ISO 13485, “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes,” is one of our top-selling medical device standards here at Document Center Inc. So our customers appreciate knowing that there’s a draft copy available. By purchasing a copy, they get a preview of changes and a chance to comment on them. It keeps folks who use this standard from being blindsided by the changes in a new edition.
The public review draft for ISO 13485 has a comment period that ends July 20th of this year. It is a technical change, and the draft is 192 pages long compared with the 64 pages of the 2nd edition that’s it is intended to replace. It’s numbered ISO/DIS 13485, with the DIS signifying that it’s at the public review stage (Draft International Standard).
As you can see, this is a massive re-write of the standard. These changes occur throughout the document and would be challenging to follow were it not for the Annex A and Annex B. The Annex A compares the new ISO/DIS 13485 to the ISO 9001 from 2008, clause by clause, so you can see how they relate to each other. The Annex B does the same thing for the previous edition of the ISO 13485 (2nd Edition) to the new proposed 3rd Edition. Of course, there’s a new draft edition (ISO/DIS-9001) for the ISO 9001 which is intended on replacing the document next year, so there are sure to be more changes later on…
Another wonderful feature of the ISO draft standard is the inclusion of 3 Annexes that provide information on the relationship of the ISO adoption by the European Union’s standards body and three applicable EU Directives — 90/385/EEC on active implantable medical devices, 93/42/EEC for medical devices, and 98/79/EC for in-vitro medical devices. These are the Annexes ZA, ZB, and ZC that are seen in the various national publications of the EN ISO 13485 standard.
You’ll find this new draft edition to be invaluable in preparing for the new revision of the standard, which should be released in late 2015. You can purchase your copy in either paper format or for pdf download at the Document Center webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) should you have any questions.
We provide support services to many medical device designing and manufacturing firms, services that ensure compliance and proper use of these technical documents. We can not only supply you with copies of the documents you need, but also with online subscription access as well. Make us your Standards Experts!
