Quality Management system

Unisensor’s Quality Management System (QMS) is certified according to ISO 9001:2008 and ISO 13485:2003 in order to meet the highest levels of quality requirements. It is still flexible enough to meet various levels of quality requirements, depending on the needs og the customer.

Environmental management is conducted according to ISO 14001:2004.

The QMS is documented in the Quality Manual and in numerous procedures specifying how to apply the required level of design control during development projects, and how to produce products ranging from industrial to medical devices.

Risk Management is applied according to ISO 14971:2007, if required by the customer, and if the product is meant for the American market, the QMS also applies to the 21 CFR 820.30 Design Control regulations and the cGMP regulations and guidelines.

The QMS is based on a series of validated quality tools, including document control, an incident reporting system, and a change control system. Production equipment is validated and quality data are analyzed regularly in order to monitor the production quality.