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Registrars Doing Synchronized (Combined) Audits to AS9100 and ISO 13485

J

Joan Lintz

#1
Are any of you aware of any registrars that are doing sychronized audits (combined audits) to AS9100 and ISO 13485?

Thanks for your help!

Joanie
 
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DannyK

Trusted Information Resource
#2
I have never heard of a registrar doing a synchronized audit for ISO 13485 and AS9100.
It may be possible if you have a lead auditor qualified for both standards
I am a lead auditor for both standards.
 
#3
Are any of you aware of any registrars that are doing sychronized audits (combined audits) to AS9100 and ISO 13485?

Thanks for your help!

Joanie
Joanie:

Interesting question. Let me check this one out for you. For my clarification, when you mean synchronized, do you mean the same auditor, or both requirements being audited during the same audit, possibly by different auditors?
 
#5
HI!

Either one. My coworker and I would entertain answers to both scenarios.
We would do the 2 auditors route, probably, since the number of dually qualified auditors is somewhat limiting when it comes to finding locally based resources, to keep expenses down. This kind of audit is quite common - so we've got a lot of experience/expertise doing them. Can I help you more? If so, please pm me.
 

RCW

Quite Involved in Discussions
#6
To throw another angle at this and ask another question, or two:

- Is it beneficial to use the same registrar for both your ISO13485 and AS9100 audit?

- Are there disadvantages to using one registrar for ISO13485 and another for AS9100?

I'm talking about two seperate, unique registrars, not two different auditors from the same registrar. I'm assuming I could also get my ISO9001 certificate from either of these audits, for more $$ of course.
 

RCW

Quite Involved in Discussions
#7
Anybody out there who is registered to both AS9100 and ISO 13485 that could answer my questions above??
 
#9
To throw another angle at this and ask another question, or two:

- Is it beneficial to use the same registrar for both your ISO13485 and AS9100 audit?

- Are there disadvantages to using one registrar for ISO13485 and another for AS9100?

I'm talking about two separate, unique registrars, not two different auditors from the same registrar. I'm assuming I could also get my ISO9001 certificate from either of these audits, for more $$ of course.
- Yes!

- No!

You can get your ISO 9001 certificate. Why do you think it costs more?

Different CBs will possibly cost you more in the miscellaneous fees charged and you will have other differences to deal with - customer service, report formats and so on. It's more and more common to have all certifications with one CB. I've personally seen a lot of consolidation of multiple sites/certificates over the past few years, due to a lack of service, for example.

As I mentioned, the likelihood of a dually qualified auditor is slim, or you'll pay to bring them to you, probably from one coast or the other. You might have to weigh that against 2 more locally based auditor 'specialists'...
 
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