystem, its overall design and structure,\nthe Register of Infrastructure, including all information as specified in the TSI,\nconceptual design and manufacturing information, for example drawings, schemes of components, sub-assemblies, assemblies, circuits, etc.,\ndescriptions and explanations necessary for the understanding of the design and manufacturing information and the operation of the subsystem,\nthe technical specifications, including European specifications, that have been applied,\nany necessary supporting evidence for the use of the above specifications, in particular where European specifications and the relevant clauses have not been applied in full,\na list of the interoperability constituents to be incorporated into the subsystem,\ncopies of the EC declarations of conformity or suitability for use with which said constituents must be provided and all the necessary elements defined in annex VI of the directives,\nevidence of conformity with other regulations deriving from the treaty (including certificates)\ntechnical documentation regarding the manufacture and the assembly of the subsystem,\na list of manufacturers involved in the subsystem's design, manufacturing, assembly and installation,\nconditions for use of the subsystem (restrictions of running time or distance, wear limits etc),\nconditions for maintenance and technical documentation regarding the maintenance of the subsystem\nany technical requirement that must be taken into account during production, maintenance or operation of the subsystem\nresults of design calculations made, examinations carried out, etc.,\nall other appropriate technical evidences, which can demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by independent and competent bodies\nall other appropriate technical evidences, which can demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by independent and competent bodies\nIf the TSI requires further information for the technical documentation, this shall be included.\n4.\nThe notified body must examine the application and the technical documentation, and identify the elements which have been designed in accordance with the relevant provisions of the TSI and the European specifications, as well as the elements which have been designed without applying the relevant provisions of those European specifications.\nThe notified body must examine the subsystem and perform (or participate to) the appropriate and necessary tests to establish whether, where the relevant European specifications have been chosen, these have actually been applied or whether the solutions adopted meet the requirements of the TSI when the appropriate European specifications have not been applied;\nThe examinations, tests and checks shall extend to the following stages as provided for in the TSI:\noverall design\nstructure of the subsystem, including, in particular and when relevant, civil-engineering activities, constituent assembly, overall adjustments\nfinal testing of the subsystem\nand, whenever specified in the TSI, the validation under full operational conditions.\nThe notified body shall take into account previous checking or tests that have been successfully performed, under comparable conditions by other independent and competent bodies. The notified body will then decide as to whether it shall use the results of these checks or tests. If it accepts, then the notified body shall investigate the evidences of these previous checking or test and shall establish the conformity of their results with the requirement of the TSI. In all case the notified body keeps the final responsibility of them.\n5.\nThe notified body may agree with the contracting entity the locations where the tests will be carried out and may agree that final subsystem tests and, whenever required in the TSI, tests in full operating conditions, are carried out by the contracting entity under direct supervision and attendance of the notified body.\n6.\nThe notified body must have entrance for testing and verification purposes to the locations of design, building sites, production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.\n7.\nWhere the subsystem meets the requirements of the TSI, the notified body must then, based on the tests, verifications and checks carried out as required in the TSI and/or in the relevant European specifications, draw up the certificate of conformity intended for the contracting entity, who shall in turn draw up the EC declaration of verification intended for the supervisory authority in the Member State where the subsystem is located and/or operates.\nThe EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language as the technical file and must contain at least the information included in Annex V of the Directive.\n8.\nThe notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file has to include at least the information indicated in Art.18 (3) of the Directive, and in particular as follows:\nall necessary documents relating to the characteristics of the subsystem\nthe list of interoperability constituents incorporated into the subsystem,\ncopies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which the constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,\nall elements relating to the maintenance, the conditions and limits for use of the subsystem,\nall elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,\ncertificate of conformity of the notified body as mentioned in point 7, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the directive and the TSI, and mentioning, where appropriate, reservations recorded during performance of activities and not withdrawn; the certificate should also be accompanied, if relevant, by the inspection and audit reports drawn up in connection with the verification,\nevidence of conformity with other regulations deriving from the treaty (including certificates)\nthe Register of Infrastructure, including all information as specified in the TSI.\n9.\nThe records accompanying the certificate of conformity must be lodged with the contracting entity. The contracting entity must keep a copy of the technical file throughout the service life of the subsystem; it must be sent to any other Member State which so requests.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Decision of 23 July 2012 amending Decisions 2006/679/EC and 2006/860/EC concerning technical specifications for interoperability (notified under document C(2012) 4984) (Text with EEA relevance) (2012/463/EU)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "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"
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "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"
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "The manufacturer's discretion may be limited in specific TSIs"
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "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"
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "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"
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "The presentation of the results of the tests can be at the same time as the application or later."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "The relevant section of a TSI may define specific requirements in this regard."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "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"
    },
    {
      "type": "footnote",
      "label": "f12",
      "text": "The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI."
    },
    {
      "type": "footnote",
      "label": "f13",
      "text": "This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated."
    },
    {
      "type": "footnote",
      "label": "f14",
      "text": "In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’."
    },
    {
      "type": "footnote",
      "label": "f15",
      "text": "For the rolling stock TSI, the notified body may participate to the final in service test of locomotives or train set in the conditions specified in the relevant chapter of the TSI."
    },
    {
      "type": "footnote",
      "label": "f16",
      "text": "The essential requirements are reflected in the technical parameters, interfaces and performance requirements set out in Chapter 4 of the TSI."
    },
    {
      "type": "footnote",
      "label": "f17",
      "text": "This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated."
    },
    {
      "type": "footnote",
      "label": "f18",
      "text": "In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’."
    },
    {
      "type": "footnote",
      "label": "f19",
      "text": "The ‘main contractors’ refers to companies, whose activities contribute to fulfil essential requirements of the TSI. It concerns the company that can be responsible for the whole subsystem project or other companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem)."
    },
    {
      "type": "footnote",
      "label": "f20",
      "text": "In particular, for the rolling stock TSI, the notified body will participate in the final in service testing of rolling stock or train set. This will be indicated in the relevant chapter of the TSI"
    },
    {
      "type": "footnote",
      "label": "f21",
      "text": "The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI."
    },
    {
      "type": "footnote",
      "label": "f22",
      "text": "This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated."
    },
    {
      "type": "footnote",
      "label": "f23",
      "text": "In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’."
    },
    {
      "type": "footnote",
      "label": "f24",
      "text": "The presentation of the results of the tests can be at the same time as the application or later."
    },
    {
      "type": "footnote",
      "label": "f25",
      "text": "The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC and in the guidelines for application of HS TSIs"
    },
    {
      "type": "footnote",
      "label": "f26",
      "text": "For the rolling stock TSI, the notified body may participate to the final in service test of rolling stock or train set in the conditions specified in the relevant chapter of the TSI."
    },
    {
      "type": "footnote",
      "label": "f27",
      "text": "The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI."
    },
    {
      "type": "footnote",
      "label": "f28",
      "text": "This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated."
    },
    {
      "type": "footnote",
      "label": "f29",
      "text": "In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’."
    },
    {
      "type": "footnote",
      "label": "f30",
      "text": "The definition of an European specification is indicated in the directives 96/48/EC and 01/16/EC and in the guidelines for application of HS TSIs"
    },
    {
      "type": "footnote",
      "label": "f31",
      "text": "The conditions to entrust previous checking and tests must be similar than the conditions, respected by a notified body to subcontract activities (see § 6.5 of the Blue Guide on the New Approach); in particular, the notified body is allowed to take into account these appropriate evidences can be solely if these bodies shall respect the same criteria of independence and competence than the notified bodies"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2006/860/annex/annex/E",
    "retrieved_at": "2026-11-01T15:17:24.266188+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}