The “Draft International Standard” (DIS) of ISO 9001:2015 was released a couple of weeks ago. The previous version of ISO 9001:2015, the “Committee Draft” (CD), was out about a year ago – this latest version brings it into more focus.  I’ll review the differences between the current version (2008) of ISO 9001 and this latest draft of ISO 9001:2015.

The game plan for the full 2015 version goes something like this:

You’ve likely noticed “FDIS Skip Possible” – what this means is that due to the later release of the DIS, there may not be enough time for a complete review so, in accordance to the rules, there is an allowance for the FDIS to be skipped. It could happen…

I’ve summarized most of the new sections of ISO 9001:2015 in previous posts, based on the CD. I’ll be continuing the summaries and re-releasing the existing ones with any needed updates as directed by the recent DIS.

Here’s a very brief overall summary of the whole 9001:2015 shebang (hey, it’s a word).

• It is restructured based on the requirements of Annex SL (previously known as ISO Guide 83). I will put a summary of what Annex SL is HERE. For now let’s say “it defines a framework for a generic management system with a reasonable analysis of risks and successful responses to them and uses metrics that are meaningful to support improvement”. Many new and updated standards will conform to Annex SL.
• So, risk is integrated into the standard at a very basic level. It challenges the organization to analyze risks in order to improve.
• Introduces the concept of “Context” – the business environment; the combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested parties.
• Eliminates “Preventive Action” as a standalone item. Preventive action is now folded into Risk.
• Documents and Records are combined into “Documented Information”.
• Stronger emphasis on leadership and commitment from top management to take accountability for the effectiveness of the quality management system.
• A stronger focus on objectives as drivers for improvements, and related planning needed to achieve the goals.
• More detailed attention to the control of externally provided processes, products and services.
• Greater emphasis on planning and control of changes, including required changes in processes and needed changes to the management system.

I purchased a copy (they may be still available) so I’ll be posting more detail on the content of this latest draft of ISO 9001:2015 in the coming weeks.

Go forth, and calibrate thyself – and thank you for visiting.

Sal