European Project adressing the safety
of blood transfusion


EuBIS Audit/ Inspection Training Guide (Manual)

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EuBIS Audit/ Inspection Training Guide (Manual)

The EuBIS Inspection Training Guide aims to assist blood establishments (BE) in setting-up an inspection process. It is complementary to the EuBIS Manual on ‘Common European Standards and Criteria for the Inspection of Blood Establishments’. The training guide can be also used, if wished by competent authorities as a reference to assist the implementation process of regulatory inspections as required by the EU blood legislation. The training guide is based on the EuBIS manual entitled ‘Common criteria fort he inspection of blood establishments’. It comprises an inspection guide with detailed audit criteria (Chapter 3), cross references to common European standards and examples of the documents required to complete an audit / inspection (preparatory documents - listed in Annex I).

The content of this manual does not necessarily reflect the views of the European Commission. Neither the Commission nor any person acting on its behalf can be held responsible for any use that may be made of the information in this report.

The editors and project participants assume no responsibility for the use to which this manual is made.