EU REGULATION 765/2008
- CONCERNING THE REQUIREMENTS FOR ACCREDITATION AND MARKET SURVEILLANCE RELATING TO THE MARKETING OF PRODUCTS.
Regulation 765 from 2008 can be seen as a form of '"constitution" for the entire accreditation area in Europe. With the regulation, which applies to all EU Member States, the European Union adopted common rules in the area of accreditation.
The regulation entered into force on January 1, 2010. It is in Denmark included in the Danish law on business promotion from 2009, "lov om erhvervsfremme".
With the regulation a common legal basis for the national accreditation bodies in the European Union was created. In Denmark DANAK must follow these rules.
This paved the way for the EU-Commission in European law to refer to accreditation or impose requirements on the use of accreditation in order to assess the companies' technical competencies or to ensure that products comply with the requirements of law.
THE REQUIREMENTS OF THIS REGULATION FOR ACCREDITATION BODIES
The regulation requires that each country must designate a national accreditation body. In addition, it defines a series of requirements for these accreditation bodies.
They can not in accordance with the regulation compete with other national accreditation bodies or with accredited companies. Accreditation must be equated with "public authority activity".
The requirements in the EU regulation is meant to strengthen the functioning of the internal market in Europe. In addition, the regulation provides increased assurance that products meet the requirements of European legislation, when they are offered on the internal market.
Already before the regulation DANAK lived up to the requirements of the standard ISO/IEC 17011, the standard for accreditation, which the EU-regulation largely relies on.
An important difference for DANAK, however, is the requirement that accreditation bodies must not compete with each other. The national bodies must primarily accredited in their home country. This meant that individual foreign customers with DANAK had to be transferred to national bodies in other countries.