Tag: iso-9001

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, www.document-center.com.

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 (info@document-center.com).   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!

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, www.document-center.com, 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 ISO9000.document-center.com.  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 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. (info@document-center.com). 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  http://isotc.iso.org/livelink/livelink/open/tc176SC2publichttp://isotc.iso.org/livelink/livelink/open/tc176SC2public.  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 www.document-center.com.   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 (info@document-center.com).  We’re your Standards Experts!

ISO 9001 2015 Final Draft issued

ISO 9001, “Quality Management Systems — Requirements,” final draft for the 2015 Edition has been formally released.  You can get your copy of this draft document from Document Center Inc. now.  It is the last issue from the committee for this new update and contains the exact language of the soon to be accepted and published ISO 9001 5th Edition.  Release of the official copy should be on September 23, 2015.

What is the final draft for ISO 9001?  A final draft is the text that is submitted for final approval and publication.  It does not have any official legal weight.  You cannot use it in place of the official edition that will be released in the fall.

Why purchase the ISO 9001 draft?  You might purchase a copy of the final draft in order to review the language that will be adopted and published by ISO.  This “preview” will enable you to do gap analysis and other internal activities with confidence prior to the official release of the new edition.

Will I have to purchase the ISO 9001:2015 in September?  If you use the document and are planning to conform with the updates, you certainly will have to get a copy of the official release later this year.  Remember, the draft and final draft copies are not valid for certification or any legal issues that might crop up.

What kinds of changes will I find in the new issue?  Here are the sections of the standard that have been updated:

  • Section 4 on the context of the organization
  • Section 5 on leadership
  • Section 6 on quality management system planning
  • Section 7 on support
  • Section 8 on operation
  • Section 9 on performance evaluation
  • Section 10 on improvement

Here are concepts that have been extended or added:

  • “Products” are now “Products and services”
  • “Suppliers” are now “External providers”
  • “Documentation and records” are now “Documented information”
  • “Work environment” is now “Environment for the operation of processes”
  • “Purchased products” are now “Externally provided products and services”
  • The terms “Exclusions,” “Management representative,” “Documented procedure,” “Quality manual,” and “Preventive action” have all be removed from the standard
  • “Leadership” and “Risk” have been added.

There are a lot of resources out there for you to use in order to make the transition from the ISO 9001:2008 to ISO 9001:2015.  If you do not already have a trusted registrar or service, be sure to research your potential vendors carefully.  Many reputable companies and consultants have provided information on the ISO 9001 transition on their websites.  Read a few and see which communicate effectively and offer services geared to your kind of organization.

And when it comes to purchasing the standards you’ll need to support your certification efforts, rely on Document Center Inc.  We’ve been an authorized dealer of standards from a wide variety of sources since the 1980’s.  We have a number of additional services that will make your management of your standards and other conformance documentation easier and more successful.  You can contact our staff by phone (650-591-7600), fax (650-591-7617), or email (info@document-center.com).

How will you get a copy of the ISO 9001 final draft?  You can order on our webstore at www.document-center.com.  Here’s a direct link to the order page for the ISO 9001 final draft.  Refer to this post when you order and the charge for the document will be $173.00.  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!

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, 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

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

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

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