Well done Paul, I totally agree.

The other ISO 9001 related quirk I constantly come up against is our employees' habit of referring to our quality system as "the ISO system", which unfortunately gives the impression (even if unintended) that it's something we HAVE to or are being forced to do, not something we WANT to do.

Continual improvement is a culture, and from my experience it takes companies a while to develop that way of thinking. But by focusing on regulatory, customer and supplier requirements as you've outlined, we can begin to help our employers (and fellow employees) move in that direction.

I've been in ISO-9000/9001 or QS/9000 factories that were putting out terrible quality. They were following procedures as written, but the procedures were bad. Often, people get told they can't update the procedure (or improve quality) without getting out of compliance with the "quality management system." It's crazy. Maybe ISO wasn't supposed to be that way, but it's a sad reality in many companies.

Now, healthcare in the U.S. has accreditation from the Joint Commission. In many of the major healthcare quality catastrophes (the big stuff that makes the news, as opposed to the low grade errors that kill people every day), you'll find that the offending hospital had just been recertified by the Joint Commission.

No assurance of quality!!!

I see I am not alone in my dislike of the ISO Standards.  I find they are only as good as the registrar and auditors, and the overall organizations commitment to their documented system.  If ISO were a series of benchmarks of what an effective quality system consited of and were a guideline for achieving a robust system than maybe they would be worth the effort going into them.

So long as registrars are in the profit making business ISO is worthless in my opinion. I have encountered registrars that would certify a compost heap if the compost heap paid their fee.  Having been thru ISO audits I question their value at no point do I see the audit truly audit and evaluate the entire organizations commitment to quality and customer satisfaction.

I have also been thru the Malcom Baldrige Process as a tool to drive organizational excellence, used for this purpose with the entire organizations commitment gaps in the systems can be identified and addressed and the process improved.   The difference between ISO and Baldridge is that one is an ongoing process for improvment and the metric is measuring the improvement the other is an audit/certification process with the goal of catching non comformances and less on improvment.

I am 100% with you on the ISO 9001 certification.  All too often, the certification is an expensive ticket you punch, with mariginal business results.  The entry fees are the travel costs and dining costs for the auditors, the ticket gets you into customer's door named qualification requirements. 

There are several elements, in particular, I find trying about ISO 9001, and its automotive analogues (guess which industry I work in):

1)  The automotive industry required all suppliers to earn various certifications.  All suppliers, whether they had a sustained record of excellence or not.  The argument might well have been that excellent suppliers used the methods embodied in the standard, so what was the big deal?  The big deal, of course, was the imposition of excess cost and the creation of a marginally valued added industry (ISO/QS Certification).

2)  The certification became the entry requirement for new customers.  The customer would ask:  Does your company have xxx certification?  If not, what is the plan to obtain xxx certification?  This requirement froze out new suppliers, with potentially new and innovative products and services, from breaking into markets they would have well served.

3)  What evidence was produced to demonstrate that xxx certification improved the quality of products and services delivered to the automotive market, and it resulted in better vehicles sold to customers.  Was there convincing evidence that obtaining the certification was the difference maker?  I may be jaundiced, but  I think the tone of my question indicates what my opinion might be.  If I had evidence, I might be convinced otherwise.

I think customer ratings provide the best feedback and quality certification.  If your customers believe you have a valid quality system, and the evidence supports it through low defect rates, high customer satisfaction rates, on time delivery, etc.  then you have a quality certiciation that matters.

Hi Paul,

Always enjoy your articles!

 I was working in the UK while the ISO Standard was being written, prior to its original release. So, I have been involved from the early stages of the Standard. I was also a Registered Lead Assessor for many years, working for Registrars as a subcontractor. I have observed as the Standard has been prostituted to its current state, and resigned from my Lead Assesor role because I was being pressured to recommend companies for registration, when I felt (and the objective evidence proved) that they were incapable of consistently satisfying customers' requirements. So, I can certainly agree with the comments made by yourself and the other contributors.

However, having worked with many companies all over the world as a consultant, I have learned a basic truth: Any system, of any kind and for any purpose, is dependent on the people using it. The source of the system, even "The Law", will not ensure compliance with the system. Compliance will only occur IF the users understand and "buy-in" to the system.

The leadership of an organization has the responsibility to ensure that the employees fully understand the system - what it is, what it is supposed to ensure, why it's importamt to the company's future (Share the strategic plan!!!!! There IS a strategic plan, right?!!!!), and most importantly of all - why they (the employees) should care (What's in it for me?).

Now, all of this "Charm School" stuff takes time and money, which most companies don't want to "waste". So, they force the new system down the throats of the employees and are fustrated when it does not produce the results that were advertised.

ISO 9001 is not a silver bullet - there are none of those around. However, I do feel, and have demonstrated through empirical results,that it is a useful tool (one of many) that are available to the process improvement practitioner. And, like all tools, it must be used properly.

I agree with ISO 9001 as a simple start point and holding a certificate may not directly equal quality.

After that, one must start with company culture and management support, then the more standards the better.

A portfolio of standards such as ASME N stamp certificates, PED Module H certificate, TPED certificates, Maritime certificates (Lloyds, BV, DNV,..), ATEX, CSA UL are required to effectively compete in a global marketplace.

These multiple standards as contributors and individual facets of a total quality system help assure quality.

Ken Kaniecki