BS EN ISO 13485 Correction Issued

BS EN ISO 13485 2016 Edition, “Medical devices. Quality management systems. Requirements for regulatory purposes,” has just been reissued with a Corrigendum 1 (correction).  This updated edition is available from Document Center Inc. now.  If you use this publication, please get your corrected copy asap as it does contain changes that will affect your compliance requirements for Europe.

The BS EN ISO 13485 is the official English language edition of the EN ISO 13485.  You will note that other national editions contain the same text for the English edition as does the BS version.  So it is possible to meet your requirements with editions from Sweden, Germany or other jurisdictions.  The English text of the standard remains the same in them all.

The corrections to the BS version center on the preliminary material, that is the forward and the various Annexes.  Since the Annexes provide you with the specific information on what clauses of the standard meet the requirements of the various Directives referenced, they’re essential to effectively implementing the standard.  Other items of note include the official requirement to use the EN edition of the ISO 9001, for example.

For those of you who have already purchased your copy of the BS EN ISO 13485 from Document Center Inc., you can get the corrected edition for a nominal service charge to cover the costs of reprinting the entire document.  For those of you who haven’t gotten a copy yet, you’ll just purchased the corrected 2016 Edition that’s available at our webstore.

You can search for an order standards here at our Document Center website, www.document-center.com.  And here’s the link to go directly to the order page for the BS EN ISO 13485.  If you have questions and would like to talk with our staff, consider giving us a phone call at 650-591-7600 or contacting us by email at info@document-center.com.  We are an authorized distributor of EN Standards in a number of European National editions.  We’ll help you choose the best one for your purposes.  Make Document Center your Standards Experts!

Published by

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+

Leave a Reply

Your email address will not be published. Required fields are marked *