Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019

[bolesen]

Hi Everyone,
We are still using /referencing 14971:2012 in our QMS. What is the required or recommended timeline to transition to 14971:2019 standard?

The updates have little impact on our products (Software - PACS) but wanted to check to see if there is a requirement to transition to the latest standard.

Thanks,

 

[yodon]

That's actually a bit of a loaded question. FDA has already adopted it as a recognized consensus standard but has not removed the :2007 version. I think there are generally a few years to allow for adoption. The EU has not harmonized it as far as I can tell (although I thought I heard they had).

It is, I believe, considered state of the art so you probably want to transition. You should do a gap analysis on all your products. Even though you might argue there's little substantive change, you may want to bolster / define your method for overall residual risk acceptability, review your postmarket support and ensure you have all the appropriate actions and information to collect well-defined, etc.

The list of hazard sources (now relocated to ISO/TR 24971) changed fairly significantly. Part of your gap analysis might be to ensure you have all hazardous situations considered. Also, since your product is software, cybersecurity and data security are being emphasized.

If your quality system is certified to 13485, you probably want to at least establish a plan to transition. AOs are asking and flagging you if you don't have a plan.

 

[mihzago]

Check with your NB or AO if you have one. Some require compliance by next audit, some give a year, but I think most if not all consider it SOTA.

As yodon mentioned, you at least should have a transition plan in place.

It's possible that the changes will have more effect on your process than the risk management file, but you may still have to revisit your risk acceptability criteria and how you evaluated residual risks.

 

[DannyK]

I read that FDA will accept ISO 14971:2007 until December 25, 2022.
See the RAPS article FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

 

[bolesen]

Thanks for all your feedback.

I am going through the ISO 14971:2019 and defining gaps and document updates and am finding a lot of reference to the ISO/TR 24971:2020 guidance doc. I wasn't planning on purchasing this guidance doc but appears it might be necessary to properly implement.
What are everyone's thoughts on the ISO/TR 24971:2020 and is it needed?

 

[yodon]

I found it pretty necessary to purchase, unfortunately. (And this was real close to starting a major rant! )

 

[ThatSinc]

I found it pretty necessary to purchase, unfortunately. (And this was real close to starting a major rant! )

Tell me about it!
But this revision of TR24971 is FAR better than the original revision - though putting some of the almost vital annexes from 14971 into it was clearly a marketing decision.

 

[Asia78]

Hi all, interesting, i was not aware of the ISO/TR 24971:2020 could you please tell me which additional information it provides comparing to the iso 14971?
Do you recommend to buy assess it? Thanks

 

[Ed Panek]

At our company, we perform a preview of the changes in any standard and then determine how we will adapt to the new standard. If the standard is a large change you may want to act aggressively to change how you work, however a risk-based approach to the changes is usually acceptable.

 

[Ed Panek]

Recently ASTM E1112 for thermometers was changed but a comparison between the two was incredibly minor to the point the changes we laughable.