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ISO 13485:2016 Lead Auditor Training

Certified by Exemplar Global

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.

Course Details

  • Length: 4 days
  • CTUs: 3.2
  • Competency Units: MD, AU, TL
  • 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

More ISO 13485 Training Options

Highlighted Topics

  • Requirements of ISO 13485, ISO 9001, and 21 CFR 820

  • How to apply the standards in the medical device sector

  • Methods for planning and conducting an audit

  • Audit skills and behaviors necessary for an effective, efficient management system audit

  • Fully understand and interpret the requirements of ISO 13485
  • Understand differences between ISO 9001 and ISO 13485, including requirements for continual improvement and customer satisfaction
  • 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

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.

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 ISO 13485:2016 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 leading management systems audit teams (TL) along with a corresponding competency exam.

The mock audits were incredibly helpful and insightful in understanding how a typical audit may go. It was both fun and educational.

Course feedback from a student, 2021

Why DEKRA?

Industry-leading accreditation and unparalleled experience

Exemplar Global-certified ISO 14001:2015 Lead Auditor Course

DEKRA Training (formerly AQS) offers a full range of training in support of organizational improvement and implementation of international management system standards.

This Exemplar Global-certified course meets the training requirements for Exemplar Global Quality Management Systems Lead Auditors, Auditors, and Provisional Auditors.

Have questions? Contact us

DEKRA Training

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800-633-2588
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