High standards confirmed
Jossi AG and its subsidiary in the Czech Republic, Jossi Systembau s.r.o, performed excellently in their two-day recertification audit for ISO 13485: 2016 respectively ISO 9001: 2015 at the end of May. The auditor of SQS has certified the management system of both companies a very good degree of maturity.
With its changes, the revised version of the world's most widely used standard ISO 9001 provides companies and organizations new and positive impulses for the adaptation or modernization of their quality management system. Also new is the consistent risk-based approach as a prerequisite for obtaining the certificate.
The SQS auditor was strongly impressed by how Jossi has taken these new impulses to actively analyze and optimize its existing management system. Among other things, the target implementation process, the feasibility clarification system and the internal process management were rated in the best possible way. The conclusion of the SQS auditor: "Jossi has been able to maintain its high flexibility despite the extended requirements".
The revised ISO 13485: 2016 for the safety of medical devices is now approaching the requirements of 21 CFR Part 820 (Quality System Regulations). Just like the FDA inspection in 2016, Jossi AG performed outstandingly also in this part of the Audit.