Paragraph 6 Quality system
The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.
The application shall include—
all relevant information for the product category envisaged,
the documents concerning the quality system,
the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.
The quality system shall ensure conformity of appliances with the type as described in the EC type-examination certificate and 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.The quality system documents shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records.
The quality system shall contain in particular an adequate description of —
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to appliance quality,
the 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 of 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 notified body shall assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) to (5) of this paragraph. It shall presume conformity with those requirements in respect of quality systems that implement the relevant harmonised standard. The auditing team shall have at least one member with experience of assessing the relevant product technology. The assessment procedure shall include an inspection visit to the manufacturer’s premises.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the duly substantiated assessment decision.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.
The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any proposed change in the quality system.
The notified body shall assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in sub-paragraph (3) to (5) of this paragraph or whether reassessment is required. (11) The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the substantiated assessment decision.