ISO stands in violation of the World Trade Organization’s “Agreement on Technical Barriers to Trade” (TBT) regulations. This article will point out just how this is so, providing evidence to support this very serious allegation. It’s a long piece, so settle in.

Quick Primer

First, one has to understand what the WTO TBT Agreement actually is. Per the WTO, the Agreement “aims to ensure that technical regulations, standards, and conformity assessment procedures are non-discriminatory and do not create unnecessary obstacles to trade.” In English, the Agreement exists to ensure that standards are useful to enhance trade, and don’t — whether accidentally or intentionally — become restrictive for trading partners, nations and industries. For example, if Microsoft stacked an ISO Technical Committee with its representatives, and managed to insert language into an ISO standard that said “compliance with this standard can only be claimed if the organization uses Microsoft Office products,” then that would be a barrier to free trade in that it unfairly punishes Microsoft’s competitors. Likewise, no single country can dominate a standards development activity which would give it unfair advantage.

The “teeth” in the Agreement are sanctions, although the WTO does not use the word. In reality, one nation files a complaint — called a “dispute” in WTO parlance — against another nation, and if the WTO process declares them the winner in the dispute, the nation can justifiably apply a sanction of some sort, and of its choosing. It legitimatizes the punitive measures issued by the prevailing party, whatever they may be; typically these would be financial penalties and/or restrictions. A nation that pursues these sanctions without a WTO “blessing” would be seen as engaging in anti-free trade practices themselves. Having said that, obtaining a WTO dispute ruling is difficult and rare.

ISO and WTO have a long history of partnership, and that history is far beyond the scope of this article. The short version is that to the WTO, ISO looked — on paper, anyway — to be a useful partner in the international free trade scheme. This relied on the WTO not realizing that ISO is, at its heart, a private publishing company — a “vanity press,” as I have argued — and for the WTO to imagine that ISO has some notion of social benefit as its core motivator. In reality, of course, ISO simply wants to sell books, and the WTO either hasn’t noticed that, ignores it, or is complicit in the hoodwinking. Again, that’s out of scope for this article.

Whatever the reason, WTO has been overwhelmingly supportive of ISO, making any challenge against ISO under the TBT Agreement that much more difficult. This article hopes to lay out that argument anyway, by showing how ISO has violated all six of the core principles of the TBT Agreement. Those principles are:

  • Transparency
  • Openness
  • Impartiality and consensus
  • Relevance and effectiveness
  • Coherence
  • Development dimension

ISO boldly claims it’s in full compliance with them, of course, providing their only evidence as, “The ISO Council has noted that ISO complies well with the WTO principles and has publicized and promoted the principles to all ISO members.” Yes, they essentially “self-declare” their own compliance, and the WTO seems satisfied with this.

Transparency

According to the text of the TBT Agreement, the principle of “transparency” mandates the following:

All essential information regarding current work programmes, as well as on proposals for standards, guides and recommendations under consideration and on the final results should be made easily accessible to at least all interested parties in the territories of at least all WTO Members.   Procedures should be established so that adequate time and opportunities are provided for written comments.

WTO fleshes out this requirement by indicating that standards developers follow six key steps when producing standards, to ensure transparency. Those steps are:

  1. Publication of an early notice of the intent to develop a standard, so that interested parties can be engaged.
  2. Notification to members (in this case, ISO members) describing the scope of the intended standard, including its objective and rationale. This has to happen early on, so that changes can be proposed and member comments “taken into account.”
  3. Draft texts must promptly be provided to members upon request,
  4. There must be “adequate” time for interested parties — this means ISO members as well as the potential users of an ISO standard — to provide comments and for these comments to be ‘[taken] into account in the further consideration of the standard.”
  5. The final standard must be promptly published upon adoption.
  6. The standards body must publish a “work program” that describes what standards are being worked on at given stages.

Where ISO ran afoul of the Agreement pertains to points 1 and 4. As I’ve written about extensively, ISO 9001:2015 was not exclusively written by the Technical Committee tasked with authoring it (TC 176), but instead largely authored by the ISO Technical Management Board (TMB). The TMB’s role is to ensure that its various TCs, including TC 176, obey ISO rules and adhere to WTO principles, and the TMB is empowered to disband TCs that fail to do so. ISO defines its responsibilities as:

… the general management of the technical committee structure. It shall approve the establishment and dissolution of technical committees, and revisions of the Directives for the work of the technical committees. It shall deal with all matters of strategic planning, coordination, performance, and monitoring of technical committee activities.

What you see missing from that mandate is the authoring of standards. The TMB is not supposed to author standards itself, since it’s not held to the rules of Technical Committees; it’s job is to enforce those rules on its subordinate TCs, but since the rules only apply to TCs, those rules don’t apply to the TMB itself.

But ISO has slowly allowed the TMB to take on more and more authoring duties, first allowing it to publish a host of ISO “Guides” — essentially international standards, but just with a different name to avoid WTO scrutiny — and then full blown ISO standards. For example, the standard on risk management, ISO 31000, was originally written by the TMB, and a TC was only convened for a later revision. Since ISO’s rules on standards development only apply to TCs, and not the TMB, the TMB can do whatever it wants when drafting standards… including ignoring the WTO regulations entirely.

Back in 2006, the TMB created the “Joint Technical Coordination Group” (JTCG) to work on a document called ISO Guide 83 which intended to provide a standard format and structure for all future ISO standards. The idea made sense: ISO standards should share a common paragraph structure whenever possible, to avoid confusion between different ISO products. But the intent was only to provide “high level structure,” not content; i.e., paragraph formatting and basic placeholders for content, such as a set place for “scope” and “normative references.” The early work of the JTCG did just that, but then they petitioned the TMB for more authority in creating actual content. The TMB should have recognized this as a violation of the TBT Agreement, but did not, and thus authorized the JTCG with an expansion of scope for their work product.

Now the JTCG was free to add actual requirements, and — under the influence of Australia, which had unprecedented political sway in the halls of the ISO TMB — they added a requirement that all standards include a section on “actions to address risks and opportunities.” This is just one example, but it’s evidence that TMB was no longer constrained to developing structure for content, but instead writing the content itself. If a given standard didn’t suit itself for addressing “risk and opportunity,” or if a given industry already had language in their standard discussing “risk” in a different way, it was too bad: the TMB language was mandatory.

ISO Guide 83 never made it out of draft. ISO “fibs” by routinely claiming that a draft of Guide 83 was circulated for “balloting” among nations, but the voting was symbolic and non-binding, and the comments arsing from that process were all but ignored.  Guide 83 was dropped and instead inserted into the mandatory procedural document called the ISO Supplement. (I’m paraphrasing; to see the full timeline, click here.) This meant it was not subject to voting, since the ISO Supplement was not a standard, but an internal set of rules dictated to ISO Technical Committees. The Guide 83 text was added into that document as “Annex SL,” resulting in it subsequently being called that.

It’s also important to note that the TMB authors of Annex SL included not a single representative of any industry other than those from the certification scheme and ISO itself. Not a single user organization was represented in this effort. Worse, not a single developing nation was represented, another potential violation of WTO rules. The membership of TMB is fixed at fifteen nations, and no other nation may join; it’s similar to the UN Security Council, with permanent members who hold sway over every other nation.

The TMB then gave contradictory messages to the various TCs as to whether they had the right to contest the Annex SL text. All the of various official communiques from the TMB ultimately gave the TMB the right to deny any rejection, and force the TC to adopt it anyway. Some within the TMB have verbally said that TCs had the right to reject Annex SL, but this was never supported in any official way, and in one case a TC was actually forced to adopt Annex SL over its objections.

And so TC 176 inserted the full text of Annex SL without objection. An analysis of the text of ISO 9001:2015 shows that about 80% of the text is just rewording of language already found in ISO 9001:2008, but of the text that was changed, just under 70% of the changes were driven by the cut-and-paste Annex SL language.

Read that again: almost 70% of the changed requirements were written by the TMB, not TC 176.

Making matters worse, the Secretary of TC 176 disallowed any actions on comments received that were critical of the Annex SL text that was eventually inserted into ISO 9001:2015. Comments against the Annex SL text were rejected solely on the basis that Annex SL could not be altered in any way. At the DIS stage, the TC 176 Secretary openly noted this as the reason:

Click to enlarge

Later, during the FDIS stage, the Secretary applied the rejection code “TN” meaning the change requested was rejected outright; no explanation was given, but all Annex SL related comments received the TN or similar rejection code.

And thus we have the violations of the TBT Agreement’s principle of transparency. In forcing the TMB-authored Annex SL on TC 176, and disallowing them from either rejecting it outright or even commenting on its text, ISO violated two of the six requirements for transparency. First, the early notifications (in 2011) of the impending ISO 9001:2015 development work product did not openly reveal that 70% of the changes had been written as far back as 2006. Second, the policies disallowing discussion, debate or rejection of the TMB-authored material violated WTOs’ requirement that comments be ‘[taken] into account in the further consideration of the standard.”

Openness

The second TBT Agreement principle is that of “openness.” WTO defines this as

Membership of an international standardizing body should be open on a non-discriminatory basis to relevant bodies of at least all WTO Members.

It goes on to clarify this as follows:

Any interested member of the international standardizing body, including especially developing country members, with an interest in a specific standardization activity should be provided with meaningful opportunities to participate at all stages of standard development.

Going back to the TMB’s incursion into the development activities of ISO 9001 — and, in fact, all future ISO management system standards, through it’s imposition of Annex SL — we see that ISO has clearly and unequivocally violated this. The TMB, as I indicated, included not a single developing nation in its ranks while drafting Annex SL, and that text comprised nearly 70% of the changes to the ISO 9001 standard.

Worse, the rushed development timeline of ISO 9001:2015 unfairly discriminated against non-English speaking nations, a group that includes nearly all developing nations. As I wrote about in my book:

In March 2014, TC 176 met in Paris and failed to complete the review of the 1,300 comments as directed. This put the planned April 2014 publication date of the next draft – the Draft International Standard version, or “DIS” – at risk; TC 176 had a team work the remaining comments “electronically,” outside of its meetings.

Meanwhile, as of the Paris meeting, no one in TC 176 had yet seen the full ISO 9001 draft, and instead only portions; nevertheless, the voting on the DIS was still on track.

Adding more pressure to the problem was the fact that rules require a two-month period to allow ISO member nations time to translate the coming DIS draft into their various national languages before it could be circulated for a three-month voting period. The entire timeline was slipping, despite the shortcuts TC 176 has taken to date, largely due to outcry over the drafts to date.

TC 176 missed its April deadline, and the DIS version of ISO 9001 was instead released in July of 2014. ISO warned TC 176 that it was risking the final publication date of September 2015, so to make up time, TC 176 came up with another shortcut: it would conduct the required 2-month translation and 3-month review periods concurrently, rather than sequentially. This shaved off months, but severely limited the ability of non-English speaking countries to properly review the draft.

This means that at a critical review stage, ISO discriminated against non-English speaking nations, who were given three months to both conduct official translations of the draft — a time consuming process that usually was given two full months on its own — as well as circulate it for national review and commentary. Meanwhile, English-speaking nations were given an unfair advantage, since they simply had to review the document, without any official translation.

Impartiality & Consensus

The third principle is actual two-pronged. WTO defines “impartiality and consensus” as requiring the following:

All relevant bodies of WTO Members should be provided with meaningful opportunities to contribute to the elaboration of an international standard so that the standard development process will not give privilege to, or favour the interests of, a particular supplier/s, country/ies or region/s. Consensus procedures should be established that seek to take into account the views of all parties concerned and to reconcile any conflicting arguments.

We’ve already seen how, by violating the 2nd principle of non-discrimination, ISO simultaneously violated the first half of this 3rd principle. By failing to equally engage with non-English speaking nations, this resulted in an overtly discriminatory development process for ISO 9001:2015, impacting unfairly on non-English speaking “countries or regions.” Furthermore, it gave enhanced authority and influence to the actual individuals within TMB and TC 176 from those English-speaking countries, and those individuals overwhelmingly represented ISO itself (as organizational staffers) and ISO 9001 registrars and consultants. This alienated all the other “particular suppliers” from the process.

But it’s the second half of this principle — consensus — where ISO’s most nefarious manipulations come to light. I’ve written an entire chapter on how ISO violates this concept in my book, and I’ve published it online so you can read it for free. I recommend doing so, as it’s complicated and lengthy; visit the site and find the “Sample Chapters” link at the bottom.

The short version is this. In order to claim it develops standards “by consensus” while ensuring that it retained complete control over standards development activities, including content, timelines, participation of members and even factors related to eventual pricing (like page count), ISO had to redefine the word “consensus.” In fact, it’s definition is so far afield of that used in any other context, it actually bears the opposite meaning. ISO’s definition of “consensus” is actually non-consensual.

WTO defines consensus as to “take into account the views of all parties concerned and to reconcile any conflicting arguments.” ISO, on the other hand, defines it as the “absence of sustained opposition.” They append that with the literal WTO language to “take into account the views of all parties concerned and to reconcile any conflicting arguments,” but that first half negates the second half, entirely. The idea of requiring “sustained opposition” neutralizes the idea of “reconciling conflicting arguments.” WTO hasn’t noticed.

What this means, in practice, is that as soon as anyone puts pen to paper and writes a sentence in a draft ISO standard, it is immediately considered internationally approved and universally accepted by default. To undo that language requires a challenge, and that challenge must rise to the level of “sustained opposition.”

Worse, ISO procedures then grant sole authority to those under its control (typically committee Chairs) to unilaterally decide when a challenge constitutes “opposition.” There’s no test for this, it’s left up to the whim of the Chair. Assuming a challenge can overcome that hurdle, it then must overcome a second: it is also up to the Chair to unilaterally decide if the opposition is “sustained.” If either metric is not met, the challenge is dropped without action.

In fact, through a host of procedures that it’s unlikely anyone at the WTO has ever read, there are seven distinct hurdles a challenge must overcome for the default text to be edited. Whereas under the WTO’s definition of “consensus,” a change might look like this:

… under the ISO definition, any change must pass through all of the following gates:

The system is so contrary to any normal idea of consensus, the final step reduces it to near parody. If the challenge makes it to the final step, the Chair can attempt to negotiate with the challenging party — this is how they get to the WTO requirement that “conflicting arguments be reconciled.” If the challenging party does not yield to the Chair, however, the Chair can arbitrarily declare the challenge “unresolvable,” and then throw out the challenge anyway. This literally means that in order for a challenger to have their request approved, they have to agree to withdraw the challenge. Yes, that makes absolutely no sense, and it hardcodes in an automatic failure for anyone who’s made it that far.

It’s astounding that the WTO has never noticed how ISO’s subtle re-defining of the term “consensus” has obliterated any hope of actually attaining it.

Effectiveness & Relevance

The fourth principle is also two-pronged: effectiveness and relevance. For this, the WTO declares:

In order to serve the interests of the WTO membership in facilitating international trade and preventing unnecessary trade barriers, international standards need to be relevant and to effectively respond to regulatory and market needs, as well as scientific and technological developments in various countries.  They should not distort the global market, have adverse effects on fair competition, or stifle innovation and technological development.  In addition, they should not give preference to the characteristics or requirements of specific countries or regions when different needs or interests exist in other countries or regions.  Whenever possible, international standards should be performance based rather than based on design or descriptive characteristics.

This one’s a bit trickier, but again ISO has violated it with the release of ISO 9001:2015. Let’s walk through it.

ISO procedures require that it review its standards every five years to see if they need to be updated. This is, accordingly to ISO, to see if there have been any significant scientific, technological or other industry changes that should be reflected in a particular standard. Specifically, ISO says this is to keep standards “current and relevant for the marketplace.”  Notice again how they borrow the language of the WTO, and how WTO never looks much further to find out that ISO is actually in violation of the requirement.

In its official statements, ISO claimed that ISO 9001:2015 was updated “to respond to the latest trends and be compatible with other management systems such as ISO 14001.” Let’s examine each half of that claim separately.

First, the claim that ISO 9001:2015 was updated to “respond to the latest trends” is an outright fallacy, if not a boldfaced lie. The standard is still very much mired in the same widget-making mentality as its source material, MIL-Q-9859 from the 1950’s; in fact, that standard included the concept of “cost of quality” which still doesn’t apper in ISO 9001, some sixty years later. Next, the standard has gone out of its way to ignore or reject advances that have occurred, such as lean manufacturing, 5S, enterprise resource planning, or agile development.

Much of the root cause of this lies with the impossible incompetence of ISO 9001:2015’s authors. Whereas industry understands the dramatic differences between manufacturers and service organizations such as hotels, law firms, software developers or restaurants, the TC 176 authors felt that service providers were properly included in ISO 9001 merely by swapping out the word “product” for “products and services,” but then keeping all the manufacturing-biased rules in place. US TAG member Denise Robitaille said, in a 2015 interview with publisher Scott Paton (emphasis added):

Despite the fact that we have long said that ISO 9001 is a generic standard and we are able to massage the language to demonstrate how it has applicability for service industries, it’s been a hard sell because people have to really understand how some of this stuff applies to the service industry,” explains Denise Robitaille, a technical expert on the U.S. Technical Advisory Group to ISO Technical Committee 176, the body responsible for revising the ISO 9001 standard. “The revised standard has greatly de-emphasized its focus on manufacturing, replacing terms like ‘products’ with ‘products and services.”

Clearly, anyone with a proper understanding of any industry will understand it takes far more to address the differences between manufacturing and service sectors than simply cutting-and-pasting a single term. This is why the CMMI standard for software development looks so alien to ISO 9001, for example. In fact, it’s why ISO’s own standard for IT service management (ISO 20000) doesn’t look anything like ISO 9001. You cannot simply address the needs of service sector companies by writing requirements for manufacturing, and then replacing the word “product” with “product or service.”

Finally, ISO ignored the industry studies that they did conduct. In 2009, ISO commissioned a “User Survey” to find out what new developments the industry actually wanted; the top three results were resource management, “voice of the customer,” and “systematic problem solving and learning.” Nevertheless, all three were ignored outright, and appear nowhere in the resulting standard. Instead, the fifth-ranked result — risk management — was inserted, but only in order to respond to the Annex SL mandate to include risk; later, ISO simply lied and said that it had done so in response to the User Survey. Again, Denise Robitaille:

The most commonly received comments from the extensive survey that SC 2 sent to ISO users related to the following: …requests to include requirements relating to risk management…

The statement was wholly untrue, but percolated through the industry anyway. Nowhere did Robitaille mention that risk was actually included to comply with Annex SL, written not by her team, but by the TMB.

She goes on, to gush poetically about why ISO 9001 was updated:

Supply chains now routinely span the globe. Vast quantities of information can be transmitted virtually instantaneously.The evolution of ideas and technology has exploded—and our ability to manage it all has become increasingly critical. It is in this tumultuous environment that the most popular standard ever published by the International Organization for Standardization (ISO) is being revised.

The only problem, of course, is that not a single change was made to ISO 9001 that reflected global supply chains, instantaneous transmission of information, or evolution of technology. Not a single word. Its entirely unclear where Ms. Robitaille is getting her information, since none of those things appear in the published, final work product.

So we see that ISO updated ISO 9001 without considering actual industry needs or changes, and instead imposed a single major change — “risk based thinking” — because of a mandate from the TMB. That shows the changes made did not reflect WTO’s need for “relevenance.”

What about effectiveness? Coming back to the invention of “risk-based thinking,” ISO 9001 again disproves the idea that ISO followed WTO principles. “Risk-based thinking” was invented over the course of a weekend in the summer of 2013, as a means of instantaneously satisfying the TMB’s demand to “include risk and opportunity” while not invoking the actual discipline of “risk management.” Sources in TC 176 reported that they were afraid invoking “risk management” would hinder sales of the standard by scaring off potential buyers who didn’t want to implement RM as a part of a quality management system. The fear was they’d have to hire professional, degreed risk managers, obtain risk management certifications, and develop complicated risk assessment schemes.

The invention of “risk-based thinking” negated that. TC 176 copied and pasted the risk language from Annex SL and then added nothing. No procedures, no records, no processes, no firm requirements at all. They then added language in an Annex and introductory clause branding this as “risk-based thinking,” but never naming it as such in the requirements themselves.

The problem with the WTO’s principle of “effectiveness” comes about because risk-based thinking was invented solely to satisfy the TMB mandate and keep ISO’s publishing date on track; it is based on no known body of knowledge, no risk management tool or concept, and has no track record at all of working. Instead, TC 176 leaders claimed they be justified in their invention of the RBT idea later, after the standard was published, and essentially decided to use the entire world as their laboratory experiment. This is the opposite of what WTO requires, which is to “take account of relevant regulatory or market needs, as feasible and appropriate, as well as scientific and technological developments in the elaboration of standards,” … not invent them outright and hope they prove effective afterwards.

Coherence

The fifth principle — coherence — is possibly one of ISO’s greatest failures, and ISO 9001:2015 yet again provides us the evidence. WTO defines this as:

In order to avoid the development of conflicting international standards, it is important that international standardizing bodies avoid duplication of, or overlap with, the work of other international standardizing bodies.  In this respect, cooperation and coordination with other relevant international bodies is essential.

With ISO 9001:2015, ISO ran afoul of international standards that were already published by — guess who — ISO itself. The definition of the term “risk” which was featured at first in a draft of ISO 9001, and later moved to ISO 9000, presented ISO’s 40th definition of the word, spread out over 140 different ISO standards. Much of the language of the TMB’s clause on risk and opportunity duplicated that of ISO 31000 on risk management, and much of the rest of it contradicted ISO 31000, proving ISO was able to violate the “coherence” clause in both ways simultaneously. The development process of ISO 9001 was not only done without “cooperation and coordination” of other relevant standards bodies, it was done in outright combat with them: the fights between TC 176 for quality management and TC 262 on risk management were legendary.

Development Dimension

The final principle — “development dimension” — aims to ensure a fully participatory standards development process that includes developing countries. This is a bit redundant with the previous principles, but it hammers home the role of developing nations ever further:

Constraints on developing countries, in particular, to effectively participate in standards development, should be taken into consideration in the standards development process.  Tangible ways of facilitating developing countries participation in international standards development should be sought.  The impartiality and openness of any international standardization process requires that developing countries are not excluded de facto from the process.

As we’ve shown, ISO not only skewed the ability of developing nations to participate by having English-only drafts voted on prior to official translation, 70% of the changed language was written by the TMB with only representatives from ten industrialized nations: Austria, German, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, UK, and USA.

The Endgame

If, as we’ve proven, ISO has violated every single principle behind the WTO’s Technical Barriers to Trade Agreement, what can be done?

ISO can be sanctioned, but the effort will be nothing less than sisyphean, with about as much chance at success. Given the risks we see from the scheme — see Takata airbags, Deepwater Horizon, TUV breast implant scandal, etc. — it’s paramount that this be pursued nonetheless.

The problem is that filing a dispute with the WTO requires a government sponsor — a nation, in fact. In the US, the office responsible for filing such complaints would be the Office of the US Trade Representative, which answers directly to the White House. The US has shown an absolute unwillingness to challenge ISO in any capacity, despite the fact that the ISO 9001 scheme is draining the economy by about $1.5B per year, which only worsens during “peak event” years when a new standard hits.  We can’t count on the US to mount the challenge, so another nation will have to step up.

Next, WTO disputes are typically filed against nations, not individual organizations. If a US-based organization, like Boeing, is at the center of a dispute, then a nation would file a dispute claim against the US, not Boeing. Therefore, it’s not clear how a dispute could be filed against ISO. It would make sense that the dispute would be filed against ISO’s home country of Switzerland, but since ISO is technically an international organization comprised of 170+ member nations, that’s not clear. A legal argument could me made that ISO is simply a publishing company that operates in Switzerland, but it would be a stretch to say that Switzerland gave unfair advantage to ISO in order to gain some kind of national advantage on its own behalf. And national advantage for what? ISO could move to Slovakia and it would have the same benefits, without any of those trickling down to Slovakia; it’s physical location on the globe is irrelevant.

In short, there may not actually be an avenue to file a dispute against an organization like ISO, and it’s likely ISO knows this, which is why they violate international trade regulations,and their own procedures, with impunity. They may literally be beyond the reach of the law.

The one good thing about this situation is that because it’s global, even if the current Presidential administration proves to be spineless on the matter, another nation can stand up. Venezuela comes to mind, as it’s been more aggressive in its posture against ISO, although its current problems may hinder it from having any efficacy. Whatever nation does pursue this will have to spend some resources on the legal wranglings that come with a formal WTO dispute. These are not cheap to prosecute.

For the mean time, Oxebridge stands ready to assist. Contact us if you are a representative of a national body that may want to take up this important, potentially life-saving cause.

 

 

    About Christopher Paris

    Christopher Paris is the founder and VP Operations of Oxebridge. He has over 25 years' experience implementing ISO 9001 and AS9100 systems, and is a vocal advocate for the development and use of standards from the point of view of actual users. He is the author of Surviving ISO 9001:2015, which can be purchased here.