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NOTIFIED BODIES EC MARKING. index. Notified Bodies. Activities Notification procedure Role of accreditation Notified Bodies cooperation Notified Bodies tasks and responsibilities Subcontracting Declaration of conformity EC marking Directive on general product safety

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index
index
  • Notified Bodies. Activities
  • Notification procedure
  • Role of accreditation
  • Notified Bodies cooperation
  • Notified Bodies tasks and responsibilities
  • Subcontracting
  • Declaration of conformity
  • EC marking
  • Directive on general product safety
  • Directive on civil liability
notified bodies nb
Notified Bodies (NB)
  • Entities that do conformity assessment activities of the NA directives where a third party intervention is requested. Laboratories, Certification and Inspection Bodies
  • Notification: activity where a MS informs the EC and other MS that a qualified body was designated to do conformity assessment according to a certain directiveDESIGNATION means assessment and approval
activities of notified bodies
Activities of Notified Bodies
  • Testing LaboratoriesTo measure, examine, test or otherwise determine the characteristics or the performance of products (ISO 17025)
  • Certification BodiesTo carry our certification according to specific rules of procedure defined in the hEN
  • Inspection BodiesTo assess, recommend for acceptance and audit FPC operations and for selection and evaluation of products to specific criteria
legal requirements of the notification
Legal requirements of the notification
  • Authorities are responsible for notification in their countries and can notify anytime
  • NB must be a legal entity established in the MS
  • MS is responsible for the technical competence of the notified body (EC can request evidence of this notification).
  • MS is free to notify or not against the requirements of the annex IV of the directive or the Decision 93/465/CE
technical basis for notification
Technical basis for notification
  • Verification of:technical competenceimpartialityavailability of staff and equipmentprofessional secrecycivil liability insurance
  • Basis for notification:Criteria of the directiveessential requirementsConformity assessment procedure
notification
Notification

Requires (in relation to 17000):

  • Specific knowledge concerning the product
  • Procedures for Conformity assessment of directive
  • Tecnology required

....requires evaluation in accordance to the general state of the art reflected in the essential requirements, the hENs,.....

notification and accreditation
Notification and accreditation...
  • Global approach mentioned:Notified bodies that prove their conformity with the EN 45000 (equivalent to ISO 17000) through an accreditation certificate have a presumption of conformity with the requirements of the directiveOnly in the 90s accreditation had a great development at european and international levelmany countries use accreditation as basis for notification
slide10

What is accreditation?

Accreditation determines the technical competence of a body to perform specific tasks.

Accreditation has to be a non-competitive activity because of its role in ensuring that standards are not compromised by competition between bodies providing services and products.

Ensuring Confidence in the Marketplace

slide12

Accreditation: key concepts (ISO/IEC 17011)

Accreditation bodies (AB) assess the competence of CABs - Conformity Assessment Bodies. CABs can promote global acceptance of conformity assessment results by mutual recognition arrangements among CABs.

Accreditation

Accreditation body

CABs assess the conformity of products, services and suppliers to specifications and requirements.

Conformity assessment bodies

Purchasers acquire products (including services) that conform to specifications or buy from suppliers that conform to specific requirements.

Regulators may set requirements for products and suppliers.

Products (including services)

Supplier

slide13

ACCREDITATION: regional and international

  • Accreditation and certification: international conformity assessment activities.
  • Accreditation is essential for the correct implementation of the certification market as an open and transparent activity Accreditation entity in each country is recognized by the authorities

EA – European co-operation for accreditation – coordinates the activities of the national accreditation bodies (www.european-accreditation.org)IAF – International Accreditation Forum(www.iaf.nu)

Multilateral Agreements (MLAs)

slide14
Worldwide Recognition and International Acceptance

CONFIDENCE IN COMPETENCE

The multilateral agreements (MLA) between accreditors provides a means for goods and services to cross boundaries in Europe and throughout the world.

The MLA makes accreditation a “passport” which facilitates access to the EU and international markets through co-operation between ILAC (International Laboratory Accreditation Co-operation), IAF (International Accreditation Forum) and EA (European Accreditation)

The Accreditation Body mark on test reports and certificates is your assurance of the benefits of the MLA.

draft certif 2005 6
Draft certif 2005-6:

Accreditation in support of designation of notified bodiesDefinition and scope of accreditation Statute of presumption of conformity of standards for accreditation Transparency and consistency of national pratices of accreditation How to support the idea of accreditation as reference...

http europa eu int comm enterprise nando is cpd home index cfm
http://europa.eu.int/comm/enterprise/nando-is/cpd/home/index.cfmhttp://europa.eu.int/comm/enterprise/nando-is/cpd/home/index.cfm

List of notified bodies is acessible on-line

One single number is given by the EC to a notified body independently of the number of directives

  • Notified bodies by countryby directiveby hEN/ETAs
slide17
Manufacturer can request services of any European notified body
  • MS supervise activities of NBs and must inform EC of annulment of a NB
  • There must be close cooperation between NBs
  • Manufacturer responsibility is not reduced even if there is a NB involved
nbs cooperation gnb national mirror groups
NBs cooperationGNB – National Mirror groups
  • Share experiences and contribute for better understanding of AoC
  • Raise common problematic situations
  • Recommend the EC on unclarified situations
  • Reporting of activities
  • Maintain coherence with European standardisation
  • Inform the EC on harmonization work
  • Discuss and give answers to questions concerning the directive
  • Comission pays for participation
nbs cooperation
NBs cooperation
  • Cooperation is limited to technical matters
  • NBs work not only for manufacturers but also for authorities
  • ONs implement decisions for harmonization
  • Documents )checklists, guidance, models,…are issued but do not have legal status
nb tasks and responsibilities
NB tasks and responsibilities
  • Provide conformity assessment services
  • Operate impartially, independent of clients and ensure confidentiality of information (separate acitivites as an NB from other activities)
  • Have a civil liability insurance
  • Inform authorities on their activities
  • Inform market surveillance on their activities
  • Participate in the activities of the european standardization bodies
tasks of the notifying authorities
Tasks of the notifying authorities
  • Use accreditation (basis of the EN 45 000/ISO 17000 series to prove technical competence and send proof of technical competence to the Commission
  • Monitor the permanent maintenance of technical competence
  • Take the necessary action in case of doubt regarding a notified body’s technical competence
  • Ensure monitoring of European standardisation activities as well as activities in the coordinationgroups
  • Inform other MS of reasons for refusal or annulment of conformity certificates
  • Send to EC information on the safeguard clause
technical dossier
Technical dossier
  • Prepared and kept by manufacturer
  • Provides information on the design, manufacture and operation of the product
  • Detailed requirements of this dossier are defined in each directive
  • Must be available to authorities and Notified bodies
subcontracting
Subcontracting
  • Notified Bodies may subcontract some activities (never the decision)
  • Subcontracted bodies must evidence same criteria (independence, competence,…)
  • Notified Bodies must be in an EC country but subcontractors can be from a third country
manufacturer declaration of conformity
Manufacturer Declaration of Conformity
  • Required always before placing in the market as part of the conformity assessment procedure
  • Only issued when manufacturer complies with the essential requirements of the CPD or is according to type (EC type approval certificate)
  • Must include all information identifying the directive, the manufacturer or his mandatory, conformity assessment, Notified Body, product and hEN. EN 45014Declaration, label, document
ec marking1
EC Marking

Symbolizes a written declaration from a manufacturer that his products are in conformity with the requirements of all applied directives

(CouncilDecision 93/465/CE)

In the CPD means that the product complies with the hEN or ETA and that the manufacturer has applied the required AoC procedure

affixing of the ec marking
Affixing of the EC Marking
  • Always by the manufacturer orhis authorized representative established in the EEE
  • Marking must be accompanied by a Declaration of Conformity
  • If there is a Certificate by a NB, it must be attached to the DeclarationThe manufacturer bears ultimate responsibility for the conformity of the product
affixing of ec marking
Affixing of EC marking

Obligatory for

  • all new products, whether manufactured in the Member States or in third countries;
  • used and second hand products imported from third countries.
advantages
Advantages
  • Only one set of technical regulations and marking requirements that gives fast access to the whole European market
  • Availability of a coherent set of European standards, which do not compete with each other
  • Same rules for importers and EU manufacturers
manufacturer in kasakshtan can apply the ec mark
MANUFACTURER IN KASAKSHTAN CAN APPLY THE EC MARK?

Yes

under the responsibility of a Notified Body in the EU

can other marks be applied next to ec mark
Can other marks be applied next to EC mark?

YES

  • As long as they do not cover the same requirements
  • As long as it cannot be mistaken with the EC mark
  • Can be affixed in the product, in the package or documentation
directive on general product safety 2001 95 ce
Directive on General Product Safety (2001/95/CE)
  • Obliges a general safety requirement for any product placed on the market
  • Safe product is a product that does not have any risk or presents only small risks compatible to its use and considered acceptable concerning health and safety of people

CSSBC – Commission for safety and health of consumer goods

directive on civil liability 85 374 ec
DIRECTIVE ON CIVIL LIABILITY(85/374/EC)

Product liability

Establishes rules for damages caused to people by defective products, manufactured or imported into the EU

Responsibility is first of all from manufacturer