ISO 13485 is the quality management system standard for organisations that design and manufacture medical devices. A blood collection kit is a medical device, which means the manufacturer of your kit works to ISO 13485 while the laboratory that analyses the sample works to ISO 15189.
Buyers mix the two standards up often, because both are ISO numbers on the same supplier's page and both sound like proof of quality. The difference matters when you sell a white-label kit under your own brand, since the tubes, the lancets, the packaging and the instructions are all parts of a manufactured product with their own paperwork.
A supplier who answers a kit question with a laboratory certificate has not answered the question, so ask again until you are given the manufacturer's own documents.
- Ask who manufactures the kit and which certificate that manufacturer holds.
- Ask whether your own branding on the box changes who is named as manufacturer.
- Ask which components are included and who is named on the instructions for use.
- Ask how a change to the kit is communicated before it reaches your customers.
In this glossary, Testkit explains what is inside the box, White-Label-Kit covers what changes when your brand is on it, and ISO 15189 covers the standard the laboratory works to.
This glossary entry is general information, not medical advice, and it is not intended to diagnose, treat or rule out any condition. Discuss your own results with a clinician who knows your history.
