For non-chemical products, compliance is central to the technical file and declaration of conformity. The product's ability to enter the market depends on this file being complete and up-to-date.
Scope
Determining the applicable legislation: Identifying which technical regulations the product falls under. A product may be subject to more than one regulation simultaneously.
Standard selection: Identifying harmonized standards to be applied and monitoring their release. Compliance should be reassessed when a standard is revised.
Selection of the assessment method: Determining whether internal production control or third-party inspection is required.
Technical file contents: Product description, design and production drawings, risk assessment, applied standards, test reports, user manual, and label samples.
Declaration of conformity generation: Automatic generation of the declaration from product and regulatory data; signature and date management.
Retention obligation: Keeping the file accessible for the period stipulated by legislation and monitoring this period.
Impact of change: Evaluating the impact of a change in product design, component, or supplier on conformity. Silent design changes are among the most common causes of nonconformity.
Continuity of mass production: Demonstrating that conformity is maintained throughout mass production, not just on a single sample.
A common mistake: preparing the technical file once and then archiving it. The file is a living document: the standard is revised, the supplier changes, the design is updated. With each change, the relevant section of the file must be updated and, if necessary, its compliance reassessed.