The Council of the European Union and the European Parliament have agreed a Regulation that will, for the first time, provide a legal framework for the provision of accreditation services across Europe. The Regulation, expected to be formally adopted in June this year, will apply from January 2010 and will cover the operation of accreditation in support of voluntary conformity assessment as well as conformity assessment required by legislation. Under the Regulation, accreditation, when carried out against the recognised harmonised standards, is regarded as a public authority activity and EU Member States will be required to appoint a single national accreditation body for these activities.
To improve the consistency of accreditation services across Europe, the Regulation sets common requirements for national accreditation bodies, to be monitored by Member State governments. In essence, the Regulation will require national accreditation bodies:
- To be independent from the conformity assessment bodies they accredit
- To be objective and impartial
- To employ competent personnel for the tasks to be carried out
- To operate on a not for profit basis
- Not to offer services offered by conformity assessment bodies
- Not to compete with other national accreditation bodies
The Regulation will also recognise the European co-operation for Accreditation (EA) as the co-ordinating organisation for the national European accreditation infrastructure. National accreditation bodies will be required to be members of EA and to participate in the peer evaluation programme operated by EA as the preferred means of demonstrating compliance with the legal requirements.
UKAS has worked in close co-operation with the UK Government as the Regulation has been developed and the requirements closely mirror the accreditation system currently in force in the UK. Under the Regulation, conformity assessment bodies will be expected to use their own national accreditation body in most cases but, in other respects, UKAS customers should not be greatly affected by the implementation of the Regulation.
A related EU Decision, expected to be adopted at the same time as the Regulation, will set a common framework for future EU Directives relating to the marketing of products. The Decision establishes a model text covering elements such as the use of standards, CE marking, conformity assessment procedures and the appointment of conformity assessment bodies (‘notified bodies’). The Decision places greater emphasis on the use of accreditation in the assessment of ‘notified bodies’, again with the intention of improving the consistency of approach across Europe.
Copies of the latest texts of the proposed
Regulation and
Decision can be downloaded but please note that they could be amended further during the final legal processes leading up to formal adoption.
Updates on the progress of the Regulation and Decision and on the arrangements for implementation in the UK will be circulated by the Department for Innovation, Universities and Skills using the Consultation on Conformity Assessment (ConCAss) mailing list. To be added to the ConCAss mailing list, contact Lisa Rogers at
lisa.rogers@dius.gsi.gov.uk