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New 9001 and 13485 standard

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Juanito Created:   Jul 20, 2017 Last commented:   Jul 20, 2017

New 9001 and 13485 standard

ISO 9001
Hi! In new 9001 standard says that there is no need to have an management representative? how about in the new 13485 standards? is the new 13485:2016 is still need the MR or not
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Strahinja Stojanovic Jul 20, 2017

Hi Juanito,

ISO 13485:2016 still requires management representative, so in order to be compliant with the standard you need to assign this role to someone in your organization.

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Jul 20, 2017

Jul 20, 2017

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