F1ANNEXTechnical Specification for Interoperability relating to the subsystem Rolling Stock — Freight Wagons
Verification of Subsystems
Structure of modules for the EC verification procedure of Subsystems
F1MODULES FOR THE EC VERIFICATION OF SUBSYSTEMSModule SB: Type Examination
F11.This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a type of a Rolling Stock Freight wagon subsystem, representative of the production envisaged,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12.The contracting entity must lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice. The application must include:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F13.The applicant must place at the disposal of the notified body a specimen of the subsystem, representative of the production envisaged and hereinafter called ‘type’.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.3.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.4.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.5.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.6.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.7.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.Where the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the 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. A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F18.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F19.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1MODULES FOR THE EC VERIFICATION OF SUBSYSTEMSModule SD: Production Quality Management System
F11.This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that a Rolling Stock Freight wagon subsystem, for which already a type-examination certificate has been issued by a notified body,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12.The notified body carries out the procedure, under the condition, that:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F13.For 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.2.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.3.The notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.1.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.2.For 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.3.The 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).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.4.The 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 for which it is implemented.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.5.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.2.The 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:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.3.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.4.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.5.The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned, must co ordinate the surveillance activities of any other notified body responsible for that task, in order:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F18.The 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:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F19.Where the subsystem meets the requirements of the TSI, the notified body must then, based on the type examination and the approval and surveillance of the quality 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F110.The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in the Art 18 (3) of the Directive, and in particular as follows:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F111.Each notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F112.The records accompanying the certificate of conformity must be lodged with the contracting entity.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1MODULES FOR THE EC VERIFICATION OF SUBSYSTEMSModule SF: Product Verification
F11.This module describes the EC verification procedure whereby a notified body checks and certifies at the request of an contracting entity or its authorised representative established within the Community, that a Rolling Stock Freight wagon subsystem, for which a type-examination certificate has already been issued by a notified body,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12.The contracting entity must lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice. The application shall include:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F13.Within that part of the procedure the contracting entity checks and attests that the subsystem concerned is in conformity with the type as described in the type examination certificate and satisfies the requirements of the TSI that apply to it.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.The notified body shall first examine the application concerning the validity of the type examination and the type examination certificate.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.2.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F18.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F19.Where 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F110.The 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:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F111.The records accompanying the certificate of conformity must be lodged with the contracting entity.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1MODULES FOR THE EC VERIFICATION OF SUBSYSTEMSModule SH2: Full Quality Management System with Design Examination
F11.This module describes the EC verification procedure whereby a notified body checks and certifies, at the request of an contracting entity or its authorised representative established within the Community, that a Rolling Stock Freight wagon subsystem
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12.The notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity and the main contractors involved are satisfying the obligations of point. 3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F13.For 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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.2.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.3.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F14.4.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.1.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.2.For the contracting entity or the main contractor responsible for the whole subsystem project, the quality management system shall ensure overall compliance of the subsystem with the requirements of the TSI.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.3.The 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).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.4.The 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 Standard EN/ISO 9001 — 2000, which takes into consideration the specificity of the interoperability constituent for which it is implemented.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F15.5.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.2.The 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:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.3.The 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.4.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F16.5.The notified body chosen by the contracting entity and responsible for the EC verification, if not carrying out the surveillance of all the quality management system(s) concerned as under point 5, must co ordinate the surveillance activities of any other notified bodies responsible for that task, in order:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F17.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F18.The 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:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F19.Where the subsystem meets the requirements of the TSI, the notified body must then, based on the design examination and the approval and surveillance of the quality 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F110.The notified body chosen by the contracting entity shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file shall include at least the information indicated in Art 18 (3) of The Directive, and in particular as follows:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F111.Each 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F112.The records accompanying the certificate of conformity must be lodged with the contracting entity
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repealed by Commission Regulation (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock — freight wagons’ of the rail system in the European Union and repealing Decision 2006/861/EC (Text with EEA relevance).