ISO 14969 (Now Obsolete) --> ISO 13485 handbook

[xcanals_tecno-med.es]

Dear all

As the ISO 14969 disappears and will be converted in a iso handbook please change the forum title of this section



Xavier

 

[Marc]

Re: ISO 14969 --> ISO 13485 handbook

It has been updated. Thank you for pointing this out.

 

[RA Lille]

Hi there,
Is this handbook available anywhere ?
thanks !

 

[Marcelo]

It's still being drafted.

 

[Jeffers]

Hello Marcelo,
It has been a few months since this post was mentioned. My best friend google was not able to uncover any new results for the ISO 13485 Handbook. Does anyone have an idea when this will be published? Are any drafts available?
Thanks in advance.

 

[Marcelo]

It's still in development, the last step was an internal ballot (which was positive) to send to the ISO TMB for publication. It is planned to be published this first semester.

The drafts are only internal to the working group.

 

[Jean_B]

It's still in development, the last step was an internal ballot (which was positive) to send to the ISO TMB for publication. It is planned to be published this first semester.

The drafts are only internal to the working group.

Do you have an idea where we can track this? 14969 was immensely helpful for interpretation and training and I'd like to get my hands on the handbook as soon as it comes out.
The ISO website has a wonderful history&future feature on its pages, but the discontinuation of 14969 doesn't refer to the superseding handbook , and it doesn't show as one of the under development projects of the responsible committee either (so I don't know whether I would see it appear in the published list there out of the blue either).
https://www.iso.org/committee/54892/x/catalogue/p/0/u/1/w/0/d/0

 

[Marcelo]

Do you have an idea where we can track this? 14969 was immensely helpful for interpretation and training and I'd like to get my hands on the handbook as soon as it comes out.
The ISO website has a wonderful history&future feature on its pages, but the discontinuation of 14969 doesn't refer to the superseding handbook , and it doesn't show as one of the under development projects of the responsible committee either (so I don't know whether I would see it appear in the published list there out of the blue either).
https://www.iso.org/committee/54892/x/catalogue/p/0/u/1/w/0/d/0

Unfortunately, ISO tracking only works for ISO deliverables (Standards, TRs and TSs), and the handbook is not of them. So the only to know is really when it's published.

 

[Sanne]

Does anybody know, what is the current status of the handbook?
Is there any timeline?
Cheers

 

[Jean_B]

Only point of reference I have available is this project (AAMI/ISO 13485 Handbook, Quality management systems - Medical devices - Guidance on the application of ISO 13485:2016) on the AAMI website.

https://standards.aami.org/higherlogic/ws/public/projects/project/details?project_id=1238