All posts 5
- What do the names BMS and ONBODY mean?2026.10.20
- When was BMS CO., LTD. founded, and what has changed since?2026.10.20
- Where does BMS CO., LTD. manufacture? The Paju factory2026.10.20
- Which quality certificates does BMS CO., LTD. hold?2026.10.20
- Who makes ONBODY? About BMS CO., LTD. in Paju, Korea2026.10.20
Which quality certificates does BMS CO., LTD. hold?
BMS CO., LTD. holds ISO 13485:2016 and ISO 9001:2015 certificates, a GMP certification for manufacturing and quality management, and a Korean manufacturing licence (No. 6594). They describe how the company is organised, not what any single item can do.
The certificates, one by one
| Certificate | What it covers | Number and dates |
|---|---|---|
| ISO 13485:2016 | Medical device quality management system | No. 26-B-2540, first issued 16 April 2026, expires 15 April 2029 |
| ISO 9001:2015 | Quality management system | No. 26-A-8318, 28 April 2026 to 27 April 2029 |
| ISO 14001 | Environmental management system | Listed in the company catalogue |
| ISO 45001 | Occupational health and safety management system | Listed in the company catalogue |
| GMP | Manufacturing and quality management certification (MFDS, Korea) | Obtained July 2019 |
| Manufacturing licence | Licence to manufacture, issued in Korea | No. 6594, granted October 2019 |
How to read a certificate like this
- Every ISO certificate carries a number, an issue date and an expiry date. You can check each one against the table above.
- Both ISO certificates listed with numbers were issued through the certification body IGC in April 2026, and each runs for three years.
- An ISO certificate is about a management system: how an organisation plans, produces, checks and corrects its work.
- It is not a statement about how a particular item performs, and it does not show whether an item is available in Australia.
Where is the certified site?
The company's factory is in Paju, in the province of Gyeonggi-do in the Republic of Korea.
FAQ
Do these certificates apply to a specific product?
No. They apply to the company's management system. For what an item is intended for, read the instructions for use that come with it.
How long is the ISO 13485 certificate valid?
Certificate No. 26-B-2540 was first issued on 16 April 2026 and is valid until 15 April 2029, which is three years.
Who issued the ISO certificates?
Both 2026 certificates name the certification body IGC. The numbers are 26-B-2540 for ISO 13485 and 26-A-8318 for ISO 9001.
Product availability and regulatory status differ by country. Always read the instructions for use before use.