Modules of Conformity Assessment

Standardisation, regulation, worldwide strategies
Modules of conformity assessment
Conformity Assessment modules

and CE marking: The context
Free Movement of Goods is one of the pillars of the Single
Market
It is confronted to Tariff and Non-Tariff Barriers
It requires a common regulatory framework
It requires adequate Certification & Testing infrastructures
Context
In case of Candidate countries, they should adopt the Acquis

Communautaire in the field of free movement of goods
It includes:
The Old Approach Directives
The New Approach Directives
Directive 83/189/EEC, which is a tool, which prevent the adoption of
national technical regulations and standards creating new Barriers to Trade
General Product Safety & Liability Directives

...
Non Harmonised Area

Old Approach
A product recognised and approved in one EC country
should also be imported and sold in other EC countries
without the need for any additional approval
Separate directive for each product
Creation of certification and authorisation structures
Mandatory pre-market control
Covers Food stuff, Pharmaceuticals, Chemicals, Cosmetics,
Textile & Motor Vehicles
Harmonised Area (1)

New Approach Principles
Legislative harmonisation is limited to essential
requirements that products placed on the Community
market must meet, if they are to benefit from free movement
within the Community
The technical specifications of products meeting the
essential requirements set out in the directives will be laid
down in harmonised standards
Harmonised Area (2)

New Approach Principles
Application of harmonised or other standards remains
voluntary, and the manufacturer may always apply other
technical specifications
Products manufactured in compliance with harmonised
standards benefit from a presumption of conformity with
the corresponding essential requirements
Supplier Declaration
Sampling post-market control
New Approach / Global Approach (1)
Every New Approach directive

will use refer to determined
modules in accordance with
the level of possible risk
The Global approach
provides 8 different modules
(design and production
phases) to perform
conformity assessment
New Approach / Global Approach (2)

The Global Approach lays down the general guidelines and
procedures (modules) for conformity assessment that are to be
used in New Approach directives
<= T & C follow the

modules to perform
CA
Conformity assessment procedures of the

new approach : the modules
Module
Type examination
Module
Module
Internal
Manufacturer: prepares technical documentation
Unit
Full
control of
Notified body: ascertains conformity of a type
verification
quality
production
assurance
(EN ISO 9001)
Manu-
Manu-
Module
facturer:
facturer:
F
Product
-prepares
-operates a
technical
verification
documen-
comprehensive QS
Manufacturer:
Module
Module
Module
-prepares
technical
documentation
C
Conformity
QS
to type
production
-declares
conformity
with
the
directive
Module
Aa:
Notified
body
also involved
QS
(EN ISO 9002)
products
tation
(EN ISO 9003)
system
Manu-
Notified
Notified
Notified
Notified
Notified
facturer:
body:
body:
body:
body:
body:
-declares
conformity
with the
-certifies
-certifies QS
-verifies
conformity
of products
-ascertains
conformity
with the directive
-certifies
type
system
QS
system
Manufacturer:
Manufacturer:
-declares
conformity
-declares
conformity
Manufacturer:
-declares
conformity
QS system
Module A
Internal control of production
It covers the design and production phases.
This module does not require the intervention of a
notified body.
10
Module B
EC type-examination
It covers the design phase, and must
be followed by a module providing for
assessment in the production phase.
A notified body issues the "EC typeexamination" certificate
11
Module C
Conformity to type
It covers the production phase and
follows module B.
It provides for conformity with the
type as described in the EC typeexamination certificate issued
according to module B. Module C dos
not require the intervention of a
notified body.
12
Module D
Production quality assurance
It covers the production phase and follows
module B.
It derives from the 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
13
Module E
Product quality assurance
It covers the production phase and follows
module B.
It 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
14
Module F
Product verification
It covers the production phase and
follows module B.
A notified body controls conformity to
the type as described in the EC typeexamination certificate issued
according to module B, and issues a
certificate of conformity for the
product
15
Module G
Unit verification
It covers the design and production
phases.
Each individual product is examined
by a notified body, which issues a
certificate of conformity
16
Module H
Full quality assurance
It covers the design and production phases.
It 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.
17
Technical documentation
The manufacturer is always required to draw
up a technical file (technical documentation).
The technical documentation provides
information on the design and
manufacturing phases of the product.
The contents of the technical documentation
are laid down directive by directive in
accordance with the products concerned.
18
The details included in the
documentation depend on the nature
of the product and on what is
considered as necessary, from the
technical point of view, for
demonstrating the conformity of the
product to the essential requirements
of the relevant directive.
19
The following might be required to be
included in technical documentation:
a general description of the product;
overall drawing of a product, design and
manufacture drawings and diagrams of
components, sub-assemblies, control circuits, etc.,
together with descriptions and explanations
needed to understand those drawings and
diagrams;
risk analysis and a description of methods adopted
to eliminate hazards presented by the product;
the essential requirements of the applicable
directives;
20
a list of the standards used, in full or in part, and a
description of the solutions employed to meet the
essential requirements of applicable directives;
other technical specifications, which were used;
results of design calculations and of checks
carried out, etc.;
test reports and/or certificates, which may be
available, either by the manufacturer or a third
party (depending on the requirements of the
directives);
a copy of the instructions (for use, for
maintenance, other instructions);
21
CE Marking
It indicates that a product has
been designed and
manufactured in conformity
with essential requirements
CE marking is mandatory and
must be affixed before the
product is placed on the
market
22
CE marking
The objective of New Approach directives is to
ensure the free circulation throughout the EEA of
products complying with the essential
requirements after having been submitted to the
relevant conformity assessment procedures.
CE marking is the synthetic way to physically show
on a given product that it is presumed to comply
with the provisions of the relevant directives and,
in most cases, that for it an EC declaration of
conformity to the relevant essential requirements
has been issued under the responsibility of a
manufacturer or his representative
23
CE marking
Conformity to essential requirements is indicated
physically by the apposition of the CE marking on the
products.
The CE marking indicates that the product has been
designed and manufactured in conformity with the
essential requirements of all relevant directives, and
submitted to the relevant conformity assessment
procedure.
The CE marking is mandatory and must be affixed
before any product subject to it is placed on the
market.
24
What is the meaning of CE marking

The CE marking consists of a neutral mandatory
marking addressed to all economic operators,
industries, inspectors and public authorities
responsible for the market surveillance. The CE
marking gives no indication of which conformity
assessment procedure has been followed by the
manufacturer. All of them are considered equivalent
and appropriate.
25
What is the meaning of CE marking

The CE marking is a conformity mark, meaning
conformity with the essential requirements by the
application of high level technical specifications for
the protection of users, consumers and other parties
involved. The CE marking is not a guarantee of only
minimal safety standards or a border control pass
intended for national authorities
26
CE marking and EC declaration of conformity

Any reference to elements, which might reintroduce
national aspects, has been avoided.
The CE marking is not intended to serve commercial
purposes and it is not a mark of origin.
But it could be used, when exporting products
outside the EEA, as a signal of the compliance of
products with EC provisions, meaning a high level of
protection.
27
Other marks affixed together

with the CE marking
New approach directives expressly forbid
marks which might confuse purchasers by
suggesting meanings similar to that of the
CE marking.
Therefore, EEA States must forbid markings
that may create confusion with the CE
marking related to the graphics and/or the
meaning of the CE marking itself.
28
Affixing the CE marking

The CE marking must be affixed visibly,
legibly and indelibly to the product or to its
data plate, depending on the directive.
However, where this is not possible or not
warranted on account of the nature of the
product, it must be affixed to the packaging,
if any, and to the accompanying documents,
where the directive concerned provides for
such documents
29

MUST
When the product belongs to one or more New Approach
directives.
When the product complies with the provisions of the
applicable New Approach directives.
For products under manufacturer self-assessment,

the CE marking is affixed on the product without
third party intervention. When there is a third party
intervention, the manufacturer will affix the CE
marking as well. Only when the notified body
participates in the control of the production phase,
the manufacturer will affix the CE marking plus the
number of the notified body
30

MUST NOT
When the product is not covered by a New Approach
directive.
When the product does not comply with the provisions
of the applicable New Approach directives.
Therefore, if the EEA States authorities find out that

the CE marking has been wrongly affixed (i.e. wrong
conformity assessment procedure, labelling
problem...) the manufacturer or his authorised
representative will be obliged to put an end to the
infringement under conditions imposed by the
member state.
31
Can other marks be affixed together with the

CE marking
Yes, but
The voluntary marks may neither refer to specific

certification schemes of conformity assessment
(all considered equivalent) nor indicate that a
harmonised standard has been used (only one of
the means to comply with the essential
requirements).
32

CE marking
Yes, but
The use of an additional mark shall not imply a
differentiation in levels of protection, because a
product is deemed to be safe when it complies
with the essential requirements of the relevant
directives (safety/protection cannot be qualified).
Additional conformity marks can only be accepted
as far as they are voluntary and do not interfere
with the scope covered by the directives and do
not create any confusion with the CE marking.
33

CE marking
Yes, but
Other marks should fulfil a different

function from that of the CE
marking.
Other marks should provide an
added value in signifying
conformity with objectives that are
different from those to which the CE
marking relates.
34

CE marking
Yes, but
Voluntary markings may not be used to

certify compliance with aspects of
security and safety already covered by the
directives as well as the conformity
assessment procedures foreseen therein.
The procedures leading to the additional
marks shall be transparent and shall
involve independent certification bodies.
The requirements shall be well defined
and open to all manufacturers. They
should be based on well-defined technical
specifications.
35
Suppliers Declaration
The manufacturer, or his
authorised representative
established within the EEA is
obliged to draw up an EC
declaration of conformity
before the product is placed
on the market.
36
Declaration of conformity
The EC declaration of conformity is a
document that ensure either
that the product satisfies the essential
requirements of the applicable directives,
OR
that the product is in conformity with the
type for which a type-examination certificate
has been issued and satisfies the essential
requirements of the applicable directives.
37
The manufacturer is always required to draw

up a technical file (technical documentation).
The technical documentation provides
information on the design and
manufacturing phases of the product.
The contents of the technical documentation
are laid down directive by directive in
accordance with the products concerned.
38
The EC declaration of conformity

shall specify some elements, ranging
from the manufacturer's address to
the technical solutions applied.
This declaration is issued after
completion of all relevant conformity
assessment procedures and it, as a
general rule, accompanies the product
bearing the CE marking.
39
The manufacturer, or his authorised

representative established within the EEA is
obliged to draw up an EC declaration of
conformity before the product is placed on the
market.
A manufacturer established outside the EEA is
entitled to carry out all the certification
procedures at his premises and, therefore, to
sign the declaration of conformity, unless
otherwise provided for in the directive(s). It is not
necessary for the signatory of the EC declaration
of conformity to be domiciled in the EEA.
40
Market surveillance (1)

Actors:
The manufacturers
Custom officials
Market surveillance
authorities
Courts
41
Market surveillance (2)

Conformity assessment
takes place before the
product is put on the market
Market surveillance takes
place after the product is
placed on the market
42
Agreements relating to CA
MRAs with third countries
PECA (Protocol on European Conformity Assessment)
Other Agreements
43

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Standardisation, regulation, worldwide strategies