Update, September 2026: this article was originally published when Khai Nguyen first received ISO 13485:2016 certification in January 2024. The certificate has since been reissued by ISOCERT on 11 March 2025 to Khai Nguyen Dental Lab Co., Ltd with an expanded scope; the current issue, dated 6 April 2026, is valid until 10 March 2028. Full details, the scanned PDF and how to verify it are on our ISO 13485:2016 certificate page.
First certification, January 2024
On 11 January 2024, ISOCERT (International Certification and Inspection Joint Stock Company) issued certificate no. 9199293420717-MED to Khai Nguyen Lab, confirming that the laboratory’s medical device quality management system conforms to ISO 13485:2016, with a scope of “manufacture and trading of all-ceramic teeth and guide splints” (decision no. 110124.11/QĐ-ISOCERT).
What ISO 13485 means
ISO 13485 is the international standard for quality management systems specific to the design and manufacture of medical devices. A dental restoration made to a clinician’s prescription is a custom-made medical device, so the standard applies directly to a dental laboratory.
Holding the certificate means the laboratory’s processes — case intake, design, production, inspection and delivery — are documented, that named individuals are accountable for each, that materials are traceable by batch, and that every piece of clinician feedback is recorded, analysed for root cause and corrected.
Certification timeline 2024 to 2026
| Date | Event |
|---|---|
| 11 January 2024 | First issue to Khai Nguyen Lab; scope: all-ceramic teeth, guide splints (decision 110124.11/QĐ-ISOCERT) |
| 11 March 2025 | Recertification to Khai Nguyen Dental Lab Co., Ltd; expanded scope: ceramic veneers, metal-free ceramic restorations, metal-ceramic restorations, implant restorations, removable dentures, dental appliances (decision 110325.02/QĐ-ISOCERT) |
| 6 April 2026 | Second issue under decision 060426.03/QĐ-ISOCERT following the annual surveillance audit; ISOCERT reissues the certificate each year, valid until 10 March 2028 |
Certificate number 9199293420717-MED has been retained across all issues. Validity can be checked on the ISOCERT verification page using reference 9199293420717, or from the scan on our certificate page.
Why an expanded scope matters to a referring clinic
The 2025 recertification widened the scope from two product categories to six. For a clinic sending work from abroad, scope is the practical part of the certificate: it states which categories of restoration are covered by the audited quality system. A certificate whose scope does not name the product you are ordering does not cover that product.
Related reading: is outsourcing dental lab work safe and how to choose a dental lab.
Our thanks go to the whole Khai Nguyen team, whose daily work produced this result, and to the clinicians, clinics and partners who have placed their trust in us. Certification is a starting point, not a destination.
Bài viết dành cho bác sĩ và kỹ thuật viên tham khảo. Khai Nguyên Dental Lab chỉ chế tác phục hình theo chỉ định chuyên môn và không bán trực tiếp cho bệnh nhân.
