Hospitals that conform or certify to ISO 9001 (specifically those in the DNV-GL Healthcare accreditation scheme) are aware of the recent revision to ISO 9001.  This 2015 version introduces a new term, “risk-based thinking”, that is raising eyebrows and causing ire in some circles.   The main source of this ire is the fact that risk-based thinking is not defined in ISO 9001:2015 or in the associated standard ISO 9000:2015, “Fundamentals and Vocabulary”. Continue reading →