Division 4.3.2 As part of the quality system, each appliance must be examined and appropriate tests as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests carried out to check its conformity with the essential requirements relating to it in this Directive.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and logical manner in the form of measures, procedures and written instructions. This quality system documentation must permit a uniform interpretation of the quality programmes, plans, manuals and records.

The quality system documentation shall contain, in particular, an adequate description of:

• the quality objectives, the organisational structure and responsibilities of management and of their powers with regard to appliance quality,

• the checks and tests to be carried out after manufacture,

• the method of verifying the effective operation of the quality system.