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NOTIFIED BODIESNOTIFIED BODIES
EC MARKINGEC MARKING
indexindex Notified Bodies. ActivitiesNotified Bodies. Activities Notification procedureNotification procedure Role of accreditationRole of accreditation Notified Bodies cooperationNotified Bodies cooperation Notified Bodies tasks and responsibilitiesNotified Bodies tasks and responsibilities SubcontractingSubcontracting Declaration of conformityDeclaration of conformity EC markingEC marking Directive on general product safetyDirective on general product safety Directive on civil liabilityDirective on civil liability
Notified Bodies (NB)Notified Bodies (NB)
Entities that do conformity assessment activities Entities that do conformity assessment activities of the NA directives where a third party of the NA directives where a third party intervention is requested. intervention is requested. Laboratories, Certification and Inspection BodiesLaboratories, Certification and Inspection Bodies
NotificationNotification: activity where a MS informs the EC : activity where a MS informs the EC and other MS that a qualified body was and other MS that a qualified body was designated to do conformity assessment designated to do conformity assessment according to a certain directiveaccording to a certain directive
DESIGNATIONDESIGNATION means means assessment and assessment and approvalapproval
Activities of Notified BodiesActivities of Notified Bodies
Testing LaboratoriesTesting LaboratoriesTo measure, examine, test or otherwise To measure, examine, test or otherwise determine the characteristics or the performance determine the characteristics or the performance of products of products (ISO 17025)(ISO 17025)
Certification BodiesCertification BodiesTo carry our certification according to specific To carry our certification according to specific rules of procedure defined in the hENrules of procedure defined in the hEN
Inspection BodiesInspection BodiesTo assess, recommend for acceptance and audit To assess, recommend for acceptance and audit FPC operations and for selection and evaluation FPC operations and for selection and evaluation of products to specific criteriaof products to specific criteria
Legal requirements of the notificationLegal requirements of the notification
Authorities are responsible for notification in Authorities are responsible for notification in their countries and can notify anytimetheir countries and can notify anytime
NB must be a legal entity established in the NB must be a legal entity established in the MS MS
MS is responsible for the technical MS is responsible for the technical competence of the notified body (EC can competence of the notified body (EC can request evidence of this notification)request evidence of this notification)..
MS is free to notify or not against the MS is free to notify or not against the requirements of the annex IV of the directive requirements of the annex IV of the directive or the Decisionor the Decision 93/465/CE 93/465/CE
Technical basis for notificationTechnical basis for notification
Verification of:Verification of:technical competencetechnical competenceimpartialityimpartialityavailability of staff and equipmentavailability of staff and equipmentprofessional secrecyprofessional secrecycivil liability insurancecivil liability insurance
Basis for notificationBasis for notification::Criteria of the directiveCriteria of the directiveessential requirementsessential requirementsConformity assessment procedureConformity assessment procedure
NotificationNotification
Requires Requires (in relation to 17000):(in relation to 17000):
Specific knowledge concerning the productSpecific knowledge concerning the product Procedures for Conformity assessment of Procedures for Conformity assessment of
directivedirective Tecnology requiredTecnology required
....requires evaluation in accordance to the ....requires evaluation in accordance to the general state of the art reflected in the essential general state of the art reflected in the essential requirements, the hENsrequirements, the hENs,.....,.....
Certificationbodies
Testinglaboratories
Inspectionbodies
Criteria for accreditationbodies
EN 45010
ISO 17011EN 45 002
EN 45 003
EN 45 010
ISO 17011
Accreditation and assessment criteria
EN 45 010
ISO 17011EN 45 002
EN 45 003
EN 45 010
ISO 17011
Operationalcriteria
EN 45 011
ISO/Guide 65EN 45 012
ISO 17021EN 45 013
ISO 17024
EN 45 001
ISO 17025EN 45 004
ISO 17020
Notification and accreditation...Notification and accreditation...
Global approach mentioned:Global approach mentioned:
Notified bodies that prove their conformity with the Notified bodies that prove their conformity with the EN 45000 (equivalent to ISO 17000) through an EN 45000 (equivalent to ISO 17000) through an accreditation certificate have a accreditation certificate have a presumption of presumption of conformity with the requirements of the directiveconformity with the requirements of the directive
Only in the 90s accreditation had a great Only in the 90s accreditation had a great development at european and international leveldevelopment at european and international levelmany countries use accreditation as basis for many countries use accreditation as basis for notificationnotification
What is accreditation?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
Accreditation bodiesISO/IEC 17011ISO/IEC 17040
Product certification bodiesGuide ISO/IEC 65; EN 45011
Inspection bodiesISO/IEC 17020; EN 45004
Bodies providing audit and certification
of management systemsISO Guides 62 and 66
(ISO/IEC DIS17021)
Bodies operatingcertification of persons
ISO/IEC 17024; EN 45013
Suppliers Suppliers People
Testing and calibration laboratories
ISO/IEC 17025
SuppliersProducts
(including services)
AccreditationAccreditation
Accreditation: Accreditation: key conceptskey concepts (ISO/IEC 17011) (ISO/IEC 17011)
Accreditation body Accreditation body
Accreditation bodies (AB) assess the Accreditation bodies (AB) assess the competence of CABs - Conformity competence of CABs - Conformity Assessment Bodies. Assessment Bodies. CABs can promote global acceptance CABs can promote global acceptance of conformity assessment results by of conformity assessment results by mutual recognition arrangements mutual recognition arrangements among CABs.among CABs.
Conformity assessment bodies
Products (including services)
Supplier
CABs assess the conformity of CABs assess the conformity of products, services and suppliers to products, services and suppliers to specifications and requirements. specifications and requirements.
Purchasers acquire products (including Purchasers acquire products (including services) that conform to specifications services) that conform to specifications or buy from suppliers that conform to or buy from suppliers that conform to specific requirements. specific requirements.
Regulators may set requirements for Regulators may set requirements for products and suppliers.products and suppliers.
ACCREDITATION: regional and internationalACCREDITATION: regional and international
Accreditation and certification: Accreditation and certification: international conformity assessment international conformity assessment activitiesactivities..
Accreditation is essential for the correct Accreditation is essential for the correct implementation of the certification market as implementation of the certification market as an open and transparent activity an open and transparent activity
Accreditation entity in each country is Accreditation entity in each country is recognized by the authoritiesrecognized by the authorities
EA – European co-operation for EA – European co-operation for accreditation accreditation – coordinates the – coordinates the activities of the national accreditation activities of the national accreditation bodies bodies (www.european-accreditation.org)(www.european-accreditation.org) IAF – International Accreditation IAF – International Accreditation ForumForum ((www.iaf.nuwww.iaf.nu))
Multilateral Agreements (MLAs)Multilateral Agreements (MLAs)
Worldwide Recognition and International AcceptanceCONFIDENCE 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 Accreditation in support of designation of notified bodiesnotified bodies
Definition and scope of accreditation Definition and scope of accreditation Statute of presumption of conformity of Statute of presumption of conformity of standards for accreditation standards for accreditation Transparency and consistency of national Transparency and consistency of national pratices of accreditation pratices of accreditation How to support the idea of accreditation as How to support the idea of accreditation as reference...reference...
http://europa.eu.int/comm/enterprise/http://europa.eu.int/comm/enterprise/nando-is/cpd/home/index.cfmnando-is/cpd/home/index.cfm
List of notified bodies is acessible on-lineList of notified bodies is acessible on-line
One single number is given by the EC to One single number is given by the EC to a notified body independently of the a notified body independently of the number of directives number of directives
Notified bodies Notified bodies by countryby countryby directiveby directiveby hEN/ETAsby hEN/ETAs
Manufacturer can request services of any Manufacturer can request services of any European notified bodyEuropean notified body
MS supervise activities of NBs and must MS supervise activities of NBs and must inform EC of annulment of a NBinform EC of annulment of a NB
There must be close cooperation between There must be close cooperation between NBsNBs
Manufacturer responsibility is not reduced Manufacturer responsibility is not reduced even if there is a NB involvedeven if there is a NB involved
NBs cooperationNBs cooperationGNB – National Mirror groupsGNB – National Mirror groups
Share experiences and contribute for better Share experiences and contribute for better understanding of AoCunderstanding of AoC
Raise common problematic situations Raise common problematic situations Recommend the EC on unclarified situationsRecommend the EC on unclarified situations Reporting of activities Reporting of activities Maintain coherence with European Maintain coherence with European
standardisation standardisation Inform the EC on harmonization workInform the EC on harmonization work Discuss and give answers to questions Discuss and give answers to questions
concerning the directive concerning the directive Comission pays for participationComission pays for participation
NBs cooperationNBs cooperation
Cooperation is limited to technical matters Cooperation is limited to technical matters
NBs work not only for manufacturers but NBs work not only for manufacturers but also for authoritiesalso for authorities
ONs implement decisions for ONs implement decisions for harmonization harmonization
Documents )checklists, guidance, models,Documents )checklists, guidance, models,…are issued but …are issued but do not have legal statusdo not have legal status
NB tasks and responsibilitiesNB tasks and responsibilities
Provide conformity assessment servicesProvide conformity assessment services
Operate impartially, independent of clients and Operate impartially, independent of clients and ensure confidentiality of information (separate ensure confidentiality of information (separate acitivites as an NB from other activities)acitivites as an NB from other activities)
Have a civil liability insurance Have a civil liability insurance
Inform authorities on their activitiesInform authorities on their activities
Inform market surveillance on their activitiesInform market surveillance on their activities
Participate in the activities of the european Participate in the activities of the european standardization bodiesstandardization bodies
Tasks of the notifying authoritiesTasks of the notifying authorities
1.1. Use accreditation (basis of the EN 45 000/ISO 17000 Use accreditation (basis of the EN 45 000/ISO 17000 series to prove technical competenceseries to prove technical competence and send proof of and send proof of technical competence to the Commissiontechnical competence to the Commission
2.2. Monitor the permanent maintenance of technical Monitor the permanent maintenance of technical competencecompetence
3.3. Take the necessary action in case of doubt regarding a Take the necessary action in case of doubt regarding a notified body’s technical competencenotified body’s technical competence
4.4. Ensure monitoring of European standardisation Ensure monitoring of European standardisation activities as well as activities in the coordinationactivities as well as activities in the coordination groupsgroups
5.5. Inform other MS of reasons for refusal or annulment of Inform other MS of reasons for refusal or annulment of conformity certificatesconformity certificates
6.6. Send to EC information on the safeguard clause Send to EC information on the safeguard clause
Technical dossierTechnical 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
SubcontractingSubcontracting
Notified Bodies may subcontract some Notified Bodies may subcontract some activities (never the decision)activities (never the decision)
Subcontracted bodies must evidence same Subcontracted bodies must evidence same criteria (independence, competence,…)criteria (independence, competence,…)
Notified Bodies must be in an EC country but Notified Bodies must be in an EC country but subcontractors can be from a third countrysubcontractors can be from a third country
Manufacturer Declaration of ConformityManufacturer Declaration of Conformity
Required always before placing in the market as Required always before placing in the market as part of the conformity assessment procedure part of the conformity assessment procedure
Only issued when manufacturer complies with Only issued when manufacturer complies with the essential requirements of the CPD or is the essential requirements of the CPD or is according to type (EC type approval certificate)according to type (EC type approval certificate)
Must include all information identifying the Must include all information identifying the directive, the manufacturer or his mandatory, directive, the manufacturer or his mandatory, conformity assessment, Notified Body, product conformity assessment, Notified Body, product and hEN. and hEN.
EN 45014EN 45014Declaration, label, documentDeclaration, label, document
EC MARKINGEC MARKING
EC MarkingEC Marking
Symbolizes a written declaration Symbolizes a written declaration from a manufacturer that his from a manufacturer that his
products are in conformity with the products are in conformity with the requirements of all applied requirements of all applied
directives directives (CouncilDecision 93/465/CE)(CouncilDecision 93/465/CE)
In the CPD means that the product complies In the CPD means that the product complies with the hEN or ETA and that the with the hEN or ETA and that the
manufacturer has applied the required AoC manufacturer has applied the required AoC procedureprocedure
Affixing of the EC MarkingAffixing of the EC Marking
Always Always by by the manufacturerthe manufacturer or orhis his authorized representativeauthorized representative established in the established in the EEEEEE
Marking must be accompanied by a Declaration Marking must be accompanied by a Declaration of Conformityof Conformity If there is a Certificate by a NB, it must be If there is a Certificate by a NB, it must be
attached to the Declarationattached to the Declaration
The manufacturer bears ultimate responsibility The manufacturer bears ultimate responsibility for the conformity of the productfor the conformity of the product
Affixing of EC markingAffixing of EC marking
Obligatory forObligatory for all new products, whether manufactured in all new products, whether manufactured in
the Member States or in third countries; the Member States or in third countries; used and second hand products imported used and second hand products imported
from third countries. 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 MANUFACTURER IN KASAKSHTAN CAN APPLY THE EC MARK?APPLY THE EC MARK?
YesYes
under the responsibility of a Notified Body under the responsibility of a Notified Body in the EUin the EU
Can other marks be applied next to Can other marks be applied next to EC mark?EC mark?
YESYES
As long as they do not cover the same As long as they do not cover the same requirementsrequirements
As long as it cannot be mistaken with the EC As long as it cannot be mistaken with the EC markmark
Can be affixed in the product, in the package Can be affixed in the product, in the package or documentationor documentation
Directive on General Product Safety Directive on General Product Safety (2001/95/CE) (2001/95/CE)
Obliges a general safety requirement for any Obliges a general safety requirement for any product placed on the marketproduct placed on the market
Safe product is a product that does not have any Safe product is a product that does not have any risk or presents only small risks compatible to its risk or presents only small risks compatible to its
use and considered acceptable concerning use and considered acceptable concerning health and safety of people health and safety of people
CSSBC – Commission for safety and health of CSSBC – Commission for safety and health of consumer goodsconsumer goods
DIRECTIVE ON CIVIL LIABILITYDIRECTIVE ON CIVIL LIABILITY(85/374/EC)(85/374/EC)
Product liabilityProduct liability
Establishes rules for damages caused Establishes rules for damages caused to people by defective products, to people by defective products, manufactured or imported into the EU manufactured or imported into the EU
Responsibility is first of all from Responsibility is first of all from manufacturermanufacturer