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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 confidence 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, role plays, case studies 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 RTP certified and include an online exam. 

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Brief Overview of This ISO 13485 Lead Auditor Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

9 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

4.4

* 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

SkillsLab $2595

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
LAF VIRTUAL DELIVERY (Eastern Time) 18 Aug 2025 28 Aug 2025 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual Call to Register
LAF VIRTUAL DELIVERY (Eastern Time) 01 Sep 2025 11 Sep 2025 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual - Spanish Delivery REGISTER
LAF Boston, MA 08 Sep 2025 12 Sep 2025 8:00AM - 5:00PM Eastern US Time In-Person REGISTER
LAF VIRTUAL DELIVERY (Eastern Time) 29 Sep 2025 09 Oct 2025 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER
LAF San Francisco Area, CA 17 Nov 2025 21 Nov 2025 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
LAF San Jose, Costa Rica 17 Nov 2025 21 Nov 2025 8:00AM - 5:00PM CR In-Person REGISTER
LAF VIRTUAL DELIVERY (Eastern Time) 01 Dec 2025 11 Dec 2025 1:00PM - 5:00PM daily (last day starts at 11:30AM) Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*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

  • Course objectives, structure, and expectations
  • Pre-test

Prepare to Audit

  • Case study introduction and background
  • Review QMS and ISO 19011:2018 auditing guideline fundamentals
  • Review inputs from the audit program manager
  • Initiate the audit
  • Review documented information
Discussion! Principles of Auditing
Discussion! Auditor Competence, Skills, and Behavior
Exercise! Select the Audit Team
Discussion! Considering Health and Safety at the Auditee Location
Discussion! Problem Solving for Scheduling Conflicts
Exercise! Assess Documented Information Against ISO 13485:2016 Criteria

Plan an Audit

  • Lead auditor planning responsibilities
  • Risk-based approach to auditing
  • Process-based approach to the audit
  • Audit plan purpose and contents
  • Assigning the work
  • Preparing audit working documents
  • Preparing verification methods
  • Developing a sampling plan
  • Formally notify the auditee
Discussion! Identify Lead Auditor Planning Roles and Responsibilities
Discussion!  Apply a Risk-Based Approach to Audit Planning
Discussion!  Identifying Risks and Opportunities
Assessment!  Develop an Audit Plan
Discussion!  Apply a Risk-Based Approach to Audit Planning
Exercise! Create a Checklist Working Document
Exercise! Develop a Sampling Plan

Lead the Execution of an Audit

  • Auditing guidelines and best practices
  • Audit communication
  • Auditing risk in the QMS
  • Interviewing personnel
  • Generate audit findings
  • Nonconformity report writing
  • Meetings during the audit
  • Determining audit conclusions
  • Conducting the closing meeting
Exercise! Prepare an Agenda and Conduct an Opening Meeting
Exercise! Interview Top Management to Evaluate Risks and Opportunities
Exercise! Write a Nonconformity Statement and Evidence
Discussion! Determining Nonconformity
Case Study! Conduct an Audit, Cases 1-5
Discussion! Arriving at Consensus
Exercise! Monitor Audit Progress and Lead a Daily Debrief Meeting
Case Study! Conduct and Audit, Cases 6-9 
Exercise! Reaching Audit Conclusions
Discussion! Closing Meeting
Exercise! Lead a Closing Meeting

Report and Follow Up on an Audit

  • Recording and presenting audit results
  • Report writing and good documentation practices
  • Follow-up and corrective action
Assessment! Write an Audit Report
Discussion! Common Problems with CAPA
Exercise! Corrective Action
Exercise! Verify Corrective Action Completeness and Effectiveness

 

Design and Manage an Audit Program

  • Apply PDCA to the creation of an audit program
  • Competence and evaluation of auditors
Discussion! Analyze Risks and Opportunities of the Audit Program
Discussion! Combined Audits
Exercise! Design an Audit Program
Exercise! Evaluate Auditor Competence
Workshop! Closing Meeting

Final Exam

What You Will Learn

What You Will Learn

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

Establish, plan, and communicate activities of an audit team, including audit team selection and assignment, review of documentation, creation of an audit plan and agenda, and preparation of working documents and sampling plans

Use of a process-based and risk-based approach to perform audit activities in the context of a case study, including interviewing and observation, documenting findings, and writing nonconformities

Manage the audit process during the conduct of an audit, including managing conflict and adjusting the audit agenda as issues arise to ensure the audit meets its objectives

Prepare an audit report and perform follow-up activities such as assessment of CAPAs

Discuss the application of the PDCA cycle to the design and management of an effective audit program, including risks and opportunities of the audit program, resources, combined audits, and evaluating auditor competency

Who Should Attend

Who Should Attend

This is an advanced-level course designed for experienced auditors who know the ISO 13485:2016 Medical Device Quality Management Systems standard and would like to learn how to lead audits. 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 and the ISO 19011:2018 guidance before attending this course. This is a prerequisite for attending the course. In addition, you must participate in workshops and exercises, and complete a mock audit report assignment outside class. Please obtain your own copy of the standard and guidance well before class begins and bring them with you to the training session, as we are unable to give you a PDF or printed copy of either due to copyright restrictions. 

  • QMS Auditors
  • QMS Professionals
  • ISO Conformance Personnel
  • Supplier QA Personnel
  • Internal Auditor Personnel
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