Appendix ANNEX Q ASSESSMENT PROCEDURESF1

Modules for Interoperability Constituents:

Characteristics

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module A: Internal Production Control

1.

2.

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.So far as relevant for the assessment, the documentation must contain:

4.

5.

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

6.

7.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module A1: Internal Design Control with Production Verification

1.

2.

3.

The technical documentation must enable the conformity of the interoperability constituent with the requirements of the TSI to be assessed. The technical documentation must also give evidence that the design of the interoperability constituent, already accepted before the implementation of the present TSI, is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use. It must, as far as relevant for such assessment, cover the design, manufacture, maintenance and operation of the interoperability constituent. So far as relevant for the assessment, the documentation must contain:

4.

5.

5.1.

5.1.1.

5.1.2.

5.2.

5.2.1.

5.2.2.

5.2.3.

5.2.4.

5.2.5.

6.

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 01/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed. The declaration must be written in the same language as the technical documentation and must contain the following:

7.

8.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module B: Type Examination

1.

2.

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

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.

4.

4.1.

4.2.

4.3.

4.4.

4.5.

4.6.

4.7.

4.8.

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.

6.

7.

8.

9.

10.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module C: Conformity to Type

1.

2.

3.

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

4.

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.

5.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module D: Production Quality Management System

1.

2.

3.

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.

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.

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.

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.

4.

4.1.

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:

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.

4.4.

5.

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

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:

7.

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

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.

9.

4 MODULES FOR INTEROPERABILITY CONSTITUENTS

Module F: Product Verification

1.

2.

3.

4.

4.1.

4.2.

4.3.

5.

5.1.

5.2.

5.3.

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.

5.5.

6.

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

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.

8.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module H 1: Full Quality Management System

1.

2.

3.

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.

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.

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 take into consideration the specificity of the interoperability constituent for which it is implemented.

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.

4.

4.1.

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 particular:

4.3.

4.4.

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:

6.

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

7.

The manufacturer or its authorised representative established within the Community must draw up the EC Declaration of conformity of the interoperability constituent. The content of this declaration shall include at least the information indicated in Annex IV (3) of Directives 96/48/EC or 01/16/EC. The EC declaration of conformity and the accompanying documents must be dated and signed.

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.

9.

MODULES FOR INTEROPERABILITY CONSTITUENTS

Module H2: Full Quality Management System With Design Examination

1.

2.

3.

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.

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.

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.

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.

4.

4.1.

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:

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.

4.4.

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:

6.

6.1.

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.

6.3.

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.

6.5.

6.6.

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.

8.

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

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.

10.

MODULES FOR INTEROPERABILITY CONSTITUENTS

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

1.

2.

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

3.

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

4.

The programme for the validation by in service experience must include:

5.

5.1.

5.2.

5.3.

5.4.

5.5.

5.6.

5.7.

6.

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

7.

8.

9.

10.

11.

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

12.