Target Audience

Anyone responsible for leading an audit program for ISO 13485, including quality assurance managers, quality assurance professionals, ISO project managers, ISO project team members, compliance managers, or regulatory personnel.

Course Objectives

• Fully understand and interpret the requirements of ISO 13485
• Understand 21 CFR 820 requirements and be able to compare these to ISO 13485 requirements
• Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
• Understand how to apply ISO 9001 and ISO 13485 standards during in-class practical audit exercises
• Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment
• Develop an ISO 9001/ISO 13485 auditing system based on the ISO 19011 auditing requirements
• Learn how to ask audit questions that get results and to construct effective audit checklists
• Learn how to conduct opening and closing meetings that have impact
• Learn how to generate effective corrective actions

Prerequisites

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

Benefits

Learn how to lead an audit program for medical device quality management systems. Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops. Participants will learn how to lead the audit process and to complete reporting. Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.

Agenda