Re: Does anyone have procedure on "Regulatory Compliance" ?
I am tasked to write a high level procedure on ?Regulatory Compliance on Medical Devices? for my company at the Corporate level that would state we are in the field of medical devices and list various markets that we serve.
In line with the markets, I will also mention our device listings against the respective facilities and applicable regulations that should be followed in each of the continents viz. America, Mexico, Europe and Asia.
Does anyone have an example ? Also if I could get thoughts on the procedure, that would be great.
SGquality,
If your process-based management system already is in place and working effectively it should include a process for "Deploying Legal Requirements" to the documented parts of your organizational management system.
The documented procedure governing this process identifies the agencies and the people responsible for monitoring changes to legal requirements. The procedure would then show what is done to deploy legal requirements and changes to legal requirements to the management system. It would include evaluating compliance and monitoring effectiveness of this process and procedure.
Of course this process would by monitored and corrected or improved as necessary before it is audited for effectivess.
When employees are trained and supervised to use and improve their management system, the organization is assured of compliance with legal requirements (laws and regulations). Indeed, this is the objective of this process and its procedure.
Your global organizational management may currently be a collection of subsystems operating at a national level. In which case corporate could establish a global policy that mandates development, use and improvement of such processes at the national level but imposing a global procedure would not work too well in my opinion.
John