ISO 13485:2016 Gap Analysis by NB

#1
Hello!

After month of interesting an informative reading and learning on this forum, its time to ask a questions... )))
Little pre-story:
We are 4 people company doing design and development of the medical device class IIb.
Still in the progress at R&D phase but almost ready for the first industrial prototype and laboratory testing.
By the way we are working parallel at Technical file for CE and started to develop our QMS
according ISO 13485:2016 ( I know its maybe to late to start doing it the right way, when a lot of job done without QMS).
We have applied for NB who can also do ISO audit.
Our business model is to make design&development and sales of our
product. All manufacturing,sterilizing, handling and logistic processes are outsourced.
We already have a list of contractors we are going to work with and they have all necessary certificates.
But, all this in the future.
I had experience going through ISO 9001 audit without D&D, and my auditor said: We can certify only past and present, not your future.

Now our NB offers pre-audit (Gap-analysis) at the nearest time. As I understand Gap analysis will show only "white spots" in the our QMS.
Probably, going through ISO 13485:2016, clause by clause and using all possible checklists we can do this gap analysis by ourselves....
NB will only say what is not right but don't say how to improve it?
Question: is it worth to pay big money for pre-audit now? ( if we are still at R&D stage making CAD models and some prototypes)

As I understand, we should be ready for an audit when we have all quality agreements with CM and we have all steps in Design and Development including
production/tests/sterilization/packing/labeling etc.
Does it mean that we should make a Demo Run of all procedures with Our product? ( And only after that we can have ISO 13485:2016 audit)

Or we can show to auditors documentation with procedures and processes/quality agreements/ ?

We had consultant helping us with CE and ISO but as this story with COVID-19 started, our communication stopped. (
So, trying to get clear.

Thank you!
Hormer
 
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indubioush

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#2
Why did your communication stop with your consultant? It seems to me that some work can be done remotely. As for paying money for the pre-audit, that will be up to you. You may want to instead bring in another consultant to do a gap audit for you.
 

mihzago

Trusted Information Resource
#3
I would second indubioush's suggestion and get a consultant to do this audit for you. If you want to save cost try to find a good independent consultant, rather than a consulting firm. Less overhead, thus lower fees, and if you find a right one, same or better level of service.
I would also suggest running this as your internal audit. You need to have one before Stage 2 (or stage 1 depending on a CB) anyway, and I'm almost certain that you cannot use pre-cert for your internal audit.
 
#5
Thank for your replies.
He was working remotely. And communication just lost.
According pre-audit from consultant and to use it as internal audit, its a good suggestion. Thank you mihzago.
I understand your opinions about offered pre-audit by Notified Body. I might be not too clear asking my previous questions.

Other question would be:
Should we completely finish our device and be through all processes till its manufacturing/sterilization/packing with real device, and only after that
when we have finished product apply for audits? Or we can do it almost now, when we still at R&D stage with some prototypes and we just have
procedures and instructions "how it will look like" in the future?
 

mihzago

Trusted Information Resource
#6
What do you mean when you say "apply for audits"? Do you mean the pre-audit or the actual certification audits. Also, do you mean applying (as in submitting an application) or actually conducting the audit?
I'll answer assuming you mean the certification audits as there are two important considerations.
1. Even if you apply today, your Stage 1 will likely be scheduled 6 months or more from now; CBs/NBs are quite busy.
2. To obtain certification, you do not have a product finished and manufactured. A CB will audit whatever you have. Keep in mind that you must have all processes implemented and all procedures available. They may not be able to audit your records from say Design Transfer or Complaints, but you still need to have these processes and procedures in place.

With that, if you're still only in the R&D stage, I would say it's too early to schedule certification audits (unless your development cycle is really short). You can certainly perform an internal audit now, if you want to see where you are, but my recommendation would be to schedule your internal audit 2-3 months before the certification audit so you can audit as many areas as possible and have enough time to fix things.
 
#7
What do you mean when you say "apply for audits"? Do you mean the pre-audit or the actual certification audits. Also, do you mean applying (as in submitting an application) or actually conducting the audit?
I'll answer assuming you mean the certification audits as there are two important considerations.
1. Even if you apply today, your Stage 1 will likely be scheduled 6 months or more from now; CBs/NBs are quite busy.
2. To obtain certification, you do not have a product finished and manufactured. A CB will audit whatever you have. Keep in mind that you must have all processes implemented and all procedures available. They may not be able to audit your records from say Design Transfer or Complaints, but you still need to have these processes and procedures in place.

With that, if you're still only in the R&D stage, I would say it's too early to schedule certification audits (unless your development cycle is really short). You can certainly perform an internal audit now, if you want to see where you are, but my recommendation would be to schedule your internal audit 2-3 months before the certification audit so you can audit as many areas as possible and have enough time to fix things.
Thank you for this reply!
Sorry, I call them NB, because we also applied for complex audit from CB/NB in one face.
But now they communicate as Certification Body for ISO 13485.Technical file with Clinical evaluation is not ready to show them.
"apply for audits" - I mean "say to CB, that we are ready to show our QMS according D&D, manufacturing and sales of our medical device"

We had applied last year (sent application and payed application fee, with plans that for this moment we would have industrial prototype.... But R&D phase is still on. And we don't have manufactured anything that looks like final product. CB contacted us this month with proposal to have pre-audit ASAP and stage 1 in next 2 month.
So, i just wondering, if we don't have real pilot run: manufacturing/sterilizing/packing, is it ok, to show them only procedures how it will look like... With R&D and some mockup prototypes... Or we should say them - that we are not ready and finish pilot run for real.
 

mihzago

Trusted Information Resource
#8
I'm not aware of a requirement that your product must be ready for initial certification, but best to check with your CB on their expectations.

A side note, during the Stage 1 they'll check whether you have all processes and required procedures implemented and determine if you're ready for Stage 2.
 
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