Quality Management System

There is a long list of requirements, procedures, activities, or arrangements that you’re obliged to document to establish a quality management system that is compliant with ISO 13485 and FDA 21 CFR 820.  For many of the requirements, the standard/regulation just requires them to be documented while for others the need for a documented procedure […]

In this post, we investigate the importance of verb choice within Quality Management System (QMS) procedures and work instructions. We will look at: All this and more to help you have a great result during your next audit or inspection! To get us started let’s look at what ISO 13485 has to say about the