Module D – Conformity to type based on quality assurance of the production process
Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned, and shall be subject to surveillance.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.
The application shall include:
- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
- a written declaration that the same application has not been lodged with any other notified body,
- all relevant information for the product category envisaged,
- the documentation concerning the quality system,
- the technical documentation of the approved type and a copy of the EC-type examination certificate.
The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument 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 system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
- the corresponding 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 on the personnel concerned, etc., and
- the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient and keep the notified body that has approved the quality system informed of any intended change to the quality system.
The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
- the quality system documentation,
- the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the responsibility of the notified body, the latter’s identification number to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.
The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.