Gentlemen - you are running into some misunderstandings here. BABT 340 implements the quality system requirements of Annex 3 of the TTE Directive, but only to the extent necessary to demonstrate the products' compliance with the "Essential Requirements". This is made abundantly clear throughout the document. There is no question of EN ISO 9002 certification being a prerequisite. There are plenty of companies around who can satisfy the regulatory requirements without having EN ISO 9002 certification. Further, the TTE Directive does not require a Notified Body to have confidence in a quality system in order to issue a Type Examination Certificate. Type Examination is just that - examination (testing) of a sample(s) of a product type. The quality system element, whether by Production Quality Assurance Approval (Annex 3) or Full Quality Assurance Approval (Annex 4), or the "alternative" to a formal quality system approval, in the form of Product Checks (Annex 2), is quite separate. The "Administrative Approval" is issued on the basis of combining the Type Examination with either Annexes 2 or 3, or is issued without the need for Type Examination in the case of an Annex 4 approval. I hope this helps. Richard Crossley, Head of Quality Group BABT.
