I am the QA Manager at a medical device company that was largely uncontrolled as a device repair facility prior to making the transition to ISO 9001 then ISO 13485 (all before my time). I am wondering if anyone here has any experience or recommendations with respect to missing design elements with medical device parts (but not medical devices by definition). In particular, we have a variety of parts that we now make that are not covered by patent and are used in our repairs as replacements for the OEM. (For example, infusion pump parts that commonly break in the OEM). Anyway, we are looking at changing registrars and I am opposed to it because I know that we are missing a variety of documents like design inputs/ouputs/ transfers to production. Should we attempt to complete some of the basic design information (inputs, etc.) with a note that it was completed "after the fact" in order to meet requirments or will the auditor be more inclined to forgive the omissions that occurred prior to registration. Thanks in advance for any insight or suggestions.

Bob

I am the QA Manager at a medical device company that was largely uncontrolled as a device repair facility prior to making the transition to ISO 9001 then ISO 13485 (all before my time). I am wondering if anyone here has any experience or recommendations with respect to missing design elements with medical device parts (but not medical devices by definition). In particular, we have a variety of parts that we now make that are not covered by patent and are used in our repairs as replacements for the OEM. (For example, infusion pump parts that commonly break in the OEM). Anyway, we are looking at changing registrars and I am opposed to it because I know that we are missing a variety of documents like design inputs/ouputs/ transfers to production. Should we attempt to complete some of the basic design information (inputs, etc.) with a note that it was completed "after the fact" in order to meet requirments or will the auditor be more inclined to forgive the omissions that occurred prior to registration. Thanks in advance for any insight or suggestions.

Bob

Bob, welcome to the Cove.

Is there any other reason(s) why you don't want to change Registrars? Is it just because you feel that a new Auditor with a new Registrar will identify the nonconformance that you are already aware of?

I am not a Medical Device person, but, if you know that there are some deficiencies, why not take the appropriate action?

In most cases (that I have been involved with) the Registrar's Auditor will note that these were already identify (either internally or externally). There was no NC generated by the Auditor, because it has already been identified.

I would discuss this with your Registrar (new or current). Just my opinion.

...I agree with Coury...

:2cents: ...compliance to the intended standard is a must… whether you are changing your registrar or not, you have to satisfy the (minimum) requirements of the standards you are following…

…if you are missing documents that would jeopardize your certification as well as your operations, why wait for some external entity to find out those things? afterall (and I believe), that is the primary reason why company hired guys like you – to make the company compliance with the standard they are subscribes, maintain and continually improve the system…

Joshua_sx1 and Corey,

Thank you for your responses.

I actually don't mind changing registrars, but I'm not sure that right now is the time. I am still pushing on Engineering to clean up some missing and incorrect product definition documentation (BOMs, drawings, specs, etc.) and we are getting there, we're just not there yet (it was one heck of a mess). On top of that, right now, the highest management would prefer that Engineering work on current projects rather than missing documents and come back to the missing documentation in a couple of months and the head of Engineering is not convinced that the design information such as design inputs, design outputs, etc., for some non-CE, non medical device parts, must be re-created since the projects have long since been transferred to production and since they are parts.
Overall, it sounds to me like a good discussion with our registrar (current and/or future) might be the best course of action since we are making progress and the devices and higher risk parts all have proper ISO 13485 documentation.

Thanks again.

Bob

I am the QA Manager at a medical device company that was largely uncontrolled as a device repair facility prior to making the transition to ISO 9001 then ISO 13485 (all before my time). I am wondering if anyone here has any experience or recommendations with respect to missing design elements with medical device parts (but not medical devices by definition). In particular, we have a variety of parts that we now make that are not covered by patent and are used in our repairs as replacements for the OEM. (For example, infusion pump parts that commonly break in the OEM). Anyway, we are looking at changing registrars and I am opposed to it because I know that we are missing a variety of documents like design inputs/ouputs/ transfers to production. Should we attempt to complete some of the basic design information (inputs, etc.) with a note that it was completed "after the fact" in order to meet requirments or will the auditor be more inclined to forgive the omissions that occurred prior to registration. Thanks in advance for any insight or suggestions.

Bob

Bob,
I must assume that your company is FDA registered. Knowing what you know (missing items), I would be more concerned with complying to 21 CFR Part 820. Remember ISO standards are voluntary, but 21 CFR Part 820 is Federal law.

Phil

Hi Phil,

Good point and thanks for asking.

Yes, we are FDA registered, and fortunately, the documentation for finished devices is in good shape.
In light of FDA's CPG 7382.8458, we have taken the approach (and formally documented it in a policy statement) that finished medical devices strictly fall under the cGMPs and design or use of parts that don't qualify as medical devices will be handled (from a documentation standpoint) according to documented risk level.
Basically, that's where my question comes from- so far as I understand and believe, ISO 13485 doesn't give us the option of handling repair parts differently than finished devices as long as repair activities and repair parts are in our registration scope.

So if you are missing DMR's (Device Master Records) of your finished products (BOMs, Drawing, Specs, etc). This has to do with FDA. I think its OK to change your registrar, because the worst that you are going to get is NONconformities, on which you could work on. You would know exactly where you stand after the audit. ARe you going for your RE-certification?