The Organisation must have appointed a
person responsible for the Traceability
System and must have clearly defined
the objectives and scope of the
Traceability System in a document
revised annually and available for aDoes the Organisation’s management team
know the objectives and scope of the
Traceability System?
The Organisation’s management team
must confirm their knowledge of the
defined objectives and scope of the
Traceability System.
No N/A.