As agreed by the EA General Assembly, EA-1/13 A 2009: EA’s Relationship with Accreditation Bodies (ABs) of Countries not being Members of the EU or EFTA has been revised to elaborate a specific process for peer-evaluating those ABs members of another region that need to demonstrate compliance with Regulation (EC) 765/2008 for accreditation in the European regulated field.
EA has a prime role to define, harmonise and build consistency in accreditation as a service to European trade, industry and society, with the aim to reduce barriers to trade and to contribute to protecting health and safety of people.
The European Union (EU) has recognised the particular importance of having close links with neighbouring countries and has established a European Neighbourhood Policy. EA considers that relationships between EA and accreditation bodies (ABs) in countries that are part of the EU’s Neighbourhood Policy and potential candidates for EU membership including regions established by those ABs should be strengthened.
Nationally-recognised ABs established in countries that are part of the EU Neighbourhood Policy (EUNP) or potential candidates for EU membership may become EA Associate Members. Associate Members may sign a Bilateral Agreement (BLA) with EA which has the same purpose as the EA MLA to establish mutual confidence in the respective accreditation systems and in conformity assessment results.
However, it is the policy of EA to rely on the ILAC Mutual Recognition Arrangement (ILAC MRA) and the IAF Multilateral Recognition Arrangement (IAF MLA) in relation to the global acceptance of reports and certificates issued by accredited CABs. Therefore, ABs joining the EA MLA through a BLA shall be peer-evaluated by EA and consequently not be peer-evaluated by ILAC, IAF or another recognised region.
But EA has recognized that ABs from neighbour countries as well as the European Commission have reasonable interest in the establishment of mutual confidence and recognition in the respective accreditation systems and in the accredited attestations of conformity in the European regulated area. In order to reach this aim of mutual confidence and recognition in the European regulated area, ABs have to demonstrate that they operate in accordance with ISO/IEC 17011 and the ILAC/IAF provisions, but also with Regulation (EC) 765/2008 and the corresponding EA provisions. The former shall be demonstrated through a peer-evaluation by a recognized region; the latter shall be demonstrated through an evaluation by EA.
The new principles set out in the 2016-revised version of EA-1/13 provide that ABs from EUNP countries where an ILAC- or IAF-recognized region is established may apply to sign a cooperation agreement (COA) with EA for the purpose of demonstrating their compliance with the additional requirements according to Regulation (EC) No 765/2008 and the corresponding EA provisions, provided that those ABs:
- fulfil the requirements in ISO/IEC 17011 by being a signatory of a MLA established by a region which is recognized by ILAC or IAF; and
- fulfil the relevant requirements in Regulation (EC) No 765/2008.
In addition, in order to gain mutual recognition in the European regulated area, ABs from EUNP countries where an ILAC- or IAF-recognized region is established may also apply to sign an agreement for mutual recognition (COAMR) with EA. The prerequisite for application is that the European Commission declares to EA the applying AB’s reasonable interest in the establishment of mutual confidence and recognition in the respective accreditation systems and in conformity assessment activities in support of EU legislation and trade policy. The conditions for those ABs to get the COAMR signatory status are:
- to be signatory of a COA; and
- having been successful peer-evaluated by EA for demonstrating competence to accredit conformity assessment bodies involved in activities based on EU legislations.
Further information, notably the detailed requirements for signing the EA COA and COAMR, are provided in EA-1/13 A 2016: EA’s Relationship with Accreditation Bodies of Countries not being Members of the EU or EFTA available on the EA website. The revised EA document will be implemented as from 1 January 2017.
Published on: 12/07/2016
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