konformitetsorgan

A konformitetsorgan, or conformity assessment body (CAB), is an organization that evaluates and confirms that products, processes, or services meet applicable standards, technical specifications, or regulatory requirements. In many regulatory contexts, CABs perform testing, inspection, certification, and related activities necessary for market access and compliance. In the European Union, the term notified body is used for CABs designated under specific directives; more generally, CABs operate under international accreditation schemes such as ISO/IEC 17025, 17065, and 17021.

Core activities include testing of products, inspection of production facilities, and certification of products or management systems. CABs may also verify technical documentation, conduct supplier audits, and issue certificates or declarations of conformity that enable manufacturers to demonstrate compliance to regulators and customers.

Regulatory framework: CABs operate under national accreditation and, in many regions, under direct oversight by regulatory authorities. They are expected to maintain impartiality, independence, and technical competence. Accreditation bodies (for example, EA and ILAC) perform surveillance and reassessments to ensure ongoing competence and impartiality. Some sectors designate bodies as notified or designated for specific directives, which imposes additional oversight and designation requirements.

Sectors: CABs operate across electrical equipment, machinery, medical devices, construction products, automotive components, toys, and consumer goods, among others. The exact role and recognition of a CAB depend on the applicable regulatory regime.

Impact: By providing third-party assessment, CABs support market access, consumer protection, and global trade. Their certificates and conformity statements are used by manufacturers, regulators, suppliers, and customers to verify that requirements have been met.