Tag: EN ISO 13485

EN ISO 13485 2016 Corrigendum

EN ISO 13485, Medical devices. Quality management systems. Requirements for regulatory purposes, has been reissued with a second correction, Corrigendum 2.  This correction sheet has been issued by CEN, the European standards body.  The correction is dated in December 2016.

The ISO 13485 and it’s European adoption EN ISO 13485 are the main quality documents for the medical device industry.  Of course, the parallel editions do cause users some confusion — Which copy should they be conforming to?  Let’s put it this way.  If your products will be certified for use and sale in Europe, get the EN ISO edition.  Any national publication will do.

Now to address the issue of the new corrigendum.  This new issue contains corrections to the European foreword, and to the 3 Annexes (ZA, ZB and ZC).  So the technical content is identical.  Only the administrative information has been updated.

Let’s take a look at what’s going on.  The Foreword’s update adds only the supersession information for the CEN ISO/TR 14969, which is now replaced by the EN ISO 13485.  Most of the changes occur in the Annexes.

Each Annex has introductory material.  New paragraphs have been added to each.  This information helps you understand the relationship of the standard to the Directive in general.  It also defines the adoption path for the standard by the European Union.  It is meant to clarify the legal requirements for conformity, either by using the standard or presenting a compelling case for compliance without the standard.   It also explains how the Annex shows you the clauses of the Directive that can be met by the use of specific clauses within the standard.

The next change in each Annex is the inclusion of additional clause references in the second column of tables 1 and 2.  So the scope of conformance will be expanded when this revision is officially adoption by publication in the Official Journal.

For those of you who have already purchased your copy of the EN ISO 13485 from Document Center Inc., the corrected copy is available for a nominal charge.  Please get in touch with us by phone (650-591-7600) or email (info@document-center.com) to place your order.  If you haven’t purchased the standard from us, now might be a good time to take advantage of the many services we offer.

To get started, use our webstore www.document-center.com to search for and order the standards you need.  Feel free to ask us about the many additional services we offer to help you keep your standards collection complete and correct.  And we have a range of delivery options as well, including company-wide portal services.

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ISO 13485 2016 is here!

ISO 13485, “Medical devices — Quality management systems — Requirements for regulatory purposes,” 3rd Edition has just been released and it’s available now from Document Center Inc., an authorized ISO distributor.  You’ll be able to get a copy in both paper format and as a pdf download.  Dated 3/1/2016, this new update replaces the previous 2nd Edition from July 2003.

The medical device industry has been waiting for this update ever since the final draft was approved at the end of last year.  This is one of our big sellers for this market sector and will be required in many of our customers’ standards collections.  It provides you with requirements for ensuring consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purposes.  And it specifically addresses compliance with regulatory and legal requirements.

One thing to note is that the new edition is not only being released as the ISO source document, but also as the European EN edition.  So if you’re using the EN ISO 13485, the new 2016 edition of that document is available now as well!  And even though EN ISO 13485 2016 Edition is out, it has not made it onto the Harmonized Lists for the various medical device directives yet.  It takes a while for newly released EN standards to make it through the administrative process and get posted to the Harmonized Lists.  When it does make it, you’ll likely have a three-year transition period for compliance for products sold in Europe.

Contact Document Center Inc. for more information and to learn how to add this standard to our enterprise multi-user subscription platform, Standards Online.  We can be reached by phone (650-591-7600) and by email (info@document-center.com).

Or order directly on the www.document-center.com website.  Here’s the direct link for the ISO 13485 order page and the direct link for the BS EN ISO 13485 order page.  Thanks so much!  We appreciate your business.