DNV GL Danmark

ISO 13485:2016 Internal Auditor Course

ISO_13485

The training is held online. 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:

• 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

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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Register for the training class here

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Varighed:

The training is held online. Duration: 2 days

Pris:

Course fee: DKK 12.500,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

About ISO 13485:2016 Internal Auditor Course

Content:

• 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

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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