Building an ideal Quality Management System (QMS) takes more than a good quality manual. You must consider people, processes, and tools as critical components of a system. We often refer to this as the three legged stool.
Our goal of building the ideal QMS is to ensure products are produced consistently to a level that satisfies the requirements of the product design and product development and usage process. Typically from both a safety and efficacy perspective (will it work) and does it work as we expected (post-market surveillance).
The following guide is very simple and covers the basic concepts of that ideal QMS.