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Which Certification - ISO 13485 vs. ISO 9001

K

Kymmie

#1
Hello everyone!

After being investigated by the FDA last year and receiving several 483s (our company didn't even HAVE a QMS at the time) I believe I have our head above water again. Now that we have a QM department (me) and things seem to be starting to roll along I am looking toward the future. My first goal is to get our MDEL with Canada, and then after that I'm looking to get us ISO certified.

I am a littlel confused about which certification we should go for. Origionally I was thinking that we should go after ISO 13485, but now I am thinking that ISO 9001 is the better fit for us? We do not do any manufacturing - we simply repackage/relabel medical devices. As I'm beginning to understand it, ISO 13485 is more directed towards medical device manufacturers? And ISO 9001 simply qualifies that you have a QMS that is "up to snuff"? Am I correct in this thinking or am I off track?

If it matters, my main goal for getting ISO certification is to make us more marketable internationally. Thoughts?

Thanks again for all of the help I keep receiving here! I hope that someday I will have learned enough to contribute back :eek:

~Kymmie
 
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L

Lucasmf

#2
Re: ISO 13485 vs. ISO 9001

If you want to be able to operate/distribute into Canada or the EU you will need ISO 13485. Also from a marketing perspective, medical device customers will value much more highly as a 13485 company than a 9001.

The standard is directed at anyone working along the medical device supply chain even though it has a strong focus on manufacturers.
 
K

Kymmie

#3
Re: ISO 13485 vs. ISO 9001

Thank you Lucasmf...

That's what I needed to know. So the 13485 would be more beneficial for us, even though it is focused on manufacturers. Would I be correct in assuming that the audit for us would be relatively mild in comparison to a manufacturer since we are a small operation and don't do any manufacturing or design?

I have been in touch for a request from one registrar for a quote. Is it bad form to ask on here for suggestions on who to do our audit? I feel like I would have us ready by mid-2013 but need to give management some sort of an idea of what it is going to cost us well ahead of time so that they can budget for it. (Amazingly - they seem to be on board with getting ISO'd despite the pain I went through getting them on board with 820).

Much appreciated!

~Kymmie
 
L

Lucasmf

#4
The most important step is at the beginning. Your quality manual should clearly state any exclusions or non applicable requirements to your business. Careful however, you can only claim exceptions from requirements in section 7 of ISO 13485. All the other sections need to be implemented in full. :read:
 

Le Chiffre

Quite Involved in Discussions
#5
I wouldn't say 13485 is more appropriate for manufacturing companies, it's more appropriate if you market medical devices bearing your company name. There's great information in these forums about the differences between ISO 9001 and 13485, but specifically 13485 includes more rigorous traceability to help with recalls and advisory notices.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Hello everyone!

After being investigated by the FDA last year and receiving several 483s (our company didn't even HAVE a QMS at the time) I believe I have our head above water again. Now that we have a QM department (me) and things seem to be starting to roll along I am looking toward the future. My first goal is to get our MDEL with Canada, and then after that I'm looking to get us ISO certified.

I am a littlel confused about which certification we should go for. Origionally I was thinking that we should go after ISO 13485, but now I am thinking that ISO 9001 is the better fit for us? We do not do any manufacturing - we simply repackage/relabel medical devices. As I'm beginning to understand it, ISO 13485 is more directed towards medical device manufacturers? And ISO 9001 simply qualifies that you have a QMS that is "up to snuff"? Am I correct in this thinking or am I off track?

If it matters, my main goal for getting ISO certification is to make us more marketable internationally. Thoughts?

Thanks again for all of the help I keep receiving here! I hope that someday I will have learned enough to contribute back :eek:

~Kymmie
Hi,

Please note that in the EC if you repackage/relabel finished medical devices under your own name, you're considered a medical devices manufacturer. ISO 13485 certification is not obligatory from a regulatory standpoint, but it's highly recommended for simplifying the clearance process (unless it's a non-measuring, non-sterile class I device). The extent of required (/recommended) compliance will be determined by the device(s) class.

Cheers,
Ronen.
 
K

Kymmie

#8
Thank you everyone for your help and guidance. I am thinking that I will go ahead and take RABQSA certification course in both. This looks like it will cost us around $2000 but in the long run I think it will help so that we don't have to use our consultant throughout this process, I can get certified as an auditor, and I don't want to attempt our certification and fail (from what I gather its pretty expensive). Do you think this type of course and certification is worth the expenditure? (My last question on this thread - just want to be sure that I'm spending the company's money wisely before I do so). Muchas Gracias!

~Kymmie
 

Ronen E

Problem Solver
Staff member
Moderator
#9
so that we don't have to use our consultant throughout this process
Companies hire consultants for their long experience, their hard-earned insights and their objectivity. You don't get all these from an entry-level course (even for auditor certification).

I don't want to attempt our certification and fail
There is normally no such thing. At worst, you get some rejects, and after you adequately address them you get certified.
 
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