Indilab Earns ISO 13485

Franklin Park, Ill.-based Indilab Inc. has received ISO 13485:2003 certification.

The registration audit was conducted by Perry Johnson Registrars Inc. and the Franklin Park site was certified for the design, manufacture and distribution of process sterilization indicators for medical device sterilization.

ISO 13485:2003 certification specifies processes for an organization’s quality management system to demonstrate its ability to provide medical devices and related services that consistently meet regulatory and customer requirements pertaining to medical device application standards.

At Indilab’s Franklin Park plant, the company manufactures chemical sterilization indicator products for medical and dental devices and healthcare product manufacturers. Sterilization indicators assist with monitoring and evaluation of sterilization processes.

Indilab makes sterilization chemical indicator products for medical and dental devices and healthcare product manufacturers. The company also manufacturers proprietary branded products used in conjunction with sterilization processes. The company specialiizes in indicators or indicator applications for steam, ethylene oxide and hydrogen peroxide plasma sterilization systems.