ISO 13485 Will Not Protect You From KGMP Major Non-Conformances. Korea Requires Korea-Specific Preparation.
ISO 13485 certification is a prerequisite for entering KGMP preparation with a credible QMS structure, but it does not satisfy KGMP. A major non-conformance at KGMP inspection triggers re-inspection, delays product license issuance, and extends the total Korea market entry timeline by 6 to 12 months minimum.
Gap Closure, Mock Audit, and Inspection Defense — Built Specifically for MFDS Inspection Criteria.
We start from a structured gap analysis of your current QMS against KGMP requirements, execute targeted remediation, conduct a mock audit, and stand alongside your team during the actual MFDS factory inspection.
KGMP QMS Gap Analysis + QMS Implementation & Remediation
Auditing your QMS against KGMP requirements line-by-line, identifying all gaps between your current documentation and what MFDS will look for, then executing targeted remediation — Korean-language SOP revision, record format correction, process validation documentation — to close every gap before the MFDS inspection date.
Foreign Manufacturer KGMP Certification
Managing the formal KGMP certification application, coordinating the MFDS inspection schedule, preparing inspection response materials, and providing on-site support during the MFDS factory inspection to ensure your team is equipped to respond to inspector queries.
Training & Competency
Delivering KGMP inspection-specific training to your quality and operations personnel — covering how MFDS inspectors conduct factory audits, what records they will request, and how to present evidence — so your team is not encountering the inspection process for the first time on the inspection day.
A Failed KGMP Inspection Does Not Just Delay Your Certificate — It Delays Your Product License.
Mock Audit Structured to MFDS Inspection Methodology
Our mock audits are structured to surface the same gaps MFDS inspectors find — before the inspector arrives. We conduct mock audits against the specific KGMP inspection criteria MFDS applies, not against a generic QMS audit standard.
On-Site Inspection Support
We stand alongside your team during the actual MFDS factory inspection — providing document coordination, real-time support during inspector queries, and ensuring your personnel present evidence in the format inspectors are trained to evaluate.
KGMP Certifications Delivered for Domestic and Overseas Manufacturing Sites.
First-Cycle KGMP Certification for an ISO-Certified European Manufacturer
Conducted a full KGMP gap analysis, executed Korean-language SOP revision and record format correction for an ISO 13485-certified European manufacturer, and supported the MFDS inspection — achieving KGMP certification on the first inspection without major non-conformances.
Re-Inspection Recovery for a Manufacturer With a Prior Failed Inspection
Managed corrective action response to major non-conformances from a prior MFDS inspection for a North American manufacturer, rebuilt the affected QMS elements, and supported the re-inspection — resulting in KGMP certificate issuance.
Your KGMP Certificate — Issued by MFDS.
Leanabl has prepared manufacturers for KGMP inspection and understands what MFDS inspectors examine, what triggers a major non-conformance finding, and what a defensible KGMP QMS looks like on inspection day.
Speak with a KGMP Certification Expert TodayFrequently Asked Questions
Common questions answered.