3-Day ISO 13485 Internal Auditor Training

This training program provides the skills necessary to perform process audits in the medical device industry, which results in findings for continual improvement. Participants learn audit activities and techniques, what objective evidence to gather, and what third-party external auditors expect when determining ISO 13485 compliance. Training focuses on process performance and compliance. The structure involves formal tutorials, group workshops and open forum discussions.

Upon course completion, participants:

  • Are able to complete an audit of their organization’s quality manual against the requirements of the standard
  • Develop an understanding of the concepts and vocabulary of quality systems, their benefits, and approaches to effective management of quality systems
  • Acquire a range of skills that will serve them well as an internal auditor, including audit diplomacy and communication skills, team-building skills, process assessment and continual improvement

Prerequisite: None

Course Schedule:

Dates: March 11-13, 2014
Time: 8am – 5pm
Venue: Ramada Hotel (formerly University Inn)