How to Become a Quality Manager in an ART Centre

• Designs and updates the document system: procedures, instructions, records.
• Organises internal audits and follows up corrective actions.
• Analyses the risks of clinical and laboratory processes.
• Manages errors, incidents and adverse events, and prevents their recurrence.
• Prepares the centre for inspections by the competent authority.

ART centres handling reproductive cells fall under the EU rules on tissues and cells (Directive 2004/23/EC and Commission Directives 2006/17/EC and 2006/86/EC), which require a documented quality management system, a responsible person and trained staff. Regulation (EU) 2024/1938 on substances of human origin (SoHO) generally applies from 7 August 2027, with transitional provisions.

Fertility physicians, biologists and embryologists, laboratory technicians and staff responsible for quality in ART centres.

ICMED offers the «Quality Manager in an ART Centre» pathway: asynchronous online training, followed at your own pace. The pathway has four modules and a final assessment:

1. Designing and implementing the quality system
2. Designing and building the organisational and document system
3. Errors, incidents, adverse events and risk management
4. Audit management

Those who pass the final assessment receive the Quality Manager certificate and are listed in the international register of Quality Managers in ART centres.

Professional registers

Regulation (EU) 2024/1938 brings blood, tissues and cells, including reproductive cells, into a single European framework. For the Quality Manager of an ART centre, now is the time to compare the quality system with the new requirements and plan the changes before 7 August 2027.

ICMED consulting on the SoHO Regulation