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AMC1 ORGH.MGM.200(d) General requirements for the management system

ED Decision 2025/007/R

INTEGRATED MANAGEMENT SYSTEM

To enable the implementation of an integrated management system, the GH organisation should identify the following elements in its structure and documentation:

(a) other certificates approvals, authorisations issued or declarations submitted under Regulation (EU) 2018/1139 and its delegated and implementing acts that are intended to be covered by the integrated management system;

(b) the domains that are integrated in its management system, with the interfaces that enable effective functioning and communication between them; and

(c) applicable requirements for each domain.