Division 3.3 Quality system
United Kingdom
- 3.3.1The manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.
- 3.3.2All 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. It shall contain, in particular, an adequate description of:
- 3.3.3The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 3.3.2. It will presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard.
- 3.3.4The manufacturer must keep the notified body that has approved the quality system informed of any updating of the quality system in relation to changes brought about by, for example, new technologies and quality concepts.
- 3.3.5Division 3.3.5