1. NOTIFIED BODIES EC MARKING

2. 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

3. 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 directive DESIGNATION means assessment and approval

4. Activities of Notified Bodies  Testing Laboratories To measure, examine, test or otherwise determine the characteristics or the performance of products (ISO 17025)  Certification Bodies To carry our certification according to specific rules of procedure defined in the hEN  Inspection Bodies To assess, recommend for acceptance and audit FPC operations and for selection and evaluation of products to specific criteria

5. 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

6. Technical basis for notification  Verification of: technical competence impartiality availability of staff and equipment professional secrecy civil liability insurance  Basis for notification: Criteria of the directive essential requirements Conformity assessment procedure

7. 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,.....

8. Certification bodies Testing laboratories Inspection bodies Criteria for accreditation bodies EN 45010 ISO 17011 EN 45 002 EN 45 003 EN 45 010 ISO 17011 Accreditation and assessment criteria EN 45 010 ISO 17011 EN 45 002 EN 45 003 EN 45 010 ISO 17011 Operational criteria EN 45 011 ISO/Guide 65 EN 45 012 ISO 17021 EN 45 013 ISO 17024 EN 45 001 ISO 17025 EN 45 004 ISO 17020

9. 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 directive Only in the 90s accreditation had a great development at european and international level many countries use accreditation as basis for notification

10. 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

11. Accreditation bodies ISO/IEC 17011 ISO/IEC 17040 Inspection bodies ISO/IEC 17020; EN 45004 Suppliers Bodies providing audit and certification of management systems ISO Guides 62 and 66 (ISO/IEC DIS17021) Suppliers Bodies operating certification of persons ISO/IEC 17024; EN 45013 People Testing and calibration laboratories ISO/IEC 17025 Suppliers Product certification bodies Guide ISO/IEC 65; EN 45011 Products (including services)

12. Accreditation Accreditation: key concepts (ISO/IEC 17011) Accreditation body 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. Conformity assessment bodies Products (including services) Supplier CABs assess the conformity of products, services and suppliers to specifications and requirements. 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.

13. 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)

14. 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.

15. Draft certif 2005-6: Accreditation in support of designation of notified bodies Definition 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...

16. http://europa.eu.int/comm/enterprise/ http://europa.eu.int/comm/enterprise/ nando-is/cpd/home/index.cfm http://europa.eu.int/comm/enterprise/ 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 country by directive by hEN/ETAs

17.  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

18. NBs cooperation GNB – 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

19. 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

20. 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

21. Tasks of the notifying authorities 1. Use accreditation (basis of the EN 45 000/ISO 17000 series to prove technical competence and send proof of technical competence to the Commission 2. Monitor the permanent maintenance of technical competence 3. Take the necessary action in case of doubt regarding a notified body’s technical competence 4. Ensure monitoring of European standardisation activities as well as activities in the coordination groups 5. Inform other MS of reasons for refusal or annulment of conformity certificates 6. Send to EC information on the safeguard clause

22. 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

23. 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

24. 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 45014 Declaration, label, document

25. EC MARKING

26. 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) (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

27. Affixing of the EC Marking  Always by the manufacturer or his 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 Declaration The manufacturer bears ultimate responsibility for the conformity of the product

28. 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.

31. 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

32. MANUFACTURER IN KASAKSHTAN CAN APPLY THE EC MARK? Yes under the responsibility of a Notified Body in the EU

33. 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

34. 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

35. 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