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Guideline D-02

Question

Answer

A notified body when approving QA systems according to the modules D, D1, E, E1, H or H1 should take into account that the manufacturer already has ISO 9000 certification particularly if it has been certified by an accredited certifying organisation. However, the notified body has overall responsibility for ensuring that the QA systems satisfy the pressure equipment directive in particular on aspects in pressure equipment technology.

Reason:
QA systems under the modules D, D1, E, E1, H or H1 must cover the technical aspects in relation to the pressure equipment.