There Is Nothing to Audit Without a QMS. Build It to KGMP Criteria Before Applying for Certification.
MFDS KGMP inspectors do not evaluate a plan to build a QMS — they audit the evidence that one exists, is implemented, and is operating. A failed KGMP inspection delays product registration and creates a documented non-conformance record that increases scrutiny in every subsequent audit.
A KGMP-Ready QMS, Built From Zero — Documented, Implemented, and Ready for Inspection.
We build your quality management system from the ground up, designed specifically against KGMP criteria, and train your team to operate it before any MFDS inspector arrives.
KGMP QMS Gap Analysis
Assessing your current state against KGMP requirements to define the full QMS build scope — identifying which systems, procedures, records, and competencies must be established from scratch before any implementation work begins.
QMS Implementation & Remediation
Authoring all required KGMP SOPs, work instructions, and quality records; designing the document control and record management system; establishing the CAPA, complaint handling, and management review processes in formats MFDS inspectors expect.
Training & Competency
Delivering structured KGMP training to your quality and operations personnel — covering QMS awareness, SOP compliance, record completion, and CAPA execution — and documenting training evidence in a format that satisfies MFDS inspection requirements.
A KGMP Inspection Conducted Before the QMS Is Built Is a Failed Inspection — and the Non-Conformance Record Follows You.
Built to KGMP Criteria, Not ISO 13485
We design the QMS specifically against KGMP criteria — not adapted from ISO 13485 guidance documents — so that when the MFDS inspector arrives, every SOP, record, and process element is in the exact format they are trained to examine.
3-to-6 Month Implementation Records Before Inspection
We build and implement the QMS with sufficient lead time to generate 3 to 6 months of operating records before any KGMP certification inspection — because MFDS inspectors audit evidence of an operating system, not a recently built one.
QMS Built From Zero for First-Time KGMP Applicants.
Full QMS Build for a Korean Subsidiary of a US Medical Device Manufacturer
Built a complete KGMP-compliant QMS from zero for a Korean subsidiary entering KGMP certification for the first time — delivering the full SOP set, document control system, and CAPA process within 9 months, in time for the MFDS inspection window.
QMS Foundation for a European Manufacturer Entering Korea
Designed and implemented a KGMP-aligned QMS for a European manufacturer with no prior Korean regulatory experience, including complete personnel training, enabling the manufacturer to pass KGMP certification on the first inspection.
A KGMP-Compliant QMS, Documented and Operational.
Korea QMS Foundation is the difference between entering KGMP certification with evidence and entering with a remediation plan.
Speak with a KGMP Implementation Specialist TodayFrequently Asked Questions
Common questions answered.