- Latest available (Revised)
- Original (As adopted by EU)
After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.
The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.
This is the original version (as it was originally adopted).
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the TSI. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, maintenance and operation of the interoperability constituent.
Wherever applicable, the technical documentation shall give evidence that the design of the interoperability constituent, already accepted before the implementation of the applicable TSI is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use.
The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the interoperability constituents with the technical documentation referred to in point 2 and with the requirements of the TSI that apply to them.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the TSI.
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, maintenance and operation of the interoperability constituent.
Wherever applicable, the technical documentation shall also give evidence that the design of the interoperability constituent, already accepted before the implementation of the applicable TSI is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use.
The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the interoperability constituents with the technical documentation referred to in point 2 and with the requirements of the TSI that apply to them.
For each individual product manufactured, one or more tests on one or more specific aspects of the interoperability constituent shall be carried out in order to verify conformity with the type described in the technical documentation and the requirements of the TSI. At the choice of the manufacturer, the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer.
The notified body shall issue an EC certificate of conformity in respect of the examinations and tests carried out.
The manufacturer shall keep the EC certificates of conformity available for inspection by the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out in point 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the TSI. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, maintenance and operation of the interoperability constituent.
Wherever applicable, the technical documentation shall also give evidence that the design of the interoperability constituent, already accepted before the implementation of the applicable TSI is in accordance with the TSI and that the interoperability constituent has been used in service in the same area of use.
The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the interoperability constituents with the technical documentation referred to in point 2 and with the requirements of the TSI that apply to them.
The notified body shall issue an EC certificate of conformity in respect of the examinations and tests carried out.
The manufacturer shall keep the EC certificates of conformity available for inspection by the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out in point 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
examination of a specimen, representative of the production envisaged, of the interoperability constituent (production type),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the interoperability constituent (combination of production type and design type),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation. The technical documentation shall make it possible to assess the interoperability constituent’s conformity with the applicable requirements of the TSI. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, maintenance and operation of the interoperability constituent. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports,
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme,
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
For the interoperability constituent:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the interoperability constituent with the requirements of the relevant TSI.
For the specimen(s):
verify that the specimen(s) have been manufactured in conformity with the requirements of the TSI and the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;
carry out appropriate examination and test, or have them carried out, to check whether requirements of the TSI have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding requirements of the TSI;
agree with the manufacturer on a location where the examinations and tests will be carried out.
The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituents with the examined type to be evaluated.
Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI that apply to them.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The certificate to be referred to is:
the EC type-examination certificate and its additions.
The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall operate an approved quality management system for production, final product inspection and testing of the interoperability constituents concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
all relevant information for the interoperability constituent category envisaged,
the documentation concerning the quality management system,
the technical documentation of the approved type and a copy of the EC-type examination certificate.
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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
the means of monitoring the achievement of the required product quality and the effective operation of the quality management system.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standard that implements the relevant quality management standard, harmonised standard and/or technical specification.
When the manufacturer operates a certified quality management system certified by an accredited certification body, for the manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment. In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the interoperability constituent only. The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, second paragraph, fifth indent, to verify the manufacturer’s ability to identify the requirements of the TSI and to carry out the necessary examinations with a view to ensuring compliance of the interoperability constituent with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality management system documentation,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The frequency of the periodic audits shall be at least once every 2 years.
When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The certificates to be referred to are:
the quality management system approval indicated in point 3.3 and audit reports indicated in point 4.3, if any,
the EC type-examination certificate and its additions.
the documentation referred to in point 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality management system approvals which it has issued.
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI that apply to them.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI.
The examinations and tests to check the conformity of the interoperability constituents with the requirements of the TSI shall be carried out, at the choice of the manufacturer either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of the interoperability constituents on a statistical basis as specified in point 5.
The manufacturer shall keep the EC certificates of conformity available for inspection by the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
The notified body shall issue an EC certificate of conformity in respect to the examinations and tests carried out.
The manufacturer shall keep the EC certificates of conformity at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The certificates to be referred to are:
the EC type-examination certificate and its additions,
the EC certificate of conformity referred to in point 4.2 or point 5.3.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 2, 5.1 and 5.2.
The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
the technical documentation for one model of each category of interoperability constituents intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports,
the documentation concerning the quality management system, and
a written declaration that the same application has not been lodged with any other notified body.
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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the interoperability constituents will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality management system.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standard that implements the relevant quality management standard, harmonised standard and/or technical specification.
When the manufacturer operates a certified quality management system certified by an accredited certification body, for the design and manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment. In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the interoperability constituent only. The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the requirements of the TSI and to carry out the necessary examinations with a view to ensuring compliance of the interoperability constituent with those requirements.
The manufacturer or his authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality management system documentation,
the quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc., and
the quality records as provided for by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The frequency of the periodic audits shall be at least once every 2 years.
When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The certificate to be referred to is:
the quality management system approval indicated in point 3.3 and audit reports indicated in point 4.3, if any.
the technical documentation referred to in point 3.1,
the documentation concerning the quality management system referred to in point 3.1,
the change referred to in point 3.5, as approved, and
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality management system approvals which it has issued.
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the interoperability constituents shall have been examined in accordance with point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
all relevant information for the interoperability constituent category envisaged,
the documentation concerning the quality management system, and
a written declaration that the same application has not been lodged with any other notified body.
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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the requirements of the TSI that apply to the interoperability constituents will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality management system.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standard that implements the relevant quality management standard, harmonised standard and/or technical specification.
When the manufacturer operates a certified quality management system certified by an accredited certification body, for the design and manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment. In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the interoperability constituent only. The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI. The audit shall include an assessment visit to the manufacturer’s premises.
The manufacturer or his authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality management system approvals which it has issued.
the name and address of the manufacturer,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation. The technical documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the relevant TSI. The technical documentation shall specify the requirements and cover, as far as relevant for the assessment, the design and operation of the interoperability constituent. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation (including conditions for use) and maintenance of the interoperability constituent,
conditions of integration of the interoperability constituent in its system environment (sub-assembly, assembly, subsystem) and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the TSI where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports,
the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituent s with the examined design to be evaluated.
Where the design does not satisfy the requirements of the TSI, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Each notified body shall inform the other notified bodies of the EC design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.
The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.
the quality management system documentation,
the quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,
the quality records as provided for by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The frequency of the periodic audits shall be at least once every 2 years.
When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.
A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
The certificates to be referred to are:
the quality management system approval indicated in point 3.3 and audit reports indicated in point 5.3, if any,
the EC design examination certificate indicated in point 4.3 and its additions.
the documentation concerning the quality management system referred to in point 3.1,
the change referred to in point 3.5, as approved, and
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.
The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation referred to in point 3,
the programme for validation by in-service experience, as described in point 4,
the name and address of the company(ies) (infrastructure managers and/or railway undertaking), with which the applicant has obtained an agreement to contribute to a suitability for use assessment by in-service experience:
by operating the interoperability constituent in service,
by monitoring the in-service behaviour, and
by issuing a report about in-service experience,
the name and the address of the company undertaking the maintenance of the interoperability constituent during the time period or running distance required for in-service experience, and
the EC type examination certificate when module CB was used for design phase, or EC design examination certificate when module CH1 was used for design phase.
The manufacturer shall place at the disposal of the company(ies), undertaking the operation of the interoperability constituent in service, a specimen or a sufficient number of specimens, representative of the production envisaged and hereinafter called ‘type’. A type may cover several versions of the interoperability constituent provided that the differences between the versions are all covered by EC certificates as mentioned above.
The notified body may request further specimens if needed for carrying out the validation by in-service experience.
The technical documentation shall contain the following elements:
the technical documentation specified in point 9 of Module CB or in point 4.6 of Module CH1,
conditions for use and maintenance of the interoperability constituent (e.g. restrictions of running time or distance, wear limits, etc.).
If the TSI requires further information for the technical documentation, this shall be included.
the required performance or behaviour in service of the interoperability constituent under trial,
the installation arrangements,
the duration of the programme — either time or distance,
the operating conditions and the service programme expected,
the maintenance programme,
the special in-service tests, if any, to be performed,
the batch size of the specimens — if more than one,
the inspection programme (nature, number and frequency of inspections, documentation),
criteria for tolerable defects and their impact on the programme,
the information to be included in the report of the company(ies) operating the interoperability constituent in service (see point 2, fifth indent).
The notified body shall:
examine the technical documentation and the programme for validation by in-service experience;
verify that the type is representative and has been manufactured in conformity with the technical documentation;
verify that the programme for validation by in-service experience is well adapted to assess the required performance and in-service behaviour of the interoperability constituents;
agree with the applicant and the company(ies) undertaking the operation of the interoperability constituent referred to in point 2 the programme and the location where the inspections will be carried out and if necessary, the test(s) and the body performing the test(s);
monitor and inspect the progress of in-service running, operation and maintenance of the interoperability constituent;
assess the report, to be issued by the company(ies) undertaking the operation the interoperability constituent referred to in point 2, and all other documentation and information, collected during the procedure (test reports, maintenance experience etc.);
evaluate whether the in-service behaviour results meet the requirements of the TSI.
A list of the relevant parts of the technical documentation shall be annexed to the EC certificate of suitability for use and a copy kept by the notified body.
Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC certificate of suitability for use and shall inform the applicant accordingly, giving detailed reasons for its refusal.
A copy of the EC declaration of suitability for use shall be made available to the relevant authorities upon request.
The certificate to be referred to is:
EC certificate of suitability for use.
EC declaration of suitability for use referred to in point 11.1, and
EC declaration of conformity.
The manufacturer’s obligations set out in points 2, 7 and 11.1 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
assessment of the adequacy of the technical design of the subsystem through examination of the technical documentation and supporting evidence referred to in point 3 (design type), and
examination of a specimen, representative of the production envisaged, of the complete subsystem (production type).
A type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the relevant TSI(s).
The application shall include:
the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation. The technical documentation shall make it possible to assess the subsystem’s conformity with the requirements of the relevant TSI(s). The technical documentation shall specify the requirements of the relevant TSI(s) and cover, as far as relevant for the EC-type examination procedure, the design, manufacture and operation of the subsystem. The technical documentation shall contain the following elements:
a general description of the subsystem, its overall design and structure,
documents necessary for the compilation of the technical file as described in point 4 of Annex VI to Directive 2008/57/EC,
a separate file with the set of data required by the TSI(s) for each relevant register provided for in Articles 34 and 35 of Directive 2008/57/EC,
copy of EC declaration(s) of intermediate statement of verification (hereinafter referred to as ISV) issued for the subsystem according to point 2 of Annex VI to Directive 2008/57/EC, if any,
if relevant, descriptions and explanations necessary for the understanding of the operation and maintenance of the subsystem,
conditions of integration of the subsystem in its system environment and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the relevant TSI(s) where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc.,
test programme and reports,
evidence of conformity with other regulations deriving from the Treaty (including certificates, if any),
supporting 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 on maintenance of the subsystem,
any technical requirement specified in the relevant TSI(s) that shall be taken into account during production, maintenance or operation of the subsystem,
all other appropriate technical evidences, which demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by competent bodies, and
any further information, if required by the relevant TSI(s),
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme,
a specimen or specimens of a sub-assembly or assembly or a specimen of the subsystem in a pre-assembled condition shall be provided, if so required for specific test or examination methods and specified in the relevant TSI(s),
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate testing body of the applicant, or by another testing body on his behalf and under his responsibility.
For the design type:
examine the technical documentation and supporting evidence to assess whether the technical design of the subsystem is adequate to fulfil the requirements of the relevant TSI(s);
where a design review is requested in the relevant TSI(s), examine design methods, the design tools and the design results to assess compliance with the requirements of the relevant TSI(s).
For the production type:
verify that the specimen(s) have been manufactured in conformity with the requirements of the relevant TSI(s) and with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant TSI(s), harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the applicant has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding requirements of the relevant TSI(s);
agree with the applicant on a location where the examinations and tests will be carried out.
The applicant shall also provide the notified body with a precise reference to the TSI(s) (or their parts) for which the derogation is requested.
The applicant shall communicate to the notified body the outcome of the derogation procedure.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems with the examined type to be evaluated.
Where the type does not satisfy the requirements of the relevant TSI(s), the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Where the subsystem referred to in point 3 is subject to derogation, upgrade, renewal or specific case, the EC-type examination certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts of the subsystem are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
The applicant shall draw up a written EC ISV declaration according to section 2 of Annex VI to Directive 2008/57/EC.
Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation intended for the technical file submitted by the applicant, until the expiry of the validity of the certificate.
The production, final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system(s) as specified in point 3, and shall be subject to surveillance as specified in point 7.
The application shall include:
the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the breakdown structure of the project management and the name and address of each involved entity,
all relevant information for the subsystem envisaged,
the documentation concerning the quality management system,
copy of EC ISV declaration(s) issued for the subsystem, if any,
the technical documentation of the approved type and a copy of the EC-type examination certificate and its annexes.
All the elements, requirements and provisions adopted by the applicant shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to subsystem quality,
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
the means of monitoring the achievement of the required subsystem quality and the effective operation of the quality management system.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standard that implements the relevant quality management standard, harmonised standard and/or technical specification.
If the compliance of the subsystem with the requirements of the relevant TSI(s) is based on more than one quality management system, the notified body shall examine in particular:
whether the relations and interfaces between the quality management systems are clearly documented, and
whether overall responsibilities and powers of the management for the compliance of the whole entire subsystem are clearly assigned to and acknowledged by each entity involved in the project.
The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem.
When the applicant operates a certified quality management system certified by an accredited certification body, for the manufacturing and final testing of the relevant subsystem, the notified body shall take this into account in the assessment. In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the subsystem only. The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant subsystem field and product technology concerned, and knowledge of the requirements of the relevant TSI(s). The audit shall include an assessment visit to the premises of the relevant entities concerned. The auditing team shall review the technical documentation referred to in point 3.1, second paragraph, seventh indent, to verify the ability of the relevant entities concerned to identify the requirements of the relevant TSI(s) and to carry out the necessary examinations with a view to ensuring compliance of the subsystem with those requirements.
The decision shall be notified to the applicant. The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the applicant of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality management system approvals which it has issued.
The application shall include:
name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
the technical documentation, regarding the approved type, including the EC 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 documents necessary for the compilation of the technical file as described in point 4 of Annex VI to Directive 2008/57/EC,
a separate file with the set of data required by the relevant TSI(s) for each relevant register provided for in Articles 34 and 35 of Directive 2008/57/EC,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the relevant TSI(s) where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
conditions for use of the subsystem (restrictions of running time or distance, wear limits, etc.),
descriptions and explanations necessary for the understanding of the operation and maintenance of the subsystem,
conditions for maintenance and technical documentation regarding the maintenance of the subsystem,
any technical requirement specified in the relevant TSI(s) that shall be taken into account during production, maintenance or operation of the subsystem,
other appropriate technical evidences, which demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by competent bodies,
conditions of integration of the subsystem in its system environment and the necessary interface conditions with other subsystems,
results of design calculations made, examinations carried out, etc.,
test reports, if any,
documentation regarding the manufacture and the assembly of the subsystem,
a list of manufacturers involved in the subsystem’s manufacturing, assembly and installation,
the demonstration, that the manufacturing and final testing as mentioned under point 2, are covered by quality management system of the applicant and the evidence of its effectiveness,
indication of the notified body, responsible for the approval and surveillance of the quality management system, and
evidence of conformity with other regulations deriving from the Treaty (including certificates, if any),
any further information, if required by the relevant TSI(s).
If the notified body considers the EC type examination certificate no longer remains valid or is not appropriate and that a new EC type examination is necessary, the notified body shall refuse to assess the quality management system of the applicant and shall justify its refusal.
The applicant shall also provide the notified body with a precise reference to the TSI(s) (or their parts) for which the derogation is requested.
The applicant shall communicate to the notified body the outcome of the derogation procedure.
the quality management system documentation,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The frequency of the periodic audits shall be at least once every 2 years.
When the applicant operates a certified quality management system, the notified body shall take this into account during the periodic audits.
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 applicant, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.
This coordination includes the right of the notified body:
to receive all documentation (approval and surveillance), issued by the other notified body(ies),
to witness the surveillance audits as in point 7.3, and
to initiate additional audits as in point 7.4 under its responsibility and together with the other notified body(ies).
Where the subsystem referred to in point 5.1 is subject to derogation, upgrade, renewal or specific case, the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts or certain stages of the subsystem are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
Where the subsystem referred to in point 5.1 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
In case of ISV procedure the applicant shall draw up a written EC ISV declaration.
The EC declaration and the accompanying documents shall be written in accordance with Annex V to Directive 2008/57/EC.
The certificates to be referred to are:
the quality management system approval indicated in point 3.3 and audit reports indicated in point 7.3, if any,
the EC type examination certificate and its additions.
A copy of the EC declaration of verification and EC ISV declaration(s), if any, shall be made available to the relevant authorities upon request.
the documentation referred to in point 3.1,
the change(s) referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 7.3 and 7.4, and
the technical file referred to in point 8.3.
Each notified body shall inform the other notified bodies of EC certificates of verification it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of EC certificates of verification which it has issued.
The applicant’s obligations set out in points 3.1, 3.5, 6, 8.2 and 9 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturing process and its monitoring shall ensure conformity of the manufactured subsystem with the approved type described in the EC-type examination certificate and with the requirements of the relevant TSI(s) that apply to it.
The application shall include:
name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
the technical documentation, regarding the approved type, including the EC type examination certificate and its annexes, as issued after completion of the procedure defined in module SB.
It shall also include the following if it is not already included in the technical documentation:
a general description of the subsystem, its overall design and structure,
the documents necessary for the compilation of the technical file as described in point 4 of Annex VI to Directive 2008/57/EC,
a separate file with the set of data required by the relevant TSI(s) for each relevant register provided for in Articles 34 and 35 of Directive 2008/57/EC,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the relevant TSI(s) where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
conditions for use of the subsystem (restrictions of running time or distance, wear limits, etc.),
descriptions and explanations necessary for the understanding of the operation and maintenance of the subsystem,
conditions for maintenance and technical documentation regarding the maintenance of the subsystem,
any technical requirement specified in the relevant TSI(s) that shall be taken into account during production, maintenance or operation of the subsystem,
other appropriate technical evidences, which demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by competent bodies,
conditions of integration of the subsystem in its system environment and the necessary interface conditions with other subsystems,
evidence of conformity with other regulations deriving from the Treaty (including certificates, if any),
results of design calculations made, examinations carried out, etc.,
test reports,
documentation regarding the manufacture and the assembly of the subsystem,
a list of manufacturers involved in the subsystem’s design, manufacturing, assembly and installation, and
any further information, if required by the relevant TSI(s).
If the notified body considers the EC type examination certificate no longer remains valid or is not appropriate and that a new EC type examination is necessary, the notified body shall refuse to carry out EC verification of the subsystem and shall justify its refusal.
The notified body shall carry out appropriate examinations and tests in order to check the conformity of the subsystem with the approved type described in the EC-type examination certificate and with the requirements of the relevant TSI(s).
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 relevant TSI(s).
The applicant shall also provide the notified body with a precise reference to the TSI(s) (or their parts) for which the derogation is requested.
The applicant shall communicate to the notified body the outcome of the derogation procedure.
Where the subsystem referred to in point 3 is subject to derogation, upgrade, renewal or specific case the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts or certain stages of the subsystem are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
The applicant shall keep the EC certificate of verification available for inspection by the national authorities throughout the service life of the subsystem.
Where the subsystem referred to in point 3 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
In case of ISV procedure the applicant shall draw up a written EC ISV declaration.
The EC declaration and the accompanying documents shall be written in accordance with Annex V to Directive 2008/57/EC.
A copy of the EC declaration of verification and EC ISV declarations, if any, shall be made available to the relevant authorities upon request.
Each notified body shall inform the other notified bodies of EC certificates of verification it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of EC certificates of verification which it has issued.
The applicant’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the applicant’s obligations set out in point 2.
The application shall include:
name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well, and
the technical documentation.
The applicant shall establish the technical documentation and make it available to the notified body referred to in point 5. The documentation shall make it possible to assess the subsystem’s conformity with the requirements of the relevant TSI(s). The technical documentation shall specify the requirements and cover, as far as relevant for the assessment, the design, manufacture, installation/construction and operation of the subsystem.
The technical documentation shall, wherever applicable, contain the following elements:
a general description of the subsystem, its overall design and structure,
the documents necessary for the compilation of the technical file as described in point 4 of Annex VI to Directive 2008/57/EC,
a separate file with the set of data required by the relevant TSI(s) for each relevant register provided for in Articles 34 and 35 of Directive 2008/57/EC,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the relevant TSI(s) where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
conditions for use of the subsystem (restrictions of running time or distance, wear limits, etc.),
descriptions and explanations necessary for the understanding of the operation and maintenance of the subsystem,
conditions for maintenance and technical documentation regarding the maintenance of the subsystem,
any technical requirement specified in the relevant TSI(s) that shall be taken into account during production, maintenance or operation of the subsystem,
other appropriate technical evidences, which demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by competent bodies,
conditions of integration of the subsystem in its system environment and the necessary interface conditions with other subsystems,
evidence of conformity with other regulations deriving from the Treaty (including certificates, if any),
conceptual design and manufacturing and construction drawings and schemes of components, sub-assemblies, circuits,
descriptions and explanations necessary for the understanding of those drawings,
results of design calculations made, examinations carried out, etc.,
test reports,
documentation regarding the manufacture and the assembly of the subsystem,
a list of manufacturers involved in the subsystem’s design, manufacturing, assembly and installation, and
any further information, if required by the relevant TSI(s).
The applicant shall keep the technical documentation at the disposal of the relevant national authorities throughout the service life of the subsystem.
The applicant shall take all measures necessary so that the manufacturing and/or installation/construction process and its monitoring ensure conformity of the subsystem with the requirements of the relevant TSI(s).
The examinations, tests and checks shall be carried out at the stages provided in point 2 of Annex VI to Directive 2008/57/EC.
The notified body may take into account evidence of examinations, checking or tests that have been successfully performed, under comparable conditions by other bodies(1) or, when this is specified by the relevant TSI(s), by (or on the behalf of) the applicant. The notified body will then decide as to whether it shall use the results of these checks or tests.
The evidences gathered by the notified body shall be suitable and sufficient to show the conformity with the requirement of the relevant TSI(s) and that all required and appropriate checks and tests have been carried out.
The extent to which the evidence originating from other parties is taken into account by the notified body shall be justified by documented analysis using the factors listed in the following paragraph.
the use of existing equipment and systems:
used identically as before,
used before but adapted for use in the new work,
the use of existing designs, technologies, materials and production techniques,
the arrangements for design, production, testing and commissioning,
previous approvals from other competent bodies,
the accreditations of other involved bodies:
it is permissible for the notified body to take account of valid accreditation to relevant European standards, provided that no conflict of interest exists, that accreditation covers the testing being performed and that accreditation is current,
where no formal accreditation exists, the notified body shall confirm that the systems for control of competence, independence, testing and material handling processes, facilities and equipment and other processes relevant to the contribution to the subsystem are controlled,
in all cases, the notified body shall consider the appropriateness of the arrangements and decide the level of witnessing required.
In all cases, the notified body keeps the responsibility of final results of the examinations, tests and checks.
The applicant shall also provide the notified body with a precise reference to the TSI(s) (or their parts) for which the derogation is requested.
The applicant shall communicate to the notified body the outcome of the derogation procedure.
Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts or certain stages of the subsystem are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
In case of ISV procedure the applicant shall draw up a written EC ISV declaration.
The EC declaration and the accompanying documents shall be written in accordance with Annex V to Directive 2008/57/EC.
A copy of the EC declaration of verification and/or EC ISV declarations, if any, shall be made available to the relevant authorities upon request.
The applicant shall keep a copy of the technical file throughout the service life of the subsystem; it shall be sent to any other Member State which so requests.
Each notified body shall inform the other notified bodies of EC certificates of verification it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of EC certificates of verification which it has issued.
The applicant’s obligations set out in points 2, 3, 5.3, 5.4, 6.2 and 6.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The design, manufacture and final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system(s) as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the subsystem shall have been examined in accordance with point 4.
The application shall include:
the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well,
the breakdown structure of the project management and the name and address of each involved entity,
all relevant information for the subsystem envisaged,
the documentation concerning the quality management system,
copy of EC ISV declaration(s) issued for the subsystem, if any, and
a written declaration that the same application has not been lodged with any other notified body.
All the elements, requirements and provisions adopted by the applicant shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and subsystem quality,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the requirements of the relevant TSI(s) 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 pertaining to the product category covered,
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
the means of monitoring the achievement of the required design and subsystem quality and the effective operation of the quality management system.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standards that implements the relevant quality management standard, harmonised standard and/or technical specifications.
If the compliance of the subsystem with the requirements of the relevant TSI(s) is based on more than one quality management system, the notified body shall examine in particular:
whether the relations and interfaces between the quality management systems are clearly documented, and
whether overall responsibilities and powers of the management for the compliance of the whole entire subsystem are clearly assigned to and acknowledged by each entity involved in the project.
The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem.
When the applicant operates a certified quality management system certified by an accredited certification body for the design, manufacturing and final testing of the relevant subsystem, the notified body shall take this into account in the assessment. In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the subsystem only. The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant subsystem field and product technology concerned, and knowledge of the requirements of the relevant TSI(s). The audit shall include an assessment visit to the premises of the relevant entities concerned.
The applicant or his authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the applicant of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality management system approvals which it has issued.
the name and address of the applicant,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation. The documentation shall make it possible to assess the subsystem’s conformity with the requirements of the relevant TSI(s). The technical documentation shall specify the requirements of the relevant TSI(s) and cover, as far as relevant for the assessment, the design and operation of the subsystem. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of subsystem, its overall design and structure,
documents necessary for the compilation of the technical file as described in point 4 of Annex VI to Directive 2008/57/EC,
a separate file with the set of data required by the relevant TSI(s) for each relevant register provided for in Articles 34 and 35 of Directive 2008/57/EC,
if relevant, descriptions and explanations necessary for the understanding of the operation and maintenance of the subsystem,
conditions of integration of the subsystem in its system environment and the necessary interface conditions,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the relevant TSI(s) where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc.,
test programme and reports,
evidence of conformity with other regulations deriving from the Treaty (including certificates, if any),
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 on maintenance of the subsystem,
any technical requirement specified in the relevant TSI(s) that shall be taken into account during production, maintenance or operation of the subsystem,
all other appropriate technical evidences, which demonstrate that previous checking or tests have been successfully performed, under comparable conditions, by competent bodies, and
any further information, if required by the relevant TSI(s),
the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests (including those in operational conditions) carried out by the appropriate testing body of the applicant, or by another testing body on his behalf and under his responsibility.
The applicant shall also provide the notified body with a precise reference to the TSI(s) or their parts for which the derogation is requested.
The applicant shall communicate to the notified body the outcome of the derogation procedure.
The certificate and its annexes shall contain all relevant information to allow the conformity of the subsystem with the examined design to be evaluated.
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC design examination certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
Where the design does not satisfy the requirements of the relevant TSI(s), the notified body shall refuse to issue an EC design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
The applicant shall draw up a written EC ISV declaration according to section 2 of Annex VI to Directive 2008/57/EC.
Each notified body shall inform the other notified bodies of the EC design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.
The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the applicant until the expiry of the validity of the certificate.
the quality management system documentation,
the quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,
the quality records as provided for by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The frequency of the periodic audits shall be at least once every 2 years, 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 design examination referred to in point 4.4.
When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.
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 applicant, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.
This coordination includes the right of the notified body:
to receive all documentation (approval and surveillance), issued by the other notified body(ies),
to witness the surveillance audits referred to in point 5.2,
to initiate additional audits referred to in point 5.3 under its responsibility and together with the other notified body(ies).
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
If only certain parts or certain stages of the subsystem are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
In case of ISV procedure the applicant shall draw up a written EC ISV declaration.
The EC declaration and the accompanying documents shall be written in accordance with Annex V to Directive 2008/57/EC.
The certificates to be referred to are:
the quality management system approval referred to in point 3.3 and audit reports indicated in point 5.3, if any,
the EC design examination certificate referred to in point 4.4 and its additions.
A copy of the EC declaration of verification and EC ISV declarations, if any, shall be made available to the relevant authorities upon request.
the documentation concerning the quality management system referred to in point 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4, and
the technical file referred to in 6.3.
Each notified body shall inform the other notified bodies of EC certificates of verification it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of EC certificates of verification which it has issued.
The applicant’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.3, 4.5, 4.7, 6.2 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.
Decision No 768/2008/EC | This Decision | Module in this Decision |
---|---|---|
product | interoperability constituent | CA, CA1, CA2, CB, CC, CD, CF, CH, CH1 |
product | subsystem | SB, SD, SF, SG, SH1 |
legislative instrument | technical specification for interoperability | CA, CA1, CA2, CB, CC, CD, CF, CH, CH1 |
legislative instrument | relevant TSI(s) as well as any other regulations deriving from the Treaty;relevant TSI(s) | SB, SD, SF, SG, SH1 |
quality system | quality management system | CD, CH, CH1, SD, SH1 |
quality assurance | quality management system | CD, CH, CH1, SD, SH1 |
conformity (assessment) | EC verification | SB, SD, SF, SG, SH1 |
manufacturer | applicant | SB, SD, SF, SG, SH1 |
certificate of conformity | EC certificate of verification | SD, SF, SG, SH1 |
declaration of conformity | EC declaration of verification | SD, SF, SG, SH1 |
Decisions2008/164/EC, 2008/163/EC, 2008/217/EC, 2008/284/EC, 2006/860/EC, 2008/232/EC, 2006/679/EC, 2006/66/EC, 2006/861/EC | Decision No 768/2008/EC | This Decision |
---|---|---|
Module A. Internal production control | Module A. Internal production control | Module CA. Internal production control |
Module A1. Internal design control with product verification | Module A1. Internal production control plus supervised product testing | Module CA1. Internal production control plus product verification by individual examination |
Module A2. Internal production control plus supervised product checks at random intervals | Module CA2. Internal production control plus product verification at random intervals | |
Module B. Type examination | Module B. EC-type examination | Module CB. EC-type examination |
Module C. Conformity to type | Module C. Conformity to type based on internal production control | Module CC. Conformity to type based on internal production control |
Module C1. Conformity to type based on internal production control plus supervised product testing | ||
Module C2. Conformity to type based on internal production control plus supervised product checks at random intervals | ||
Module D. Production quality management system | Module D. Conformity to type based on quality assurance of the production process | Module CD. Conformity to type based on quality management system of the production process |
Module D1. Quality assurance of the production process | ||
Module E. Conformity to type based on product quality assurance | ||
Module E1. Quality assurance of final product inspection and testing | ||
Module F. Product verification | Module F. Conformity to type based on product verification | Module CF. Conformity to type based on product verification |
Module F1. Conformity based on product verification | ||
Module G. Conformity based on unit verification | ||
Module H1. Full quality management system | Module H. Conformity based on full quality assurance | Module CH. Conformity based on full quality management system |
Module H2. Full quality management system with design examination | Module H1. Conformity based on full quality assurance plus design examination | Module CH1. Conformity based on full quality management system plus design examination |
Module V. Type validation by in-service experience (suitability for use) | Module CV. Type validation by in-service experience (suitability for use) | |
Module SB. Type examination | Module SB. EC-type examination | |
Module SD. Product(ion) quality management system | Module SD. EC verification based on quality management system of the production process | |
Module SF. Product verification | Module SF. EC verification based on product verification | |
Module SG. Unit verification | Module SG. EC verification based on unit verification | |
Module SH2. Full quality management system with design examination | Module SH1. EC verification based on full quality management system plus design examination |
The conditions to entrust checking and test must be similar to the conditions, respected by a notified body to subcontract activities (see §6.5 of the Blue Guide on the New Approach).
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