Legal basis of DAkkS
As the national accreditation body, DAkkS has a statutory mandate and acts solely in the public interest. In its structural and procedural organisation, it complies with legal requirements at European and national level as well as international standards and rules for accreditation bodies.
European legal framework
In the area of accreditation, a uniform European system was established in 2010. This accreditation system covers both the regulated area, in which accreditation is required by law, and also areas in which a body wishes to be accredited voluntarily.
In the European legal framework, attention should be drawn in particular to Regulation (EC) No 765/2008 “setting out the requirements for accreditation and market surveillance relating to the marketing of products”. This Regulation is intended in particular to ensure that accreditation serves the public interest.
The EU Regulation achieved the successful adaptation of the legal framework for accreditation to the requirements of the rapidly growing international trade in goods and services and harmonisation of the accreditation system across countries.
Requirements of the EU Regulation for national accreditation bodies
The EU member states are given clear and uniform guidelines for the organisation and implementation of accreditation. At the core of the Regulation (EC) No 765/2008 are the following issues:
- Since 1 January 2010, member states must have established a single national accreditation body.
- The responsibilities and tasks of the national accreditation body are clearly demarcated from those of other national authorities.
- Accreditation is an activity in the public interest and must be carried out on a statutory basis.
- DAkkS operates in a non-profit distributing manner.
- There is no competition with other national accreditation bodies, cross-border accreditation within the EU and the European Economic Community is only possible to a very limited extent.
- The accreditation body fulfils the specified requirements with respect to its organisation, work practices and competence and ensures that objectivity, impartiality and confidentiality are guaranteed. It must be independent of the conformity assessment bodies to be assessed and free from commercial influence.
- It must meet the requirements of the international standard ISO/IEC 17011 for accreditation bodies, and therefore capable of achieving international recognition.
- The national accreditation body is subject to regular peer evaluation by the European co-operation for Accreditation (EA).
Other elements of the European legal framework
In addition to Regulation (EC) No 765/2008, the European legal framework for the accreditation system also comprises other elements. Some examples:
At the horizontal, cross-sectoral level:
- Regulation (EC) No 764/2008; now Regulation (EU) 2019/515
- Decision (EC) No 768/2008
At the vertical, sectoral level:
- EU directives or EU regulations within the meaning of Article 288 of the Treaty on the Functioning of the European Union (TFEU)
In addition, the following legal bases are also relevant for the accreditation system:
- Standards Regulation (EU) 1021/2012
- Information Directive (EU) 1335/2015
- Procurement Directive (EU) 24/2014
National legal framework
In Germany, the German legislature has implemented the European requirements for accreditation set out in Regulation (EC) No 765/2008 with the adoption of AkkStelleG, the Act on the Accreditation Body, of 31 July 2009. Under this law, accreditation is undertaken by the accreditation body as a public authority task of the Federation. According to the requirements of the European legal framework, each member state may establish only one national accreditation body.
With AkkStelleGBV, the ordinance on the entrustment of the accreditation body, the German legislature took the decision to assign this statutory duty to DAkkS as a private company. For the conduct of all proceedings under public law, DAkkS is subject to German state and administrative law. In third countries outside the EU and the European Economic Community, DAkkS operates in the non-statutory area beyond the scope of Regulation (EC) No 765/2008.
The Act on the Accreditation Body (AkkStelleG)
The act defines the following key points:
- Duties and powers as well as organisational form of the accreditation body
- Establishment and composition of the Accreditation Advisory Board
- Use of the accreditation symbol
- Determination of fees and disbursements
- Entrustment Supervision
- Cooperation with regulators
- Transfer of existing surveillance obligations
Legal basis at a glance
The statutory activities of DAkkS, as Germany’s national accreditation body, and the requirements it is obliged to meet are based primarily on the following legal and normative foundations: