Modules of conformity assessment

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Modules of conformity assessment
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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

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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
• ...

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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

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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

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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

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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

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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

lt T C follow the modules to perform CA
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Conformity assessment procedures of the new
approach the modules
B
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Module A

• Internal control of production
• It covers the design and production phases.This
  module does not require the intervention of a
  notified body.

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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

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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.

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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

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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

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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

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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

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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.

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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.

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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.

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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

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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)

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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

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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

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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.

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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.

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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

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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.

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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.

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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

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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

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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 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.

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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).

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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.

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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.

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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.

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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.

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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.

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• 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.

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• 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.

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• 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.

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Market surveillance (1)

• Actors
• The manufacturers
• Custom officials
• Market surveillance authorities
• Courts

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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