Success Stories
Real cases of how ICMED has supported healthcare facilities in achieving the highest quality standards — with a 100% success rate.
First JACIE accreditation for an allogeneic transplant programme
A university hospital in Southern Italy needed to obtain its first JACIE accreditation for the allogeneic haematopoietic stem cell transplant programme. The centre lacked a structured quality system and documentation compliant with international standards.
- Initial gap assessment against FACT-JACIE standards
- Design and implementation of the complete quality system
- Development of over 80 standard operating procedures (SOPs)
- Training of medical, nursing and technical staff
- Implementation of document management system on IAAPP
- Execution of 3 internal audit cycles
- Full mock inspection simulation
- JACIE accreditation obtained on first attempt
- Zero major non-conformities found during inspection
- Fully operational quality system within 14 months
- Staff trained and autonomous in quality management
JACIE re-accreditation with CAR-T extension
A transplant centre in Central Italy, already JACIE-accredited, needed to undergo re-accreditation while integrating the new CAR-T unit. The challenge was unifying existing JACIE requirements with specific GMP qualification requirements for advanced cell therapies.
- Complete review of existing quality system
- Integration of GMP requirements for the CAR-T unit
- Update of 45 operating procedures
- Specific training on the CAR-T pathway
- Internal audits focused on new areas
- Coordination with manufacturing GMP facilities
- JACIE re-accreditation confirmed with CAR-T extension
- Qualification obtained from all commercial manufacturers
- Preparation time reduced by 30% thanks to IAAPP
- Model replicated across 3 other centres
Quality system for an assisted reproduction centre
A level III PMA centre in North-East Italy needed to implement a quality system compliant with CNT/CNS requirements and European tissue and cell directives. The centre operated without a structured document system and without performance indicators.
- Assessment of applicable regulatory requirements (CNT/CNS, D.Lgs. 191/2007)
- Design of PMA-specific quality system
- Development of laboratory and clinical procedures
- Implementation of traceability system
- Definition of quality indicators (KPIs)
- Staff training on requirements and procedures
- Preparation for CNT inspection
- Full compliance with CNT/CNS requirements achieved
- End-to-end traceability system implemented
- 12 KPIs defined and monitored quarterly
- CNT inspection passed without critical observations
ISO 9001 certification for a transfusion service
A transfusion service in a Southern Italian hospital needed to obtain ISO 9001:2015 certification to comply with regional requirements and improve quality management. The service managed over 15,000 annual donations without a formalised quality system.
- Mapping of transfusion processes
- Design of ISO 9001:2015 quality management system
- Development of Quality Manual and operating procedures
- Implementation of non-conformity and CAPA management
- Definition of indicators and Management Review
- Internal audits and internal auditor training
- Support during CSQA certification audit
- ISO 9001:2015 certification obtained at first audit
- Zero major non-conformities
- 25% reduction in adverse events in the first year
- Replicable system adopted by 2 other services in the network
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