A quality standard usually reserved for medical device manufacturers, a stricter bar than most home appliance companies ever have to meet.
ISO 13485 is a specialized quality management standard built specifically for companies that manufacture medical devices. It requires tighter controls on traceability, risk management, documentation, and manufacturing consistency than the general ISO 9001 standard.
Very few manufacturers of home water ionizers hold this certification, because it isn't required for their product category. Enagic has built its manufacturing system to meet it anyway, which means the same rigor used for hospital-grade and diagnostic equipment is applied to the machines it builds for the home.
It reflects the level of manufacturing discipline behind the machine sitting on your countertop, well beyond what's legally required for its product category.
Book a free in-home demo and we'll walk you through the machine, the certifications, and the science behind it.
