ISO 13485:2016 Lead Auditor Training for Medical Devices Quality Management Systems

ISO 13485:2016 Lead Auditor Training for Medical Devices

Course Duration: 5 Days - 8 Hours/day

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL Competency Units. This 5-Day ISO 13485 training course fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

  • Exemplar Global-MD
  • Exemplar Global-AU
  • Exemplar Global-TL

Learning Objectives

  • Understand the application of Quality Management Principles in the context of ISO 13485:2016.
  • Relate the quality management system to the organization’s medical devices and provision of related services.
  • Understand the application of the principles, procedures and techniques of management systems auditing.
  • Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
  • Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
  • Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
  • Establish, plan and task the activities of an audit team.
  • Communicate effectively with the auditee and audit client.
  • Organize and direct audit team members.
  • Understand conflict management principles.
  • Prepare and complete the audit report.

Course Outline

Day One

  • Introduction and Welcome
  • Chapter 1 - Introduction to ISO 13485
  • Chapter 2 - The ISO 13485 Standard Explained
  • MD Written Exercise 1 (individual)
  • Chapter 3 - Overview of ISO 13485:2016 Requirements
  • MD Written Exercises 2a, 2b (Audit Scenarios)

Day Two

  • Overview of ISO 13485:2016 Requirements (cont’d)
  • Breakout Exercise 2c (Audit Scenarios)
  • MD Written Exercise (individual)
  • Introduction to Management System Audit Trails
  • AU Breakout Exercise 1: Scope and Objectives
  • Management of Audit Programs
  • Management System Audit Planning and Preparation
  • AU Breakout Exercise 2: Documentation Review
  • AU Breakout Exercise 3: Audit Plan

Day Three

  • Performing the Audit
  • AU Breakout Exercise 4: Conducting the Audit
  • Writing Nonconformity Statements
  • AU Breakout Exercise 5: Writing Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
  • AU Written Exercise (individual)

Day Four

  • Review of Audit Process and Audit Management Strategies
  • Case Study Mock Audit

Day Five

  • Instructor Interviews as needed
  • TL Written Exercise (individual)

Who Should Attend

This seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process.

Course Materials

Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 or 3 days of this class are offered separately for those new to auditing or quality management.

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