The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
1.10.
The manufacturer’s authorised representative may lodge the application referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided that they are specified in the mandate.
2.
Module D: Conformity to type based on quality assurance of the production process
2.1. 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 in points 2.2 and 2.5, and ensures and declares on his sole responsibility that the instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
2.2.
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the instruments concerned as specified in point 2.3, and shall be subject to surveillance as specified in point 2.4.
2.3.
Quality system
2.3.1.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.
The application shall include:
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) all relevant information for the instrument category envisaged;
(d) the documentation concerning the quality system; and
(e) the technical documentation of the approved type and a copy of the EU-type examination certificate.
2.3.2.
The quality system shall ensure that the instruments are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive 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:
(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, etc.;
(e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
2.3.3.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 2.3.2.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
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