ISO 13485:2016 Internal Auditor Training

Course Description

At TÜV SÜD Academy, we agree with Dr. Eamonn Hoxey, Chair of ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the patient comes first.

ISO 13485:2016 is the management system that governs medical devices, the management system upon which compliance with regulatory and customer compliance can be built. It embodies an agreed upon, repeatable way of managing production, validation, quality, and risk management.

At the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market.

This two-day course, conducted by our experienced TÜV SÜD Academy instructors, will introduce students to the requirements of ISO 13485:2016 and will explain in detail how to integrate the requirements into quality management systems. Students will be equipped with the knowledge and skills needed to plan and conduct effective internal audits.

This online course is designed to illustrate how organizations can benefit from becoming skilled in integrating this standard into their processes. By learning how to audit your processes, you signal to your customers that you take quality and customer needs seriously.

Course Benefits

This course is intended to help you to understand ISO 13485:2016 and to conduct internal audits. Through examples, exercises, and a final exam, you will be familiar how this standard applies to the life-cycle of a medical device. The course covers the entire standard ISO13485:2016, and participants will learn about audit techniques, including behavior as well as questions and approaches for different clauses and requirements. Explanations of the necessary audit tasks and appropriate treatment of the nonconformities are an integral part of the training.

Who Will Benefit

This course is designed for every employee who can perform internal audits under the scope of ISO 13485:2016, including medical device manufacturers and vendor personnel who will be involved in the launch of management systems or updating of the current management system, quality management officers (QMOs), product managers, and consultants in the medical device industry.

Learning Objectives

• Learning to plan, conduct, and report the audit in accordance with the ISO13485:2016 standard
• How to prepare audit reports
• The roles and responsibilities of an internal auditor in keeping medical devices safe

Course Agenda

ISO 13485:2016 Management System Implementation

• Risk Management: Identify hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of these controls.
• Risk Management Process: Risk Analysis, Risk Evaluation, Risk Control, Production and Post-Production Information.
• Risk Analysis & Preliminary Hazard Analysis
• Risk Control
• Validation/Packaging Validation
• Production
• Device History Record

Auditing Concepts and Principles

• Roles and responsibility of Auditors
• Planning an internal audit part 1
• Audit plan and Checklists
• Initiating the audit
• Collecting objective/audit evidence
• Effective interviewing techniques
• Identifying and recording nonconformities
• Conducting the closing meeting
• Preparing and distributing the audit report
• Corrective and preventive actions
• Follow-up scheduling
• Monitoring corrective actions
• Conducting an audit
• Reporting audit results
• Corrective actions and follow-ups
• Examination

Course Materials

Learners must obtain a copy of the ISO standard to be referenced during the course. The standard may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).