Division 2.2 The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.

It must contain, in particular, an adequate description of:

• the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,

• the technical design specifications, including standards that will be applied and, where the standards referred to in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety requirements of this Directive are fulfilled,

• the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by this Directive,

• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

• the inspections 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, and reports on the qualifications of the personnel concerned,

• the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.