Division 3.3.2 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. It 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 manufacturing processes, quality control and quality assurance techniques and systematic actions that will be used,

the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out,

the method of monitoring attainment of the required appliance quality and the effective operation of the quality system.