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

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

Posted by Tami New on Nov 19, 2019 5:49 pm

I am not a big poster in this forum, but I am completely and passionately opposed to the name change. Changing the name from ‘Biomedical’ to just ‘Medical Device’ division is a discredit to all those ASQ members (and interested future members) who are currently serving in biomedical fields  as we should serve not only device, but combination device, cell technologies, biomedical engineering, Life Sciences and Biologicals.  Do we really want to disclude a segment of membership in the division, rather than growing the current division to support one of the biggest growing industrial segments? Doesn't our current Certified Biomedical Auditor (CBA) cert support this industry? 

Here are Bureau of Labor Statistics stats for Biomedical Engineers (note this does not include biomedical scientists, biomedical auditors and other supporting fields:)
https://www.bls.gov/ooh/architecture-and-engineering/biomedical-engineers.htm

When I joined the division, I was working in Life Sciences that included supporting biological customers and the CBA was very attractive to my employer and me. By removing Biomedical and focusing on only Medical Device alone, you will in effect be removing a valuable set of ASQ members and future members from interest in this division.
Regarding the body of knowledge scope for CBA, it need revising anyway regardless of name change. There have been regulation and standard changes, e.g updates to ISO 13485, ISO 14971, Japanese regulations and EUMDR to name some - and these are just for medical device. Looking at the BoK needs for Biomedical professionals should be included in the updates to CBA.


 

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 Nov 22, 2019 7:37 pm

Thank you for posting.  I concur that changing the name would unintentionally narrow the focus of members and the industry we serve.