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 guidelines in addition to preclinical services with AAALAC accreditation and GLP compliance. 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
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Extensive proficiency testing program through RfB, INSTAND, CAP and NGSP
- External audits and regulatory inspections
MLM Medical Labs is*:
- American Association for Accreditation of Laboratory Animal Care (AAALAC) accredited
- College of American Pathologists (CAP) accredited
- Clinical Laboratory Improvement Amendments (CLIA) accredited
- Good Laboratory Practices (GLP) certified
- DIN EN ISO15189 accredited
- 1 of 8 National Glychemoglobin Standardization Program (NGSP) certified Level 1 Labs in Europe
Our quality certificates can be downloaded here:
*Accreditations and certifications may vary depending on business location. For further information please get in contact with qa@mlm-labs.com
