2017 EN ISO 13485 Corrigendum

Sometimes you want to know only the changes that are made to an EN Edition.  The new 2017 Corrigendum for EN ISO 13485 is a good example.  You have the option of purchasing a consolidated edition to get this information (BS EN ISO 13485).  But you can also purchase the Corrigendum only if you like (SIS EN ISO 13485).  Why would you want to do that?  To make your gap analysis easier.

The EN ISO 13485 2017 Corrigendum makes changes to the Annexes only.  These changes are noted by symbols at the beginning and end of either added or deleted text.  In the Corrigendum, only the areas with the changes are included.  The balance of the text of the EN ISO 13485 2016 Edition is not included.

Why is a Corrigendum like this available as a stand-alone item in one Edition and not in the other?  Each country in Europe can provide the changes either way.  So this is strictly a national convention.  And you can use it as a way to make your life easier.

Document Center Inc. offers you a number of national edition choices when it comes to purchasing EN documents.  The ones we carry are usually in English.  The text of the EN standard itself is identical in all cases.  It comes directly from CEN or CENELEC, the two European regional standards bodies.  So there is no technical reason to choose one national edition over another.

So how will you make your purchasing decision?  Our customers decide which edition suits them best based on available formats, the price, and any preferences their auditors may have.  If you are uncertain what to do, just get in touch with us.  Our knowledgeable staff can assist you with the information you need to make up your mind. You can reach us by phone at (650) 591-7600 or by email at info@document-center.com.

To see what’s available, just search for the EN standard you’re interested in at our webstore, www.document-center.com.  The various acronyms at the beginning of each document number designate the country that has published that edition.  You’ll notice that there is never a price for the source EN edition itself.  EN’s are only available in each of the national editions.

More questions, please get in touch.  We are always glad to help you with your compliance documentation questions.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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