ISO 13485:2016 Internal Auditor Training

Course Overview

This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization. Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

Covered Topics

§  Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance

§  Identify the key principles of auditing and auditor responsibilities

§  Plan an internal audit

§  Conduct an effective audit based on process identification, sampling and questioning

§  Determine if corrective action has been effectively implemented

Who Should Attend This Course?

Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016 Individuals interested in conducting first-party or second-party audits Management representatives Internal auditors Consultants “We are continually securing new business because of our certification.”

Study Material

§  Lecture sessions are illustrated with examples based on case studies

§  Practical exercises are based on a case study which includes role playing and discussions

§  Practice tests are similar to the Certification Exam

End Of Course Instruction

After completing the session and passing each session examination, the students can take the final exam. Once the final exam is passed, then it is considered as an end of course.