quality system - the organization structure, responsibilities, activities, resources and events that together provide organized procedures and methods of implementation to ensure the capability of the organization to meet quality requirements
The notified body shall withdraw the EC type-examination certificate referred to in Annex I, the EC quality system approval decision referred to in Annex III or the EC quality system approval decision as referred to in Annex IV, notwithstanding any decisions taken under Article 8 Annex III Production quality assurance is the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them. ... The manufacturer shall operate an approved quality system for production, final product inspection and testing as specified in point 3 and shall be subject to monitoring as specified in point 4. ... The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them. ... The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with these requirements in respect of quality systems that implement the relevant harmonized standard(1). ... The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. ... The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system. ... The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. ... Each notified body referred to in Article 10 (1) shall make available to the other notified bodies referred to in that Article the relevant information concerning the quality system approvals issued and withdrawn.
