Excellence Beyond Compliance

As a Quality professional working in the Medical Device industry since 1991, I have experienced the challenge of setting up a Quality Management System (QMS) from scratch, as well as working within a mature QMS a decade or so later and dealing with changes in the industry and changes in regulations. Both have their difficulties, however if I had had this book during those "fun" times, my job would have been soo much easier! Working with different functions in a multi-site matrixed organization that share a QMS is no joke---the struggle is real! This book breaks it down in easy to follow sections that anyone can understand and gives great advice on using your registrar to your best advantage. I now have a hardcover copy on my desk and use it often. I will definitely be recommending this book to my friends colleagues.

Now more than ever is needed is a book such as this for Medical Device Quality systems. This book outlines in a clear format the processes to be Excellent with Compliance. As a former VP/GM in Sales & Marketing of a leading Medical Device company, I found at times the need to understand the processes but afraid to ask! This book lays out all the key components and recommendations to have a "Best in Class" system in today's demanding global environment.This is a book for every senior manager to have on his desk or within short reach for reference and assurance systems are in place...and to have confidence to ask informed questions. For individuals who want to explore this high paying field, this is your guide to entry. For QMS leaders, this is your teams' toolbox reference guide.Mike R.

I just finished the book and enjoyed it very much. Very well done, very educational, and great references. This could easily be a text for ASQ quality system training. I especially like the stories and the general flow of the text. A surprisingly easy read for such a dry subject.I recommend this book for those new to quality management systems in regulated industries as well for those established in this industry to remind them of the need to pursue making quality systems not only compliant but also "effective and efficient".

This is a very practical guide to understanding Medical Device Quality Systems (MDQS). It does an excellent job in explaining both the big picture such as how the various regulations and standards drive the design of the MDQS, as well as providing very useful examples in the appendix of governing procedures. I recommend this book to anyone who is trying to set up a MDQS or those who are involved in a major change initiative or upgrade of their existing MDQS.

As a 20+ veteran in the medical device industry, I enjoyed Dr. William White's "Excellence Beyond Compliance". Bill does a terrific job of explaining details of a QMS in a simple, easy to follow way. This book would serve as an excellent guide / workbook for any medical device company, especially those setting up their initial QMS.

This book is an excellent guide for new start ups wishing to develop a solid quality system that will grow with the company, and for established companies wishing to improve their quality systems beyond compliance.Well done!