NB-CPD All-12 110c Conference P2-1 Yiorgos Kallergis - Accreditation to the CPR

7/29/2019 NB-CPD All-12 110c Conference P2-1 Yiorgos Kallergis - Accreditation to the CPR

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Accreditation of CPR Notified Bodies

Yiorgos Kallergis

EA CPR Conveyor


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Content

About EA

The Role of EA EA Organization - Structure The Development of European Accreditation EAs Relationship with the European Commission Accreditation for Notification according to CPD Accreditation for Notification according to CPR


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About EA

Association of European National Accreditation Bodies ofEU / EFTA / candidate countries

34 Full Members

A not-for-profit association registered in the Netherlands

Secretariat based in Paris and Utrecht


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The Role of EA

To define, harmonise and build consistency in

accreditation as a a Public Authority service in Europe To maintain a multilateral agreement on mutualrecognition between the accreditation schemes

To be a technical resource on matters related to theimplementation and operation of the European policies onaccreditation


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The Role of EA

In other words:To provide Europe with an effective and reliableaccreditation infrastructure to serve the needs of theeconomy and society, representing the last level of control

of conformity assessment services in both voluntary andmandatory areas.


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EA Organization - StructureEA Advisory

Board

GeneralAssembly

Executive

CommitteeSecretariat

Multilateral

AgreementCouncil (MAC)

Horizontal

HarmonisationCommittee

Laboratory

Committee

Inspection

Committee

Certification

Committee

Communications

& PublicationsCommittee

DirectivesNetworks

Technical

Networks


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The Development of European Accreditation (1)

European Regulation 765/ 08

The European legislation on accreditation and marketsurveillance

Legal basis for accreditation and EA in both voluntaryand regulated sectors

Recognizes EA as the European accreditationinfrastructure


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The Development of European Accreditation (2)

European Regulation 765/ 08

Accreditation:

One National Accreditation Body (NAB) per Member

State (MS)

Public authority activity

Independent, not-for-profit

Not compete with conformity assessment bodies Appropriately resourced by MS

NABs to be members of EA

Balanced participation of interested parties


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EAs Relationship with the European Commission Key issues resulting from EC 765/2008:

- Revision of the Articles of Association and of the Rules ofProcedure for the operation of EA.

- Enhancement of the role of the EAAB and of the interactionwith the stakeholders.

- Focus on the role and operation of accreditation in theregulated sectors: cooperation between ABs and notifying

authorities.

- Official recognition of the EA MLA.

- Evaluation of the implementation of EC 765/2008 by all MLAsignatories.


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Accreditation for Notification according to CPD (1)

The European Commissions Blue Book(Guide to

implementation of directives based on the NewApproach and the Global Approach) published in 2000and the European Commission CERTIF 2009 08document SOGS N612 describe for every NLF

conformity assessment module which of the standardsreflect the criteria conformity assessment bodies mustfulfill in order to be notified for the module in question.


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Accreditation for Notification according to CPD (2)Guidance Paper A

Accreditation oflaboratories

System 3 ISO/IEC 17025

Accreditation ofcertificationbodies

Product CertificationSystem 1 and System 1+

(accredited laboratories)

EN 45011

FPC Certification

System 2 and System 2+(non-accredited laboratories)

ISO/IEC 17021

and/or EN45011

Inspection bodies FPC Inspection ISO/IEC 17020


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Accreditation for Notification according to CPD (3) Following the issue of the European Regulation765/2008, EA has produced a mandatory guidance forNBs, which is titled EA-2/17 - EA Guidance on the

horizontal requirements for the accreditation ofconformity assessment bodies for notificationpurposes.

EA-2/17 document shall be used in combination with therelevant harmonised standards for conformityassessment bodies (CAB standards) and the relatedguidance documents issued by EA, ILAC and IAF.


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Accreditation for Notification according to CPR (1)

Alternative approaches:

Assessment of NB compliance with the requirementsofharmonised standards and EA-2/ 17 document

Assessment of NB compliance with the requirementsofOne (1) P lus (+) Approach (under development)


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One (1) Plus (+) Model Approach

Module Description EN 45011ISO / IEC

17020ISO / IEC

17021ISO / IEC

17025

AInternal productioncontrol

N/A N/A N/A N/A

A1

Internal production

control plus supervisedproduct testing

1+ t 1+ t 1 + cd

A2

Internal productioncontrol plus supervisedproduct checks atrandom intervals

1 +t 1 +t 1 + cd

B EC type examination 1 +t 1 +t

CConformity to type basedon internal productioncontrol

N/A N/A N/A N/A

C1

Conformity to type basedon internal productioncontrol plus supervisedproduct testing

1 +t 1 +t 1 + cd

C2Conformity to type basedon internal productioncontrol plus supervisedproduct checks atrandom intervals

1 +t 1 +t 1 + cd

DConformity to type basedon quality assurance ofthe production process

1 + qa 1 + qa 1 + pj

D1Quality assurance of theproduction process

1 + qa 1 + qa 1 + pj


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Thank you for your attention!

Contact details:e-mail address: [email protected]

Documents

NB-CPD All-12 110c Conference P2-1 Yiorgos Kallergis - Accreditation to the CPR