GET IT RIGHT: A GUIDE TO STRATEGIC QUALITY SYSTEMS

Many companies do not truly understand the difference between simply having a quality system and having a customer-centric strategic quality system that continuously drives value-added improvement. Get It Right illuminates the difference, and teaches where and how to start strategically planning a quality system. It also provides ways to create, evaluate, and/or re-engineer an existing quality system. The concepts are based on the trials and tribulations seen by the author in nearly 30 years of experience at a wide variety of companies. The book is meant to be read and enjoyed by management-level quality and business professionals, and the executives to whom they report. It has a strategic emphasis and management overview that distinguishes it from most quality assurance, quality control, and tactical references. While the perspective is mainly from regulated industries, the book is designed to be applied by both regulated and non-regulated companies.

The examples used throughout are based on actual companies and experiences. They are not specific to any individual company, but rather are composites of the good and the not-so-good practices and approaches the author has seen over the years.

Ken Imler is currently a Quality and Regulatory consultant at Quintiles Consulting, where he has consulted at a variety of companies (drugs, devices, biologics and combination products) for the past seven years. He helped design, reengineer and implement several effective quality systems, and assisted companies in both strategic and tactical aspects of Quality Systems. He has a BS from the University of California, an MT (ASCP) from St. Joseph’s Hospital School of MT, and an MBA National University.