Sch 1B Pt 3 para 3
The quality system shall ensure that the regulated measuring instruments are in conformity with the type described in the type examination certificate and comply with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out; (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.