I recently sent emails to a number of quality professionals asking the question: Is the use of the equivalent ISO document acceptable in the place of the EN-ISO adoption of the same standard?
I got back a wide variety of responses and am culling the best suggestions here for you!
As one consultant put it, “The bottom line [is that it] will ultimately be a decision made by the registrar.” Or, as another expert wrote, “The only issue would be if the Notified Body is BSI… they may ‘prefer’ the client using the BS[-EN version].”
However, there was a response from a Regulatory Compliance Specialist who works for a major international medical devices company that did provide a rationale for the use of the EN documentation, and a suggestion on how to keep from having to purchase multiple copies of the same material.
He notes that auditors will require the use of the EN editions because they are specifically called out in the supporting harmonised lists for specific directives. However, he has found that the original source documents can be substituted if the organization being registered will take the time to do the following steps:
1. Provide a reason for choosing a different document than the EN Edition.
2. Provide written justification that the ISO documents are identical to the EN adoptions. (Document Center Inc. can provide you with documentation that this is so.)
3. For those EN adoptions that have a conflicting date due to the addition of the annexes, provide documentation that shows that the differences do not affect your product. (Again, Document Center Inc. can help you with this.)
I also asked if there were other jurisdictions that presented similar documentation issues. Here’s some of the feedback:
1. Canada – Note that CSA has lists of recognized standards, similar to the lists issued by the EU. However, they not only list the CSA National publications but also the source ISO documents when applicable — they are more flexible in their published approach.
2. There are countries like Japan and China that will not recognize certain ISO standards.
3. Certification in the U.S. is more flexible than EU certification, with more acceptance of the various national adoptions.
And in a phone conversion, it was pointed out that an EN standard with the same number as an ISO document, but without the ISO as part of the number, is not an equivalent standard. So the above suggestions for gaining acceptance of the ISO original for EN certification will only apply to EN documents that are identical.
All comments will be appreciated. And if you’d like to get in touch directly, contact us at info@document-center.com, to my attention, Claudia Bach.