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Risk Management Standard Revised

MeddiQuest's Mariona Casals has been reviewing the changes in ISO 14971 The special Risk Management Standard for Medical Devices, ISO 14971, has been revised. MeddiQuest's Mariona Casals has been reviewing the changes from the 2000/1 version in the new 2007 revision.


When you buy the new version of the ISO 14971 standard the first change you will notice is that it is twice the size (well actually you might notice first that it is nearly twice the price as well - so shop around for cheaper national versions)! The extra bulk comes from the numerous new “explanatory pages” (annexes). Of course, the idea is that these are informative and non-mandatory ... we will just have to see how the various notified bodies and certification authorities (third parties) interpret this: concrete instructions or helpful guidance?

That really leads me to the second big change: some third parties are starting to offer certification to ISO 14971, just like ISO 9001 or ISO 13485. I imagine there will be instances where a customer requests such a certificate, and of course it is always beneficial to have an independent third party review any system to highlight issues that you have missed, but then again there is a cynical view that the third parties have just found another service to sell! Whether companies will take up this "service" needs to be seen, but in our competitive world once one supplier offers a certificate (valuable or value-less) they have an advantage (however slight) over their competitors!

With these conceptual changes, it is all too easy to miss the important changes at the technical level, and these need to be implemented in a compliant risk management system.

There also seems to be a general consensus emerging that the 2007 version of the standard agrees better with ISO 13485:2003 (although this standard is itself now under revision) and the revised Medical Devices Directive (2007/47/EC), and, importantly if we are to see third party certification, the revised standard is more suited to auditing.

Mariona Casals

Comments or questions?
email Mariona at mariona.casals@meddiquest.com
Uploaded October 19, 2007
Last updated October 19, 2007
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