Laboratory Information

EONE continues its efforts to serve as a leader
of the medical science of the future.

Quality management

Based on more than three decades of experience with clinical testing, EONE Laboratories provides specialized clinical laboratory testing services. We are continuously improving all processes and services supporting patient care.

Quality management system

Our quality management goal is to provide the qualified testing services, to meet customer requirements and to exceed customer expectations. We have implemented a systematic quality management program for continuous quality improvement.
Eone Laboratories conducts quality control to ensure accuracy and minimize errors. At every stage of the test, we select and periodically review the core quality indicators and strive to maintain the highest level of laboratory testing services.

Key indicator

Based on the Clinical and Laboratory Standards Institute (CLSI) guidelines, the quality management system of Eone Laboratories is composed of 12 essential elements.

Organization and Leadership
  • Structure
  • Mission, Vision, Value
  • Quality Planning
Facilities and Safety
  • Structure and Utilities
  • Environmental conditions
  • Communications
  • Safety Programs
  • Emergency Management
  • Staff Qualifications
  • Job Description
  • Orientation and Training
  • Competency
  • Continuing Education
Purchasing and Inventory
  • Supplier Qualification
  • Supplier/Customer Agreements
  • Item Inspection
  • Inventory Management
  • Market Tracking
  • Selection and Acquisition
  • Equipment Qualification
  • Operations and Calibration Maintenance and Repairs
  • Expired Device Management
  • Equipment record
Process Management
  • Process Development
  • Validation
  • Quality Control
  • Change Control
Documents and Records
  • Document Management
  • Document Creation
  • Annual Review
  • Document Tracking
  • Retention, Storage and Retrieval
Information Management
  • Security
  • Software Validation and Interface Testing
  • Review Errors
Risk Management
  • Detection, Documentation and Investigation
  • Categorization and Analysis
  • External Notification
  • Correction
Monitoring and Assessment
  • Quality Indicators
  • External Inspections/Assessments
  • Internal Audit Program
  • Proficiency Testing
Service and Satisfaction
  • Needs Assessments
  • Customer Service
  • Customer Comments
  • Complaint Resolution
Continual Improvement
  • Quality Management System
  • Quality Improvement
Proficiency testing

Eone Laboratories participates in the national and international quality management program to ensure the accuracy of test results.

International proficiency testing programs :
  1. 1
    College of American Pathologists (CAP) Proficiency Testing
  2. 2
    CDC Newborn Screening Quality Control Program
  3. 3
    German External Quality Assessment Scheme (G-EQUA3)
  4. 4
    Vitamin D External Quality Assessment Scheme
  5. 5
    National Glycohemoglobin Standardization (NGSP) Program
  6. 6
    Asian Quality Assurance Survey Program
National proficiency testing programs :
  1. 1
    Korean Association of Quality Assurance for Clinical
    Laboratories Proficiency Testing
  2. 2
    Korean Society of Nuclear Medicine Proficiency Testing
  3. 3
    Neonatal Screening Quality Control Association Proficiency
  4. 4
    Korean Society of Pathologists Proficiency Testing
  5. 5
    Korean Society for Cytopathology Proficiency Testing
  6. 6
    Korea Institute of Genetic Test Evaluation Proficiency Testing

We participate in external assessments that include regulatory inspections and/or accreditation assessments.
For more information, refer to our Certificates