Quality Standards

Quality Systems that Deliver Quality Results

Quality is embedded in all facets of MLM Medical Labs operation and service offerings. Along with being compliant with multiple relevant certifications and accreditations, our labs conduct clinical trials in full compliance with EMA, FDA and GCLP. All services, such as sample handling, analytical procedures, disease modeling and kit building, are only conducted by qualified personnel. To guarantee data integrity, we record data in our laboratory information management system (LIMS), ensuring seamless tracking from sample receipt through analysis to final report generation.

Our quality management relies on:

Qualified and trained personnel
Qualified equipment
Validated computer systems
Internal audits (>400 per year) and quality checks
Methods validated according to the FDA and EMA guidelines
Standard Operating Procedures for all methods, instruments and process steps
Archiving of all raw data for at least 25 years
Comprehensive CAPA system, issue, complaint and risk management
Highly robust vendor selection and management system, including vendor assessments, qualifications and audits
Extensive proficiency testing program through RfB, INSTAND, CAP and NGSP
External audits and regulatory inspections