There is so much fundamentally wrong with this piece, it requires serious clarification. I really am at a loss how this stuff gets published by a magazine that has an editorial staff. Much of this represents Mr. Nelson's old arguments which have been largely debunked by other professionals, and yet this gets re-published here without any editing. 

So let's look at the facts. 

ISO 9001 was NOT "designed to work from the very beginning" under the process approach. The process approach was introduced with the 9001:2000 revision with much fanfare, as the process approach had never been part of ISO 9001 -- nor its precursors of MIL-Q-9858 or NATA AQAP-1, BS9000, BS 5750, BS 5179, ISO 9001:1986 and ISO 9001:1994. Given that Mr. Nelson touts himself a "process approach pro" one would hope he would have a sense of the history that got him there.

Next, Mr. Nelson's idea of what ISO 9001 is for -- and (the most egregious) his view of who it's "users" are -- are grossly incorrect. ISO 9001 was not designed solely for the use by auditors, and auditors are not its user base. This point has been corrected time and time again to Mr. Nelson in other forums, but he sticks to it like glue. 

Fixating on a single half-sentence in ISO 9001's scope, Mr. Nelson ignores the entirety of everything else in the standard, and the entirety of everything that ISO itself has ever said about ISO 9001. He has to ignore and contradict the very authors of the document to get to this position. The standard says, ISO 9001 "can be used ... to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements." But Mr. Nelson interprets the word "can" as "shall" and has to strip out every other possible use for the standard to get to his unique, registrar-centric position. He ignores the entire six-point bulleted list that precedes the very sentence he fixates on, which explains some criteria on which to design a QMS.

Mr. Nelson wrongly claims ISO 9001, "never purported to contain instructions for how to run a business. It was merely intended to provide auditors with a consistent set of criteria with which to assess quality management systems" and "ISO 9001 was not supposed to be implemented as a QMS by management; it was supposed to be applied as audit criteria by auditors." 

Wrong. So wrong it's mind boggling. 

In order to reach this impossible interpretation, Mr. Nelson has to utterly contradict nearly everything ever said by ISO about its own product. In its "ISO 9000 Family of Standards" guide, ISO clearly explains that ISO 9001 is intended to ISO 9001 is be "used when you are seeking to establish a quality management  system."  It goes on to say ISO 9001 "defines what you should do to consistently provide product that meets customer and applicable statutory and regulatory requirements [and] enhance customer satisfaction."

There are so many quotes from ISO on this, it would be impossible to include them all. Meanwhile, there is not a single quote that claims the standard is intended to be used solely by auditors, for auditing. 

Mr. Nelson then goes on to say, "A process-based mindset, on the other hand, concludes that documented procedures—whatever their number—must address the requirements of the 20 elements." As previously debunked on LinkedIn, a "process-based approach" does not mandate that "documented procedures" are to be used to define anything. This shows a deep and fundamental misunderstanding of the process approach by Mr. Nelson -- who, by the way, was absent from TC 176 activities during the development of the process approach, so it's not clear where he got this viewpoint. ISO, TC 176 and the rest have repeatedly, clearly and vocally said how ISO 9001:2000 attempted to get away from "documented procedures" and into measuring the outputs of processes in order to ensure effective processes. 

Mr. Nelson's divination of the thinking process of ISO TC 176 and their use of User Survey results is factually wrong on every level, and clearly derived from thin air in order to support his view. If anything, criticism should be laid at TC 176's feet for not using User Survey data at all. But they clearly didn't make the changes in 2000 in the manner he claims.

I really have to admonish Quality Digest for running stuff like this. I half wonder if I post a story that "ISO 9001 has always been about making boats out of fruit" it would get published without so much as a spell-check.

This article is so wrong, it had me laughing all the way through.  I hadn't realised QD had begun a comic parody line... Oh wait, actually it is intended to be serious.  Really???

Like Chris Paris, I wonder what the editorial staff are up to or on, that they let it be published.  it certainly does the magazine no good, to say the least..  Chris  has done a great job in pointing out the numerous errors of fact and the convenient ignoring of pretty much everything that  ISO has written about the Standard.  After all, no sense in letting any thing get in the way of opinions, is there?  Especially a tiddly little thing like evidence or facts. But then, who needs to bother about  what ISO and the relevant Technical Committee have said, if you just  want to spout a load of untruths?

What IS next from Quality Digest, wonder?  The earth has been flat all along? Why the law of gravity is a complete furphy?

And why, oh, why are you actually publishing such utterly incorrect and silly opinionated nonsense?  Jumping the shark, is a phrase that comes to mind for both author and magazine.

Jane Bennett

Another gross factual error: Mr. Nelson says, "Apparently resigned to the fact that management was going to use the standard as a basis for QMS design, the authors did what they could to promote application of a process approach by an audience with a standard-based mindset. The first attempt to stymie a standard-based mindset can be found in ISO 9001:2000 clause 0.1—Introduction, where it is stated that it is not the intent of the standard to compel uniform QMS structure and documentation."

Apparently Mr. Nelson has never read either the 1987 or 1994 versions of ISO 9001, which included the same statement, although worded a bit differently:

"It is not the purpose of these International Standards to enforce uniformity of quality systems." (Introduction, page vii) In fact, there's a whole paragraph on it.

This debunks his entire argument that the sentence was added to 2000, and therefore all of his incorrect assumptions about the rationale for such an addition. It was always there.

Reading the academic explanations of how wrong we (users) understand the ISO 9001 it seems to find impressions of a persons that never redacted and implemented a QMS. Even the title, "You can shoot yourself in the foot trying to achieve customer satisfaction" confirm that. I have all respect for Mr. Nelson's experience but I thanks to God that I was never audited by his coursants. Just saying that we design and implement QMS conforming to ISO 9001 is not enough. The design of this important and useful tool for management shall be related to organization's culture, know how, resources and so on, as specified in Clause 01.

I ask Mr. Nelson to explain me why the companies which adopted this approach recorded real improvement?

And I ask Mr. Nelson what he tries to communicate through this article?

Yes Mr. Nelson, it's what they are: ISO 9001's paranoia on customer satisfaction - and continual improvement, which seems practically the same to me - leads organizations to strive for wrong, expensive, often useless objectives. Any standard is made of words, any word has more than one meaning, we've to be more careful when using words: they can hurt more than a sword.