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ISO 13485 Lead Auditor Training Course

Our #1 best selling class! Ready to become a LEAD auditor? Over several rigorous days, you will go through every phase of an audit, giving you the skills and conidence to lead audits against the ISO 13485 standard. While other classes may bore you with an endless series of PowerPoint slides, this class includes numerous hands-on workshops and exercises so you understand how to apply what you just learned in real world situations. Our course teaches the audit discipline according to ISO 19011:2018. We also offer an ISO 13485 internal auditing class. Both courses are Exemplar Global certified. 

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Brief Overview of This ISO 13485 Lead Auditor Course

SkillsLab Class ?

Class Content


Class Duration

9 Half-Days*

Teaching Format

Live, Instructor Led

Delivery Options

Virtual or In-Person**

Certification of Completion


Continuing Education Units (CEU)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 5 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming ISO 13485:2016 Lead Auditing Classes

SkillsLab $2595

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
LAF Boston, MA 02 Oct 2023 06 Oct 2023 8:00AM - 5:00PM Eastern US Time In-Person REGISTER
LAF VIRTUAL DELIVERY (Eastern Time) 09 Oct 2023 19 Oct 2023 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LAF Minneapolis, MN 30 Oct 2023 03 Nov 2023 8:00AM - 5:00PM Central US Time In-Person REGISTER
LAF VIRTUAL DELIVERY (Eastern Time) 06 Nov 2023 16 Nov 2023 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LAF San Diego, CA 13 Nov 2023 17 Nov 2023 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
LAF VIRTUAL DELIVERY (Eastern Time) 27 Nov 2023 07 Dec 2023 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
LAF San Jose, Costa Rica 04 Dec 2023 08 Dec 2023 8:00 a.m. - 5:00 p.m. CR In-Person REGISTER
LAF VIRTUAL DELIVERY (Central European Time) 04 Dec 2023 14 Dec 2023 13:00-17:00 daily (last day starts at 11:30) Central European Time Virtual REGISTER


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*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive ISO 13485:2016 Lead Auditor Training 

Learn how to assess quality management system conformance with ISO 13485:2016 and other applicable standards by understanding how to plan, conduct, and follow up on audits based on the guidelines of ISO 19011:2018. At the end of this class, you will walk away with the confidence to lead a medical device QMS audit. Expert instruction, engaging class discussions, and workshops use ISO 13485:2016 as the primary audit criteria.

Course Overview
SkillsLab Class

Overview of Training Course for ISO 13485 Lead Auditors

  • Certification criteria for quality management system (QMS) auditors
  • Professional behavior for auditors
  • Auditor Code of Conduct
  • Auditor competence and evaluation

Quality Management System Requirements

  • QMS basics, including process and risk-based approach
  • ISO 9000 series
  • ISO 9001:2015
  • ISO 13485:2016
Workshop! Interpretation of ISO 13485

Auditing Basics and ISO 19011:2018

  • Auditing basics
  • Role of ISO 19011:2018
  • Principles of auditing
  • Managing an audit program: Plan-Do-Check-Act
  • Identifying risks and opportunities related to the audit
  • Key terms

Auditing: Process Approach and Risk-Based Approach

  • The process approach to auditing, including interrelationships with other processes
  • Using a risk-based approach to auditing
Exercise! Process Mapping as an Auditor Tool

Audit Planning

  • Initiating the audit; role of remote audits
  • Reviewing documented information
  • Preparing for the audit
  • Checklists
  • Verification methods
Workshop! Prepare Audit Plan and Working Documents
Workshop! Compare Documented Information to ISO 13485:2016

Performing the Audit

  • Audit roles
  • Auditing guidelines and best practices
  • Conducting an opening meeting
  • Audit communication
  • Reviewing documented information
  • Collecting and verifying information
  • Sampling
  • Interviewing
  • Auditing risk in the QMS
  • Evaluating and recording audit findings and nonconformities
  • Determining audit conclusions
  • Conducting the closing meeting
Workshop! Plan and Conduct Opening Meeting
Workshop! Interviewing Techniques
Exercise! Nonconformity Reports
Workshop! Audit Conduct
Workshop! Closing Meeting

Recording and Following Up on the Audit

  • Recording and presenting audit results
  • Audit report writing
  • Follow-up and corrective action
Workshop! Final Report – Team Component
Individual Exercise! The Final Report
Individual Exercise! Evaluate Corrective Actions

QMS Certification

  • Describe the systems of accredited certification
  • Describe the process of certification of an organization’s QMS
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Describe auditor certification, expected competence, roles, and responsibilities. 

Identify QMS requirements from ISO 9001:2015 in general and ISO 13485:2016 in detail.

Describe ISO 19011:2018 and the overall audit process. 

Explain how to use a process and risk-based approach to auditing.

Planning an audit, including the creation of auditor working documents. 

Conducting an audit, including managing an audit, collecting audit evidence through document review, interviewing and observation, and documenting audit findings. 

Recording and following up on an audit, including writing an audit report. 

Describe the ISO 13485 certification process. 

Who Should Attend

Who Should Attend

Designed for quality management system auditors and professionals leading organizational ISO 13485 conformance activities. Perfect for those involved with their organization’s internal auditing process who wish to broaden their understanding of the total audit process. Recommended for anyone heavily involved in supplier quality assurance activities. All participants must read – and be familiar with the contents of – the ISO 13485:2016 standard before attending this course. This is a requirement from Exemplar Global, our certification body. In addition, you must participate in workshops and exercises, and complete a mock audit report assignment outside class. We highly recommend that you purchase your own copy of the standard well before class begins as we are unable to give you a PDF or printed copy due to copyright restrictions. 

  • QMS auditors
  • QMS professionals
  • ISO conformance personnel
  • Supplier QA personnel
  • Internal auditor personnel

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