Division 3.5 Quality system
United Kingdom
- 3.5.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.
- 3.5.2The quality system shall ensure compliance of the instruments with the requirements of this Directive that apply to them.
- 3.5.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.5.2.
- 3.5.4Division 3.5.4
- 3.5.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.