ISO 13485. The next revision.

The DIS2 of the ISO 13485 now and projected for the release in end 2015.
Why not scrap this project, let the ISOTC210 take due time and come up with the ISO 13485: 201x aligned to the ISO 9001: 2015 on the lines of the HLS.
Any standard must standardize at the minimum. I guess this version of the 2015 will not map to the HLS.
Comments ~~~~~

 

The quick answer is that a conscious decision was approved in the beginning of the process (2011) to avoid the HLS.

A more detailed answer - ISO 13485 is used in a heavily regulated environment, and is heavily used, even if generally not mandatory.

ISO 9001 is not the standard to be used in the medical device sector - that´s why ISO 13485 exists.

HLS is still a bet - we do not know if it really will work out well. We can´t risk creating a big chaos in the heavily regulated medical device world by using something that we do not know if it will add benefit or even work out well.

ISO TC 210 WG 1 is a somewhat different group from other WGs - due to the regulated approach, there´s a lot of regulators participating. Most of the regulators that spoke out during the discussions were against any change such as the HLS, because it´s important for them that ISO 13485 is harmonized with their regulatory requirements. Which means, for example, that if we change to the HLS either regulators will need to change their regulations to adapt (almost impossible to do) or will drop acceptance of ISO 13485. This does not seem like a good outcome.

 

My company carries both registrations - We discussed this at our management review last week and I told the group that I am leaning towards dropping the 9001 standard. Our customers only care about 13485 and compliance to FDA QSR anyway. I don't think they are worth reconciling.

 

I think developing a QMS that meets both ISO 9001:2015 and ISO 13485 should not be all that difficult. As it is 13485 and 21 CFR 820 do not line up exactly, and companies can integrate the two without too much difficulty. Similarly, many companies have successfully integrated ISO 14001 and ISO 9001. I am not sure the value in dropping ISO 9001 when it changes unless it has no real value for you now.

 

As a 13485 newbie, could you tell me what this translates to? Are we talking a whole new rewrite, or another appendix or what?