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ISO 13485 Internal Auditor Training Class

Learn how to plan and perform internal quality management system audits against the requirements of ISO 13485:2016. Based on our popular ISO 13485 lead auditor course, this class includes workshops tailored to the changing medical device industry and discussions of auditing techniques and best practices with a focus on internal audits. Exercises and workshops feature audit criteria from ISO 13485:2016. This class is certified by Exemplar Global. 

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Brief Overview of This ISO 13485 Auditing Course

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Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 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 Internal Auditor Training Classes

SkillsLab $2195

SkillsLab $2195

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
IAF VIRTUAL DELIVERY (Eastern Time) 28 Oct 2024 01 Nov 2024 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 Internal Auditing Course

Learn how to assess quality management system conformance with ISO 13485:2016 and other applicable standards as an internal auditor by understanding how to plan, conduct, and follow up on audits based on the guidelines of ISO 19011:2018.

Course Overview
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Quality Management System Requirements

  • QMS basics, including process and risk-based approaches
  • ISO 9000 series
  • ISO 9001:2015
  • ISO 13485:2016
Workshop! Interpretation of ISO 13485 Clause 4
Workshop! Interpretation of ISO 13485 Clauses 5-8

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! Compare Documented Information to ISO 13485:2016
Workshop! Prepare Audit Plan and Working Documents

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! Conduct Opening Meeting
Workshop! Interviewing Techniques
Workshop! 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
Exercise! Evaluate Corrective Actions

Auditors and QMS Certification

  • Certification criteria for QMS auditors
  • Professional behavior for auditors
  • Auditors’ Code of Conduct
  • Auditor competence and evaluation
  • QMS certification
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
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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 process and risk-based approaches to auditing.

Plan an audit, including creating auditor working documents.

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

Record and follow up on an audit, including an audit report.

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

Who Should Attend

Who Should Attend

Designed for anyone who will be conducting, managing, or participating in internal (first-party) or supplier (second-party) quality management system audits. Perfect for those involved with developing, implementing, and maintaining the organization’s quality management system internal auditing process to meet the requirements of ISO 13485. All participants must read – and be familiar with the contents of – the ISO 13485:2016 standard before attending this course. 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. 

  • Internal QMS Auditors
  • Supplier QMS Auditors
  • QMS Audit Management
  • QMS Audit Implementors
  • QMS Audit Developers
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