Question on Finding - BSI Stage 2 ISO 13485:2016 Certification - PMS


Hi everyone!

My company successfully passed Stage 2 ISO 13485 certification but we got a minor finding which stated, "The documentation of a post market plan is not fully effective" per ISO 13485:2016 Clause 8.5.1. The scope of our PMS SOP specifies that Post market activities will be conducted for medical devices which we currently do NOT have - we are RUO for the time being.

Anyone else have experience with creating PMS plans for RUO products? A part of me wants to push back on the NB that the scope of the SOP isn't applicable to our products yet. Am I interpreting the finding incorrectly?


Trusted Information Resource
It's a bit odd (early) to complete ISO certification while still in research. I guess the auditor didn't see it this way.
You can write a Memo-to-file explaining why you are postponing the implementation of PMS activities for next year and have your CEO sign on it.



Super Moderator
I've encountered auditors that feel if it's in your QMS then it must be done - irrespective of timing. I found that pretty silly since the explanation is pretty obvious.

Do you have a project plan or anything that might show WHEN you will trigger the PMS Plan? That might provide justification for the push-back suggested by @Randy and align with what @shimonv recommended.


Involved In Discussions
I think there's a basic philosophical question here; why are you seeking ISO certification right now?
From the auditor's perspective, you are trying to qualify a quality management system capable of handling the full life cycle of a medical device. Remember, they are certifying a system - not a product. That means if you're going to need post-market procedures in your system, that they need to see you have them and that they work reasonably well. That you don't have an actual product to use with those procedures is an unfortunate side-effect of certifying early - but it's not hard to understand why the auditor wants evidence the system works.

So, how can you demonstrate those procedures are effective without real product?


Involved In Discussions
In this perspective, it's not about whether there's a reasonable explanation. The explanation is obvious. Instead, think about it as if you were taking a driver's license exam in a car without a rear-view mirror.

How should the examiner assess your ability to check the rear-view mirror if there isn't one? The explanation for why you didn't do it was perfectly reasonable - nonetheless, a conscientious examiner couldn't tick off your competence for checking the mirror if they weren't able to gather the evidence.

Given this, I would say there are two obvious solutions. The first is what most would do - which is to push back and insist on certification anyway. Normally this should come with a reduced scope or a follow-up audit as appropriate. I don't prefer this - because, effectively, they are giving you a drivers' license on the promise that you'll definitely practice your rear-view mirror skills later on. Still, there are times where that's practical.

My preferred solution is to just do a basic dummy run of a simple procedure. Document it like a test report- pretend you have a product, and run through the steps you would do to conduct basic post-market surveillance as per your SOP. You show them the report, and hey presto, you have evidence that your system is functional.


Quite Involved in Discussions
I have limited experience with IVD, but the IVDR clearly excludes research-use only IVD's. The finding is to ISO, so this doesn't necessarily mean that there is no ISO requirement. However, it seems like BSi should have given you some latitude.

I wonder if you specifically excluded clause 8.5.1 and 8.2.1 in the quality manual for research-use only IVDs, whether this would have made a difference.. This exclusion seems justifiable, because research-use only products are not technically diagnostics, because they are not to be used to diagnose patients. You might also have to exlude 8.2.6 and other clauses as well. There are a lot of links to PMS in the standard. Just a thought, not making any promises. It does seem to me like it's reasonable for the notified body to require an exclusion be documented in this case.


Involved In Discussions
Something that gets my attention here is "RUO for the time being". Does that mean you're making only research devices for the foreseeable future, or does it just mean you are currently in some sort of trials and intend on going to market?
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