Quality

ISO 13485:2016

IQ’s quality system is based on ISO 13485, published in 2016, and dictates quality-management standards and requirements for a comprehensive management system for design and manufacture of medical devices. IQ has met ISO 13485 conditions as well as 21 CFR 820 corresponding subparts. The company is ISO 13485:2016 & EN ISO 13485:2016 certified by DEKRA Certification B.V. for all activities, including research & development, manufacturing and marketing & sales.

Audits

By internal and external audits we actively maintain and improve our quality management system. Our current certificate is dated on February 1, 2022 and will be valid until February 1, 2025.

In May 2019 IQ Products was audited with respect to the South Korean KGMP requirements and obtained approval to manufacture in vitro diagnostic devices for the Korean market. We are happy to work together with our distributor Dow Biomedica to facilitate CMV antigenemia testing.