ISO 13485 Internal Quality Auditing

This course is designed for both new auditors and those looking to sharpen their current auditing skills. Participants will acquire the necessary skills to become a leader in preparing and conducting 1st and 2nd party audits through interactive methods and avoiding lecture based learning. This course includes a simulated audit, based on documentation from an actual organization, so participants can develop and refine their newly acquired knowledge and skills.

Length:  2 days     Prerequisites:  Understanding 13485

Learning Objectives

  • Perform audits based on the ISO 19011 Standard
  • Comply to the ISO 13485 Standard by applying the Process Approach to your quality management system
  • Form an audit team
  • Conduct an audit meeting
  • Determine needed documentation and organize according to the standard
  • Classify, record, and resolve nonconformities
  • Implement preventative measures to avoid future nonconformities

Plexus Learning Model

Learning is maximized through participation. That is why Plexus training avoids lecture-based teaching and focuses on group activities, case studies and hands-on applications. Learn by doing.

Who Should Attend

  • Any member of an ISO 13485 implementation team
  • Risk managers
  • Quality managers
  • New internal auditors and experienced auditors that have not attended training in over three years
  • Representatives from key functional groups involved in an organization’s quality management system

Instructors

Plexus Master Trainers. Plexus Master Trainers train and evaluate:

  • ISO 9001:2008, ISO/TS 16949:2009, AS9100, ISO 14001:2004 Environmental Management Systems, FSSC 22000:2005 Food Safety, ISO 9001:2008 for Healthcare and ISO 13485:2003 for Medical Devices.
  • Plexus trains 3rd party auditors and wrote the materials used to certify all of them

Agenda


Day 1

  • A brief review of ISO 13485
  • Understand the relationship with ISO 14969
  • Understand essentials of ISO 14971
  • Quality System Terminology
  • What is an Audit? Types, objectives and relation to a standard
  • Internal Auditors: attributes, roles and responsibilities
  • Communication Skills: verbal, nonverbal and conflict situations

Day 2

  • Plan For The Audit
  • Prepare For The Audit
  • Perform The Audit
  • After The Audit