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Paul22
Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?
Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?
Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?
ISO has just released ISO 31010:2009. Risk management -- Risk assessment techniques
HiI have some info, sorry for not answering before, just a little busy here
ISO 31000 is being developed as THE standard on risk management in ISO (following an strategy of ISO on having general management systems standards).
The problem here is that ISO 31000 is for business risk (it details a general enterprise risk management process applicable to all enterprises). ISO 14971, on the contrary, is for product risks. Their similarities, then, are only a few.
Tehy might be able to co-exist because they deal with different things, but the main concern is that, as 31000 is being published to be the general risk management standard on ISO, it will be "forced" into other risk manbagement standards. ISO TC 210, JWG 1, which is the originator of ISO 14971, has been aware of this for some time and is studying possible situations around this scenario.
Hi
We are ISO 13485 certified, and aligned ourselves to the 14971 standard.
Now our CEO wants us to become ISO 27001 and ISO 27799 certified. Both these standards talk about the 31000 risk management standard.
The question is whether we can keep using ISO 14971 to manage the risk of ISO 27001 and ISO 27799 (with adaptations of course).
Would appreiciate any advice.
Thanks
Mandy