E
egonzalez215
I am currently in the middle of a gap analysis for MDSAP implementation and I am curious as to how I should format my procedures for this.
Am I required to specifically reference the individual country requirements on the procedure in the references section (i.e. TG, RDC, MHLW, and QSR- in addition to 13485)? Or, alternatively, are you just referencing MDSAP guidance doc there?
Or should the individual country requirements have separate sections with in the SOP maybe?
But then again if MDSAP is an audit methodology, maybe you really do have reference each individual country regulation in the reference section...
Am I required to specifically reference the individual country requirements on the procedure in the references section (i.e. TG, RDC, MHLW, and QSR- in addition to 13485)? Or, alternatively, are you just referencing MDSAP guidance doc there?
Or should the individual country requirements have separate sections with in the SOP maybe?
But then again if MDSAP is an audit methodology, maybe you really do have reference each individual country regulation in the reference section...