Final Draft for ISO 13485 3rd Edition is here!

ISO 13485 is under revision and the proposed 3rd Edition is at the final stage!  Titled “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes,” the final draft is up for voting by ISO membership from 10/29/2015 to 12/29/2015.  It is expected to be adopted and published soon thereafter.

Let’s take a moment to review what ISO drafts are, their stages, and why you might be interested in purchasing a draft document.  We’ll also suggest when you might want to wait until the authorized edition for a draft is released.

ISO drafts come in three basis stages:  The Committee Draft (ISO/CD) which is NOT publicly distributed, the Draft International Standard (ISO/DIS) which is publicly distributed for comments, and the Final Draft International Standard (ISO/FDIS) which is presented as a finalized edition for ISO acceptance.  If you look at the ISO website, you can find information on what stage a publication is in (relating to the three stages above plus withdrawn or in force status).

So, if you see an ISO standard with the acronym ISO/CD at the start, the only way you’ll be able to get a copy is to find out what organization in your country is the TAG (Technical Advisory Group) and see if you can join the committee itself.

If you see an ISO standard that starts with the acronym ISO/DIS, you can get a copy.  This is useful for documents that have a major impact on your product or business.  You can review the proposed new edition and make comments (usually suggestions for improvement or criticisms of the content).  The committee is obliged to review your comments and take action on them in some way.

When an ISO committee has reviewed a ISO/DIS standard and has reconciled all issues, it then developes the final language for the proposed document.  This is the language that will be exactly used when the new edition is released, pending approval by ISO members.  Again, this ISO/FDIS is available for the general public to purchase.  It offers you an opportunity to look at the final language and start to make your transition plans.  However, it does NOT take the place of the eventual authorized edition when it is released.  So if you purchase a final draft, you will need to repurchase the same information in the form of the authorized edition when it’s available.

Now for a review of what will be different in the new 3rd Edition of the ISO 13485.  Annex A provides users of this standard with a comparison of the ISO 13485:2003 with this new ISO 13485:2016.   Significant changes have been made to the introductory material, expanding the influences on an organization’s QMS (Quality Management System) to include organizational environment and regulatory requirements.  This is part of an increased focus on the regulatory concerns in this new edition.

Reference to ISO 9001 now uses the new 2015 Edition of the quality standard.  Details are provided in Annex B, with some changes to how this material is referenced within the ISO 13485.  The scope of the standard is also expanded.  As you move throughout the publication, you’ll also see that requirements in many clauses have been expanded.  In the later clauses, there is also more attention to the issues raised by changes in how we view risk management for medical devices.

For me, another surprising addition to the ISO 13485 is the inclusion of the Z Annexes!  These tools for identifying what Essential Requirements are fulfilled by the use of specific clauses within the ISO standard have been solely used in EN adoptions.  We’ll see if this improves the clarity of EN requirements or if it creates issues with the New Approach Harmonized Standards system adopted by the European Union.

If you would like a copy of the Final Draft for ISO 13485, just remember you will need to purchase the authorized edition when it is released in 2016.  You can buy your copy on the Document Center website, www.document-center.com.  Here’s a direct link to the order page for the ISO/FDIS 13485.  It’s available in both paper format and for pdf download.  ISO 13485 can be included in your multi-user Standards Online subscription as well.

Still have questions? Contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982 and have the knowledge you need to understand and use these compliance documents.  Make Document Center your Standards Experts!