FOCUS: Audit practices in Blood Establishments

Date12 September to 14 October 2022

Location: Online



The concept of quality management in the field of blood transfusion has greatly evolved over the last decade. Moreover, blood establishments (BEs) have had to continually adapt their quality management system (QMS), ensuring that they fully comply with new regulatory and technical requirements.

Auditing, in addition to being a key driver in the continual improvement of QMS, contributes to ensuring compliance with regulatory and technical requirements, as well as organisational success. This is emphasised in the applicable European Union blood legislation, the Good Practice Guidelines (GPGs) and the Guide to the preparation, use and quality assurance of blood components from the European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe (CoE).

BE personnel responsible for conducting internal and external audits therefore require sound knowledge of audit practices, enabling them to develop and implement robust auditing processes.

The EDQM/CoE plays a central role in the field of blood for human application by facilitating the exchange of knowledge and promoting the harmonisation of practices throughout Europe and beyond.

With this in mind, the EDQM/CoE is conducting a training course on auditing practices for blood establishments. This course is intended to staff responsible for conducting audits internally or externally.

It will also contribute to supporting blood establishments in implementing and further developing a robust, risk-based QMS.

Important note: following the completion of the course and exam (see details below), successful candidates may be given the opportunity to join a pool of external auditors contributing to the EDQM B-QM Programme.

Programme overview

The course will cover the fundamental aspects of audit practices and equip participants with the advanced knowledge, skills and tools necessary to implement robust audit practices.

Key topics covered in the training course include:

  • auditing concepts, fundamentals and methodology;
  • preparing an audit;
  • conducting an audit;
  • communication during an audit;
  • reporting, findings and audit follow-up;
  • exercises in auditing management, core, support and continual-improvement processes (e.g. auditing qualification, cold chain, CAPA management).
Dates and format

The training course will be delivered in five modules over five weeks, as follows:

Self-training during the first four weeks:

  • Pre-learning material and exercises will be supplied at the beginning of each week (on 12, 19 and 26 September and on 3 October 2022). Participants will have one week to complete each module.
  • During this period, participants will have the opportunity to provide their feedback to the Training Team.

Live online sessions over five days:

From 10 to 14 October 2022, participants will have the opportunity to further exercise the knowledge and skills acquired during the first four modules, benefit from advanced live presentations and case studies, and interact with experienced experts in the field of auditing.

  • Monday 10 October 2022, 14:00 - 16:30 (CEST, France)
  • Tuesday 11 October 2022, 9:30 - 17:00 (CEST, France)
  • Wednesday 12October, 9:00 - 12:15 (CEST, France)
  • Thursday: 13 October, 9:00 - 17:00 (CEST, France)
  • Friday 14 October, 9:00 - 12:00 (CEST, France)

Online exam:

The following week, participants will have the opportunity to take part in an online exam. The most successful candidates will be given the opportunity to join a pool of external auditors contributing to the EDQM B-QM Programme.

Who should apply & eligibility

This training course will be of interest to blood establishment personnel responsible for implementing auditing and carrying out audits in their BEs.

In order to maintain a fair representation of Council of Europe member states, participants may be subject to selection.

Before applying, please check that you meet the following mandatory eligibility criteria:

Given the course is interactive, the number of places available is limited.

How to register

Given the course is interactive, the number of places available is limited.

The deadline for pre-registration has passed.

Registrations are no longer being accepted.

Accepted participants will be notified by email.


There is no attendance fee for this course. It is co-funded by the EDQM/Council of Europe and the European Commission.


If you have any questions about registering or require further information, please contact the EDQM's Public Relations and Documentation Division via the EDQM HelpDesk.