All posts 5
- Autumn walks: how do you care for the Dr.Join Knee Support?2026.10.20
- What is the Dr.Join Knee Support from BMS CO., LTD.?2026.10.20
- How are ONBODY medical devices and appliances made in Paju?2026.10.20
- What do BMS's ISO and GMP certificates actually cover?2026.10.20
- Who is behind ONBODY? About BMS CO., LTD.2026.10.20
What do BMS's ISO and GMP certificates actually cover?
BMS CO., LTD., the maker of ONBODY, holds certifications that describe how it manages quality: a Korean medical device manufacturing licence, GMP certification, ISO 13485:2016 and ISO 9001:2015. They cover the company's systems, not the performance of any one product.
Certificates are easy to list and easy to misread. This note sets out what the company holds, when each one was issued, and what a certificate of this kind can and cannot tell you.
What does the company hold?
| Certification | Details | Dates |
|---|---|---|
| Medical device manufacturing licence (Korea) | No. 6594 | Acquired October 2019 |
| GMP certification | For medical device manufacturing and quality management | Acquired July 2019 |
| ISO 13485:2016 | Medical device quality management system; certificate No. 26-B-2540, issued by IGC | Issued 16 April 2026; valid until 15 April 2029 |
| ISO 9001:2015 | Quality management system; certificate No. 26-A-8318, issued by IGC | Issued 28 April 2026; valid until 27 April 2029 |
| ISO 14001 and ISO 45001 | Environmental management system, and occupational health and safety management system; listed in the company's catalogue | Not stated |
How should you read a management-system certificate?
A management-system certificate looks at how an organisation works: how it plans its processes, records them and checks them. It does not test an individual product, and it is not a product approval in any country. The same is true of the GMP certification above, which is about manufacturing and quality management at the company.
The Korean licence is different in kind. It is the licence that allows the company to manufacture medical devices in Korea, and it is held by the company rather than by any product.
What can you compare for yourself?
When anyone shows you a certificate, the details worth comparing are the certificate number, the name of the certifying body, the date of issue and the expiry date. ISO 13485 and ISO 9001 in the table run for three years from the day they were issued, so the dates are easy to check.
Do these certificates apply in the UK?
They are certificates held by a Korean company about its own quality management. They are not UK product markings or approvals. Availability and regulatory status differ by country and by product, so each product note on this site states its own position.
FAQ
What is GMP certification?
GMP certification is listed by the company as certification for medical device manufacturing and quality management, acquired in July 2019. It relates to how products are made and how quality is managed at the company.
Is ISO 13485 an approval for a product?
No. ISO 13485:2016 is the certificate for the company's medical device quality management system. It describes the organisation, not what a particular product does.
When do the ISO certificates expire?
ISO 13485:2016 is valid until 15 April 2029, and ISO 9001:2015 is valid until 27 April 2029.
Does BMS CO., LTD. hold other management-system certificates?
The company's catalogue also lists ISO 14001, an environmental management system, and ISO 45001, an occupational health and safety management system.
Product availability and regulatory status differ by country. Always read the instructions for use before use.