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Decision No 768/2008/EC of the European Parliament and of the CouncilShow full title

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance)

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TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

a

Supplementary requirements which may be used in sectoral legislation.

b

Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement.

c

Except for subclauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 and requirements relating to customer satisfaction and continual improvement.

d

Except for requirements relating to customer satisfaction and continual improvement.

DESIGN
A.Internal production control
B.Type examination
G.Unit verification
H.Full quality assurance
EN ISO 9001:2000d

Manufacturer

  • keeps technical documentation at the disposal of national authorities

Manufacturer submits to notified body

  • technical documentation

  • supporting evidence for the adequacy of the technical design solution

  • specimen(s), representative of the production envisaged, as required

Manufacturer

  • submits technical documentation

Manufacturer

  • operates an approved quality system for design

  • submits technical documentation

Notified body

  • ascertains conformity with essential requirements

  • examines technical documentation and supporting evidence to assess adequacy of the technical design

  • for specimen(s): carries out tests, if necessary

  • issues EC-type examination certificate

Notified body

  • carries out surveillance of the QS

H1

Notified body

  • verifies conformity of designa

  • issues EC-design examination certificatea

PRODUCTION
C.Conformity to type
D.Production quality assurance
E.Product quality assurance
F.Product verification
EN ISO 9001:2000bEN ISO 9001:2000c
A. C.
ManufacturerManufacturerManufacturerManufacturerManufacturerManufacturerManufacturer
  • declares conformity with essential requirements

  • affixes required conformity marking

  • declares conformity with approved type

  • affixes required conformity marking

  • operates an approved quality system for production, final inspection and testing

  • declares conformity with approved type

  • affixes required conformity marking

  • operates an approved quality system for final inspection and testing

  • declares conformity with approved type

  • affixes required conformity marking

  • declares conformity with approved type

  • affixes required conformity marking

  • submits product

  • declares conformity

  • aAffixes required conformity marking

  • operates an approved QS for production, final inspection and testing

  • declares conformity

  • affixes required conformity marking

A1. C1. D1. E1. F1.
Accredited in-house bodyAccredited in-house bodydeclares conformity to essential requirementsdeclares conformity to essential requirementsdeclares conformity to essential requirements

or notified body

  • tests on specific aspects of the producta

or notified body

  • tests on specific aspects of the producta

  • affixes required conformity marking

  • affixes required conformity marking

  • affixes required conformity marking

Notified bodyNotified bodyNotified bodyNotified bodyNotified body

A2.

  • Product checks at random intervalsa

C2.

  • Product checks at random intervalsa

  • approves the QS

  • carries out surveillance of the QS

  • approves the QS

  • carries out surveillance of the QS

  • verifies conformity to essential requirements

  • issues certificate of conformity

  • verifies conformity to essential requirements

  • issues certificate of conformity

  • carries out surveillance of the QS

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