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Guideline F-01

Question

Answer

No, in accordance with and under the responsibility of the notified body or of a third party organisation recognised by a Member State, some practical tasks concerning the approval of joining operating procedures and personnel may be accomplished by a competent person of a manufacturer according to a quality system.

Note 1:
The Notified Body or Recognised Third Party Organisation must attend part of the different steps in the process for each procedure and for each person.

Note 2:
See also section 5.2.5 of the “Blue Guide