They’re here! New ISO 9000 and ISO 9001 2015 Editions…

ISO 9000 and ISO 9001 have been updated.  The authorized 2015 Editions are here now for you to download in single user pdf format from Document Center Inc.  Prefer paper copies?  You can order those now too!  Want access for your whole company?  You’ll check in with our staff to get your Standards Online service started for “standards in the cloud” service!

Here’s what.  The ISO 9000, “Quality management systems – Fundamentals and vocabulary,” 2015 Edition was released this morning.  The pre-order price of $51.00 proved wrong and so the corrected price is now $240.00.  (Don’t you wish you had pre-ordered your copy from Document Center Inc.?)  It’s a lengthy update – 58 pages compared to the 3rd Edition’s 37 page count.   I bet there will be a corrected reprint fairly shortly, as it is marked with the wrong price code on the last page (the reason for the confusion regarding the price.)

The ISO 9001, “Quality Management Systems — Requirements,” 2015 Edition was also issued today.  No pricing goof-ups on this one — The $173.00 pre-order price is correct.  Remember, this is your requirements standard so if you are ISO 9000 “certified” this is the document you’ll need for your next audit.  Get your copy now, review the changes and make those modifications to your quality system now while there’s plenty of time!

How can you get your copies?  Use the Document Center website,, of course.  Here’s the direct link to get your copy of ISO 9000 and your link for your copy of ISO 9001.  And we’ve just launched an ISO 9000 store, with all your ISO 9000 standards and collections gathered in one location.  Check it out at  What are the benefits of using the ISO 9000 store?  You can pay with a credit card and download your standard immediately — It’s fully automated.  And there’s a Quality Toolbox for you to use with helpful tools for your gap analysis!

Remember, we’re your Standards Experts.  Use Document Center Inc. every time you need a standard!

ISO 9000 2015 Final Draft Edition

ISO 9000, “Quality management systems – Fundamentals and vocabulary,” is on track to be released as a new 2015 Edition in September.  For those of you who would like to take a look at the final language now in preparation for upcoming changes, the ISO 9000 Final Draft is available.

One of the first questions people have is “What is a final draft?”  A final draft is the finished standard as written by the authoring committee.  At the final draft stage, it is submitted to the voting population of the standards developer for acceptance or rejection.  Once the vote has taken place, if it is successful the draft is handed over to the publishing arm of the organization for release.

Is a final draft an authorized standard?  Actually no.  Since it is the document that is submitted for a final vote by an association at large, it does not have any legal weight.  Only the accepted version will be authorized.  So for example,  you will not use the ISO 9000 2015 final draft as a replacement for the actual 4th Edition that should be publicly available September 23, 2015.

What is in the ISO 9000 2015 Final Draft?  The ISO 9000 itself is an overview document, with information on quality management principles and terms and definitions that support the proper use of the ISO 9001 requirements document.  So you must use ISO 9001 in order to register as “ISO 9000” compliant.  However, during your preparation phase the use of the ISO 9000 will provide you with a background on quality to support your implementation of the quality management system.

Since there are significant changes both to management systems in general (harmonization of concepts and standard formats) as well as to the upcoming ISO 9001 2015, it stands to reason that the overview document ISO 9000 would need technical changes as well.

In the review of the fundamental concepts and principles, you’ll find important guidance on such topics as rationale, key benefits, and possible actions.  Further there are some new concepts in the ISO 9001 2015 like documented information.  You’ll find good definitions of these new terms in the ISO 9000 2015 final draft.

Who should be using the ISO 9000 2015?  For anyone with an interest in the quality management scheme (ISO 9001 and it’s variants) or in management systems in general (ISO 14001, ISO 22000, and so on), the ISO 9000 is a useful publication.  So both suppliers and customers who are interested in quality or certification, standards developers,  and those involved in quality training should be using this standard.

Why should I get a copy of the ISO 9000 2015 final draft?  If you want more information on the changes to the quality management concepts in order to facilitate the transition to the new ISO 9001 2015 Edition that should be released in September, the ISO 9000 final draft can be of assistance.

Why would I want to wait for the ISO 9000 2015 Edition instead of purchasing the ISO 9000 2015 final draft?  You  may prefer to wait if you only want to purchase one copy of the new material.  If you purchase the final draft, you will need to buy the authorized edition when it comes out in September.  Also, you will have up to three years in order to make the transition from the old version of the ISO 9001 to the new one.  So you may feel that there is no urgent need to get started already.

Where should I buy my copy of my ISO standards, drafts and final drafts?  ISO publications are covered by copyright and must be purchased from authorized distributors like Document Center Inc.  You can order copies in both paper format and for pdf download at the Document Center webstore,  Here’s a link directly to the order page for the ISO 9000 2015 Final Draft.  If you’d rather have multi-user access, try our Standards Online subscription service.  All ISO standards can be included.  For more information, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  We’ve been working with ISO since the 1990’s.  Make us your Standards Experts!

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012.  Do you use any of these popular items?

  1. BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
  2. BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
  3. ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
  4. BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
  5. ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  6. AMS 2750, New Revision E, Pyrometry
  7. 21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
  8. ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
  9. SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
  10. IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  11. MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
  12. ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
  13. ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  14. ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. IPC-A-610, Revision E, Acceptability of Electronic Assemblies
  16. ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
  17. ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  18. ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
  19. ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
  20. IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies  — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (  We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

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.

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

Attack of the Clones: Why are there so many versions of some ISO standards?

Here is a question I get asked all the time:  “Which standard should I use:  ASQ-Q9000, ISO-9000 or BS-EN-ISO-9000?”

And every day I look at the 2002 poster for World Standards Day with the tag line “One standard, One test, Accepted everywhere.”

So the question is, why are there so many editions of some ISO documents when our stated goal is to just have one?

To get to the bottom of this question, we’ll be talking about 3 concepts:  Jurisdiction, Adoption, and Translation.  When we get done, you’ll at least know the reason for the many “clones” of some of the most widely used ISO standards.

First of all, the concept of jurisdiction.  The ISO standards are meant to be International Standards, hence ISO, International Organization for Standardization.  However, there are other jurisdictions as well — Regional (like the European Union) and National (like the United States).

You might think that once an International Standard is published, everyone should be free to use it and that would be the end of the story.

But no — In the European Union, for example, regional standards are a response to legal regulation (the directives).  In order  to assure legal compliance to regional regulation and laws, EN standards are created as designated by applicable directives.

If an ISO document meets  the requirements of a particular directive, it can be adopted by the European Standards Body (CEN).  Then, it is published for public distribution by each country in Europe as the document is implemented.  That way, it is clear which countries are in compliance at any given time.

So, with the ISO-9000, EN adoption creates 27 differently numbered documents (like, BS-EN-ISO-9000, the official English language edition, DIN-EN-ISO-9000, the official German language edition, and so on), one for each country in the European Union.

ISO standards are also adopted by  countries as well as regions.  An example of this is the Canadian Standards Association document  CSA-ISO-9000.  In this case, the ISO-9000 is republished when Canada adopts the standard, at the national rather than  regional layer of jurisdiction.

One feature to pay attention to is the fact that the ISO standard will be reprinted in it’s entirety when adopted, but will have cover sheet administrative information as well in most cases.  This information may be about what national documents were withdrawn in favor of the ISO or EN adoption, or when the standard must be implemented by users.

And lastly, a country that is involved in the development of an ISO standard has the right to republish the document as a country-specific translation.  So, because ASQ (the American Society for Quality)  participates for the U.S.  in the Quality committee at ISO, the ASQ-Q9000 is the U.S. translation of the ISO-9000.  The U.S. translations are almost word-for-word identical to the English language ISO originals — the only difference is that the ISO standard uses British English spelling, and the U.S. uses American.  So if an ISO standard includes the word “colour” the U.S. translation would have the word spelled “color.”

So in 1992, there were 42 adoptions or translations of ISO-9000 in existence.  In 2002, 134 countries were issuing certificates of compliance and in 2007 there were 175 countries counted.

Our advice to customers is to use the highest level of jurisdiction whenever possible, because it will be revised first at the highest level.  So for the ISO-9000 standard series, ISO (the international jurisdiction) will be the first to issue technical content changes.  All adoptions and translations will happen after the initial ISO release.

However, sometimes there are reasons to choose other editions.  If cost is a factor, a national translation may often be the least expensive way to go, as all revenues go to the publishing organization only, as a way to cover the costs of committee participation.

Another reason to choose a different edition is to cater to either an important customer or a particular auditing body.  If your auditor is from BSI, you might choose the BS-EN-ISO-9000 series so that your auditor is impressed by your concern to follow the administrative information that is published in the adoption section of the publication.  If you do business in Australia, you might use the AS/NZS ISO 9000, the Australian/New Zealand joint adoption of the ISO standard.

This is always a hard concept for many people to understand.  If you’ve still got questions, please ask us by emailing us at

For our next blog, we’ll be looking at this same issue but from a different viewpoint.  I’m getting a lot of questions about why EN adoptions of ISO standards are coming out with new revisions when the ISO documents remain unchanged.  So, until next time…