How to Become a Quality Manager in a Tissue Establishment

• Sets up and maintains the quality system.
• Designs and updates the organisational and document system.
• Plans and conducts internal audits.
• Assesses process risks.
• Manages errors, incidents and adverse events and the related corrective actions.
• Reads and applies accreditation standards and prepares the organisation for inspections.

Tissue establishments 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.

Physicians, biologists, laboratory technicians and staff responsible for quality in tissue establishments, blood establishments and transplant programmes.

ICMED offers the «Quality Manager in Tissue Establishments, Blood Establishments and Transplant Programmes» pathway: asynchronous online training. The pathway has four modules and a final assessment:

1. Quality, risk and safety
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 blood establishments, tissue establishments and transplant programmes.

Professional registers

Regulation (EU) 2024/1938 brings blood, tissues and cells into a single European framework. For the Quality Manager, 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