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