814.501RPOFederal Council OrdinanceJan 1, 2018Original source
If the FOPH engages third parties for the coordination and preparation of clinical audits (Art. 189), they must be experts from various institutions and professional bodies.
If the FOPH engages third parties for the conduct of clinical audits (Art. 189), these auditors must have many years’ professional experience in their field and must be independent of the audited licence holders.
The FOPH shall make the necessary data concerning licence holders available to the third parties engaged.
If, in the evaluation of audits, the third parties engaged discover significant deviations from the requirements of this Ordinance or from the current state of science and technology, they shall inform the FOPH.
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