ISO 13485:2016 Internal Auditor Course

In this two day internal auditor training course you will learn the principles and practices of effective quality management process audits in accordance with ISO 13485:2016 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 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

• 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.

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 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

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.

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