ASQ Q9001 2015 Released

ASQ Q9001 has been updated.  The new ASQ/ANSI/ISO 9001:2015, “Quality management systems – Requirements,” is available now from Document Center Inc. in both paper and pdf formats.  And you can add it to our enterprise solution subscription service, Standards Online, as well.

This new 2015 Edition is an identical adoption of ISO 9001:2015.  This means that there is no difference in the text of the ASQ Q9001 to the ISO 9001, with the possible change in spelling from the British convention used by ISO to the American spellings found in the ASQ editions.

Price used to be a distinct advantage of using the ASQ edition over the ISO.  However, this time there is little difference in the price one to the other.  So in many ways it is only a matter of preference and past practice that should help you determine which Edition to use.

The ASQ ISO 9001:2015 adoption was approved by ANSI on 10/21/2015, making it not only an ASQ publication but also an American National Standard.  That’s why the correct number on the publication is now ASQ/ANSI/ISO 9001:2015.  You’ll find the number contains the reference to all three “participating” organizations.

As with all national and regional adoptions of the ISO 9001, the ISO text is reprinted in it’s entirety.  The only modification is the addition of cover sheet and back sheet information from ASQ, the adopting organization in this case.  This is typical of all ISO adoptions.  Only in a few cases will you find your cover sheets to reference material changes to the ISO content for a particular jurisdiction.  This practice of making specific modifications for a particular country is called national deviations.  And of course, each page is labeled “ASQ/ANSI/ISO 9001:2015” as well.

In the past, ASQ pdf format standards had the print function turned off.  However, this practice has been abandoned, so you’ll be able to print one paper copy from the single-user license pdf version available at the Document Center webstore,

Want to get your copy of ASQ/ANSI/ISO 9001:2015 now?  Here’s a link to the order page for the ASQ Q9001!  Have more questions?  Get in touch with our staff by phone (650-591-7600) or email (   We’ve been working with Standards since 1982.  Our staff is familiar with standards from all over the globe.  So make Document Center Inc. your Standards Experts!

ISO 9001 2015 Release date – 9/23/2015!

ISO 9001 2015 Edition, “Quality management systems – Requirements,” is officially set to be released on September 23rd, 2015!  For all of you with ISO 9000 Certification, this new 5th Edition will present challenges and opportunities.  You can pre-order your copy now from Document Center Inc. ( The new ISO 9001:2015 will cost $173.00 and will be available in paper format, for pdf download, and as part of our multi-user Standards Online subscription service.  We know how important this standard is to many of you.  We’re here to support your use of standards like the ISO 9001 for your compliance requirements.

When it comes to transitioning from the ISO 9001 2008 to the ISO 9001 2015, there are many questions about the new requirements and when you’ll need to have made the transition.  Let’s talk about your timeline first and then I’ll offer you some free resources that you may want to take advantage of for your Gap analysis and the implementation of the new update in order to meet the September 2018 deadline.

Normally, for transitioning from one edition to the next, your standards developers like ISO and IEC will recommend a three year migration period.  This is certainly true for the new 5th Edition of the ISO 9001.  However, you may wish to make the move the next time your registration is up for renewal.  Just remember to allow for plenty of time for remediation of any non-conformities that emerge during your audit.

And there may be one additional wrinkle for you — the official adoption of the EN ISO 9001 by the European Union.  Since this is a harmonized standard under Regulation (EC) No 765/2008, you may find that you need to comply with the EN Edition rather than the ISO original.  If so, the harmonized list for that regulation will provide you with a “cessation of presumption of conformity” date.  This is the date when the 2008 Edition will no longer be valid within the European Union and will be your “must transition by” date in that case.

Now, how to figure out what you need to do to make your transition effectively.  Our first stop for clarification is the committee page for ISO TC (Technical Committee) 176 Sub-committee 2, the “owners” of the ISO 9000 Quality Standards series.  You’ll find them at  As you scroll down their page, you’ll find a number of useful documents, including their ISO 9001 Implementation Guidance.  Another useful tool is the IAF (International Accreditation Forum, Inc.) article entitled “Transition Planning Guidance for ISO 9001:2015.”

Additionally, a number of Certified Bodies and Notified Bodies have material available to assist you.  BSI offers a useful transition guide, “The New ISO 9001, BSI’s Best Practice Transition Journey.”  It’s a basic guide to how to set up a plan for the migration itself.  Perry Johnson Registrars offers another view of the same issue with it’s “Preparing for the Change – Transition to ISO 9001:2015 .”

There’s also material directly addressing the problems of Gap analysis that you’ll need to do in order to assure that all issues in the new edition have been addressed within your organization.  One of my favorites is NQA’s (National Quality Assurance)  ISO 9001 2015 Transition Gap Analysis publication.  TUV offers a similar review, this time including a checklist that you may find to be helpful.  It’s their “ISO 9001:2015 Revision  – Guidance & Self Evaluation Checklist.”

Lastly, there’s the question of which edition you should purchase.  You’ll find that there are many to choose from: The ISO 9001 original, regional adoptions like the EN ISO 9001, and a plethora of national adoptions like the ASQ Q9001 here in the U.S.  Reasons to pick one over the other may have to do with regulatory requirements, as noted in the discussion of the EN ISO 9001 above.  Or they may have to do with the formats a standard is available in or the costs involved.

Our Document Center staff can help you understand the various criteria.  And you can always take a look on our website for yourself!  Just search at   We’re setting up a specific page for the ISO 9000 and ISO 9001 2015 Editions, and I’ll add a link to that when it’s available.  Meantime, should you have any additional questions, please get in touch with us via phone (650-591-7600), fax (650-591-7617) or email (  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,, or contact us by phone (650-591-7600), fax (650-591-7617) or email (  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,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email ( for more information.  We’re happy to help you with all your standards questions and requirements.

Happy New Year!

What is ISO 9000? Why do I use ISO 9001?

Since we’ve been selling standards since 1982, we’ve seen the business of standards-based quality schemes (like 6 Sigma, TQM, etc.) really take off .  And the certification for ISO 9000 has been the most successful of all of these programs.  ISO states that ISO 9001:2008 is implemented by over a million organizations in 176 countries.  But for the new-comer to the standard, there are any number of questions that always come up.

The first issue that new customers have is understanding why they need to purchase ISO 9001 when they are going for ISO 9000 certification.

This is because ISO 9000 really refers to a family of standards.  The ISO 9000:2005 is an overview document, covering “Quality management systems — Fundamentals and vocabulary.”  The document number is ISO 9000, the 2005 refers to the year that it was published.

An organization actually certifies to the ISO 9001 standard.  It is called out as ISO 9001:2008, even though it was corrected and reprinted in 2009.  This document, “Quality management systems — Requirements,” provides for the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.  It specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes.  This means that when an organization is certified to “ISO 9000,” it is actually judged against the requirements of ISO 9001.

There are additional offspring of ISO 9001 for various industries.  So, you may prefer to be certified to AS 9100, “Quality Management Systems – Requirements for Aviation, Space and Defense Organizations,” ISO/TS 16949, “Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations,” or ISO 13485, “Medical devices – Quality management systems – Requirements for regulatory purposes.”

If you’d like to take a look at the documents that make up the ISO 9000 family, take a look at our ISO 9000 Compendium page.  It offers a listing of the ISO 9000 standards family as of the date of the last published ISO compilation of the documents.

As always, the standards mentioned are available for sale at our Document Center Inc. website,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (  We’re open from 8 am to 5 pm California time to assist you with all your standards requirements.

ISO/TS 16949 – Quality in the Automotive Industry

When ISO 9001, “Quality management systems — Requirements” was first released in 1987, it provided a platform on which to build a verifiable quality program in any business.  But over time, specific industries wanted to tailor the requirements to suit their particular needs.  Thus in 1999, ISO/TS 16949, “Quality management systems — Particular requirements for the application of ISO 9001 for automotive production and relevant service part organizations,” was issued.

The TS in the document number stands for Technical Specification.  This is a normative specification representing a level of technical consensus within an ISO committee.  It requires a consensus vote accepted by 66% of the committee members, rather than the 75% needed to create an ISO standard.

The current 2009 edition of the document includes the text of the ISO 9001:2008, with the paragraphs of the standard in boxed sections.  When needed, there is additional text providing additional commentary and requirements.  The convention in the document is that the word “shall” indicates a requirement.  The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.

ISO/TS 16949:2009 also includes an Appendix A, which covers Control Plans.  This includes both Phases of the control plan and Elements of the control plan.

The document has the support, and is copyrighted by, not only ISO but also ANFIA, FIEV, SMMT, VDA, and the companies Chrysler, Ford Motor Company, General Motors Corp., PSA Peugeot Citroen, and Renault.  It was written with the assistance of the International Automotive Task Force.

For automotive manufacturers and their supply chain, the ISO/TS 16949 remains a critical document for compliance with quality requirements in this industry.  The document, and all ISO standards, can be purchased from Document Center Inc. at our website,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (  Your questions and comments are welcome.