4.EC DECLARATION OF TYPE CONFORMITY (guarantee of product quality)U.K.
4.1.The EC declaration of type conformity (guarantee of product quality) is that part of the procedure whereby a manufacturer who fulfils the obligations in point 4.2 declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential requirements of this Directive which apply to them. The manufacturer or his authorised representative established within the Community must affix the CE marking to each appliance and draw up a written declaration of conformity. This declaration may cover one or more appliances and must be kept by the manufacturer. The CE marking must be followed by the identification number of the notified body responsible for EC surveillance.U.K.
4.2.The manufacturer shall apply an approved quality system for the final inspection of the appliances and the tests, as specified in point 4.3, and is subject to EC surveillance as specified in point 4.4.U.K.
4.3.Quality systemU.K.
4.3.1.Under this procedure, the manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.U.K.
The application must include:
the quality system documentation,
an undertaking to carry out the obligations arising from the quality system as approved,
an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness,
the documentation relating to the approved type and a copy of the EC type-examination certificate.
4.3.2.As part of the quality system, each appliance must be examined and appropriate tests as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests carried out to check its conformity with the essential requirements relating to it in this Directive.U.K.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and logical manner in the form of measures, procedures and written instructions. This quality system documentation must permit a uniform interpretation of the quality programmes, plans, manuals and records.
The quality system documentation shall contain, in particular, an adequate description of:
the quality objectives, the organisational structure and responsibilities of management and of their powers with regard to appliance quality,
the checks and tests to be carried out after manufacture,
the method of verifying the effective operation of the quality system.
4.3.3.The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 4.3.2. It will presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard. It must notify the manufacturer of its decision and inform the other notified bodies thereof. The notification to the manufacturer must contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment decision for the appliances concerned.U.K.
4.3.4.The manufacturer must keep the notified body which approved the quality system informed of any adaptation of the quality system made necessary, e.g. by new technology and quality concepts.U.K.
The notified body must examine the proposed changes and decide whether the amended quality system satisfies the relevant provisions or whether a reassessment is necessary. It must notify the manufacturer of its decision. The notification must contain the conclusions of the inspection and the reasoned assessment decision.
4.3.5.A notified body which withdraws approval of a quality system must inform the other notified bodies that it has done so and give reasons for its decision.U.K.
4.4.EC surveillanceU.K.
4.4.1.The purpose of EC surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.U.K.
4.4.2.The manufacturer must allow the notified body access for inspection to the place of inspection, testing and storage and must provide it with all necessary information, in particular:U.K.
the quality system documentation,
the quality files such as inspection reports and test data, calibration data, report on qualifications of the staff concerned.