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  3. ISO 13485:2016 Internal Auditor Training Course

Course Objectives

The aim of this 2 day course is to provide information and knowledge about the internal auditing of the standard ISO 13485:2016. This course is intended for the management and implementation teams, internal auditors and persons who would like to develop ISO 13485 in their company. This course will also help first, second and third party auditors learn the ISO 13485:2016 auditing process.


The course will include:

  • An overview of ISO 13485:2016  Auditing Principles
  • Auditor responsibilities and competence requirements
  • Internal audit planning process and execution
  • Documentation and reporting of non-conformities
  • Internal audit report
  • Internal audit corrective actions verification and closure

Course Agenda

Day One

Introduction and welcome
Introduction of objective/goals of the training.
 
Development of the Internal Audit Program
1. Overview of the ISO13485 Internal Audit Requirements
2. Review of Internal Audit Procedure(s)
3. Development and Maintenance of the Audit Schedule
 
The Internal Audit Process
Management System Audit Planning and Preparation
1. Audit Planning and Preparation
Desktop Review
• Importance of selecting the appropriate criteria, scope, objectives, and methods
• Breakout Exercise No. 1
2. Selection of Auditors and Subject Matter Experts
3. Agenda Development and Issuance
• Breakout Exercise No. 2
 

Day Two

Recap of Day One/Questions


The Internal Audit Process Continued
 
4. Opening Meeting
5. Conduct the Audit
• Audit Techniques, skills and audit trials

• Process auditing, risk based approach and data analysis, sampling and questioning

Break out Exercise 3

6. Writing clear nonconformity statements

Break out Exercise 4

1. Writing, Review and Issuance of Audit Results

• Closing Meeting

Break out Exercise 5 Part I

Break out Exercise 5 Part II

• Completing the Audit Report

2. Follow up Activities and Closure

• Response to non-conformance

• Verification of Corrective Actions

 

 

Upcoming Classes

Orlando Dates

November 14 - 15, 2017 - Class filled

February 22-23, 2018 (Medical Devices Roadshow)

 

 

Contact us for Early Bird, Group Discounts and for information on the Medical Devices Roadshow

Meet our Trainers

Trainer

Biography

Indira Garcia

Indira is subcontract Lead Auditor for TUV USA, Inc. She is a subject matter expert in quality management systems with more than 20 years of experience in auditing Quality Management Systems to ISO13485, ISO 9001, CMDCAS, and the MDD as part of the CE Marking process. Her expertise is in sterile disposable medical devices. Prior to joining TUV USA, Indira worked in the Medical Device Industry in Quality and Regulatory Affairs functions.

Bodo Mestmacher

 

 

Currently acting as Global regulatory support for medical devices under the name QUADRAS. During his over 25 years of experience in Medical Device regulatory affairs he actively accompanied as member of the various European notified body groups the introduction of the European Medical devices directives as Head of certification for medical devices at RWTÜV. This act Later on he shared his experience under the name QUADRAS as trainer and regulatory affairs expert for international regulations in over 60 countries of the world now introducing again the new european MDR as well as the MDSAP principles.

 

Need more information on this class? Contact us.

Katie Lehoullier

TUV Academy Training Coordinator

844-488-8872 x200

klehoullier@tuv-nord.com


Katie Lehoullier joined the TUV USA team in 2016 as Administrative Office Support. Katie assists in the development of TUV USA’s Academy Division as the Academy Training Coordinator. She has a bachelor’s degree in clinical psychology.