Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.
In the European Union harmonisation legislation, conformity assessment procedures cover both design and production phases of a product; those procedures are called “modules”.
There are modules covering the design phase, the production phase or both. The main document on conformity assessment is the Decision No 768/2008/EC, which lays down the modules usable for all the regulated sectors.
The specific nature of the regulated railway sector, needs a specific set of “modules” implementing the generic provisions; the specific railway modules are defined in the Decision 2010/713/EU.
In most of the modules, there is the need to have a third party independent conformity assessment, performed by bodies notified by Member States to the Commission. Those bodies are known as “notified bodies - NoBos”; they are gathered for coordination under a specific group called NB-Rail. The European Union Agency for Railways (the Agency) is also an active partner of the NB-Rail in each of its subgroups.
Recently, the Agency has developed an “assessment scheme” which details the legal requirements for notified bodies contained in the Interoperability Directive 2008 and 2016.
Today the Agency is finalizing a monitoring system for notified bodies which shall support the activities already developed by each Member State.
ERA has already performed the first step towards this direction with the adoption, by the ERA Management Board, of the Decision num. 156 adopting the provisions for audits. Attached to the ERA MB Decision is the ERA technical document containing the harmonized set of requirements for notified conformity assessment bodies (aka as “Assessment Scheme”).
This Agency’s task is stated by the Art. 34 of the Agency Regulation 2016.