Our Methodology
A structured and proven approach that has led to a 100% success rate in accreditation inspections.
Gap Assessment
Analysis of the facility's current state against the reference standard (JACIE/FACT, CNT/CNS, ISO 15189, GMP, GCP). Identification of organisational, documentary and training gaps.
2-4 weeksAction Plan
Definition of a customised work plan with objectives, timelines, responsibilities and milestones. Every project is unique and calibrated to the centre's needs.
1-2 weeksImplementation
Quality system development: documentation, operating procedures, functional org chart, data management system. Staff training on standard requirements.
6-12 monthsInternal Audits
Execution of internal audits to verify compliance of the implemented system. Identification of improvement areas and corrective actions before inspection.
2-4 weeksMock Inspection
Simulation of the real inspection with the same criteria and methodologies of accrediting bodies. Staff preparation for inspection management.
1-2 weeksInspection & Accreditation
Support during the official inspection by the accrediting body. Management of any observations and response plan. Success rate: 100%.
VariableMaintenance
Ongoing post-accreditation support: periodic audits, document updates, indicator monitoring, Management Review, preparation for surveillance visits.
Ongoing