Advice and counsel on ISO 13485 Implementation and Certification

M

mestrella

#1
Hello Everyone,

I am looking to the masses for advice and counsel. I am a quality engineer recently layed off from the auto industry. As many I am looking to re-invent myself, so I have been looking for a new industry. It seems that there are quite a few positions available in the medical devices industry. Unfortunately, no one will even look at me without the ISO 13485 Certification. I am hoping that someone will be able to advise me to a good way to get this certification. I have seen some places online that give it, are any of them trustworthy and worth wild.

Thank you ahead of time.
Mark
 
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JoCam

Trusted Information Resource
#2
Re: ISO 13485 Certification

Hi Mark,

It may be me, it's very hot here today, but I'm not sure what you're asking for. Are you looking to gain experience in how to implement and maintain a system to ISO 13485?

Jo
 

GStough

Staff member
Super Moderator
#3
Re: ISO 13485 Certification

Hi Mark,

It may be me, it's very hot here today, but I'm not sure what you're asking for. Are you looking to gain experience in how to implement and maintain a system to ISO 13485?

Jo
...or perhaps looking to attend an ISO 13485 Lead Auditor training course?

Agree that clarification is needed to get the answers you need/are looking for...
 
M

MIREGMGR

#4
Re: ISO 13485 Certification

"Certification", as used in the ISO 13485 context, refers to an evidence provided by a Notified Body to a company that has the quality system, affirming that per audit and review their quality system is appropriately implemented and functional. It doesn't refer to evidence of an individual's qualifications in regard to that standard.

Presumably the potential employers of interest to you, want you to have a skillset and experience related to creation, application and management of a 13485-based quality system.

A basic ISO 13485 training course could be a start in that direction. There are a number of quality-systems training companies that have such offerings. A Google or equivalent search on "ISO 13485 training" gets a lot of hits.

I doubt if anyone knowledgable is going to regard such a training course by itself as much of a qualification, though, unless your auto-industry credentials are pretty substantial. With only such a training course, you won't be very well equipped for senior or managerial positions in medical device regulation and quality. A period of time in a junior position with varied responsibilities for a regulatorily active company, combined with such training and a strong background, would help a lot.
 
M

mestrella

#5
I probably should of stated my question more in the lines of training vise certification. I have Quality Engineer training in the auto industry, and Quality Control in the Aviation Industry, but I am being told that unless I have the ISO 13485 under my belt my resume will not even get looked at.

I agree, I would much rather start off in the junior end of quality in a new industry and grow into positions with more responsibility.

Thanks for helping me clarify.
Mark
 

DannyK

Trusted Information Resource
#6
If there are any medical device companies in your area looking for employees, you may want to offer to perform a project or ask if you can do an apprenticeship to get into the front door.

As a Quality Engineer there are many of the same processes and tasks involved.

Do not sell yourself short. Highlight the experience that you may have that will benefit the medical device company.

Learning the standard is not difficult.
 
A

Abhishek Katiyar - 2009

#7
Hi Mark,

If you are looking for ISO 13485 quality related training webinars you can refer following websites -

1.The British Standards Institution
2. ComplianceOnline
3. Omnex
4. CALISO Consulting, LLC

Hope this helps you.

Regards,
Abhishek
 
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