ISO 13485:2016 Internal Auditor

This is a comprehensive 2-day course which provides delegates with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485, and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

Delivered by our experienced Medical Device Certification team, the course includes interactive exercises and workshops as well as a Medical device-based company case study and role play.

The course is comprehensive and covers all stages, including:

  • Audit planning & preparation
  • Audit checklists
  • Audit skills
  • Audit practice
  • Correctly identifying and documenting non-conformances
  • Compiling effective, clear and concise audit reports

Guided by our experienced team, you will discuss every stage of the internal audit process using role-play, workshops and tutorials. You will also plan and conduct an audit and assess if it was done effectively.

At the end of the course, you will:

  • Understand the principles of auditing, the audit cycle and the roles and responsibilities of the team involved with an internal audit program
  • Have a clear awareness and understanding of the skills and attributes of an effective internal auditor
  • Understand how to plan, prepare and conduct an effective internal audit
  • Have undertaken a medical device-based internal audit via a case study role play
  • Understand how to correctly identify and document non-conformances and compile effective, clear and concise audit reports

If you would like more information or wish to book this course please call 0330 430 3456, complete the form below or email quoting course code T014.