Scope. Normative References. Terms and Definitions. Context of the Organization. Leadership. Planning. Support. Operation. Performance Evaluation. Continual Improvement.
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.