ISO 13485:2016 and Medical Device Regulation (MDR) Internal Auditor Course

In this three days internal auditor training course you will learn the principles and practices of effective quality management process audits in accordance with ISO 13485:2016, the MDR and ISO 19011:2018. You will be taken through the entire audit process from planning the audit to reporting and follow up on non-conformities.

About ISO 13485:2016 and Medical Device Regulation (MDR) Internal Auditor Course

Content:

• Introduction to ISO 19011:2018

• Introduction to ISO 13485:2016 and focus on checklists for each chapter in the standard

• How to plan and conduct effective audits for ISO 13485 including preparation of checklists

• Introduction to the MDR requirements not covered by ISO 13485 and what to look for when auditing QMS against the MDR requirements

• How to plan and conduct effective audits for ISO 13485 and MDR including preparation of checklists

• Internal audit plan MDR article 10, annex I, II and III.

• 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 and the Medical Device Regulation.

You will learn how to plan and perform audits, how to use the ISO 13485 to prepare checklists and how to report the audit. In addition, you get an insight into the MDR requirement not covered by ISO 13485 and you will learn what to look for when auditing the QMS against the MDR requirements.

On completion of the training, you will:

• Have an understanding of ISO 19011 and its benefits

• Have an understanding of the principles and the benefits of ISO 13485 and MDR auditing

• Have an understanding of the MDR requirements that are not covered by ISO 13485 and what to look for when auditing the QMS against the MDR requirements

• Have obtained the skills necessary to plan and conduct audits based on ISO 13485 and the MDR

• Be able to plan, prepare, conduct and report on internal audits against ISO 13485 and the MDR

Course Leader:

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).

Language:

The training is held in English.