Korea QMS Foundation
No QMS, Nothing to Audit. Build It to KGMP Criteria Before Applying.
When Korea QMS Foundation Is the Right Fit.
Three scenarios where foreign manufacturers fail KGMP because the underlying QMS was never built to MFDS-inspectable standards.
First-Time KGMP Certification With No QMS
Foreign manufacturer or Korean subsidiary entering KGMP with no QMS — documented system built from zero before MFDS inspection.
ISO 13485 Site Adapting for KGMP
ISO 13485 QMS never audited against KGMP — system rebuilt to MFDS inspector expectations, not loosely adapted from ISO.
Post-Failure QMS Remediation
Prior MFDS inspection returned KGMP non-conformances — SOP, record, and evidence remediation closing the gaps before re-applying.
Every Deliverable Required to Build an MFDS-Inspectable QMS.
Three coordinated services that produce a KGMP-ready QMS and the personnel competent to operate it.
- / 01
Current-State Assessment Report
Written assessment of existing systems, procedures, and records against KGMP criteria — defining the full build scope upfront.
- / 02
SOP & Procedure Inventory
KGMP-required SOPs, work instructions, and procedural records mapped to existing, revise, or author-from-scratch.
- / 03
Record & Document Control Gap List
Document control, record management, and traceability gaps to close before an MFDS inspector will accept the system.
- / 04
Competency & Training Gap Report
Quality and operations roles where personnel aren't yet competent to run the QMS to KGMP.
- / 05
Build Plan & Timeline
Sequenced implementation plan with milestone deliverables and an inspection-readiness target date.
QMS Built From Zero for First-Time KGMP Applicants.
Full QMS Build for a Korean Subsidiary of a US Medical Device Manufacturer
QMS Foundation for a European Manufacturer Entering Korea
Frequently Asked Questions
Common questions answered.
A KGMP-Compliant QMS, Documented and Operational.
The difference between entering KGMP certification with evidence and entering with a remediation plan.
Speak with a KGMP Implementation Specialist Today