ISO 13485:2016 Lead Auditor Training

Course Overview

To fulfil all requirements of Quality Management System for medical devices, Online ISO 13485 lead auditor training course provides training and certification which is very useful for users to become ‘Certified ISO 13485 lead Auditor’. In this ISO 13485 lead auditor training online, you will learn everything you need to know about the QMS and ISO 13485:2016 requirements as the ISO 13485 lead auditor. This online ISO 13485 lead auditor training course will help to guide company employees of any organization as well as provides a well understanding of various activities involved in Audit Techniques, Audit Processes, and Requirements. The participants will be awarded ISO 13485 Lead Auditor certificate for a trained lead auditor with successful completion of this online lead auditor training course.

Covered Topics

There is including a total of 9 interactive online sessions this ISO 13485 lead auditor training with combinations of lectures with audio-visual presentation, hand-outs, and videos as well as online exams to ensure a complete understanding of the subject.

Session – 1: Overview of Course and Standard

Session – 2: ISO 13485 Principles

Session – 3: ISO 13485:2016 Requirements

Session – 4: Control of Documents and Records

Session – 5: Risk Management

Session – 6: ISO 13485:2016 Internal Audit Process

Session – 7: Audit Terms and Definitions and Roles and Responsibilities

Session – 8: Performing an Audit

Session – 9: Nonconformity and Corrective Action

Who Should Attend This Course?

This ISO 13485 Lead Auditor Training course is developed for working professionals, management students, and other individuals for enhancing their career to new heights. Our e-learning courses help them to succeed in today’s competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get a certification or start a new profession. Any working professional, any graduate, undergraduate, management student, an entrepreneur, quality manager, technical manager, etc., are eligible to attend this certified ISO 13485 lead auditor training.

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.