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ISO 13485:2016 Lead Auditor (Medical Devices Quality Management System Training)—Exemplar Global Certified

Course ID MDLA2019AQS
Format Classroom

This course is intended to qualify ISO 13485:2016 auditors to conduct effective audits of an organization’s medical devices.

Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. The course includes hands-on workshops to prepare you for real-life auditing situations. You’ll learn to manage the audit process and complete reporting.

This course is being offered in cooperation with DEKRA AQS, an Exemplar Global certified provider.

Course Data

  • CEU Hours: 3.3
  • Length: 33 Hours
  • ASQ RU: 3.3
  • Audience: Practitioner, Professional
  • Provider: ASQ - ILT
Course Overview

Learning Objectives:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) - Requirements for Regulatory Purposes standard and development process
  • Identify medical device QMS terms
  • Describe the intent and requirements of IAO 13485:2016
  • Determine the evidence needed to demonstrate conformity to ISO 13485:2016
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
  • Describe the relationship between ISDO 13485:2016 and applicable regulatory requirements
  • Apply the principles, processes, and methods of auditing
  • Demonstrate the activities involved in preparing for an audit
  • Determine an effective audit in the context of the auditee’s organizational situation
  • Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
  • Establish and plan the activities of an audit team
  • Manage the audit process
  • Prepare the audit report and perform an audit follow-up


All attendees are required to bring their own copy of the ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Copies will not be provided for you.

Who Should Attend:

Those responsible for planning and scheduling an internal audit program for ISO 13485:2016 and those who must perform audits to ISO 13485:2013, medical device personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.
Day One
  • Introduction to Quality Management Systems
  • ISO 13485 family of documents
  • ISO 13485 Standard
  • Applying ISO 13485 Standard
Day Two
  • FDA Quality System Regulation General Provisions
  • Medical Device Single Audit Program (MDSAP)
  • Requirements for Product Realization Methods and Documentation
  • PDCA
  • Risk Management
  • ISO 13485 Audit Specifics
Day Three
  • Types of Audits
  • Audit Approaches
  • Audit Objectives, Scope, and Criteria
  • Auditor Competence
  • Auditor Principles and Methods
  • Audit Program
  • Audit Roles and Responsibilities
  • Audit Techniques
  • Gather Information
  • Audit Cycle
Day Four
  • Team Leader Roles and Responsibilities
  • Conflict Management
  • Select Audit Team
  • Prepare for an Audit
  • Plan the Audit
  • Conduct an Audit
  • Opening Meetings
  • Gather Information
  • Closing Meetings
  • Prepare Audit report
  • Audit Follow-Up


This is an instructor-led classroom course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam. Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
Cancellation Policy
ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.
  • If you need to cancel, we will refund your paid registration fee as noted below.
    • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.

Enrollment Details

Format: Classroom
Format: Classroom

An instructor-led traditional classroom experience. Classroom-based instruction involves the highest level of instructor/student interaction. We offer classroom style training in two formats. See public and on-site.

October 19, 2020 - October 22, 2020 Austin ILT0518 TX US AQS Solutions English Early Bird Ends September 13, 2020 List: $1899     Member: $1699 Regular List: $2189     Member: $1959



ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.

5 Benefits of On-Site Training

  1. Expertise to your location: Saves time and travel expenses
  2. Convenient scheduling: Train groups of five or more
  3. Customizable courses: Training tailored to your groups’ needs
  4. Immediate results: Employees complete courses ready to apply what they’ve learned
  5. Value-add support: Instructors available to answer questions after session