Quality Evaluation
Quality Evaluation
On-Site Inspection
Document Assessment
On-Site Inspection
External Quality Assessment
On-Site Inspection
Target of on-site inspection
Genetic testing agencies will be classified into medical and non-medical institutions for evaluation

Article 24, Clause 3 of the Bioethics and Safety Act: The Minister of Health and Welfare can mandate an agency that intends to perform genetic testing (hereafter referred to as “genetic testing agency”) to undergo an accuracy assessment and disclose the results in accordance with Clause 1 of this Act.

  • Bioethics and Safety Act

  • Medical Service Act (Regulation on medical personnel and medical practice)
Structure and contents of the inspection checklist
Common components for medical and non-medical institutions
  • External quality control
    • External quality control
  • Internal quality control
    • Quality improvement
    • Quality control guidelines
    • Evaluation instructions
  • Pre- and post-inspection evaluation
    • Sample collection and processing
    • Sample transport
    • Request for sample and registration
    • Review and report of inspection results
    • Reconsignment inspection
  • Inspection and
    equipment operation
    • Operation of general equipment
    • Sterilization of glass containers
    • Computers
    • Guidebook
    • System security
    • Recorded and reported results
    • Search and preservation of resources
    • Hardware and software
    • Maintenance of computer system
  • Human resources
    • General information
    • Laboratory supervisor
    • Laboratory staff
    • Training program
  • Facility and work environment
    • Workspace
    • Amenities and environment
  • Safety
    • Safety
On-site inspection procedure
  • 01

    Survey of current status

  • 02

    Review of inspection checklist

  • 03

    Organization of inspection team

  • 04

    Determination of inspection schedule

  • 05

    On-site visit

  • 06

    Analysis of inspection results

  • 07

    Report of inspection results