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Which ISO Standard to purchase?

#1
We are a small company in Canada looking to obtain our ISO 13485 certification for an EMR software package. We are just starting out and would like to know if the standard from iso.org is fine to purchase or should we purchase the version from BSIgroup? I would happy take other suggestions as well.
 
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Edward Reesor

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#2
If it helps, we purchased ISO 13485: 2016 from one source (I believe it was ISo_Org) but recently purchased another ISO standard for one of our products from another source. All we needed was a printable pdf. The second group required some secure software that limits the opening of the document to the device that purchased the document. First it was a pain to access the document (simple solution but it was frustrating). Then we discovered that it was limited to device. I used my aging work laptop. I am confident that my purchase may be transferable but once the laptop dies, it will be another pain. I may be wrong in my frustrations, but you may want to explore this experience when you decide.
 

planB

Super Moderator
#3
dasmann,

ISO 13485:2016 is identical to BS EN ISO 13485:2016 in its normative part. You will find differences in the foreword and in the additional Z-Annexes the latter has.

Hope this helps,
 

blackholequasar

Involved In Discussions
#4
The second group required some secure software that limits the opening of the document to the device that purchased the document. First it was a pain to access the document (simple solution but it was frustrating). Then we discovered that it was limited to device.
This has been an issue that I've encountered as well. When I got BS EN ISO 13485, however, it did watermark the PDF but it did not limit it to a specific user. I understand the need to protect these documents, but they really go out of their way to make it really complicated sometimes!
 
#5
Thank's for both of your replies. I have found the ISO standard on CSA's web site - to my dismay I see another version of the standard on the site "CAN/CSA-ISO 13485:16" could anyone comment on this release?

EDIT: Thank's for your reply as well blackholequasar.
 
#6
Thanks all. I've figured out which one to buy CAN/CSA. It's published by CSA and would make sense to buy the one made by my regulatory body.
 

Philip B

Involved In Discussions
#7
This has been an issue that I've encountered as well. When I got BS EN ISO 13485, however, it did watermark the PDF but it did not limit it to a specific user. I understand the need to protect these documents, but they really go out of their way to make it really complicated sometimes!
Yes, they watermark them with your name and they are intended for your personal use only. If you want to put them on a shared network or company drive then you are supposed to purchase a network licence. I doubt many people do this but they could raise this during an audit if spotted,
 
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