Device Industry Reps Secure Favorable Changes To ISO 9001 Rewrite
This article was originally published in The Silver Sheet
Executive Summary
REVISIONS TO THE ISO 9001 QUALITY SYSTEMS STANDARD will place added emphasis on continual improvement and customer satisfaction; new document will follow "process approach" structure WARNING LETTERS: FDA requests outside certification of corrective actions for QS reg deficiencies at Medi-Physics; Thoratec Labs video promotion claims require PMA supplement approval