Robert Barber More to the point, isn't it about time 21 CFR 820 was scrapped and replaced by ISO 13485?

Alison Bourne Hello, could you please let me know where I can read about the proposed changes to ISO 13485? Many thanks, Alison

Robert Barber This is a pretty good overview, written in plain English: http://www.praxiom.com/iso-13485-new.htm
BSI also publish a lot of guidance. Obviously this is all conjecture until the final text is approved, but it probably gives a good idea of where it is heading.

Alison Bourne Thank you Rob!

Bill White Although it is regrettable that the new ISO 13485, by maintaining the structure of the former version, will for some years to come diverge from the new structure the ISO organization is promoting for all management system standards, the new ISO 13485 is a step forward in many ways and will prove useful particularly for companies that are also adjusting to the coming new European device regulations. The most helpful aspect of the new version is a fuller incorporation of risk management principles.
For many reasons - copyright issues being among the most prominent - the FDA is not going to abandon the approach of 820. It is conceivable that there would be some tweaking (if it ever happens also likely to involve more thorough incorporation of risk management principles), but 820 is with us to stay.
Given the fact that a quality management system for each company today must incorporate the requirements of both 13485 and 820, it will also be possible to map the requirements of the new ISO 9001 into that same qualify management system if the company desires. I agree it is unfortunate that incorporation of the few additional requirements of 9001 will now be more difficult. It will also make it more difficult for device companies that choose to structure their management systems to include requirements of Environmental, Safety and other standards. Nevertheless, it is a step forward and one that will benefit the industry.

Ole Overgaard If 13485 DIS2 is approved as an IS in december 2015, how long will it take to become an EN harmonized with the MDD/IVDD/AIMDD? And how will this align with the coming change of the directives to a regulations?

Rob Packard I few months ago I did a comprehensive gap analysis of ISO 13485 (DIS2) against the current version. The changes are minor and in general the ISO 13485 is moving closer to harmonization with 21 CFR 820. The ISO 13485 Standard will never be as prescriptive as a law by necessity, but the addition of stronger supplier controls, justification of management review cycles and the addition of a Clause for Complaint handling dramatically improve ISO 13485.

I also just finished a review of ISO 9001 in its latest draft. The changes are not just structural. The required procedures have changed to documented requirements, preventive action was completely dropped and the definition of risk does not align with ISO 14971 at alll. I see no way that ISOTC210 could have followed the path of revisions that ISO 9001 is taking. In fact, I am concerned that ISO 9001 will fail to be relevant to medical device manufacturers and contract manufacturers in the future. For those that need to be compliant with both standards, they will need to be creative and it will take all of the 3-year transition period to resolve the conflicts.

Somashekar BV ISO 14971 was never a requirement even in the present ISO 13485. The standard directed to ISO 14971 for guidance related to risk management in NOTE 3. at clause 7.1.
The same can be continued when the new revision of ISO 13485 is taken up to be made to the Annex SL or the High level Structure (HLS)
Its sad if it is not aligning with the new ISO 9001 structure.
Not doing so now when a revision is taken up after 12 years is going back two steps after moving a step ahead. The MDSAP, if it gathers momentum will sideline the ISO 13485 further.
This will further bring down its popularity with Medical device industry.....

Bill White I cannot agree that MDSAP will sideline ISO 13485. Rather, the MDSAP will surely incorporate the ISO 13485 changes into its program.
As for "popularity" within ;the Medical Device industry, there is essentially no choice. This industry must comply with ISO 13485 if it chooses to sell almost any place in the world outside the US. (Although, for example, the European requirements technically do not require ISO 13485, in fact it is easier to be certified to the standard than to go down other paths.)
I regret that so few medical device companies choose to comply with 9001. I know of at least one company formerly certified to both that was encouraged by their registrar to discard the 9001 and continue only with 13485. I continue to see value in 9001, but I find that I am very much in the minority in this view.

Somashekar BV The MDSAP is a direct confrontation to the ISO 13485, by the regulators through the same few CB (call them AO) making it look dummy. The US FDA cares not if you have an ISO 13485, as long as you are good through the FDA inspection. What commercial value does it offer to the MD industry ? At best I can only see the Medical Device contract manufacturers going the 13485 way, as they have very little regulatory obligations.

Barnaby Keller At @ Keller Technology's CM facility we have elected to maintain certifications in both ISO 9001 and ISO 13485. We have embraced the former and it has made us a better business operationally. ISO 13485 has also been helpful, and in many cases it is a requirement some of our customer's have for their medical device CM's