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5th Edition of NAS-410 Coming Soon. Preorder Your Copy Today!

NAS-410: Certification and Qualification of Nondestructive Test Personnel is scheduled for release in 2020. As of this time we have not been informed of the changes that will be made for the new edition, but we will release that information as we receive it. This document is currently only available in physical paper format. We will notify you if this document becomes available in other formats.

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How to Preorder

To preorder this document, head over to our website and place your order. You will receive an order confirmation number sent to your desired email. You will not be charged until the item has shipped. If you have any questions, please feel free to contact us! If you would like to stay informed about all news on quality standards, make sure you give us a follow.

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Get the New 3rd Edition of ISO 14155

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice, is now in it’s third edition. You can pick up your copy from our website in either Paper of PDF format. This standards is eligible for our Standards Online Subscription Service. Ask for your quote today.

This document is a good reference for the conduct, design, recording and reporting of clinical investigation. It can be used to asses the performance, effectiveness, or safety of medical devices. This standard addresses a few specific general requirements with the intention to:

protect the rights, safety, and well being of the patient
it ensures the scientific conduct of clinical investigation in a credible manor
defines the responsibilities of investigator
aids investigators or other regulatory authorities in the conformity assessment of medical devices

Note: Please check to see if there are other standards that apply to your the investigation, other documents might be more relevant than this one. This document does not apply to in vitro devices, unless otherwise specified. This document does not apply to in vitro devices, unless otherwise specified. This document also makes references to ISO 14971

The Changes

This document completely replaces the second edition. According to the publisher, the changes to this document include the following

summary section of GCP principles
references of registration of the clinical investigation in a publicly accessible database
clinical quality management
risk based-monitoring
statistical considerations
guidance for ethics committees
risk management throughout the process of a clinical investigation
clarification of applicability of this document
guidance on clinical investigations audits

You can grab your copy from our web store. We offer both printed and pdf format. This document is also available for on our Standards Online Subscription service. You can read more about our Standards Online Service on a previous post. We offer a 14 day trial so that you can determine if this service is right for you. Ask us today!

New Standards on Properties Of Surfaces for Q1 of 2020

This is a list of standards on properties of surfaces that were updated in the first quarter of 2020. If you would like to view a complete list on the subject, check it out here. To search other standards by ICS or subject, check out our complete list here. Please note that links for standards that have been replaced or renumbered will take you directly to the most recent replacement.

Most of these standards will be available for purchase through our standards online service. This service is especially great if you have a big team that needs to share a standard. Instead of buying multiple copies for a team, you will only need to pay for one site. Add as many people as you like and they can access it anywhere anytime. For more on this service, check out a complete description here or ask us today!

Don’t forget to follow us for regular updates on everything standards!

New Standards on Environmental Economics Including Sustainable Development for Q1 of 2020

Here is list of standards on Environmental Economics Including Sustainable Development that were updated in the first quarter of 2020. For a complete list of standards got here.

You can search other standards by subject and ics code here. Don’t forget to follow us for updates on all things quality standards.

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We offer multiple services to make it easy for you to stay current so that you can focus on your projects. We will check your library and help you update the standards you use every day and even send you real time updates when they are released. For a complete list of what we have to offer, check us out here.

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knowing when to update the standard, we will do it for you
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We are able to offer most standards through this service. Our subscription service truly is the best and easiest way to build a standards library. To learn more and try it out, please visit our site.

New Standards on Anaesthetic, Respiratory And Reanimation Equipment Including Medical Gas Installations Q1 of 2020

This is a list of all the standards that were updated in the first quarter of 2020. The list is alphabetical. Documents that have been replaced will link to its replacement. A complete list on the subject can be found here.

Some of these standards are available for our subscription service. Documents purchased this way are uploaded to a personalized website so you and your team can access the standards you need anywhere. For more information, read here. For all our other services to help you keep compliant, check out a full list here.

To search up other standards by ICS subject check here.

New Standards on Health Care Technology for Q1 of 2020

Here is a list of all the updates for standards on health care technology for the first quarter this year. Follow us for more updates!

To search other standards by subject, go here!

It’s Finally Here! ISO/TR 24971

The wait is finally over! ISO has finally released the long awaited companion standard for ISO 14971:2019. Get your copy of ISO/TR 24971 here.

As per the publisher, this technical report provides guidance to help manufacturers develop, implement, and maintain the risk management process described in ISO 14971:2019. It includes medical devices such as active, non-active, implantable, non implantable, in vitro diagnostic medical devices as well as software used as medical devices. If you need a little more information about this document, please look at our previous post on the topic found here.

So What’s New?

The new edition of ISO/TR 24971 cancels and replaces the 1st Edition of the report. If you would like to remain compliant, this document will be needed. Aside from some format changes for readability, here are some of the changes of note according to the publisher:

Clauses and annexes have been merged, restructured, technically revised and supplemented with additional guidance
Some structural changes for readability
Addition of informative annexes for additional guidance on specific aspects of rist management

Get your copy of ISO/TR 24971:2020 this companion standard today. You can also get yourself a copy of ISO 14971 while you are there if you need one. This document is also available for our standards subscription service. Add this document to a personalized site where you and your team can access it on any device at any time. Stop being limited by a shared single copy. Stop buying multiple copies of the same document. to learn more or try a demo, click here!

If you would like to keep up to date on new releases, ask us about our notification services. Get emails about updates on all the standards you need as soon as they come out. No more guess work or having to do research. With a simple email, you never have to worry about not being ready for your next audit. Ask us today!

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

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.

Document Control – How to manage a Standards Collection

Quality and Compliance professionals know the importance of standards in the business setting. But keeping a standards collection current and correct can be a challenge for any organization.

Here at Document Center Inc., we’ve been working with standards for over 28 years. So we’ve got some experience in collecting and maintaining standards!

Managing standards is an essential function in any organization. Standards can positively or negatively impact your reputation and cause regulatory and quality problems. And regulatory and quality problems eventually create legal liabilities which are much cheaper to avoid than to repair.

We believe that by separating the documentation function into 5 easy pieces, any organization can have a reliable standards system. Here’s our plan:

Rule 1 – Define

Rule 2 – Assess

Rule 3 – Control Usage

Rule 4 – Procure

Rule 5 – Monitor

I’ll be using subsequent blogs to review the 5 Rules. Each requires some discussion so that you are able to institute good practices throughout the standards lifecycle.

Contact us any time with any questions or for assistance. We can be reached at our website www.document-center.com and via email at info@document-center.com. Of course, feel free to call us at 650-591-7600 or fax 650-591-7617.

Out of Sync — Why EN-ISO’s are changing and the core ISO’s are not…

There’s been a lot of confusion in the standards-using community over recent EN-ISO revisions just issued on some very popular ISO titles. Some examples? The EN- ISO-10993 series is out in 2009 Editions, while the ISO-10993 series itself hasn’t changed. Another? EN-ISO-11607-1 was upgraded to a 2009 Edition replacing the 2006 Edition, yet still remains identical to the ISO-11607-1 1st Edition from 2006.

How can the EN adoption of the ISO come out in a new edition and still be identical to the original ISO document?

Here’s the reason — The EN (European Union) administrative information has been modified, which has prompted the revision of the document even though the ISO document which it adopts remains the same.

So for the EN-ISO-11607-1, the change is the addition of Annex ZA, which is an informative annex only. This 1 page addition to the document has a table which identifies the relationship between the EN-ISO-11607-1 and the essential requirements of EU Directive 93/42/EEC.

How about the EN-ISO-10993-1? It has the insertion of 2 Annexes, both informative: ZA, again on the relationship between this standard and the EU Directive 93/42/EEC, and ZB, on the relationship of EN-ISO-10993-1 to Directive 90/385/EEC.

The rest of the EN-ISO-10993 series has been revised for the very same insertions.

If you reference the EN-ISO documents in your documentation, you are required to purchase the new revisions or risk being out of compliance.

If you reference the source ISO standards instead, no revisions are necessary, as the underlying ISO documentation remains stable.

More questions? Contact us at info@document-center.com or check out the website at www.document-center.com.