ISO 13485:2016 Internal Auditor Training

About Course:

This Classroom Based two full days course aims to provide participants, the skills required to conduct internal audits, using interactive training by experienced medical device lead auditors for ISO 13485.

Delegates will learn the principles and practices of effective quality management system, process audit in accordance with the ISO 13485 and ISO 19011.

Course delivery will comprise presentations, workshops, and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 certified industries.


Course type: Classroom Based

Timing: 16 Hours/ Two Day

Assessment By: Examination


Learning Objectives:

* Understanding the ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide

* Understanding the auditing principles with ref to ISO 19011

* Understanding how to Plan an internal audit and the responsibilities of an Auditor

* Types of audit, Checklist development & internal audit objectives

* How to conduct opening and closing meetings

* Conduct an audit based on process identification

* How to write nonconformities & Audit report, follow-up on corrective actions

* Medical devices, quality and auditing terminology

* Structure & intent of the medical devices standard ISO 13485:2016

* Planning, preparation and management of audits

* Internal audit scope and criteria

* The audit process

*Roles and responsibilities of the internal auditor

* Interviewing skills


Who should attend?

*Medical device quality professionals having knowledge of quality management systems and ISO 13485

*Management Representatives

*Internal auditors

*Individual Consultants


What you will get?

All delegates will get:

*Hard copy of Study Material (includes copy of ISO 13485 and ISO 19011 Standards subject to return to EACS on completion of Course)

*Notes for Training

*Lunch & Refreshments (as per season)