Quality Assurance

Feel Secure that We Hold the Highest Quality Standards

Quest Diagnostics Clinical Trials strives to ensure that high levels of operational quality are consistently achieved in a manner that meets regulatory and sponsor requirements. Quest Diagnostics Clinical Trials has a dedicated Quality Assurance unit to ensure global standardization, oversight, and regulatory compliance.

1. Dedicated Global QA team: Global Director, Certified Auditors, IT Specialist, and Document Controllers
2. Electronic document management system to ensure global compliance with documents and records, SOPs, employee training, and annual competency assessments
3. Internal and External Global Audits
4. Commitment to Six Sigma quality and dedicated Program Management Office to lead and monitor service and process improvements
5. Accreditation / Certification & Regulatory Compliance and Data Privacy ISO 9001:2000, CAP/CLIA & National Standards, 21CFR part 11, GCP (Click here for Accreditation information)

Our comprehensive Inter-laboratory Proficiency Testing Programs includes:

External

Internal

College of American Pathologists (CAP) Northwest Lipid Research Laboratories Reference Lipoprotein Analysis Basic Survey (ReLABS) National Glycohemoglobin Standardization Program (NGSP) HbA1c Standardization New York State CDC and National Heart, Lung and Blood Institute (NHLBI) Lipid Standardization Program

Document Control and Review Internal audits including lab and non-lab departments, IT systems Global audits with alliance labs and subcontractors Six Sigma and program management office Metrics including audit findings, quality issues, and proficiency test results Quality issue tracking system to document and manage preventative and corrective actions UK National External Quality Assessment Scheme (NEQAS)