ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

Photo by Angel Norris from FreeImages

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

  • a clause on normative references to respect requirements for fixed ISO/IEC directives
  • terms have been updated to match up with ISO/IEC Guide 63:2019
  • Definitions of certain terms such as benefit, state of the art have been added
  • More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
  • The process descruved can be used for managing risk
  • Requirements to disclose residual risks have been merged into one requirement
  • Results of reviews is now risk management report
  • Requirements for production and post production activities have been restructured and clarified.
  • Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

This document is part of our yearly subscription service, StandardsOnline. We make it easy for you and your team to access the same document without the hassle of buying multiple copies. If you would like to learn more about this service, go here.

AHRI and Document Center Inc. sign Distribution Agreement for Standards

AHRI and Document Center Inc. have just signed a new distribution agreement for the AHRI standards.  This adds AHRI standards in both pdf single copy format and as multi-user subscriptions to Document Center’s rapidly expanding catalog.  For those of you in the air-conditioning, refrigeration, and heating industry, you’ll appreciate the extension of our services for the AHRI standards set.

What is AHRI?  AHRI is the Air-Conditioning, Heating and Refrigeration Institute.  The organization has a long history, starting with the Refrigeration Equipment Manufacturers Association and the Air-Conditioning and Refrigerating Machinery Association.  These two entities merged in 1953 to form the ARI, Air-Conditioning and Refrigeration Institute.  So many of you know this standards set as the ARI standards.

In 2008 ARI then merged with GAMA, the Gas Appliance Manufacturers Association, thus forming AHRI as we know it today.  The Institute maintains over 115 Standards as well as approximately 16 Guidelines (some are published both in inch-pound and metric formats).   And the number of these publications continues to grow each year.

You’ll also be interested to know that it is part of AHRI’s mission to promote HVACR Industry issues both at the U.S. federal level and with various states around the country.  This involves an active advocacy program as well as education, training and regulatory support.  AHRI considers the HVACR community to be an essential component for meeting energy conservation goals around the world.  In particular, it’s workforce training program is geared to help develop the 57,000 skilled workers needed for this critical industry.

Where does Document Center Inc. come into all this?  Here at Document Center we have a clearinghouse of standards from around the globe.  Our customers can use our catalog at www.document-center.com to search for and order standards from a wide selection of standards developing organizations.  The addition of AHRI standards in pdf format and as part of our Standards Online multi-user platform will be of value to our customer base and to the standards community at large.

We’re pleased to have AHRI join our family of standards developers.  The new agreement for AHRI and Document Center will mean your standards purchasing options have been expanded.  Here at Document Center we look forward to providing you, the AHRI standards user, with the services and formats you need when you’re making the standards purchasing decision.  Remember, Document Center Inc. has been working with standards since 1982.  Make us your Standards Experts!

What makes Document Center different than other standards resellers?

SES, the Society for Standards Professionals, had it’s annual conference this week in Savannah GA.  There’s always informational sessions as well as good chances to network with a wide variety of folks interested in standards — standards users, writers, publishers and enforcers.  I enjoy attending to represent Document Center and also participating in the association.  This year I put together the legal session, “Standards Free on the Internet??  Do you know what your IP is doing tonight?”  My speakers were

  • Thomas Sehested from MarkMonitor on digital piracy in general and the tactics for removing such IP infringement,
  • Nicholas Fleury from ISO on what the International Standards community is doing to combat piracy, and
  • Scott Cooper from ANSI on how standards organizations can approach the requirements of inclusion of standards by reference in U.S. regulations (known as Inclusion by Reference or IBR).

Mike Tiller from CGA, the Compressed Gas Association, moderated the session and was able to provide the background on the challenges that standards developers have always had with protecting the copyrighted publications they produce.  It turned out to be a lively and well-received presentation and again, thanks to the participants.

But while I was at the event, I was asked to define what makes Document Center Inc. different from the other resources one can use to purchase standards.  For us, there are clear differences in how Document Center does business.

In comparison to the Standards Developers themselves, Document Center sells and monitors over 500,000 globally generated publications covering a wide range of government and industry sources.  We not only sell and track what would be traditionally considered “standards,” but also regulatory conformance information as well.

Unlike our direct competitors, Document Center is not only interested in selling you standards, but also in making you a more educated and informed standards user.  We have our 2 blogs, StandardsForum.com and blog.document-center.com, to provide you with information on hot topics in standardization, new releases, and general standards questions.  And we have current awareness products, so you can see the activity in standardization in your field.

Document Center has a superior monitoring service so you can track when changes are issued to the documents you use.  Our regular notification service happens every 2 to 3 weeks, and there are premium services that are run every day.  We notify you not only of complete revision updates, but also when errata and other kinds of change notices are issued.

Additionally, Document Center has auditing services and reporting products that will help you review the status of your standards collection prior to any audits you might have to meet.  We realize that maintaining your standards collection is not an easy task, but we have the knowledge to support you so that you can easily meet your legal and contractual requirements.

When you register at Document Center’s website, www.document-center.com, you’ll see the list of the standards you’ve purchased from us each time you log in.  How does this help you?  Any item that has a change since you purchased it will be highlighted!

Our company was founded in 1982 and is a small woman-owned business.  We’re located in Silicon Valley and have been at the forefront of the migration of standards information from paper distribution to electronic delivery.  We put our catalog of standards on the web in 1993, with the latest update of our site last year bringing you even more tools to find and purchase standards.

Document Center is here to answer your questions about standards and improve the use of standards within your organization.  I can’t tell you the number of times our customers have put us on speaker phone so that their co-worker can talk with us about the nuances of some standards issue or another.  You can use other resources, but they will not support you and your company to the extent that Document Center will.  We are your Standards Experts and look forward to working with you!