Question 1

Our facility already holds ISO 13485 certification. Do we still need a KGMP Gap Analysis?

Accepted Answer

Yes. ISO 13485 and KGMP share a common structural framework, but KGMP imposes additional, Korea-specific requirements for procedural content, record formats, and site documentation that are not explicitly required under ISO 13485. Our analysis targets precisely these delta requirements — the gaps that ISO 13485 certification leaves unaddressed and that KGMP inspectors will probe.

Question 2

What documents do you need from us to conduct the analysis?

Accepted Answer

We require your current QMS documentation set: your quality manual, SOPs, work instructions, and representative quality record forms. We execute a strict NDA prior to any document exchange. You do not need to provide product-specific technical files or test reports for this engagement.

Question 3

How long does the Gap Analysis take, and how long will it take us to close the identified gaps?

Accepted Answer

The analysis itself typically takes 3 to 5 weeks depending on the size and complexity of your QMS documentation. Remediation timelines vary by the number and severity of gaps found, but our report includes a realistic implementation schedule to guide your team's preparation effort before the inspection.

Question 4

If you find gaps, can you help us create the missing SOPs and forms?

Accepted Answer

Yes. As part of our Project Delivery service, we author or co-author the required KGMP procedures and record forms in both English and Korean, integrate them into your existing QMS structure, and support your team through a readiness verification review prior to the inspection date.

KGMP Gap Analysis

ISO 13485 compliance does not equal KGMP compliance.

SOP & Work Instruction Coverage

Form & Record Compliance

Process-Level Gap Mapping

The KGMP Gap Analysis Report & Remediation Roadmap

Findings

Roadmap

KGMP success across modalities.

Class III Orthopedic Implant

Contract Manufacturer

Multi-Site Global Brand

Frequently Asked Questions

Eliminate the risk of a Major Non-conformity before it happens.