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.

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