ISO 13485:2016 Internal Auditor Training – Medical Device Management

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. 

Hours:24

• Understand concepts and vocabulary of quality systems, their benefits, and approaches to effective management of quality systems to improve company performance
• Complete internal process audits of an organization’s Quality Management System (QMS) while ensuring it meets requirements of the standard
• Comprehend implications of an increased focus on regulatory and statutory requirements
• Acquire a range of skills needed to be an effective internal auditor, including audit diplomacy and communication skills, team-building skills, process assessment and continual improvement

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

None