GLGlossary
ISO 13485.
The international standard setting out the quality management system a medical device company is expected to have in place.
It requires a company to document and actually operate the procedures that keep quality under control, from design through production and on to post-shipment management. Korea's KGMP (Korean Good Manufacturing Practice) notification reflects much of this standard, so preparing for a Korean audit overlaps substantially with meeting the international baseline. That said, some export markets and certification bodies ask for a separate ISO 13485 certificate, so the scope of preparation can vary depending on the product and the markets you are targeting.
Related work & timing
This is the standard you work against when tidying up the quality manual and procedures ahead of a KGMP audit. If overseas expansion is on the roadmap, building the documentation to the international standard from the start reduces rework later.
Basis
- ISO 13485:2016 (Medical devices — Quality management systems)
- Regulation on Medical Device Manufacturing and Quality Control (MFDS notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- CB test report
- Validation
- Risk management