konformitetsevaluering

Konformitetsevaluering, ofte termed conformity assessment in English, is a systematic process by which a product, service, process, or management system is judged to meet specified requirements, such as technical standards or regulatory obligations. The aim is to provide objective confidence to manufacturers, regulators, customers, and the public that the subject meets applicable requirements and can be placed on the market or operated safely.

Conformity assessment typically includes testing, inspection, certification, and calibration, as well as verification and validation of design or processes. These activities may be performed by independent conformity assessment bodies, sometimes accredited to international standards. In many jurisdictions, certain products or systems require conformity assessment for market access or legal compliance. In the European Union, conformity assessment is closely linked to CE marking and the involvement of notified bodies for certain product classes.

The conformity assessment process generally involves: defining the applicable requirements; selecting a conformity assessment route; producing technical documentation; conducting testing and inspection; evaluating results; and issuing a certificate or declaration of conformity. Ongoing surveillance, periodic reassessment, or re-certification may be required to maintain conformity over time.

Standards and organizations underpinning konformitetsevaluering include the ISO/IEC 17000 family for terminology and schemes, ISO/IEC 17025 for testing and calibration laboratories, ISO/IEC 17020 for inspection bodies, ISO/IEC 17065 for product certification, and ISO/IEC 17021 for management system certification. Accreditation bodies assess the competence of CABs against these standards to ensure consistency and trust in conformity assessments.