conformiteits

Conformiteits is a Dutch term that refers to the state of being in accordance with applicable rules, standards and specifications. In practice the word appears most often in compound forms such as conformiteitsbeoordeling (conformity assessment) and conformiteitsverklaring (declaration of conformity). The concept is central to regulatory regimes for products, services and processes, where an actor must demonstrate that requirements set by law or standards are met before market access or use in a safe context.

Conformiteit en conformiteitsbeoordeling are integral to the European internal market. Conformiteitsbeoordeling involves procedures to evaluate whether a product, a production process, or a quality management system complies with relevant requirements. This may include testing, inspection, certification and auditing by an external body, sometimes a notified body under EU directives. If conformity is established, the manufacturer or importer issues a conformiteitsverklaring and may affix the CE mark, indicating conformity with the applicable rules.

Related concepts include harmonized standards, which provide a presumption of conformity with essential requirements, and technical documentation such as a technical file, risk assessment, and design and manufacturing data. The specific procedures and documents required depend on the product category and the controlling directive or regulation (for example in electrical equipment, machinery, or medical devices).

In Dutch usage, conformiteits is embedded in regulatory language and in communications from manufacturers, regulators, and conformity assessment bodies. It is distinct from general notions of quality, focusing on compliance with mandatory requirements rather than perceived quality alone.