In its new form, the ISO 9001:2015 standard activates and utilizes a thought pattern based on risk assessment functioning in parallel with the implementation of the system regarding quality management. Therefore, we strive to identify the risks and opportunities associated with the processes and...

Healthcare organizations in Germany exploit the benefits of the ISO 9000 family of international standards as it became compulsory to implement a quality management system in accordance with ISO 9001 requirements. Until the innovative ISO 9001:2015 proposal it was no direct connection to the...