ISO 9001:2015 Archives - Document Center's Standards Forum

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!