Change of name to the Division and Biomedical Auditor? by Jim Shore; repost from https://www.l...

Change of name to the Division and Biomedical Auditor? by Jim Shore; repost from https://www.linkedin.com/groups/1027567/

Posted by George Marcel on May 30, 2019 6:11 pm

Repost from Jim Shore - ASQ Biomedical LinkedIn Group - Please provide your input:

 

Change of name to the Division and Biomedical Auditor?


This topic has been discussed during the past couple of years - change the name to better reflect what we actually focus on - Medical Devices! The proposed name change would be Medical Device Division and the Certified Medical Device Auditor.

During the World Conference, we polled ~ 100 people and 90% agreed with this change. Please read the attached document and share your thoughts.


Regards,
Jim Shore
Chair, Biomedical Division 2019

#asq#asqbiomedical #qualitygeek


 
Background to this proposal - please read first 1 page

 

 
 
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Re: Change of name to the Division and Biomedical Auditor? by Jim Shore; repost from https://www.linkedin.com/groups/1027567/

Posted by James Shore on May 30, 2019 11:41 pm

There has been some comments regarding combination devices and biomedical engineering.  I would suggest everyone take another look at the current Body of Knowledge, which does not cover either item:
https://asq.org/cert/resource/docs/cba_bok.pdf

  

Re: Change of name to the Division and Biomedical Auditor? by Jim Shore; repost from https://www.linkedin.com/groups/1027567/

Posted by Lisa Grosskopf on Jun 5, 2019 8:12 pm

Hi Jim,

Regarding "There has been some comments regarding combination devices and biomedical engineering.  I would suggest everyone take another look at the current Body of Knowledge, which does not cover either item".  In my opinion, this is a failing of the Division's certification.  The Biomedical Division covers more than auditing and medical devices. A full BoK would include technical certification and include combo devices and biomedical engineering topics.  I am not an auditor, nor do I intend to ever become one.  I am an engineer and would like to see certification relative to quality tools and biomedical affairs.  Limiting the Division's focus to the CBA BoK is the wrong direction.  My thoughts.

  Lisa 

Re: Change of name to the Division and Biomedical Auditor? by Jim Shore; repost from https://www.linkedin.com/groups/1027567/

Posted by Brijesh Patel on Jun 21, 2019 11:20 am

I assume I was among the 10% that did not agree. It's sad but I would assume most voters were from Medical Device industry or just wanted the free stuff and voted yes for it.
Brijesh Patel