What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001:2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.

Itay Abuhav has been acting as a consultant for many organizations in various areas for the past 10 years, specializing in the quality management/control industry, consulting with a number of small- to medium-sized firms dealing with implementing quality management systems, with a major focus on the European medical device industry. He is highly qualified to certify organizations to various standards: ISO 9001 and ISO 13485. The author has two active websites related to these topics, namely, www.9001quality.com and www.13485quality.com.