Tag: Quality

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
Image by Pasi Mäenpää from Pixabay

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 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.

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.

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Top Quality Standards for the Aerospace Industry

Our Top Quality Standard for the Aerospace Industry is the AS-9100,  Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.  It is the successor document to the first Aerospace Quality Standard, the now obsolete AS-9000.  The current Revision C dated in 2009 will replace the previous Revision B in July 2012.

SAE International states that the document “specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.”

The next Quality Standard is the AS-9110, Quality Management Systems – Requirements for Aviation Maintenance Organizations.  This is the standard for certification for Maintenance groups.  Built on the foundation of ISO-9001, the additional aviation maintenance industry requirements, definitions and notes are highlighted in the text of this standard.

And the final certification standard in the series is the AS-9120,  Quality Management Systems – Requirements for Aviation, Space and Defense Distributors.  Again, the document is based on the ISO-9000, with deviations in the text highlighted for use by distributors.

Next on our list is the AS-9101, Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations.  This essential standard provides you with the requirements for the actual audit.  It is the guide by which a certification process will be judged.

We should also mention AS-9003 at this point,  Inspection and Test Quality System.  SAE International states, “This document contains the minimum requirements for supplier Inspection and Test Quality System. It is emphasized that the quality system requirements specified in this standard are complementary (not alternative) to the contractual and applicable law and regulatory requirements.”

Another standard in this series is the AS-9006,  Deliverable Aerospace Software Supplement for As9100a.  However, as the AS-9100 Revision A is now obsolete, this document is not useful for new projects.

And the last standard we need to reference in this list is AS-5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.  With the quality concerns that arise from the use of sub-standard component parts, this standard is essential to the manufacture of safe products.

At the time of this post, draft documents are under review for the AS-9110, AS-9003 and AS-5553 Standards.

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

ISO 9001:2008 – Are you using the right edition?

If you’re certified to ISO 9001, Quality Management Systems – Requirements, you’ll want to make sure you’re using the right edition of the document.

With new changes released in 2009, there’s some confusion over exactly what is the current edition of the ISO-9001:2008.

The problem stems from having a corrected and reprinted edition released at the same time the Technical Corrigendum was issued (7/15/2009).

So in fact, you can have your document one of two ways, and you’re going to be just fine:

1.  You can use the corrected and reprinted 4th Edition from 7/15/2009.  This is a completely reprinted copy with the changes integrated into the text of the standard.

or

2.  You can use the original 4th Edition from 11/15/2008 and the Technical Corrigendum from 7/14/2009.  In this case, the changes are contained in the Corrigendum (correction sheet) only.  So you’ll have to manually integrate the 7 pages of changes into the original 11/15/2008 copy of the standard.

What determines which path you take?  If you get the reprinted and corrected document, you’ll have to pay for the standard again.  If you just get the corrigendum, the costs will be minimal.  But you’ll have to spend the time to get the changes integrated into your original copy.

In either case, Document Center Inc. can help you with copies available of all 3 components.  Just get in touch with us at info@document-center.com, by phone at 650-591-7600 or on our website at www.document-center.com.