Gaining ISO 13485 Certification - New Startup Company

Dobby1979

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#1
Hello.

A former colleague has a start-up and they are looking to gain 13485 accreditation. They are in the very early stages and one question asked was whether they would be able to gain certification whilst their product is in development?

They are are looking to gain certification by late November but do not anticipate the finished product to sign-off until late December, would this be a show stopper for gaining certification?

Thanks
 
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Sidney Vianna

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#2
would this be a show stopper for gaining certification?
In principle, no. There are no requirements in ISO 17021-1 nor the IAF MD9 Document which prohibits the issuance of an ISO 13485 certificate if the organization has not fully released a device in the market. Having said that, different lead auditors working for different CB's might have different expectations concerning the nature and amount of evidence necessary before they feel comfortable recommending a system to be certified.

Your best bet is to discuss this as early as possible with your CB candidates and put the conversation in writing, so you avoid misunderstandings, later on.

Good luck.
 

Mark Meer

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#4
Thanks Sidney. I did not think it was but wanted to check. Definitely worth confirming with the NB though.
Can you post back to this thread when you discuss with your NB? I'd be really interested to know the details...

I've often wondered how an initial certification audit would go if there are no records to audit (e.g. no orders, no complaints, no product non-conformances, ...).

Do they just look at your procedures, and confirm that you've got everything in place to meet the standard's requirements once the product is eventually developed and goes to market?

If this is the case, then that would definitely be the time to get certified! Simplest audit ever! :notme:
 
L

Lbrager

#5
Hello.

A former colleague has a start-up and they are looking to gain 13485 accreditation. They are in the very early stages and one question asked was whether they would be able to gain certification whilst their product is in development?

They are are looking to gain certification by late November but do not anticipate the finished product to sign-off until late December, would this be a show stopper for gaining certification?

Thanks
Depending on who your registrar is they will come out to conduct a Stage 1 audit. You want to have at a minimum a Quality manual and procedures in place for the applicable clauses of ISO13485 that you are currently practicing. If you are developing product that is expected to be completed soon then at a minimum you should have Design Control, Risk Management, Management Controls, Document Control, Change Control, Records Control, Validation, CAPA, and Training procedures and processes in place. You should also have held at least 1 Management Review and generated records. It helps to have a few CAPAs and in particular Preventive actions in place. If you are looking at launching only a month after your registrar has come in then you would likely be in the Process Validation and PQ stages which would mean you should have batch records for those runs, have inspected incoming parts, and have started to qualify suppliers. That being said you would also be expected to have procedures and processes in place for Validation, Material Controls, Equipment Controls, Manufacturing Controls, Calibration, Inspection and Acceptance Status, Non-Conforming Product and Supplier Controls. So if you are looking to get certification a month before product launch it is likely that you will (or should) have the majority of required processes and procedures in place and for many of them have generated records. Many times they will grant you certification based on the current scope of activities e.g. Design and Development and then once you have gained regulatory approval and are ready for sales and distribution they will come back and audit you on the remainder of activities.

I would be happen to discuss in more detail if you like as I provide QMS implementation consulting services for medical device manufacturers. Hope this helps!

-Laurie
 
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