To be a leading company of medical devices,
we should achieve the quality goal as follows.
Quality Goal
Three quality goals interlock
toward one outcome
Where the quality management system, a quality mind across all staff and risk management overlap, the quality goal promotion plan is achieved, and the whole process cycles back through continuous improvement.
- Quality Management System
- Quality Mind
- Risk Management
- Continuous Improvement (cycle)
01
Implementation of Quality Management System
We apply procedures based on international standards from design to shipment.
02
Improvement of Quality Mind
Every member of our team shares ownership of quality.
03
Implementation of Risk Management
We identify and manage risks across the product life cycle.
04
Continuous Improvement
We keep raising our quality level through measurement and review.
Continuous Improvement CyclePDCA
PlanSet goals & plans
DoDesign & produce by procedure
CheckMeasure, audit & analyze
ActCorrective & improvement actions
Achievement of Quality Goal Promotion Plan
Quality Management System
ISO 13485:2016
International standard for medical device QMS (certified by DNV)
View certificate →KGMP
Korea Good Manufacturing Practice certification (KTL)
View certificate →FDA QMSR
Compliance with US FDA Quality Management System Regulation (21 CFR Part 820)
Quality inquiries and customer claims are received by our Sales team. Contact us →