Event Details

40 hours
Combination lecture and individual/group exercises
Available virtually in conjunction with a partner organization

Description

This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting as defined in ISO 19011. Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

This is a four-day, instructor-led, course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover medical device auditing along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover lead auditor requirements with a competency exam (TL).

Who Should Attend

This course is designed for individuals who are responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, including: Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel, or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.

Learning Objectives

Through training, participants will learn to:

Fully understand and interpret the requirements of ISO 13485
Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
Understand how to apply the requirements of the ISO 13485 Standards during 5 practical audit exercises conducted during the class
Understand the terminology of ISO 13485 and how these apply in a Medical Device Environment
Apply the fundamentals of ISO 19011 to master the auditor skills required for an effective and efficient audit
Ask audit questions that get results
Conduct opening and closing meetings that have impact
Construct effective audit checklists
Generate effective corrective actions
Write the audit report and take corrective action
Prepare Audit report
Audit Follow-Up

Course Outline

Day 1

Course introduction
History of Quality Management
In-depth Review of the Standard
Exercise: Audit Case Studies

Day 2

Learning Game on Pre-assignment
Test on Standard / Review test
Review 21 CFR 820 & Exercise
AU Module – Part 1. Intro to Auditing
Test on Part 1 / Review Test
Part 2. Preparing for an Audit

Day 3

Test on Part 2 / Review Test
Part 3. Conducting the Audit
Test on Part 3 / Review Test
Audit Role Play Exercise 1
Part 4. Completing the Audit
Test on Part 4 / Review Test
Exercise: Writing Audit Findings

Day 4

TL Unit: Leading an Audit Team
Audit Role Play Exercise 2
Exercise: Conducting a Closing Meeting
Writing the Audit Report
Test on TL Unit / Review Test
Class Wrap-Up

Prerequisites

All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.

Instructors

Bob Lerner

★★★★★ 5/5

Chris, Angelo and Barbara,

The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.

Barbara

Hi Angelo,

We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.

ISO 13485:2016 Lead Auditor, Exemplar Global Certified

Course Summary

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