Get a good, practical basis of the implications of auditing to the new Standard ISO 13485:2016
Prior knowledge and use of ISO 13485 is helpful, but not required.
This course provides attendees with knowledge and skills to understand the ISO 13485:2016 requirements for the medical device industry and to manage the risk-based quality management system. Topics include:
♦ Regulatory requirements
♦ Risk Assessment
♦ Work Environment
Instructor Kent Keeney is an engineering professional with more than 35 years of practical experience in quality and manufacturing process improvement methods. Keeney excels in design and implementation of quality management systems. He is experienced and knowledgeable in all areas of Quality and Lean Manufacturing. His education, many years of industry experience and a creative attitude has uniquely positioned him as a leading author and trainer in the field of Quality and Lean Manufacturing.