Quality Management

To ensure accuracy, reliability, and consistency of laboratory testing, GC Labs operates a comprehensive
Quality Management system across the entire organization.

Quality Management Based on a Standardized Quality System

With the goal of providing accurate and reliable test results, GC Labs implements Total Quality Management (TQM) based on a standardized quality management system. Our quality management framework goes beyond simple post-error control. Instead, it is built upon Quality System Essentials and focuses on proactive risk management and continuous improvement (QI/CI) throughout the entire testing process - Pre-analytical, Analytical, and Post-analytical phases. Through this systematic approach, potential errors at each stage are effectively managed and minimized, enabling continuous improvement in testing quality and ensuring high levels of clinical reliability.

[ Pre-analytical stage ]

Verification of accuracy and appropriateness of test request information
Compliance with SOPs for sample collection, transportation, registration, and processing
Management of sample quality risk factors
Staff training and competency management

[ Analytical stage ]

Selection of test method and adherence to SOPs during testing
Result review and follow-up actions
Interpretation of test results
Internal quality control (IQC/EQC)
External quality assessment (EQA)

[ Post-analytical stage ]

Result verification
Issuance of final reports and record management
Critical/abnormal result reporting system
Multi-step cross-check system
Sample management and storage

Quality system
elements

Continuous Quality Improvement

At GC Labs, continuous Quality Improvement (QI) activities are carried out under the leadership of the independently operated Quality Management Center. These activities include monitoring and analyzing key Quality Indicators (QI), implementing improvement initiatives based on risk management, operating Corrective and Preventive Actions (CAPA), conducting regular management reviews and internal audits, and promptly reflecting updates in certification and evaluation standards. Through these systematic efforts, GC Labs ensures ongoing enhancement of its quality management practices.

Quality certification and management aligned
with International standards

GC Labs is a globally recognized reference laboratory committed to delivering the highest level of diagnostic accuracy and quality. The laboratory is accredited by the College of American Pathologists (CAP) and fully complies with ISO 15189, demonstrating internationally validated technical competence. GC Labs actively participates in global External Quality Assessment (EQA) programs, including those organized by the Centers for Disease Control and Prevention (CDC), and is an official member of the Clinical and Laboratory Standards Institute (CLSI). Through these programs, GC Labs continuously benchmarks its performance against leading laboratories worldwide. In addition, GC Labs maintains multiple domestic certifications and quality evaluation programs, including accreditation from the Laboratory Medicine Foundation as an Excellent Laboratory, Confirmation certification for consignment institution, accreditation for genetic testing institutions, and certification of consignment enforcement institution for Pathology department. By maintaining these national and international certifications, GC Labs ensures the highest standards in clinical specimen testing and guarantees quality as a laboratory for clinical trial sample analysis. Furthermore, as a member of the Global Diagnostics Network (GDN), GC Labs provides international clinical laboratory services to more than 30 partners across over 16 countries. The organization also supports overseas partners with laboratory establishment, preparation for quality accreditation, workflow optimization, and LIS implementation. By combining certified quality systems with global consulting expertise, GC Labs continues to strengthen laboratory excellence worldwide as a trusted partner.