ISO 9001:2008 Certified Lead Auditor with Medical Device Focus (ISO 13485:2016)

21. to 25. Jan 2019

Houston, TX

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

Course Details

• 5 Days

• 3.6 CTUs

• $1995

Share page