ISO 9000 is not required. However, a manufacturer must have a legitimate quality system with a quality manual. For the purposes of this Directive, machinery means an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control, and power circuits, etc., joined together for a specific application, in particular for processing, treatment, moving, or packaging of a material. The term machinery also covers an assembly of machines, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole. Machinery also means interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of machines or with a tractor by the operator himself insofar as this equipment is not a spare part or a tool.
Manual machinery is excluded, except for lifting equipment.
Machinery must be for specific applications. Unfinished machinery is not covered by the directive. Assemblies of machines are covered. Determine which conformity assessment procedure to follow. Each directive requires conformity assessment, which includes all of the activities that assure the product meets its requirements.