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Allan Proudfoot
PoE, RF and Power Management Quality Manager at Microsemi Corporation
February 2016
ISO13485:201x
< 1 min reading time

After watching this release get pushed back quarter after quarter for longer than some documents exist, does anyone in the group have any visibility on when ISO13485:2016 (2017?) is actually likely to be released. Or even what the review status of the standard is.

source: https://www.linkedin.com/groups/2070960/2070960-6108415833199960067

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Posted by Allan Proudfoot
Asked on February 25, 2016 8:00 am
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Good question for Robert Packard or Jon Speer.
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Carolyn LaWell The ISO website has a publish date of March 1. http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752
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Clarisa Tate Final draft was completed late last year 2015, it's now being voted on from what I understand. I was told that it is possible it will be released in March or April. That's all I know at this time.
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Pernelle Kruse Schøndorff It was released yesterday (Feb.24.)
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Leonard Eisner I just double checked the ISO website and they say it is published but actually it is under the process of being released. It is at stage 60.60. The date of publication that is shown is March 1, 2016. I found out fairly recently that ISO only publishes standards only on 2 dates a month for any standard even if released a bit before that date. Officially all ISO standards are either released on the 1st or the 15th of a month. You are already allowed to purchase this standard thru ISO and most standards sales organizations are still selling the FDIS or Final Draft which is not the final document. So, if you purchase through a standards sales portal I would wait a week or two and make sure you purchase the published ISO 13485:2016 version of the standard. If you have standards questions please feel free to contact me thru LinkedIn. I specialize in medical device standards, regulatory, quality systems and product safety (60601-1).
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Steve Kent Have a look at this link to the BSI site: http://shop.bsigroup.com/ProductDetail/?pid=000000000030331463
I now have copy of the FDIS and as indicated I will get the full standard when published at no extra cost. From various sources I understand that the standard should be released in March.
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Rob Packard FInal version was released yesterday for sale. Link is posted in today's announcement, but you should be able to purchase almost everywhere.
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Marcelo Antunes ISO released it by mistake three days ago. The correct release is March 1st.
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Edwin Bills, ASQ Fellow, RAC The 2016 standard is now released
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