ISO13485: 2016 Amendment coming?

chris1price

Trusted Information Resource
#1
Per BSI, regarding ISO 13485:2016, "The draft of an amendment to this standard is out for approval and, if approved, has a projected publication date of Jul 2021."

Does anyone know what is in the amendment and the likelihood of publication in July?
 
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somashekar

Staff member
Super Moderator
#2
This is perhaps to the EN ISO 13485:2016 only.
Can you have a relook...
I get this information ...
A systematic review of ISO 13485 was started in April. ... As a result, CEN has initiated the process to make an amendment to EN ISO 13485:2016. This amendment will only affect the European Foreword and the European Annexes Z. There will be no changes to the requirements in the standard itself
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
So,....if the claim is there is a pending draft/amendment, and that is specific to BS-EN, then the result would be no change to the ISO 13485:2016 text.

It is still the ISO 13485:2016 revision.
 

Jean_B

Trusted Information Resource
#5
The DIN EN ISO 2019 A1 amendment draft shows the EU MDR annexes and can also already be purchased. It shares it root with the A1 of BSI, being EN ISO 13485:2016/prA1:2019.
In my reading of the german one (which includes an english text) I didn't find this significantly different from CEN TR 17223 from 2018.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
It is still the ISO 13485:2016 revision.
Yes, the ISO website shows the standard was confirmed in January of 2020. So, next review should be around 2024. And, very interestingly, the TC 210 was not "forced" to align ISO 13485 to the High Level Structure (or Harmonized Structure), while the ISO TMB wants to make everyone believe that the common structure is "mandatory" for all ISO Management System Standards....

Screenshot 2021-06-29 082155.jpg
 

LUFAN

Involved In Discussions
#7
Yes, the ISO website shows the standard was confirmed in January of 2020. So, next review should be around 2024. And, very interestingly, the TC 210 was not "forced" to align ISO 13485 to the High Level Structure (or Harmonized Structure), while the ISO TMB wants to make everyone believe that the common structure is "mandatory" for all ISO Management System Standards....
I was wondering if the FDA's decision to align had anything to do with TC 210's decision to confirm the 2016 revision and wait until [at least] 2024 to revise it.
 

RCW

Quite Involved in Discussions
#8
I see that BS EN ISO 13485:2016 + A11:2021 has been released now. Is the A11:2021 portion of this document the section that addresses the EU directives (Annex Z)? I really don't want to spend $300+ for the new standard if all that has changed is information in Annex Z.
 

LUFAN

Involved In Discussions
#9
I see that BS EN ISO 13485:2016 + A11:2021 has been released now. Is the A11:2021 portion of this document the section that addresses the EU directives (Annex Z)? I really don't want to spend $300+ for the new standard if all that has changed is information in Annex Z.
I haven't seen it posted yet but you should be able to get it on the Estonian or Latvian Standards store for in the 20 euro range (for the EVS-EN or LVS-EN version(s)) when it becomes available. They are the same thing.

Estonian Centre for Standardisation and Accreditation
Jaunumi

Keep checking them. I find they usually show up about ~1 to 3ish months after publication.
 
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