The purpose of this training is to clarify the requirements of the ISO 13485 Standard and share information on how to audit the how these requirements are met and the efficiency of the quality management system. The training will be done through sample internal audit plans, internal audit question lists and internal audit reports.
General principles of audit
How to prepare an audit program?
Points that should be taken into consideration when auditing
Qualifications and abilities of internal audits
ISO 13485 Standard Internal Audit Candidates
Each candidate will receive an “ISO 13485 Standard Internal Audit Training Participation Certificate”.