Is BS-EN-ISO-14971 identical to ISO-14971?

Here at Document Center Inc. we have bought in to the concept of “One Standard, One Test, Accepted everywhere”, the theme of World Standards Day 2002.

So when BSI, the British Standards Institute,  states that BS-EN-ISO-14971 (Medical devices. Application of risk management to medical devices) is identical to both EN ISO 14971:2009 and  ISO 14971:2007, we believe it.

However, we’ve heard of a couple of cases where auditors at customer sites have not accepted the ISO-14971 2007 Edition as being equal to the BS-EN-ISO-14971 2009 Edition for use in certifying to the EU Medical Device Directive.

We are putting out a call to the auditors themselves to see if we can get clarification on why the documents are not interchangeable for purposes of meeting the EU Directive requirements.

Having to purchase multiple copies of a single  ISO standard to meet certification requirements for different jurisdictions is problematic.  The costs can rise rapidly and references to multiple versions of a document can be cumbersome and difficult to manage when updates are made.

Do you have an opinion on this?  Are you an auditor who can speak with authority on this issue?  We ‘d love to hear from you.

Claudia Bach, President, Document Center Inc (www.document-center.com)