Regulatory compliance without SMS is like a bias selection of a still picture.
A vehicle operator has a license to operate, has passed both a knowledge test and practical test to drive. The road system, consisting of highways for cross country travel, access roads to local places and streets for city addresses. All aspects conform to regulatory requirements.
An airplane comes off the assembly line in the same manner as a car. The system has put in place runways and airways for travel between points of destinations. An airplane is regulatory compliant with wings, flaps, power units, control-input units, and pilots who have a pilot license to operate and qualified of aircraft type.
When SMS is Regulatory compliant, that is when operational facts are discovered.
It was not until a Safety Management System came into play in aviation that operations had a tool to manage and make safety happen.
A Safety Management System (SMS) is safety in operation, safety in human factors, environmental factors, organizational factors, supervision factor and it is to make regulatory compliant operating processes. When these processes are in place, the risk in flying is reduced to a level of certainty of processes effectiveness.