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)
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions
Article 4
Conformity assessment procedures
Article 5
Procedure for assessment of suitability for use
Article 6
EC verification procedures
Article 7
Subsidiaries of and subcontracting by notified bodies
Article 8
Application
Article 9
Addressees
ANNEX I
Modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability
MODULES FOR CONFORMITY ASSESSMENT OF INTEROPERABILITY CONSTITUENTS
Module CA.
Internal production control
2. Technical documentation
3. Manufacturing
4. EC declaration of conformity
5. Authorised representative
Module CA1.
Internal production control plus product verification by individual examination
2. Technical documentation
3. Manufacturing
4. Product checks
5. EC certificate of conformity
6. EC declaration of conformity
7. Authorised representative
Module CA2.
Internal production control plus product verification at random intervals
2. Technical documentation
3. Manufacturing
4. Product checks
5. EC certificate of conformity
6. EC declaration of conformity
7. Authorised representative
Module CB.
EC-type examination
Module CC.
Conformity to type based on internal production control
2. Manufacturing
3. EC declaration of conformity
4. Authorised representative
Module CD.
Conformity to type based on quality management system of the production process
2. Manufacturing
3. Quality management system
4. Surveillance under the responsibility of the notified body
5. EC declaration of conformity
8. Authorised representative
Module CF.
Conformity to type based on product verification
2. Manufacturing
3. Verification
4. Verification of conformity by examination and testing of every interoperability constituent.
5. Statistical verification of conformity
6. EC declaration of conformity
7. Authorised representative
Module CH.
Conformity based on full quality management system
2. Manufacturing
3. Quality management system
4. Surveillance under the responsibility of the notified body
5. EC declaration of conformity
8. Authorised representative
Module CH1.
Conformity based on full quality management system plus design examination
2. Manufacturing
3. Quality management system
4. Design examination
5. Surveillance under the responsibility of the notified body
6. EC declaration of conformity
8. Authorised representative
MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS
Module CV.
Type validation by in-service experience (suitability for use)
5. Type validation by in-service experience
11. EC declaration of suitability for use
12. Authorised representative
MODULES FOR EC VERIFICATION OF SUBSYSTEMS
Module SB.
EC-type examination
Module SD.
EC verification based on quality management system of the production process
2. Manufacturing
3. Quality management system
5. EC verification
7. Surveillance under the responsibility of the notified body
8. EC certificate of verification and EC declaration of verification
9. The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
11. Authorised representative
Module SF.
EC verification based on product verification
2. Manufacturing
3. The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
4. EC verification
5. EC declaration of verification
7. Authorised representative
Module SG.
EC verification based on unit verification
2. The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
3. Technical documentation
4. Manufacturing
5. EC verification
6. EC declaration of verification
8. Authorised representative
Module SH1.
EC verification based on full quality management system plus design examination
2. Manufacturing
3. Quality management system
4. EC verification
5. Surveillance under the responsibility of the notified body
6. EC certificate of verification and EC declaration of verification
7. The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
9. Authorised representative
ANNEX II
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 |
ANNEX III
Decisions 2008/164/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 |