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Internal audit

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Guest user Created:   Aug 24, 2020 Last commented:   Aug 26, 2020

Internal audit

We had an internal audit earlier this year of company QMS to  the ISO 13485:2016 and MDD 93/42/EEC, do we need to schedule another internal audit beforeQMS audit to assess company compliance with MDR? 

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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 Aug 26, 2020

According to the ISO 13485:2016, requirement 8.2.4 Internal audit states that the organization must conduct internal audits at planned intervals. The purpose of an internal audit is to determine whether your quality management system conforms to both all documented arrangments, requirements of the ISO 13485:2016, and all other applicable regulatory requirements. So, yes, you need to perform another internal audit to assess the compliance with MDR. 

For more information on how the internal audit should be performed, please see following articles: 

You can even see which documents our ISO 13485:2016 Internal audit documentation toolkit have:

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