Tag: quality standards

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.


Photo by Startup Stock Photos from Pexels

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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The New IEC 61000-4-11 is out now!

The new IEC 61000-4-11: Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase, is now in edition 3.0 and replaces the previous 2.1 edition. This section of IEC 61000 defines the immunity test method and range of preferred test levels for electrical and electronic equipment connected to low-voltage power supply networks for voltage dips, short interruptions, and voltage variations.

This applies to electrical/electronic equipment with a rated input current not exceeding 16A/phase, for 50 Hz or 60Hz networks. This document aims to establish a common reference for evaluating the immunity of electrical and electronic equipment when subjected to voltage dips. This document makes references to IEC 61000-2-8.

So What Changed?

Aside from some formatting changes, there are a few technical changes that have been made. Some sections that were optional in the previous editions are now required. Some sections were also taken out of this edition entirely. The biggest change is the addition of Appendix D which talks about the generator specification requirements for voltage, rise and fall time, and inrush current capability. to easily see the changes between editions make sure you grab the red-line edition here. Redline editions come pre-marked from the publisher and clearly show the changes that were made this time around.

To purchase the regular unmarked version, you can get your copy here. This copy is available for our standards online subscription service. For a yearly fee, we will add this and any other standard you need to a personalized website that you and your team will have access to anywhere at anytime Stop buying multiple copies or sharing the one copy. Have everything readily and easily accessible on one website when you need it. Standards purchased in this way will be automatically updated at no extra cost as long as your subscription is active. For more information on this service, read about it here or ask us today!

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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!

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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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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.

AMS2750 has Been Updated! Revision F out now!

Revision F for AMS2750: Aerospace Material Specification is out. This revision replaces the previous now obsolete revision E. This document covers the pyrometric requirements for equipment used for thermal processing of metallic materials. This specification applies to laboratory furnaces. It covers: temperature sensors, instrumentation, thermal processing equipment, correction factors, instrument offsets, system accuracy tests, and temperature uniformity surveys. This document is not applicable to heating or to intermediate thermal processing.

Steel Mill, Workers, Foundry, Metal, Molten, Hot
Picture by skeeze

What’s New?

This document is a rewrite of the previous standards. There is no tracked changes edition for this document. Technical changes have been made to resolve issues found in revision E. AMS2750 makes updates to the resolution requirements for recording instruments. There are also updates made to demonstrate that the equipment meets the accuracy tolerance when using the percentage instead of numerical tolerance. Other technical adjustments have been made for readability and to accommodate different systems of measurements.

Get your copy today!

You can get the latest edition of this document here. This document is also available for our subscription service. Instead of buying multiple copies of this document, it is uploaded to a personalized site where you and your team will have accessible anywhere from any computer. For more information on this service, go here. We offer various other service to make it easy for you to stay complaint with all of your future projects, a list of which can be found 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.

Photo by Jan Friml from FreeImages

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!

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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.

The ISO 9000 Compendium – The top quality standards at a low price

The ISO-9000 Compendium 12th Edition is a real bargain in the world of standards.  You get a real cross-section of the important quality standards at a reasonable price.  Yes, it is only available in CD Rom format (Now in pdf format as well.)  But you will be able to review many more documents than you could otherwise.

Of course, there is one major problem with ordering any compilation of standards.  The documents may be revised individually while the compilation stays static.  This is certainly the case with the current issue of the ISO 9000 Compendium.  The final draft for the ISO-9004 has been approved and is now available as an authorized edition, rather than the draft included in the compendium.

So, if you need to be sure you’re meeting the ISO-9001 certification requirements but want to take a look at the balance of the collection just for informational purposes only, you may want to purchase the compendium.  Then, get notification service for the ISO-9001 document.  That way, you’ll find out right away when any changes are made to the document you use for certification.

Here’s the contents of the current  Twelveth Edition  (along with links to the current edition of each item as a solo purchase):

  • ISO 9000 : 2005 Quality management systems — Fundamentals and vocabulary
  • ISO 9001 : 2008 Quality management systems — Requirements (With Technical Corrigendum)
  • ISO 9004 : 2000 Quality management systems — Guidelines for performance improvements
  • ISO 10001 : 2007 Quality management systems — Customer Satisfaction — Guidelines for codes of conduct for organizations
  • ISO 10002 : 2004 Quality management systems — Customer Satisfaction — Guidelines for complaints handling in organizations
  • ISO 10003: 2007 Quality management systems — Customer Satisfaction — Guidelines for dispute resolution external to organizations
  • ISO 10005 : 2005 Quality management systems — Guidelines for quality plan
  • ISO 10006 : 2003 Quality management — Guidelines for quality management in projects
  • ISO 10007 : 2003 Quality management systems — Guidelines for configuration management
  • ISO 10012 : 2003 Measurement management systems — Requirements for measurement processes and measuring equipment
  • ISO/TR 10013 : 2001 Guidelines for quality management system documentation
  • ISO 10014 : 2006 Quality management — Guidelines for realizing financial and economic benefits (With Technical Corrigendum)
  • ISO 10015 : 1999 Quality management — Guidelines for training
  • ISO/TR 10017 : 2003 Guidance on statistical techniques for ISO 9001:2000
  • ISO 10019 : 2005 Guidelines for the selection of quality management system consultants and use of their services
  • ISO 19011 : 2002 Guidelines for quality and/or environmental management systems auditing
  • ISO/DIS 9004 Managing for the sustained success of an organization — A quality management approach