Tag: Sampling Procedures and Tables for Inspection by Attributes

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!

Whatever happened to MIL-STD-105?

MIL-STD-105, “Sampling Procedures and Tables for Inspection by Attributes,” is another of those popular military standards that got cancelled during Mil Spec reform in the mid-1990’s.  The documents referenced in the cancellation notice can cause confusion for users, so some assistance with this can be helpful.

The last revision of the MIL-STD-105 was Revision E from 1989.  This last issue was cancelled three times, first in 1995, then in 2001 and finally in 2008.  Cancellation Notice 1 from 1995 simply replaced the standard with ASQC-Z1.4 (now ASQ-Z1.4).  This ASQ document is actually a reprint of the MIL-STD-105 and an obvious choice to use in lieu of the MIL Standard.

However, Notice 2 from 2001 really put a wrench in the works.  It stated “MIL-STD-105E … is hereby canceled without replacement.  Current DOD PREFERRED METHODS FOR ACCEPTANCE OF PRODUCTS are described in MIL-STD-1916… and should be considered for future acquisitions.”  However, MIL-STD-1916 is an administrative standard.

In fact, MIL-STD-1916 was developed to encourage defense contractors to submit process control (prevention) procedures instead of using prescribed sampling requirements like those detailed in ASQ-Z1.4.  In other words, the standard supports the DoD desire to change contractual requirements from a system of acceptable quality levels to one of continuous improvement.

Quality documents referenced by MIL-STD-1916 include ASQ-B1, B2, and B3, ISO-8402, and ISO-9000 (ASQ-Q9000) and ISO-9004 (ASQ-Q9004).  They are all quality standards, but do not address the issue of sampling by attributes, with the many tables that ASQ-Z1.4 contains.

Apparently, this approach got some push-back because in 2008, Cancellation Notice 3 again modified the replacement information.  It now allows for use of either the MIL-STD-1916 or the ASQ-Z1.4.

And while we’re on the topic of the ASQ-Z1.4, we should also mention the ASQ-Z1.9 standard, “Sampling Procedures and Tables for Inspection by Variables for Percent Non-conforming.”  It’s the replacement document for the cancelled MIL-STD-414 (with the same title).  The two ASQ documents are often purchased at the same time and can really be considered to be a set.

All the standards above can be purchased from Document Center Inc.  You can use our website, www.document-center.com, but if you need any of the obsolete documents, you’ll get a quote before you purchase.  That’s because we want to confirm that you understand you’re purchasing a withdrawn document prior to purchase.  Or you may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re able to provide you with many obsolete standards, as well as help you determine what replacement documents are available.