Medical devices - Quality management systems - Requirements for regulatory purposes Archives

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.

Document Center Inc. has been working with standards since 1982. Make us your Standards Experts!

BS EN ISO 13485 Correction Issued

BS EN ISO 13485 2016 Edition, “Medical devices. Quality management systems. Requirements for regulatory purposes,” has just been reissued with a Corrigendum 1 (correction). This updated edition is available from Document Center Inc. now. If you use this publication, please get your corrected copy asap as it does contain changes that will affect your compliance requirements for Europe.

The BS EN ISO 13485 is the official English language edition of the EN ISO 13485. You will note that other national editions contain the same text for the English edition as does the BS version. So it is possible to meet your requirements with editions from Sweden, Germany or other jurisdictions. The English text of the standard remains the same in them all.

The corrections to the BS version center on the preliminary material, that is the forward and the various Annexes. Since the Annexes provide you with the specific information on what clauses of the standard meet the requirements of the various Directives referenced, they’re essential to effectively implementing the standard. Other items of note include the official requirement to use the EN edition of the ISO 9001, for example.

For those of you who have already purchased your copy of the BS EN ISO 13485 from Document Center Inc., you can get the corrected edition for a nominal service charge to cover the costs of reprinting the entire document. For those of you who haven’t gotten a copy yet, you’ll just purchased the corrected 2016 Edition that’s available at our webstore.

You can search for an order standards here at our Document Center website, www.document-center.com. And here’s the link to go directly to the order page for the BS EN ISO 13485. If you have questions and would like to talk with our staff, consider giving us a phone call at 650-591-7600 or contacting us by email at info@document-center.com. We are an authorized distributor of EN Standards in a number of European National editions. We’ll help you choose the best one for your purposes. Make Document Center your Standards Experts!

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.

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!

Correction issued to BS EN ISO 13485:2012 Edition for Medical devices. Quality management systems. Requirements for regulatory purposes

It seems like the 2012 of BS EN ISO 13485,”Medical devices. Quality management systems. Requirements for regulatory purposes,” was just released. But a few corrections have been found so the consolidated BS EN ISO 13485:2012 with Corrigendum 1 is now available from Document Center Inc. A Corrigendum is a technical correction sheet and the EN standards are released as interfiled reprints of the original document.

The CENELEC corrigendum is from July 2012, but the integration into the BS Edition is dated 9/30/2012. There are two corrections: the title was altered and Table ZC.3 (Relationship with Annex IV of Directive 98/79/EC) was updated.

If you bought your copy of the BS EN ISO 13485:2012 from Document Center Inc., we’ll provide you with a corrected copy for a modest printing fee. If not, you’ll need to purchase the new copy in its entirety. You can order the document on our website, www.document-center.com. Otherwise, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

New BS EN ISO 13485 2012 Edition, Medical devices. Quality management systems. Requirements for regulatory purposes

BSI has just released the new 2012 edition for BS EN ISO 13485, “Medical devices. Quality management systems. Requirements for regulatory purposes,” and it’s available from Document Center Inc. now.

BS EN ISO 13485:2012 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can be used by internal and external parties, including certification bodies which test an organization’s ability to meet both customer and regulatory requirements.

This edition is the UK implementation of EN ISO 13485:2012. It is identical to ISO 13485:2003, incorporating the corrigendum from August 2009. It supersedes BS EN ISO 13485:2003, which will be withdrawn on August 31, 2012.

The document is now 86 pages in length, compared to the 72 pages of the 2003 Edition republished in 2010 with the 3 corrigenda interfiled. Changes have been made to the foreword and especially to the annexes, which accounts for the additional material.

It is 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). It’s our 30th year in business — we’ve been supplying companies around the world with standards and services since 1982. We’d love to help you with your standards requirements as well!

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!