Compliance Dossier
A systematic collection of engineering records, test reports, and material declarations proves that an electronic product complies with environmental and safety regulations. For printed circuit board assemblies, a technical documentation dossier compiles the bill of materials, supplier declarations, and chemical analysis reports into a single organized file. This file must be maintained by the manufacturer for ten years after the product is placed on the market to satisfy market surveillance authorities.
Documentation Structure
The assembly of this file must follow the guidelines established in standard EN IEC 63000 to demonstrate sufficient diligence. This process involves evaluating each component on the board for compliance risk, where low-risk parts like metal resistors require simple declarations while high-risk parts like plastic connectors require analytical test reports. If the risk assessment indicates a high likelihood of restricted substances being present, the manufacturer must include quantitative testing data from an accredited laboratory in the document.
This methodical approach ensures that the environmental compliance of the entire product can be audited and verified without needing to re-test the physical product.
Scope Maintenance
The obligation to compile and maintain this document applies to the organization that places the finished electronic product on the market. It is not required for intermediate boards or sub-assemblies sold solely to other manufacturers who will incorporate them into a larger system that receives its own final dossier.
