1

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

Modules of conformity assessment

2

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

3

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

...

4

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

5

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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

6

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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

7

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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 approachprovides 8 different modules (design and production phases) to perform conformity assessment

8

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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

9

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Conformity assessment procedures of the new approach : the modules

Module

A Internal

control of

production

Manu-

facturer: -prepares technical documen- tation

-declares conformity with the directive

Module Aa: Notified

body

also involved

Module Module

G H Unit Full

verification quality

assurance

(EN ISO 9001)

Type examination

Manufacturer:

Notified body:

Module

prepares technical documentation

ascertains conformity of a type

Module Module Module

Manu-

facturer:

-prepares

technical

documen-

tation

Notified

body: -ascertains conformity with the di- rective

Manu-

facturer:

-operates a

comprehen- sive QS

system Notified

body:

-certifies

QS system

C D E F Conformity QS QS Product

production products verification to type

Manu-

facturer

(EN ISO 9002)

Notified

(EN ISO 9003)

Notified Notified

body: -verifies conformity of products

Manu-

body : : body : -certifies

system

Manu- facturer:

-declares conformity

QS -declares conformity with the

type

-certifies system

Manu- facturer:

-declares conformity

QS

facturer :

-declares conformity

B

10

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Module A

Internal control of production It covers the design and production phases.

This module does not require the intervention of a notified body.

11

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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 type-examination" certificate

12

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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 type-examination certificate issued according to module B. Module C dos not require the intervention of a notified body.

13

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

14

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

15

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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 type-examination certificate issued according to module B, and issues a certificate of conformity for the product

16

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

17

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

18

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

19

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Technical documentation

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.

20

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Technical documentation

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;

21

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Technical documentation

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);

22

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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

23

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

24

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

25

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

26

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

27

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

28

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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.

29

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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

30

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Affixing the CE marking

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

31

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Affixing the CE marking

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 State’s 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.

32

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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).

33

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Can other marks be affixed together with the 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.

34

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Can other marks be affixed together with the 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.

35

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s Can other marks be affixed together with the 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.

36

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

Supplier’s 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.

37

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s 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, ORthat 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.

38

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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.

39

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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.

40

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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.

41

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

Market surveillance (1)

Actors:

The manufacturers

Custom officials

Market surveillance authorities

Courts

42

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

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

43

Sta

ndard

isati

on

, re

gula

tion

, w

orl

dw

ide s

trate

gie

s

Agreements relating to CA

MRAs with third countries

PECA (Protocol on European Conformity Assessment)

Other Agreements