Approved External Audit

Care of Sweden has had a follow-up external audit for ISO 1348 quality certification for two days. In view of the current situation, all meetings were held digitally, which has worked very well.

– The audit received an approved result with only three minor deviations, all of which can be extinguished shortly, says Susanne Svensson, environmental and quality manager at Care of Sweden.

The ISO 13485 standard concerns quality management for how to publish and manage medical device equipment for use in healthcare, an important prerequisite for a medical device company like Care of Sweden. Among other things, the report from the auditor reads:

“The company’s management system for the quality of medical technology products is very good and shows that the company retains the effect of its management system. The impression from sampling in the preservation of product safety and the efficiency and effectiveness of the quality management system, as well as the identification and fulfillment of regulatory requirements, is that this is handled in a very good way.”

– We received a lot of praise for the work we do in our processes and it’s really nice to hear, says Susanne.

You can read the report here (In Swedish).