ISO 13485 Archives - Document Center's Standards Forum

ISO 13485 2016 finalized

ISO 13485, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was approved in final draft format at the end of the year. FYI: Voting on the final draft closed on 12/29/2015 and the publication has been accepted. This means that we’ll see the release (at last) of the new 3rd Edition of this essential medical device standard sometime during the first quarter. For those of you in this industry, it’s just one of a series of major changes coming to your regulatory and compliance environment. Get ready for a wild year!

What’s been going on with the ISO 13485? Let’s say, what hasn’t been going on with it! The whole issue of risk management for medical devices has been under intense scrutiny for the last several years. This is the result of the faulty breast implant devices provided by a French manufacturer (the PIP scandal.) Now we’ll be seeing the results of the discussions and negotiations.

First, the ISO 13485 hasn’t been updated since 2003, which is a fairly long time considering the changes in our approaches to risk management. Secondly, not only will the standard be updated, but the EU regulations for both medical devices and in vitro medical devices will also be revised this year. Click here for the official executive summary of the regulatory impact assessment of the proposed EU Directives’ changes.

Of course, those of you in the industry will be grateful for better guidance with regards to the issue. These last few years of poorly defined expectations with regards to appropriate risk management parameters has been difficult for many of our Document Center customers.

Your main changes to the ISO 13485 should be in the areas of regulation, risk management, validation, verification, and design transfer, your outsourcing practices, and post-market feedback. There has also been a push to have all quality standards meet the same format as the ISO 9001. So you will see extensive documentation of the relationship between the two documents.

You will have three years to make the transition to the new ISO 13485 2016. If you’re anxious to take an “early bird” look at the changes you are always welcome to purchase the final draft. Just be aware that you will have to repurchase the new edition once it is released.

Concerned that the new edition will come out and you won’t be informed? Contact our Document Center staff to get put on our notification list for this standard. We’ll send you an email as soon as the new 3rd Edition is published. Have additional questions or want to get a copy of the draft? You can get in touch with us by phone (650-591-7600) or by email (info@document-center.com). We’ve been working with ISO standards under contract since the early 1990’s. You can make us your Standards Experts with confidence.

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!

Document Center’s Top 20 Best Selling Standards for 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011! Here’s what Document Center customers wanted this year:

ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information. We’re happy to help you with all your standards questions and requirements.

Happy New Year!