Posts Tagged ‘iso-9001’

What ever happened to MIL-Q-9858?

Thursday, January 5th, 2012

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the issuance of cancellation notice 2 on 10/1/1996 and left many companies in a quandary over what to do, since it was withdrawn without replacement.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

Friday, December 30th, 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!

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

Wednesday, November 2nd, 2011

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, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re open from 8 am to 5 pm California time to assist you with all your standards requirements.

Document Center recommends Standard MSA, Measurement Systems Analysis, for assessing the quality of a measurement system

Wednesday, April 27th, 2011

MSA, “Measurement Analysis System,” is the widely referenced standard for measurement system quality.  Generated by the automotive industry, the standard presents guidelines for assessing the quality of a measurement system.  Currently it’s the 4th Edition, released in June of 2010, with an errata from the same month.

Its primary focus is measurement systems where the readings can be replicated on each part.  The standard helps the user analyze the collection of equipment, operations, procedures, software and personnel that affects the assignment of a number to a measurement characteristic.

If you need to plan and prepare a Measurement System Analysis (MSA) program and understand process variation and its impact, this standard is for you.  It will provide insight into organizational applications, categories of measurement system variation, and gage repeatability and reproducibility.

MSA has direct application to ISO/TS 16949:2002, “Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations,” as well.  So if you’re certifying to the ISO document, the MSA can provide practical information for meeting your requirements.

The MSA and ISO standards can be purchased from Document Center Inc. at our website, www.document-center.com.  Or call us (650-591-7600), fax us (650-591-7617) or email us (info@document-center.com) your request.  We’re here to help you with your standards needs.

ISO/TS 16949 – Quality in the Automotive Industry

Friday, April 8th, 2011

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, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Your questions and comments are welcome.

The ISO 9000 Compendium – The top quality standards at a low price

Wednesday, July 7th, 2010

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?

Tuesday, June 1st, 2010

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.

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

Wednesday, May 12th, 2010

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 info@document-center.com.

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…