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