In July 2008 the Council of the European Union and the European Parliament agreed a Regulation that for the first time, provides a legal framework for the provision of accreditation services across Europe. The Regulation covers 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 are 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 requires national accreditation bodies:
The Regulation also recognises 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.
In response to the new legal framework, UKAS has been appointed as the national accreditation body for the UK by the statutory instrument (No 3155/2009) providing, for the first time, a legal basis for accreditation in the UK.
A related EU Decision, adopted at the same time as the Regulation, sets 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.
The adopted texts of the Regulation and Decision were published in the Official Journal of the European Union Ref L218 of the 13th July 2008 as Regulation (EC) No 765/2008 and Decision No 768/2008. Copies can be downloaded from the Official Journal website. The statutory instrument is available from the OPSI website.
Further information on the arrangements for the implementation of the Regulation and Decision in the UK is available from the Department for Business Innovation and Skills website.