In a recent article published March 26th, it was reported that the FDA is strongly considering updating its quality system requirements for medical device manufacturers to utilize the ISO updated quality management standard, 13485:2016. What are your thoughts on FDA updating QSR to include an ISO standard? Do you think this will actually happen? What would this mean for manufacturers?
I think its completely logical for FDA to update QSR to include parts of ISO 13485:2016, because they are very similar. I'm not sure if this will actually happen or how they will integrate, but if it does I believe that it would take a while to make a a decision and implement so this would allow manufacturers enough time to make any necessary changes.
http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=5811
The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the Part 820 regulation requirements are covered in ISO 13485. However, there are some requirements that might not be included explicitly in ISO 13485, for example Device History Record (FDA Part 820.184). But, the ISO 13485 standard’s Control of Records (Clause 4.2.5), Planning of Product Realization (Clause 7.1), and Identification (Clause 7.5.8) implicitly relate to the requirements of Device History Record. It has been noted that any changes to the existing regulation to help create closer alignment between the two standards would not simply replace QSR standards.
Because the two are so similar, my only concerns with hard wiring the ISO standard in to the QSR standard is ensuring that there are not gaps created with the integration and that QSR will be at the mercy of ISO if they make a future revision.
Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don't think QSR would be replaced completely. And I think the article mentioned that QSR will (possibly) include parts of ISO 13485, not the other way around to replace QSR standards.
