This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the standard, audit activities and techniques, required documented information, objective evidence to gather, and third-party external auditor expectations when assessing ISO 13485 management system compliance for certification.
TCIE’s business-centric approach prepares participants to not only assist their companies in becoming ISO compliant, but in driving efficiencies, error reduction and increased profitability through proper use and management of the ISO system.
Individuals interested in planning, scheduling or performing first-party (internal) audits; outsourced team members performing second-party audits; quality assurance professionals and managers; management representatives; and ISO 13485 implementation and/or transition team members
“The only thing worse than training your employees and having them leave is not training them and having them stay.”
— Henry Ford, founder, Ford Motor Company