Commission Decision of 28 July 2006 concerning the technical specification of interoperability relating to the subsystem ‘rolling stock — freight wagons’ of the trans-European conventional rail system (notified under document number C(2006) 3345) (Text with EEA relevance) (2006/861/EC) (repealed)

ANNEX AA ASSESSMENT PROCEDURES

Verification of Subsystems

Structure of modules for the EC verification procedure of Subsystems U.K.

Modules for the EC verification of subsystems

• Module SB: Type examination

• Module SD: Product quality management system

• Module SF: Product verification

• Module SH2: Full quality management system with design examination

MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS Module SB: Type Examination U.K.

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 Rolling Stock Freight wagon subsystem, representative of the production envisaged, U.K.

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(1) of Directive 2001/16/EC(2) have been met

• complies with the other regulations deriving from the Treaty.

The 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.

2. The contracting entity(3) must lodge an application for EC verification (through type examination) of the subsystem with a notified body of his choice. The application must include : U.K.

• name and address of the contracting entity or its authorised representative

• the technical documentation, as described in point 3.

3. The applicant must place at the disposal of the notified body a specimen of the subsystem(4), representative of the production envisaged and hereinafter called ‘type’. U.K.

A type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme.

If so required for specific test or examination methods and specified in the TSI or in the European specification(5) 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.

The 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.

The technical documentation must include:

• a general description of the subsystem, overall design and structure,

• the Rolling Stock register, including all information as specified in the TSI

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

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

• the technical specifications, including European specifications, that have been applied,

• any 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,

• a list of the interoperability constituents to be incorporated into the subsystem,

• copies 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,

• evidence of conformity with regulations deriving from the treaty (including certificates)

• technical documentation regarding the manufacture and the assembly of the subsystem,

• a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem

• any technical requirement that must be taken into account during production, maintenance or operation of the subsystem

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

• test reports.

If the TSI requires further information for the technical documentation, this shall be included.

4. The notified body must: U.K.

4.1. Examine the technical documentation, U.K.

4.2 Verify 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. U.K.

4.3. Where a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at the completion of the design process U.K.

4.4. 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; U.K.

4. 5 .Perform 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; U.K.

4.6. Perform 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. U.K.

4.7. Agree with the applicant the location where the examinations and necessary tests will be carried out. U.K.

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. A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body. U.K.

If the contracting entity is denied a type-examination certificate, the notified body must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

6. Each notified body must communicate to the other notified bodies the relevant information concerning the type-examination certificates issued, withdrawn or refused U.K.

7. The 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. U.K.

8. The 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. U.K.

9. The 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. U.K.

MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS Module SD: Production Quality Management System U.K.

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 Rolling Stock Freight wagon subsystem, for which already a type-examination certificate has been issued by a notified body, U.K.

• complies with this TSI and any other applicable TSI, , which demonstrate that the essential requirements(6) of Directive 01/16/EC(7) have been met

• complies with the other regulations deriving from the Treaty,

and may be placed in service.

2. The notified body carries out the procedure, under the condition, that : U.K.

• the type examination certificate issued prior to the assessment remains valid for the subsystem subject to the application,

• the contracting entity(8) and the main contractors involved are satisfying the obligations of point 3.

The ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns:

• the company responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

• other companies only involved in a part of the subsystem project, (performing for example assembly or installation of the subsystem).

It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

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. U.K.

When 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.

If 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.

4. EC verification procedure U.K.

4.1. The 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. U.K.

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. U.K.

The application must include:

• name and address of the contracting entity or its authorised representative

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in module SB,

  and, if not included in this documentation,

  • a general description of the subsystem, its overall design and structure,

  • the technical specifications, including European specifications, that have been applied,

  • any 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.

  • The Rolling Stock register, including all information as specified in the TSI,

  • the technical documentation regarding the manufacture and the assembly of the subsystem,

  • evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

  • a list of the interoperability constituents to be incorporated into the subsystem,

  • copies 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,

  • a list of manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

  • the 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,

  • indication of the notified body, responsible for the approval and surveillance of these quality management systems.

4.3. The notified body shall fist examine the application concerning the validity of the type examination and the type examination certificate. U.K.

If 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.

5. Quality management system U.K.

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. U.K.

The application must include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

  the technical documentation of the approved type and a copy of the type examination certificate, issued after the completion of the type examination procedure of module SB.

  For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

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. U.K.

All 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.

It must contain in particular an adequate description of the following items for all applicant(s):

• the quality objectives and the organisational structure,

• the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

• the examinations, checks and tests that will be carried out before, during and after manufacture, assembly and installation, and the frequency with which they will be carried out,

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

  and also for the contracting entity or the main contractor responsible for the whole subsystem project:

• responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management. The examinations,

  tests and checking shall cover all of the following stages:

• structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

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)(9). U.K.

If 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,

• if the relations and interfaces between the quality management systems are clearly documented

• and 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.

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 for which it is implemented. U.K.

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

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team must have at least one member experienced as an assessor in the subsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant's premises.

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

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. U.K.

They 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.

The 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.

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

6. Surveillance of the quality management system(s) under the responsibility of the notified body U.K.

6.1. The 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. U.K.

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: U.K.

• the quality management system documentation, including the particular means implemented to ensure that:

  • for 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,

  • for each applicant, the quality management system is correctly managed for achieving integration at subsystem level,

• the 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.

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. U.K.

The frequency of the audits shall be at least once a year, with at least one audit during the time period of performing relevant activities (manufacture, assembly or installation) of the subsystem being the subject of the EC verification procedure mentioned under point 8.

6.4. Additionally 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. U.K.

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: U.K.

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed,

• to 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.

This co ordination includes the rights of the notified body:

• to receive all documentation (approval and surveillance), issued by the other notified bodies,

• to witness the surveillance audits in point 6.3,

• to initiate additional audits as in point 6.4 under its responsibility and together with the other notified bodies.

7. The 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. U.K.

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: U.K.

• the documentation referenced in the second indent of the second subparagraph of point 5,1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body, which are, referenced in points 5.4, 5.5 and 6.4.

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. U.K.

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

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 Art 18 (3) of the Directive, and in particular as follows: U.K.

• all necessary documents relating to the characteristics of the subsystem,

• a list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which said constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality management system approvals and surveillance documents) issued by the notified bodies,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and the accompanying technical documentation as defined in the module SB,

• evidence of conformity with other regulations deriving from the treaty (including certificates)

• certificate 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:

• the Rolling Stock register, including all information as specified in the TSI.

11. Each notified body must communicate to the other notified bodies the relevant information concerning the quality management system approvals issued, withdrawn or refused. U.K.

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

12. The records accompanying the certificate of conformity must be lodged with the contracting entity. U.K.

The 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.

MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS Module SF: Product Verification U.K.

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 Rolling Stock Freight wagon subsystem, for which a type-examination certificate has already been issued by a notified body, U.K.

• complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements(10) of Directive 01/16/EC(11) have been met

• complies with the other regulations deriving from the Treaty

and may be placed into service

2. The contracting entity(12) must lodge an application for EC verification (through product verification) of the subsystem with a notified body of his choice. The application shall include : U.K.

• The name and address of the contracting entity or its authorised representative

• the technical documentation.

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. U.K.

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.

4. The contracting entity must take all measures necessary in order that the manufacturing process (including assembly and integration of interoperability constituents by main contractors(13) 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. U.K.

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. U.K.

The application must include:

• the technical documentation regarding the approved type, including the type examination certificate, as issued after completion of the procedure defined in module SB,

and, if not included in this documentation,

• a general description of the subsystem, overall design and structure,

• the Rolling Stock register, including all information as specified in the TSI,

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

• the technical documentation regarding the manufacture and the assembly of the subsystem,

• the technical specifications, including European specification, that have been applied,

• any 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,

• evidence of conformity to other regulations deriving from the treaty (including certificates) for the production phase

• a list of the Interoperability Constituents, to be incorporated into the subsystem,

• copies 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,

• a list of manufacturers involved in the subsystem's design, manufacture, assembly and installation,

If the TSI requires further information for the technical documentation, this shall be included.

6. The notified body shall first examine the application concerning the validity of the type examination and the type examination certificate. U.K.

If 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.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type, as described in the 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

7. Verification by examination and testing of every subsystem (as a serial product) U.K.

7.1. The 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. U.K.

7.2. Each subsystem (as serial product) must be individually examined, tested and verified(14) 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 applicable. U.K.

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. U.K.

The 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.

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. U.K.

These 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.

The EC declaration of verification and the accompanying documents must be dated and signed.

The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

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 : U.K.

• all necessary documents relating to the characteristics of the subsystem

• the Rolling Stock register, including all information as specified in the TSI,

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which 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,

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance,

• the type-examination certificate for the subsystem and accompanying technical documentation, as defined in the module SB

• certificate 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.

11. The records accompanying the certificate of conformity must be lodged with the contracting entity. U.K.

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.

MODULES FOR THE EC VERIFICATION OF SUBSYSTEMS Module SH2: Full Quality Management System with Design Examination U.K.

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 Rolling Stock Freight wagon subsystem U.K.

• complies with this TSI and any other applicable TSI, , which demonstrate that the essential requirements(15) of Directive 01/16/EC(16) have been met

• complies with the other regulations deriving from the Treaty.

and may be placed in service

2. The notified body shall carry out the procedure, including a design examination of the subsystem, under the condition, that the contracting entity(17) and the main contractors involved are satisfying the obligations of point. 3 U.K.

The ‘main contractors’ refers to companies, whose activities contribute to fulfil the essential requirements of the TSI. It concerns the company:

• responsible for the whole subsystem project (including in particular responsibility for subsystem integration),

• other companies only involved only in a part of the subsystem project (performing for example design, assembly or installation of the subsystem).

It does not refer to manufacturer sub contractors supplying components and interoperability constituents.

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 U.K.

The 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.

In 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.

Applicants which are only involved in assembly and installation, may operate only an approved quality management system for manufacture and final product inspection and testing

4. EC verification procedure U.K.

4.1. The 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. U.K.

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. U.K.

The application must include:

• name and address of the contracting entity or its authorised representative,

• the technical documentation including:

  • a general description of the subsystem, overall design and structure,

  • the technical design specifications, including European specifications, that have been applied,

  • any 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.

  • the test programme

  • theRolling Stock register, including all information as specified in the TSI,

  • the technical documentation regarding the manufacture, the assembly of the subsystem,

  • a list of the interoperability constituents to be incorporated into the subsystem,

  • copies 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,

• evidence of conformity to other regulations deriving from the treaty (including certificates)

• a list of all manufacturers, involved in the subsystem's design, manufacturing, assembly and installation,

• conditions for use of the subsystem (restrictions of running time or distance, wear limits etc),

• conditions for maintenance and technical documentation regarding the maintenance of the subsystem

• any technical requirement that must be taken into account during production, maintenance or operation of the subsystem

• the 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,

• indication of the notified body (ies) responsible for the approval and surveillance of these quality management systems.

4.3. The contracting entity shall present the results of examinations, checking and tests(18), including type tests when required, carried out by its appropriate laboratory or on their behalf. U.K.

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. U.K.

If the contracting entity is denied a design examination report, the notified body must provide detailed reasons for such denial. Provision must be made for an appeals procedure.

5. Quality management system U.K.

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. U.K.

The application must include:

• all relevant information for the subsystem envisaged,

• the quality management system documentation.

For those only involved in a part of the subsystem project, the information to be provided is only that for the relevant part.

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. U.K.

The 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. All the elements, requirements and provisions adopted by the applicants must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality management system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

The system must contain in particular an adequate description of the following items :

• for all applicants:

  • the quality objectives and the organisational structure,

  • the corresponding manufacturing, quality control and quality management techniques, processes and systematic actions that will be used,

  • the 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,

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

• for the main contractors, as far as relevant for their contribution to the design of the subsystem :

  • the technical design specifications, including European specifications(19), 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,

  • the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystem,

  • the means to monitor the achievement of the required design and subsystem quality and the effective operation of the quality management systems in all phases including production.

• and also for the contracting entity or the main contractor responsible for the whole subsystem project:

  • responsibilities and powers of the management with regard to overall subsystem quality, including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

• overall design,

• structure of the subsystem, including, in particular, civil-engineering activities, constituent assembly, final adjustment,

• final testing of the subsystem,

• and, where specified in the TSI, the validation under full operation conditions.

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)(20). U.K.

If 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,

• if the relations and interfaces between the quality management systems are clearly documented

  and if overall responsibilities and powers of the management for the compliance of the whole entire subsystem for the main contractor are sufficiently and properly defined.

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 Standard EN/ISO 9001 — 2000, which takes into consideration the specificity of the interoperability constituent for which it is implemented. U.K.

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

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem. The auditing team must have at least one member experienced as an assessor in the subsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant's premises.

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

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. U.K.

They 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.

The 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.

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

6. Surveillance of the quality management system(s) under the responsibility of the notified body U.K.

6.1. The 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). U.K.

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: U.K.

• the quality management system documentation, including the particular means implemented to ensure that

  • for 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,

  • for each applicant, the quality management system is correctly managed for achieving integration at subsystem level,

• the quality records as foreseen by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part (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.

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. U.K.

The 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.

6.4. Additionally 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. U.K.

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 : U.K.

• to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed.

• to 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.

This co ordination includes the right of the notified body

• to receive all documentation (approval and surveillance), issued by the other notified body(s),

• to witness the surveillance audits as in point 5.4.,

• to initiate additional audits as in point 5.5. under its responsibility and together with the other notified body(s).

7. The 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. U.K.

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: U.K.

• the documentation referenced in the second indent of the second subparagraph of point 5.1,

• the updating referenced in the second subparagraph of point 5.5,

• the decisions and reports from the notified body which are referenced in the points 5.4, 5.5 and 6.4

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. U.K.

The EC declaration of verification and the accompanying documents must be dated and signed. The declaration must be written in the same language of the technical file and must contain at least the information included in Annex V of the Directive.

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 Art 18 (3) of The Directive, and in particular as follows: U.K.

• all necessary documents relating to the characteristics of the subsystem

• the list of interoperability constituents incorporated into the subsystem,

• copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which 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,

• evidence of conformity to other regulations deriving from the treaty (including certificates)

• all elements relating to the maintenance, the conditions and limits for use of the subsystem,

• all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance

• certificate 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.;

• the Rolling Stock register, including all information as specified in the TSI.

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. U.K.

The other notified bodies may receive on request copies of :

• the quality management system approvals and additional approvals issued and

• the EC design examination reports and additions issued

12. The records accompanying the certificate of conformity must be lodged with the contracting entity U.K.

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.

(1)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(2)

This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated.

(3)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(4)

The relevant section of a TSI may define specific requirements in this regard.

(5)

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

(6)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(7)

This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated.

(8)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(9)

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.

(10)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(11)

This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated.

(12)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(13)

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).

(14)

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

(15)

The essential requirements are reflected in the technical parameters, interfaces and performance requirements, which are set out in Chapter 4 of the TSI.

(16)

This module could be used in the future when the TSIs of the HS directive 96/48/EC are updated.

(17)

In the module, ‘the contracting entity’ means ‘the subsystem contracting entity, as defined in the directive. or his authorised representative established within the Community’.

(18)

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

(19)

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

(20)

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.