Quality Plan at a small Medical Device Company - Is the quality plan a DMR document

[snoopy2017]

Hi everyone,

This has been such a helpful forum.

I am planning to work on a quality plan at our small medical device company. Is the quality plan a DMR document? Where should it exist?

Thank you very much.

 

[Ronen E]

Re: Quality Plan at a small Medical Device Company - Is the quality plan a DMR docume

Hi,

The quality plan is not normally a part of the DMR, although there may be some overlap (and the QP may reference the DMR instead of duplicating). Normally the QP is an independent item, one of the top-level documents of the QMS.

From the FDA’s QSIT (inspection guidance):

Much of what is required to be part of the plan may be found in the firm's quality system documenta-tion, such as, the Quality Manual, Device Master Record(s), production procedures, etc. Therefore, the plan itself may be a roadmap of the firm's quality system. The plan in this case would need to include reference to applicable quality system documents and how those documents apply to the device(s) that is the subject of the plan.

Quality plans may be specific to one device or be generic to all devices manufactured at the firm. Quality plans can also be specific to processes or overall systems.

For a small company (with a single or a few device models) I would recommend having a single, generic QP for all device models designed and manufactured by the company, with a statement that all referenced QMS documents apply to all these devices. Some details may be added as necessary but I wouldn’t go into too much detail as this is supposed to be a high-level document (“roadmap”, as above), and to avoid the need for frequent updates.

 

[locutus]

Re: Quality Plan at a small Medical Device Company - Is the quality plan a DMR docume

For a small company, I usually suggest an "annual quality plan" basically a document that is created each year that talks about what the company is doing. This can be general routine things or very specific activities. Also, highly recommend obtaining and reviewing ISO 10005 standard as this is quite helpful and provides some examples in the Appendix.

An annual quality plan could address things like:
- Reference to the audit programme
- When management review meetings are held
- When external audits are held (ISO cert audits)
- Documentation review
- Regulatory review
- Regulatory license renewals

Then if you need create specific quality plans for activities like a company acquisition or moving facility. Personally, my own thoughts are that a DMR is kind of like a quality plan because it tells how to make the product - bit of a stretch for the definition, but many also term their "quality plan" as the DMR. No problem referencing a quality plan from the DMR though.

 

[Ronen E]

Re: Quality Plan at a small Medical Device Company - Is the quality plan a DMR docume

many also term their "quality plan" as the DMR. No problem referencing a quality plan from the DMR though.

Reading 21 CFR 820 and QSIT I find it a little difficult to see how the QP can be termed DMR or vice versa. I also don’t understand why the DMR should reference the QP (the QP described in part 820 and QSIT; I’m not familiar with 10005). At most, the DMR would reference documents that the QP may reference too (which is not the same as referencing the QP itself).

 

[Shivani N]

Hello
Could anyone possibly help me in preparing Quality plan (as per ISO 13485:2016) for AI enabled Medical software company by providing some sample/ template of the same?

Thank you

 

[yodon]

First off, 13485 doesn't require a quality plan but does require a Quality System. Do you have a Quality System? If that's what you're asking for, I would caution against using someone else's templates - they may not be a fit for your company - especially an AI-driven device company (mostly uncharted territory). If you're trying to put together a quality system and you don't have the background, I would suggest engaging with a consultant.

I don't know of any general guidance docs on AI systems. In general, though, in addition to 13485, you'll want a quality system compliant with IEC 62306 (Medical Device Software lifecycle processes). You'll want to conduct risk management per ISO 14971.

The FDA (with full recognition this is posted under the 13485 forum) has a proposed regulatory framework paper. That will likely drive some of your processes.

Cybersecurity is on everyone's mind these days so you'll want to find and incorporate applicable cybersecurity guidance. Pretty much every country / jurisdiction now has something.

The point is, doing what you ask is not a trivial matter by any means. There are very few AI systems on the market so you're unlikely to get anything very appropriate for your company.

 

[Shivani N]

First off, 13485 doesn't require a quality plan but does require a Quality System. Do you have a Quality System? If that's what you're asking for, I would caution against using someone else's templates - they may not be a fit for your company - especially an AI-driven device company (mostly uncharted territory). If you're trying to put together a quality system and you don't have the background, I would suggest engaging with a consultant.

I don't know of any general guidance docs on AI systems. In general, though, in addition to 13485, you'll want a quality system compliant with IEC 62306 (Medical Device Software lifecycle processes). You'll want to conduct risk management per ISO 14971.

The FDA (with full recognition this is posted under the 13485 forum) has a proposed regulatory framework paper. That will likely drive some of your processes.

Cybersecurity is on everyone's mind these days so you'll want to find and incorporate applicable cybersecurity guidance. Pretty much every country / jurisdiction now has something.

The point is, doing what you ask is not a trivial matter by any means. There are very few AI systems on the market so you're unlikely to get anything very appropriate for your company.

Thank You for your reply. And yes I was asking about Quality plan only and wasn't sure if it's mandatory. I have already considered IEC 62304 and ISO 14971 for QMS implementation but was looking for particular guidance for AI-driven software.
Anyways, Thank you so much for your post. I got somewhat better idea for implementation of ISO 13485:2016.