Certificate Product Conformity

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					Modules of conformity assessment




                                   1
          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




                                                                    2
                                  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
    ...



                                                                     3
                  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




                                                             4
                    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




                                                                 5
                   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




                                                            6
         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




                                              7
         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




                                                            8
       Conformity assessment procedures of the
             new approach : the modules

Module                                                                         Module          Module
                          B   Type examination
     A                                                                                G              H
Internal         Manufacturer: prepares technical documentation                Unit           Full
control of                                                                     verification   quality
                 Notified body: ascertains conformity of a type
production                                                                                    assurance
                                                                                              (EN ISO 9001)


Manu-                                                                          Manu-          Manu-
facturer:       Module          Module          Module          Module         facturer:      facturer:
-prepares                                                                      -prepares      -operates a
technical          C
                Conformity    QS
                                      D         QS
                                                     E              F
                                                                Product        technical      comprehen-
documen-
tation                                                                                        sive QS
                to type       production        products        verification   documen-
-declares                      (EN ISO 9002)    (EN ISO 9003)
                                                                                              system
                                                                               tation
conformity
with      the   Manu-         Notified          Notified        Notified       Notified       Notified
directive
                facturer:     body:             body:           body:          body:          body:
                -declares     -certifies   QS   -certifies QS   -verifies      -ascertains
Module                                                                                        -certifies
                conformity    system            system          conformity     conformity
Aa:                                                             of products                   QS system
                with the      Manu-                                            with the di-
Notified                                        Manu-                          rective
                              facturer:         facturer:       Manu-
                type
body                                                            facturer:
                              -declares         -declares
also involved                 conformity        conformity      -declares
                                                                conformity
                                                                                                         9
                     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 type-
 examination" 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 type-
 examination 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 type-
 examination 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
        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.




                                         19
        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;


                                                 20
       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);




                                                            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
          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
                                                        30
            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.




                                                            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
  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.




                                                          33
  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.



                                                 34
  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.


                                                  35
                   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.




                                            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




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               Agreements relating to CA

 MRAs with third countries


 PECA (Protocol on European Conformity Assessment)


 Other Agreements




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