Course Overview

Our ISO 13485:2016 Medical Device Quality Management System Lead Auditor course is delivered on the GRS Learning Portal. Once logged in using your account, you will be able to browse through the sections of the training course. A look inside how the course will be conducted: In addition to having the training course content in video format, you will also be able to access the regular training course materials format structured in different training course days with the additional files available in an editable format (depending on the training course, the case study, exercises, and exercises correction key files will also be available). In addition to the lectures and the training course materials, quizzes have been incorporated into the each section of the training to ensure that our training courses are as interactive as possible. While taking the training course, access the materials on GRS Learning Portal, Enter the exam at your most convenient date, time, and location via GRS Exams.

By end of course you are expected to be able to get the knowledge:

The purpose, content and interrelationship of ISO 13485 . The ISO 13485 MD QMS focuses on eight core principles: customer focus, people involvement, continual improvement, a decision-making process that is fact-based, a process approach, a system approach to management, supplier relationships that are mutually beneficial and leadership.; 

Responsibilities of an internal auditor and describe the role of internal audit in the maintenance and improvement of management systems

Plan, conduct, report an internal audit of part of quality management system in accordance with ISO 19011.

Course Content