ISO 13485:2016 Certified Lead Auditor Training

18. to 21. May 2020

Philadelphia, PA

4 Days - $1995 - 3.6 CTUs - Competency Units MD, AU, TL

This course will help you:

  • Fully understand and interpret the requirements of ISO 9001 in a Medical Device Environment
  • Fully understand and interpret the requirements of ISO 13485
  • Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
  • Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
  • Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
  • Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
  • Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
  • Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
  • Learn how to ask audit questions that get results
  • Learn how to conduct opening and closing meetings that have impact
  • Learn how to construct effective audit checklists
  • Learn how to generate effective corrective actions

Format

This is a four-day, 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 medical device auditing 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 lead auditor requirements with a competency exam (TL).

Certified by Exemplar Global
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