Quality and certifications

ENAC accreditation. ISO 9001:2008. Date of issue: February 12, 2015
ENAC accreditation. ISO 9001:2015. Date of first issue: June 23, 2016
Under the ISO 9001:2015 quality system, the unit works with 4 general procedures and 12 standard operating procedures:
- GP for documentation and record control
- GP for managing non-conformities, complaints, and AACC
- GP for service provision
- GP for system planning and monitoring
- SOP for First Aid
- SOP for minimum permanence requirements
- SOP for transferring subjects to the emergency room
- SOP for communicating with the responsible physician
- SOP for locating physicians outside of working hours
- SOP for reporting adverse reactions
- SOP for use, maintenance, and verification of equipment
- SOP for medication management
- SOP for training unit personnel
- SOP for sample management
- SOP for personnel management
Standard operating procedure for warehouse management
Standard operating procedure for management of equipment, medication, and documentation in blind and non-blind trials
Team specifically dedicated to quality management
Number of sponsor audits in the last 5 years: 8
Number of internal audits in the last 5 years: 5
Number of inspections in the last 5 years: 1
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