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ISO 13485:2016 Internal Auditor Course

ISO_13485

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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Hvornår:

5. oktober - 6. oktober 2022

Add to calendar 2022/10/05 09:00 2022/10/06 18:00 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.
https://www.dnv.dk/training/iso-13485-2016-internal-auditor-course-188279
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Varighed:

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.dnv.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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