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ISO 13485 Lead Auditor

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Guest user Created:   Sep 16, 2020 Last commented:   Sep 24, 2020

ISO 13485 Lead Auditor

1. Is it possible for An ISO9001:2015 auditor to audit Medical Devie manufacturer?
2. How can I qualify myself on ISO13483

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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 Sep 18, 2020
1. Is it possible for An ISO9001:2015 auditor to audit Medical Devie manufacturer?

This depends on how the auditor is familiar with the production of medical devices, how much does the auditor understand the production and safety requirements regarding the medical device. 

Also, it is important that ISO 9001:2015 is familiar with the ISO 13485:2016. It is not possible to make an audit without the knowledge and understanding the requirements from ISO 13485. 

In the following links, you can find some useful articles:

2. How can I qualify myself on ISO13483

Most Notify bodies are providing a course for ISO 13485:2016 internal auditor. Of course, you can always read the standard by yourself and find some webinars online.

We have soon one free webinar regarding ISO 13485 and EU MDR, so feel free to check can it be helpful for your needs:

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Ernest Robert Sep 24, 2020

Thanks for your reply to my questions. I do appreciate it.

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Ernest Robert Sep 24, 2020

Thanks for your reply to my questions. I do appreciate it.

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Sep 16, 2020

Sep 24, 2020