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Is special training necessary to get company certified to ISO 13485?

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Guest user Created:   Jul 07, 2020 Last commented:   Jul 09, 2020

Is special training necessary to get company certified to ISO 13485?

We are ISO 9001 certified company. I'm lead auditor certified. Do I need to take special training to get the company certified to ISO 13485?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 09, 2020

No, I do not think that you need special training. You have to study the ISO 13485:2016 requirements that differ from the ISO 9001:2015.

For start, I recommend you read the following article:

You can find a lot of articles in our ISO 13485:2016 Knowledge database and on ISO 13485:2016 Academy Blog.

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Jul 07, 2020

Jul 09, 2020