Division Module H1 Conformity based on full quality assurance plus design examinationF1

United Kingdom Repealed

1. 1Division 1
2. 2Manufacturing
3. 3Division 3
4. 3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.
5. 3.2The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.
6. 3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
7. 3.4Division 3.4
8. 3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
9. 3.6Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
10. 4Division 4
11. 4.1Division 4.1
12. 4.2The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it. It shall include:
13. 4.3The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.
14. 4.4The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
15. 4.5Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
16. 4.6Division 4.6
17. 5Division 5
18. 5.1Division 5.1
19. 5.2The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
20. 5.3Division 5.3
21. 5.4Division 5.4
22. 6Division 6
23. 6.1Division 6.1
24. 6.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up and shall mention the number of the design examination certificate.
25. 7The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
26. 8Authorised representative