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AMC1 21.B.432(b)(1) Oversight programme

ED Decision 2023/014/R

ASSESSMENTS, AUDITS AND INSPECTIONS

(a) The oversight programme should indicate which aspects of the approval will be covered by each assessment, audit or inspection.

(b) Audits may be complemented by a review of the independent monitoring function results related to the topic of the audit.

(c) At the conclusion of the assessment, audit, or inspection, the DOA team should complete a report that identifies the areas and processes that were covered and includes all the findings and observations that were raised.