Is ISO 9001 Undergoing a Midlife Crisis? | Opinion

ASQ has recently posed a plethora of introspective and analytical articles in its flagship Quality Progress magazine on the current state of the ISO 9001 standard, its waning influence in the world, and even questioning the efficacy of its use.  These, I’ve found, are an invigorating and honest look at the world’s most popular and – still – most influential quality management standard.  

While the motives are likely to be debated by the usual suspects (read: dissidents) who cling to the notion that TC 176 is overrun with corruption and any such reflection would not be for the sake of improvement but could only be to bolster revenue for ISO and their own consulting firms – while somehow also using such claims as a vehicle to usher prospects towards their own in-house publications that appear to be completely written, edited, vetted, and overseen by a single entity, paradoxically under the pretext that this would somehow reduce risk of such corruption – frankly, I find it refreshing to see ASQ and its authors taking a critical look at the text, its failings and successes, its challenges, and, most importantly, its future.

In On the Brink?, authored by Mary Duffy and Santosh Mishra, it is suggested that there are signs of ‘midlife crisis’ showing with the world’s foremost quality standards, as they pose several ways to rejuvenate the approach to implementing and using the standard to more closely align with its original intent in order to maximize efficacy, with much of the article mirroring comments that we made last year in Have You Truly Integrated QMS Requirements in Your Business Processes?, published in Quality Digest and later in Exemplar Global’s The Auditor.

The authors open by painting a scene during a recent webinar in which it was posed that customers today no longer care much as to whether an organization has an ISO 9001 certification, but, rather, they care more as to whether the firm provides quality products and/or services, painting a dichotomy where authors have in the past connected dots as if the quality of a firm’s products and services could be instantly assumed based on certification to ISO 9001.  

This conversation during the webinar, the authors claim, caused many in the audience, and, somehow, the authors of this article to begin doing what any serious quality management practitioner has been doing for years – critically evaluating the value of an ISO 9001 certification, with the authors using it as a vehicle to examine the causes behind the significant drop in the standard’s popularity and whether the standard’s original intent was being met, likening the scenario, being that the standard has recently turned 35 years old, to what is commonly felt by middle-aged Americans reflecting on their own life, accomplishments, purpose, and overall place in the world.

“The original intent of ISO 9001,” the article states, “was to demonstrate the ability to provide products and services that consistently meet customer and regulatory requirements…[it] aimed to make organizations competitive within a given market, be consistent in operations and provide an engine for continuous improvement.” (Duffy & Mishra, 2022)

The first iteration of the standard being published the same year as Malcolm Baldrige National Quality Improvement Act of 1987 showed a desire within the United States at the time to improve efficiency, productivity, and overall quality of products and services to maintain a competitive edge in an increasingly difficult global economy that saw the US shrink in influence under the shadow of the rapidly industrialized Asian continent.  There was a fervent passion for increased productivity and quality felt at every level of our nation, including the White House and halls of Congress, at the time that is largely lost today, which is surely contributing to the lull in zeal for the proper implementation and use of the standard, in which the authors bemoan, “Concerning…are worldwide trends for the number of ISO 9001 certifications…[that] show a decline in recent years, documented by many reports and studies.” (Duffy & Mishra, 2022)

The authors then jostle with the idea of whether the standard has truly delivered on its aims.  The standard set out to be universally accepted to such a degree that it was expected that there would be a diminished need for industry and economic-specific quality standards, and the original standard has been lauded for standardizing vocabulary and conformity to assessment processes.  With its focus on the 7 quality management principles, adopted in ISO 9000:2000 and making their way into ISO 9001 during the 2015 revision, the authors argue that a QMS that meets the standard’s requirements should still give organizations a competitive edge in the global marketplace, citing studies that suggest that ISO 9001 certified organizations enjoy higher returns and that the standard has statistically shown a positive effect on workplace injury rates and safety performance and growth in employment, but cite the unmistakeable signs of crisis: resistance to change, loss of direction or purpose, too many things seeking attention, restlessness, stagnation, and a plan that is no longer working.

The question is: why?

They continue to wrestle, but start to turn the questioning away from the standard itself – which, again, they argue should theoretically still bring value to an organization by increasing returns, improving safety, increasing employment, and bringing a higher level of competition – and instead direct emphasis on how the standard is employed.

“Has it become merely an exercise in documentation?”

“Do management and leadership truly support ISO 9001 certification?”

“Is the certification simply something to hang on the wall and satisfy customer demand?”

Again, in our piece for Quality Digest late last year, we posed the exact questions.  We jostled with the same ideas.  We came to the same conclusions.  The standard, albeit needing to remain agile enough to evolve with changing industry needs, is largely sufficient to guide organizations toward excellence in the provision of their products and services, but if it is implemented to tick off a box for a customer requirement without the requirements being integrated into business processes to foster a quality culture, it will fail to meet its intended goals.

“Manager, if you truly want your QMS to add value to your organization, which a properly implemented QMS inevitably will, then you need to make sure that you understand the requirements of the Quality Management System standard that you are certified or certifying against.  The clauses of popular quality management standards, such as ISO 9001, are built based on decades of defined best practices and intended to be integrated with one another and fully integrated into business practice.  You, as top management, have a requirement to own and support the QMS and to ensure that it is truly integrated into your business.  Throwing some buzzwords in your Quality Policy from the documentation template package that you purchased online or were handed from a consultant isn’t going to truly make you compliant to the requirements of ISO 9001, and, even if you can successfully fake out an auditor with a superficial QMS implementation and blitz efforts ahead of audits to put on a good show, doing so will rob you of the opportunities to improve your business processes, customer satisfaction, and overall increased profitability that would come from truly embracing the precepts outlined in your QMS.  Implementing ISO 9001 or similar standard will add incredible value to your business, but only if you let it.” – Steven Severt, from the Quality Digest piece

Aside from checking the motives for certification, lack of true quality culture that values continual improvement,  or misalignment with strategic goals as being some of the biggest causes of the erosion of efficacy, the authors pointed out several other noteworthy items that we’ve also at times touched on in other articles: 

  • A focus on supplier quality, as all of the auto recalls in the last two decades were related to supplier issues (you might remember our 5×5-why approach to improving supplier relationships and, ultimately, supplier quality)
  • The effectiveness of internal audits and reducing variability among auditors, and the more crucial in an era where remote audits are the norm and most audits are outsourced (also a topic of a recent article from Isometric that was published in Quality Digest)
  • A focus on systems approach rather than departmental approach – something that we’ve admittedly not given a lot of attention
  • Take risk analysis seriously – something that we cannot stress enough, proponents of FMEA such as we are

Perhaps the most controversial part of the article comes with a statement near the end in which the authors posit:

“Perhaps reducing the time it takes to publish a standard should be considered…standards seem to lag current practices by five to seven years.” (Duffy & Mishra, 2022)

Personally, I wish that this statement had been left out.  It’s cleverly tucked between the careful analysis of implementation issues that we are discussing here with little qualification, with the statement being dismissed as easily as it’s introduced.  This type of statement, however, is not the type lost to dissidents and will likely provide even more ammunition for claims of corruption, a disregard for established ISO rules relating to the revision and publication of standards, and the consensus of the international community.  We’d be disingenuous, however, if we did not also see this as a bit more preparation for early revision, as revision was rejected in 2020 following the typical 5-year cycle, but we have ultimately decided that the standard probably could have used revision in 2020 and is certainly ripe for it now.  While we’d argue that rules would dictate that, as it was not revised during its normal cycle, the chance had been missed and we should wait until 2025 for revision, hopefully all learning valuable lessons along the way, the article ultimately concludes:

“ISO 9001 is not in serious crisis or nearing its demise.  The standard is alive and remains relevant, particularly the 2015 version with its focus on risk management and leadership.  However, it must continue to grow and age appropriately, adapting to the times.  The standard cannot become static and must be revised every few years to keep up with the industry trends and technological progress worldwide.  The concept of progressing from meeting minimum requirements to operating at world-class QMS performance levels seems to have been lost in many organizations today.  Most are happy with meeting the minimum standards and hanging a certification on the wall.  If that’s the case, they should not expect sustained success.  Do not blame the standard.” (Duffy & Mishra, 2022)

Indeed.  But such a strange bit of dissonance that I now feel.  If the standard is still relevant, especially the 2015 revision, and still offers everything needed to improve productivity and competitiveness, with most detriments to efficacy being in implementation, management support, quality culture, and the like – and – as the authors correctly and poignantly state, that the standard is not to blame for failure, does the proposition that the revision cycle be reduced from its historic 5-years have merit?  If we give the standard another 3 years before preparing for revision, will the 2015 revision have become irrelevant?  I think this is a topic that deserves more attention.


Duffy, M., & Mishra, S. (2022, August). On the Brink? Quality Progress, 55(8), 26-31.