ISO 13485:2016 Internal Auditor Training for Medical Devices Quality Management Systems

ISO 13485:2016 Internal Auditor Training for Medical Devices QMS

Course Duration: 3 Days - 8 Hours/day

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD and Exemplar Global-AU Competency Units. This seminar fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report, and taking corrective action. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

• Exemplar Global-MD
• Exemplar Global-AU

*FOR PUBLIC TRAINING ONLY - The requirements portion of this training is conducted online prior to the in-classroom or virtual course. The seated or virtual classroom portion of the class will begin on Tuesday morning with a review and testing. The Monday of that training week will be offline and for finishing the e-learning or contacting the instructor with questions. The auditor portions (AU and TL) will continue as appropriate according to the dates scheduled.

Note: For ISO 13485 Lead Auditor Training, please [Click Here].