Division 3.2

The quality system must ensure conformity of appliances with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documents must permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

It must contain in particular an adequate description of:

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

• the manufacturing, quality control and quality assurance techniques, processes 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 quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means of monitoring the achievement of the required appliance quality and the effective operation of the quality system.