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Accreditation of CPR Notified Bodies

Yiorgos Kallergis EA CPR Conveyor

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

About EA
Association of European National Accreditation Bodies of EU / EFTA / candidate countries 34 Full Members A not-for-profit association registered in the Netherlands Secretariat based in Paris and Utrecht

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 mutual recognition between the accreditation schemes To be a technical resource on matters related to the implementation and operation of the European policies on accreditation

The Role of EA
In other words: To provide Europe with an effective and reliable accreditation infrastructure to serve the needs of the economy and society, representing the last level of control of conformity assessment services in both voluntary and mandatory areas.

EA Organization - Structure
EA Advisory Board

General Assembly
Executive Committee Secretariat

Multilateral Agreement Council (MAC)

Horizontal Harmonisation Committee

Laboratory Committee

Inspection Committee

Certification Committee

Communications & Publications Committee

Directives Networks

Technical Networks

The Development of European Accreditation (1)


European Regulation 765/08 The European legislation on accreditation and market surveillance Legal basis for accreditation and EA in both voluntary and regulated sectors Recognizes EA as the European accreditation infrastructure

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

EAs Relationship with the European Commission


Key issues resulting from EC 765/2008:
- Revision of the Articles of Association and of the Rules of Procedure for the operation of EA. - Enhancement of the role of the EAAB and of the interaction with the stakeholders. - Focus on the role and operation of accreditation in the regulated sectors: cooperation between ABs and notifying authorities.

- Official recognition of the EA MLA.


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

Accreditation for Notification according to CPD (1)


The European Commissions Blue Book (Guide to implementation of directives based on the New Approach and the Global Approach) published in 2000 and the European Commission CERTIF 2009 08 document SOGS N612 describe for every NLF conformity assessment module which of the standards reflect the criteria conformity assessment bodies must fulfill in order to be notified for the module in question.

Accreditation for Notification according to CPD (2)


Guidance Paper A
Accreditation of laboratories System 3 Product Certification System 1 and System 1+ (accredited laboratories) FPC Certification System 2 and System 2+ (non-accredited laboratories) FPC Inspection ISO/IEC 17025 EN 45011

Accreditation of certification bodies

ISO/IEC 17021 and/or EN 45011 ISO/IEC 17020

Inspection bodies

Accreditation for Notification according to CPD (3)


Following the issue of the European Regulation 765/2008, EA has produced a mandatory guidance for NBs, which is titled EA-2/17 - EA Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes. EA-2/17 document shall be used in combination with the relevant harmonised standards for conformity assessment bodies (CAB standards) and the related guidance documents issued by EA, ILAC and IAF.

Accreditation for Notification according to CPR (1)


Alternative approaches: of harmonised standards and EA-2/17 document
Assessment of NB compliance with the requirements

of One (1) Plus (+) Approach (under development)

Assessment of NB compliance with the requirements

One (1) Plus (+) Model Approach


Module
A A1

Description
Internal production control Internal production control plus supervised product testing Internal production control plus supervised product checks at random intervals EC type examination Conformity to type based on internal production control Conformity to type based on internal production control plus supervised product testing Conformity to type based on internal production control plus supervised product checks at random intervals Conformity to type based on quality assurance of the production process Quality assurance of the production process

EN 45011
N/A 1+ t

ISO / IEC ISO / IEC ISO / IEC 17020 17021 17025


N/A 1+ t N/A N/A 1 + cd

A2 B C

1 +t 1 +t N/A

1 +t 1 +t N/A N/A

1 + cd

N/A

C1

1 +t

1 +t

1 + cd

C2

1 +t

1 +t

1 + cd

D D1

1 + qa 1 + qa

1 + qa 1 + qa

1 + pj 1 + pj

Thank you for your attention! Contact details: e-mail address: kallergis@esyd.gr