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ISO 13485:2015 Pre-Release News and Discussion - Page 22


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  Post Number #169  
Old 18th June 2015, 07:15 AM
CBAL08

 
 
Total Posts: 165
Re: ISO 13485:2015 Pre-Release News and Discussion

Well more hard work and struggle to keep all documentation for both standards. Or choose to drop ISO 9001 as being a Medical Device industry it hardly is required for any registration. Any idea of when will the New ISO 13485 will
be publised? Any plans for making it similar to the New ISO 9001:2015?

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  Post Number #170  
Old 18th June 2015, 08:00 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: ISO 13485:2015 Pre-Release News and Discussion

Quote:
Any idea of when will the New ISO 13485 will
be publised?
Well, we will have a meeting at the end of August to finish the FDIS, which will take some more months for ballot, so we will probably have the standard published in the beginning of 2016 if everything goes well.

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Any plans for making it similar to the New ISO 9001:2015?
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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