Annex X Full quality assurance

United Kingdom

1. 1Division 1
2. 2Division 2
3. 2.1The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.
4. 2.2The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.
5. 2.3The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.
6. 2.4The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.
7. 3Division 3
8. 3.1Division 3.1
9. 3.2The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:
10. 3.3Division 3.3
11. 3.4Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:
12. 4The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture: