The New ISO 9001 Version

ISO 9001 GraphicWhat’s Wrong With ISO? was posted to this blog over three years ago. [1] That post discussed the ISO 9001 Standard for Quality Management Systems and why companies choose to (or choose not to) implement and become certified to the ISO 9001 Standard. What’s Wrong With ISO? continues to be one of the most often read of the 200+ posts to this blog.

The ISO 9001Standard has now been revised and released as ISO 9001:2015. Companies certified to ISO 9001:2008, the previous release, will have about three years to revise their management system in accord with the new ISO 9001:2015 release, and to be recertified.

Capture - ISO Focus magazine coverIn August 2013, What’s Ahead for ISO? was posted to this blog to provide some insights as to what to expect in the new release. A mildly edited version of What’s Ahead for ISO? is republished below to provide a preliminary look at the new version. What’s Ahead for ISO? is based on a late draft of the 2015 version – the ISO 9001:2015 as published may differ slightly. The International Organization for Standards, the folks who create and publish ISO Standards, also offers a free on-line magazine that discusses ISO 9001:2015. [2]


What’s Ahead for ISO? (1 August 2013)

Products and Services

The earliest versions (ISO 9001:1987 and ISO 9001:1994) focused almost exclusively on tangible products. Since the ISO 9001:2000 version, services have received increasing attention. ISO 9001:2015 uses the term “products and services” to replace the term “products” throughout the Standard. This change makes it clear that the Standard is applicable to service businesses as well as to producers of tangible products. More importantly, in my view, is the recognition that “products” are defined by customers. The “product” that a customer buys is an array of tangibles and intangibles — in-spec widgets, technical services, warranties, packaging, delivery, relationships, perceptions and much more — except when there are no widgets involved. Consider the importance of the sound a car door makes when it closes!

In the current (ISO 9001:2008) and prior versions of the Standard, it has been possible to exclude requirements covering product development, in cases where a facility does not actually develop products: job shops, for example. The 2015 version may, practically speaking, limit the product development exclusion to tangibles, since the development of at least some intangible product aspects is usually local.


The 2015 draft proposes two new requirements, both of which illuminate the context in which the organization operates. The proposed additions are: [3]

“The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality management system” , and 

“The organization shall determine

  1. a) the interested parties that are relevant to the quality management system, and
  2. b) the requirements of those interested parties”

These proposed requirements make it mandatory to explicitly think through and articulate these matters, assuring that they are addressed in the architecture of the management system. While these proposals are far from final, there is an easy (and free) way to begin right now. National Baldrige Award applications complete a five page Organizational Profile as a preface to their application. The Organizational Profile provides context, much as these proposed requirements do. You can download the questions that comprise the Organizational Profile and a completed sample for a smaller manufacturing firm. [4]

“Know yourself” is good advice.

Risk and Preventive Action

ISO 9001:2015 draft drops the long-standing requirement for a Preventive Action procedure, on grounds that the entire Standard is an instrument for prevention. Instead, the draft makes numerous references to risk assessment and risk management.

Explicit attention to risks and potential downsides is good business, especially when both the probability of occurrence and the potential for loss or disruption are considered. For that reason, this blog often mentions the use of Failure Mode Effects Analysis (FMEA) as a management tool. [5]

Incidentally, ISO is quite familiar with risk management. ISO 31000:2009, Risk management – principles and guidelines “provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.” ISO 31000 and its associated documents provide a good way to come up to speed on risk management.

For Smaller Manufacturers

The real question for smaller manufacturers is whether to utilize the ISO 9001 Standard, or not. For many, compliance with and certification to the Standard is a marketing necessity. For those interested in Sustainability — thriving in perpetuity [6] ISO 9001 (especially along with ISO 9004) offers a sound organizational approach, although there are other approaches. As mentioned earlier, consensus standards lag the state of the art. Simple compliance with the present standard is yesterday’s thinking.

As of 2012, 1,101,272 organizations worldwide have been certified to the ISO 9001 Standard. Also, 285,844 organizations have been certified to the ISO 14001 Standard for Environmental Management Systems. [7] The great majority of the manufacturing firms that are certified to the ISO 14001 Standard are also certified to ISO 9001. The ISO 14001 Standard has also being revised and reissued for 2015. The good news for those certified to both Standards is that form and format of the two Standards is much more consistent in the 2015 revisions. The bad news is that revising and recertifying to two Standards at the same time is a pretty stout piece of work.  … C.H.

Chuck at ReneThoughtful comments and experience reports are always appreciated.

…  Chuck Harrington (

P.S: Contact me when your organization is serious about pursuing Sustainability … CH

This blog and associated website ( are intended as a resource for smaller manufacturers in the pursuit of Sustainability. While editorial focus is on smaller manufacturers, all interested readers are welcome. New blog posts are published on Wednesday evenings.

ISO 9001 Graphic:

[1] What’s Wrong With ISO? this blog,

[2] ISO Focus magazine, November issue, available at

[3] From ISO committee TC176/SC2 draft on revision to the ISO 9001 Standard, dated 3 June 2013.

[4] Download the Organizational Profile questions at

And the sample completed Organizational Profile at

[5] See both parts of Downside Up – Risk Management, this blog,—managing-risks-part-1/


[6] Werbach, Adam, Strategy for Sustainability, Harvard Business Press, Boston (2009) page 9.

[7] From the ISO 2012 survey, executive summary, available at: