Page 14 - CE Marking

PART 3 CE-Marking
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to determine the safety risks for that specific product (see Figure 1).
The modules can be combined with each other in a variety of ways
in order to establish a complete conformity assessment procedure for
each product. Each New Approach directive describes the range and
contents of possible conformity assessment procedures. Moreover,
for each directive the European Union provides a flow chart of the
conformity assessment procedure, which has been designed to help
you decide which modules to use. So before you start testing, take a
good look at the information that is provided. In the CBI’sAccessGuide
database you will find a document on each directive, including a link
to the EU flow chart.
Figure 1 : All of the New Approach directives include the same conformity assessment
procedure. It is subdivided into eight modules described here.
Source : Guide for the implementation of Directives based on the New Approach and the Global
Approach, European Communities, 2000.
Covers the production phase and follows module B. Derives from
quality assurance standard EN ISO 9002, with the intervention of
a notified body responsible for approving and controlling the quality
system for production, final product inspection and testing set up by
the manufacturer.
Covers the production phase and follows module B. Derives from
quality assurance standard EN ISO 9003, with the intervention of
a notified body responsible for approving and controlling the quality
system for production, final product inspection and testing set up by
the manufacturer.
Covers the production phase and follows module B. A notified
body controls conformity to the type as described in the EC type-
examination certificate issued according to module B, and issues a
certificate of conformity.
Covers the design and production phases. Each individual product
is examined by a notified body, which issues a certificate of
conformity.
Covers the design and production phases.
Derives from quality assurance standard EN ISO 9001, with the
intervention of a notified body responsible for approving and controlling
the quality system for design, manufacture, final product inspection
and testing set up by the manufacturer.
C.
Conformity to
D.
Production
quality
F. Product
verification
A. Internal control
of production
B. EC type-
examination
E. Product quality
assurance
G. Unit verification
H. Full quality
assurance
Covers internal design and production control. This module does
not require a notified body to take action.
Covers the design phase, and must be followed by a module providing
for assessment in the production phase. A notified body issues the
EC type-examination certificate.
Covers the production phase and follows module B. Provides for
conformity with the type as described in the EC type-examination
certificate issued according to module B. This module does not require
the intervention of a notified body.