About ISO 13485:2016 Internal Auditor Course
• ISO 19011:2018 introduction
• ISO 13485:2016 introduction and focus on checklists each chapter one day
• How to plan and conduct effective audits for ISO 13485 including preparation of checklists
• Workshop on Preparation of checklists and presentation
Who should attend:
The training is for all individuals and organizations who need to perform internal or external audits (supplier audits) within a medical device life-cycle based on ISO 13485:2016.
You will learn how to plan and perform audits, how to use the ISO 13485 to prepare checklists and how to report the audit.
What will you learn:
• Have an understanding of ISO 19011 and its benefits
• Have an understanding of the principles and the benefits of ISO 13485 auditing
• Have obtained the skills necessary to plan and conduct audits based on ISO 13485
• Be able to plan, prepare, conduct and report on internal audits against ISO 13485
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Anette is also a member of the new task force for Annex L (high level structure).
The training is held in English.