Tag: AS 9100

AS 9100 D is here!

AS 9100, “Quality Management Systems – Requirements for Aviation, Space and Defense Organizations,” has been updated!  The new Revision D is available from Document Center in both paper format and for pdf download.  This is one of three highly anticipated new Quality Standards for the Aerospace Industry.  If this is your field of interest, you’ll want to get your new copy right away.

Of course, the new AS 9100 has been issued to bring the QMS (Quality Management System) requirements for the aerospace industry in line with the requirements of the newly issued ISO 9001:2015.  Apparently one issue that you will have is the transition to the new Revision D should be made in conjunction with the transition to the ISO 9001:2015.  So there will be less time for you to comply with the AS update.  Your “drop dead” date for registration will be September 14, 2018.  Those in the know suggest that your process be complete by mid-June to avoid any issues.

Also, if you are certified to both documents, you’ll want to be careful about the order in which you handle your audits, etc.  You may need to have your registrations for both editions of the ISO 9001 active during the period that you complete the requirements for AS 9100D.  Once you’ve made the upgrade to both, you can let the earlier certificates lapse.  What if you don’t complete your process in time?  Your certificate will expire and you will no longer be able to reference it in your contractual obligations.

There are a lot of training programs in the works for this new AS 9100.  Both auditors and users will need to familiarize themselves with all the nuances of the update.  We suggest that you get your copy of the new Revision D as soon as possible, review, and then chart your course.  You can purchase it online at www.document-center.com in either paper format or for pdf download.  Here is a direct link to the order page for AS 9100 for your convenience.

There is a lot of activity going on right now in the aviation space.  New updates for both the AS 9110 and the AS 9120 are expected to also be released soon.  Document Center’s notification service will keep our customers on top of any changes.  Do consider using our “best in class” updating for your critical compliance documentation.  Our staff can assist you with this and any other standards-related issues you may have.  Contact us by phone (650-591-7600) or email (info@document-center.com).  Remember, we’re your Standards Experts!

What ever happened to MIL-Q-9858?

One of our all-time best selling military specifications was MIL-Q-9858, “Quality Program Requirements.”  From 1958 to 1996, the document was a staple of the defense contracting system.  It provided guidance for a quality management system for thousands of companies, large and small, involved in defense work both as a prime contractors and subcontractors.

What happened to MIL-Q-9858?  The document was cancelled with the issuance of cancellation notice 2 on 10/1/1996 and left many companies in a quandary over what to do, since it was withdrawn without replacement.   This means that there is no guidance given regarding what document can be used instead.

In the main, the move has been to use the ISO 9000 series of quality standards in lieu of the old MIL-Q-9858.  ISO 9001 was adopted by the DoD in April 2001, as was the AS9100 in 2002 (for aerospace applications).  This resulted in a sharp uptick in ISO 9000 registrations in the U.S.

What’s the main impact of the cancellation of MIL-Q-9858?  This shift to industry quality standards has allowed the U.S. Department of Defense to move out of the business of certifying quality in it’s supply chain, leaving this work to third party auditors.

Military specifications and standards (both current and obsolete) and industry standards are all available from Document Center Inc.   Use our website, www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.

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:

  1. ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
  2. ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
  3. AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
  4. 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
  5. BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
  6. ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
  7. IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
  8. AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
  9. ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
  10. ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
  11. ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
  12. ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
  13. ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
  14. SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
  15. ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
  16. ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
  17. BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
  18. 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”
  19. ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
  20. 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!

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.