ANNEXES (TO THE TSI)Scope: Whole Subsystems Aspect: Accessibility for Persons with Reduced Mobility

ANNEX FProcedures for assessment of conformity and suitability for use

F.2.Modules for Interoperability Constituents

F.2.5.Module D: Production Quality Management System

3.2.The quality management system shall ensure compliance of the interoperability constituents with the type as described in the type-examination certificate and with the requirements of the TSI 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. The quality management system documentation shall permit a consistent interpretation of the quality programmes, plan, manuals and records.

It shall contain in particular an adequate description of:

  • the quality objectives and the organisational structure,

  • responsibilities and powers of the management with regard to product quality,

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

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

  • the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

  • the means to monitor the achievement of the required product quality and the effective operation of the quality management system.