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There are currently no known outstanding effects for the Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) (Text with EEA relevance) (2010/713/EU) (revoked).
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Article 7.Subsidiaries of and subcontracting by notified bodies
MODULES FOR CONFORMITY ASSESSMENT OF INTEROPERABILITY CONSTITUENTS
Module CA1. Internal production control plus product verification by individual examination
Module CA2. Internal production control plus product verification at random intervals
Module CB. EC-type examination
1. EC-type examination is the part of a conformity assessment procedure...
2. EC-type examination may be carried out in either of the...
3. The manufacturer shall lodge an application for EC-type examination with...
5. The notified body shall draw up an evaluation report that...
7. The manufacturer shall inform the notified body that holds the...
8. Each notified body shall inform its notifying authorities concerning the...
9. The manufacturer shall keep a copy of the EC-type examination...
10. The manufacturer’s authorised representative may lodge the application referred to...
Module CC. Conformity to type based on internal production control
Module CD. Conformity to type based on quality management system of the...
1. Conformity to type based on quality management system of the...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure that the interoperability constituents...
3.3. The notified body shall assess the quality management system to...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
4. Surveillance under the responsibility of the notified body
6. The manufacturer shall, for the period defined in the relevant...
7. Each notified body shall inform its notifying authorities of quality...
Module CH. Conformity based on full quality management system
1. Conformity based on full quality management system is the conformity...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure compliance of the interoperability...
3.3. The notified body shall assess the quality management system to...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
4. Surveillance under the responsibility of the notified body
6. The manufacturer shall, for the period defined in the relevant...
7. Each notified body shall inform its notifying authorities of quality...
Module CH1. Conformity based on full quality management system plus design examination...
1. Conformity based on full quality management system plus design examination...
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality management system shall ensure compliance of the interoperability...
3.3. The notified body shall assess the quality management system to...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
3.6. Each notified body shall inform its notifying authorities of quality...
4.1. The manufacturer shall lodge an application for examination of the...
4.2. The application shall make it possible to understand the design,...
4.3. The notified body shall examine the application, and where the...
4.4. The manufacturer shall keep the notified body that has issued...
4.5. Each notified body shall inform its notifying authorities of the...
5. Surveillance under the responsibility of the notified body
7. The manufacturer shall, for the period defined in the relevant...
MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS
Module CV. Type validation by in-service experience (suitability for use)
1. Type validation by in-service experience is the part of assessment...
2. The manufacturer shall lodge an application for type validation by...
3. The technical documentation shall make it possible to assess the...
4. The programme for the validation by in-service experience shall include:...
7. The manufacturer shall inform the notified body that holds the...
8. Each notified body shall inform its notifying authorities concerning the...
9. Each notified body shall inform the other notified bodies concerning...
10. The Commission, the Member States and the other notified bodies...
MODULES FOR EC VERIFICATION OF SUBSYSTEMS
Module SB. EC-type examination
1. EC-type examination is the part of an EC verification procedure...
3. The applicant shall lodge an application for EC-type examination with...
6. The notified body shall draw up an evaluation report that...
7. Where the type meets the requirements of the relevant TSI(s)...
8. The applicant shall inform the notified body that holds the...
9. Each notified body shall inform its notifying authorities concerning the...
10. The applicant shall keep a copy of the EC-type examination...
11. The applicant’s authorised representative may lodge the application referred to...
Module SD. EC verification based on quality management system of the production...
1. EC verification based on quality management system of the production...
3.1. The applicant shall lodge an application for assessment of the...
3.2. The quality management system shall ensure that the subsystem is...
3.3. The notified body shall assess the quality management system to...
3.4. The applicant shall undertake to fulfil the obligations arising out...
3.5. The applicant shall keep the notified body that has approved...
4. Each notified body shall inform its notifying authorities of quality...
6. When the subsystem referred to in point 5.1 is subject...
7. Surveillance under the responsibility of the notified body
7.1. The purpose of surveillance is to make sure that the...
7.2. The applicant shall, for periodic audits purposes, allow the notified...
7.3. The notified body shall carry out periodic audits to make...
7.4. In addition, the notified body may pay unexpected visits to...
7.5. The notified body responsible for the EC verification of the...
8. EC certificate of verification and EC declaration of verification
9. The applicant shall, throughout the service life of the subsystem,...
10. Each notified body shall inform its notifying authorities of EC...
Module SF. EC verification based on product verification
1. EC verification based on product verification is the part of...
3. The applicant shall lodge an application for the EC verification...
4.1. The notified body chosen by the applicant shall first examine...
4.2. All subsystems shall be individually examined and appropriate tests set...
4.3. The notified body shall agree with the applicant the locations...
4.4. When the subsystem referred to in point 3 is subject...
4.5. The notified body shall issue an EC certificate of verification...
6. Each notified body shall inform its notifying authorities of EC...
Module SH1. EC verification based on full quality management system plus design...
1. EC verification based on full quality management system plus design...
3.1. The applicant shall lodge an application for assessment of the...
3.2. The quality management system shall ensure compliance of the subsystem...
3.3. The notified body shall assess the quality management system to...
3.4. The applicant shall undertake to fulfil the obligations arising out...
3.5. The applicant shall keep the notified body that has approved...
3.6. Each notified body shall inform its notifying authorities of quality...
4.1. The applicant shall lodge an application for EC verification of...
4.2. The application shall make it possible to understand the design,...
4.3. When the subsystem referred to in point 4.1 is subject...
4.4. The notified body shall examine the application, and where the...
4.5. The applicant shall keep the notified body that has issued...
4.6. Each notified body shall inform its notifying authorities of the...
5. Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the...
5.2. The applicant shall, for periodic audits purposes, allow the notified...
5.3. The notified body shall carry out periodic audits to make...
5.4. In addition, the notified body may pay unexpected visits to...
5.5. The notified body responsible for the EC verification of the...
6. EC certificate of verification and EC declaration of verification
7. The applicant shall, throughout the service life of the subsystem,...
8. Each notified body shall inform its notifying authorities of EC...
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