Appendix ANNEX E F1
United Kingdom Repealed
MODULES FOR INTEROPERABILITY CONSTITUENTS
Module B: Type examination
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2.
The application for the EC type-examination must be lodged by the manufacturer or his authorised representative established within the Community.
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3.
The 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.
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4.
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4.1.
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4.2.
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4.3.
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4.4.
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4.5.
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4.6.
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4.7.
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4.8.
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5.
Where 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.
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6.
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7.
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8.
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9.
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10.
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Module D: Production quality management system
1.
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2.
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3.
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3.1.
The manufacturer must lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.
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3.2.
The 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.
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3.3.
The notified body assesses the quality management system to determine whether it satisfies the requirements of point 3.2. It presumes compliance with these requirements if the manufacturer implements a quality system for production, final product inspection and testing in respect of the Standard EN/ISO 9001-2000, which take into consideration the specificity of the interoperability constituent for which it is implemented.
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3.4.
The 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.
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4.
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4.1.
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4.2.
The manufacturer must allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:
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4.3.
The 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.
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4.4.
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5.
Each notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals, issued, withdrawn or refused.
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6.
The manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
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7.
The manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent. The content of this declaration shall include at least the information indicated in Annex IV(3) of Directives 96/48/EC or 2001/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed.
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8.
The manufacturer or his authorised representative established within the Community must keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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9.
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Module F: Product verification
1.
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2.
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3.
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4.
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4.1.
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4.2.
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4.3.
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5.
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5.1.
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5.2.
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5.3.
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5.4.
In the case of accepted lots, the notified body shall draw up a written certificate of conformity relating to the tests carried out. All interoperability constituents in the lot may be placed on the market except those interoperability constituents from the sample, which were found not to be in conformity.
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5.5.
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6.
The manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.
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7.
The manufacturer or his authorised representative established within the Community must keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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8.
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Module H2: Full quality management system with design examination
1.
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2.
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3.
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3.1.
The manufacturer must lodge an application for assessment of his quality management system with a notified body of his choice, for the interoperability constituents concerned.
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3.2.
The 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.
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3.3.
The 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.
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3.4.
The 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.
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4.
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4.1.
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4.2.
The manufacturer must allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, including:
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4.3.
The 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.
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4.4.
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5.
The manufacturer must, for a period of 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
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6.
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6.1.
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6.2.
The 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.
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6.3.
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6.4.
The notified body must examine the application and assess the results of the tests. Where the design meets the provisions of the TSI that apply to it, the notified body must issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the product's functioning.
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6.5.
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6.6.
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7.
Each 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.
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8.
The manufacturer or his authorised representative established within the Community must draw up the EC declaration of conformity of the interoperability constituent.
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9.
The manufacturer or his authorised representative established within the Community must keep a copy of the EC declaration of conformity for a period of 10 years after the last interoperability constituent has been manufactured.
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10.
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MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS
Module SB: Type examination
1.
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 control-command subsystem, representative of the production envisaged,
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2.
The contracting entity must lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice.
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3.
The applicant must place at the disposal of the notified body a specimen of the subsystem, representative of the production envisaged and hereinafter called ‘type’.
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4.
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4.1.
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4.2.
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4.3.
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4.4.
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4.5.
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4.6.
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4.7.
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5.
Where the type meets the provisions of the TSI, the notified body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the 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.
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6.
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7.
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8.
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9.
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Module SD: Production quality management system
1.
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 control-command subsystem, for which already a type-examination certificate has been issued by a notified body:
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2.
The notified body carries out the procedure, under the condition, that:
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3.
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.
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4.
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4.1.
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4.2.
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.
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4.3.
The notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate.
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5.
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5.1.
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.
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5.2.
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.
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5.3.
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).
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5.4.
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 which it is implemented.
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5.5.
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.
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6.
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6.1.
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6.2.
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:
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6.3.
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.
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6.4.
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6.5.
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:
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7.
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8.
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:
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9.
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.
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10.
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 Article 18(3) of the Directive, and in particular as follows:
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11.
Each notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused.
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12.
The records accompanying the certificate of conformity must be lodged with the contracting entity.
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Module SF: Product verification
1.
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 control-command subsystem, for which a type-examination certificate has already been issued by a notified body,
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2.
The contracting entity must lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice.
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3.
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.
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4.
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5.
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.
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6.
The notified body shall first examine the application concerning the validity of the type examination and the type examination certificate.
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7.
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7.1.
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7.2.
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8.
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.
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9.
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.
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10.
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:
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11.
The records accompanying the certificate of conformity must be lodged with the contracting entity.
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Module SH2: Full quality management system with design examination
1.
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 control-command subsystem:
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2.
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
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3.
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.
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4.
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4.1.
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4.2.
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.
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4.3.
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4.4.
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.
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5.
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5.1.
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.
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5.2.
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.
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5.3
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).
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5.4.
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 harmonised standard EN/ISO 9001/2000, which takes into consideration the specificity of the interoperability constituent for which it is implemented.
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5.5.
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.
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6.
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6.1.
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6.2.
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:
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6.3.
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.
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6.4.
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6.5.
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 :
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7.
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8.
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:
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9.
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.
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10.
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 Article 18(3) of the Directive, and in particular as follows:
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11.
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.
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12.
The records accompanying the certificate of conformity must be lodged with the contracting entity
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Module SG: Unit Verification
1.
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 control-command subsystem:
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2.
The contracting entity must lodge an application for EC verification (through unit verification) of the subsystem with a notified body of his choice.
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3.
The 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.
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4.
The 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.
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5.
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6.
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7.
Where 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.
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8.
The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file has to include at least the information indicated in Article 18(3) of the Directive, and in particular as follows :
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9.
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