ISO 13485:2016 Internal Auditor

Course Objectives

• Understand the requirements of ISO13485:2016 for medical products and related services
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Acquire the skills to take on the position of an internal medical services auditor in the company

Target Audience

This training is designed for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives, Internal Auditors and Consultants.

Methodology

Training input will consist of practical knowledge, role plays, case studies and self-revealing instruments and questionnaires. Learning will be enhanced through active involvement; individual and group exercises followed by review. Opportunities for self-assessment will be provided and feedback on individual and group performance will be encouraged. Participants will work on their own individual team issues during the program.

Course Modules

Module 1: Introduction to Quality Management System
Module 2: Overview of ISO 13485:2016 requirements
Module 3: Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
Module 4: Audit planning and preparation
Module 5: Audit execution
Module 6: Non-conformity reporting
Module 7: Closing meeting
Module 8: Audit report preparation
Module 9: Audit follow-up