The following official Oxebridge position is being sent to all US TAG 176 members, its leadership, as well as key leaders in ANSI, IAAR and government agencies. To download a PDF copy of this Public Call document, click here. Please feel free to circulate this to your US TAG representatives, as well as government contacts.

CORRECTION 30 August 2015: The first version of this document incorrectly indicated that ISO Guide 83 was “rejected.” This is not true; Guide 83 was voted on and narrowly approved, but ISO – for reasons we are still parsing – elected not to publish it as a Guide and move the text to the mandatory ISO procedures under Annex SL.  The 3rd paragraph has been updated accordingly.

ISO’s Development Process Violated its Own Rules and WTO Regulations

Throughout the development process for ISO 9001:2015, the International Organization for Standardization (ISO) has routinely ignored key rules governing the development of international standards, possibly in violation of World Trade Organization regulations. The WTO demands that ISO standards be both voluntary and developed by consensus. ISO has been able to bypass traditional concepts of consensus by taking the extraordinary step of redefining the word as “a lack of sustained opposition.” By doing so, ISO leadership need only obstruct any international member who disagrees with its position, and declare the opposition as “not sustained.” Under ISO’s definition of “consensus” a military dictatorship that imprisons dissidents would be considered a “consensus government” because democratic reformers would be unable to maintain a sustained opposition.

Even under this warped definition, nearly a quarter of the content of the new ISO 9001:2015 standard was not developed through participation by members of TC 176, but instead by mandate from the non-elected ISO Technical Management Board (TMB). The TMB used its authority over TC 176 to impose content in ISO 9001 and other standards by mandating the compliance with “Annex SL.” The language of the Annex was taken from ISO Guide 83; that document was cancelled at its draft stage and never formally published. From that, ISO took the Guide 83 text and inserted it into a mandatory “ISO Supplement” procedural document, for which all TC’s must obey lest they be disbanded. As a result, Annex SL was not subject to the same TC member voting or international consensus of a standard, meaning at least a quarter of ISO 9001:2015’s text was developed in violation of both ISO rules and WTO regulations.

The US Technical Advisory Group (TAG) to TC 176 has likewise repeatedly made the point that ISO 9001:2015’s development did not comply with the design specification originally put forth by ISO, and has rejected previous drafts of the 2015 standard on these grounds. Of particular concern were the gross deviations from the design spec related to the requirement that ISO 9001 be “easy to read and understand by line managers and everyone in the organization.” The US TAG has pointed to ISO’s decision to create “an Annex, the number of Notes within the FDIS, and the work item for a separate TS to clarify what the standard says and means” as proof the design spec was not adhered to, and that the resulting standard will not be readily understood.

The US TAG has also rightfully pointed out that “changes made in the progression from DIS to FDIS have not been fully considered by all US TAG members and opportunities for technical feedback have not been provided” in violation of ISO rules. Oxebridge adds that some significant language, especially that pertaining to a requirement that ISO 9001 companies maintain a “calm and emotionally protective work environment” were added by ISO after the DIS commenting period, against overwhelming rejection of the language; because the language was inserted at the FDIS stage, it cannot be removed, since the FDIS can only be edited for grammar and formatting.

Next, throughout the development stages of ISO 9001:2015, ISO refused to adjust the publication deadline to accommodate the input of member nations, including the United States. As a result, international comments were routinely ignored or given lip service, as there was simply no time to properly address and disposition the comments. ISO has alleged that it did properly disposition these comments, but ISO’s own documents show that it merely compiled the comments into a spreadsheet, and then had a small “working group” choose which comments to reject or accept; these final decisions were not even binding, and the FDIS language shows that in some cases the final text contradicts even the official dispositions by this working group, proving the entire exercise was irrelevant.

Throughout the process, ISO made it clear that a fast development cycle was more important than a thoughtful, consensus-driven one. Because of internal “dashboard” metrics which push for faster standard development cycles – and thus faster publication cycles – robust standard development has fallen second to publication release dates, since ISO generates revenue only when standards are offered for sale, and not while they are in development. As a result ISO has co-opted its consensus process in the quest for revenue.

Impossible Requirements

The ISO 9001:2015 standard includes impossible requirements which cannot be met by user organizations, or which may raise serious legal and financial entanglements if they are adopted.

The requirement for a “calm and emotionally protective” work environment is sufficient enough for the US to reject the standard, and demand it return to the DIS stage. The determination of what constitutes “calm” and “emotionally protective” is not only entirely subjective, it is not within the scope of a standard intended for quality management systems. It is impossible for US companies to comply with this requirement, since it is impossible to interpret the meaning of the requirement.

In addition, this requirement immediately makes ISO 9001 an untouchable “third rail” for any organization which engages in any form of dangerous work, such as police departments, military agencies, or even most manufacturing facilities where ensuring a “calm” environment is not possible. While laws demand companies provide personal protective equipment (PPE) to maintain worker health, there are no laws or standards governing how to protect the “emotional state” of employees, since this has been determined impossible to legislate; TC 176 would have us believe that it has somehow managed to accomplish something that legislators and regulators themselves have not. It is also impossible to predict how third party certification auditors will approach this requirement, adding further uncertainty into the process.

The standard also includes a de facto requirement that the workplace be “anti-discriminatory,” something already governed by local, state and Federal laws; it is not clear how ISO 9001 would claim authority in these matters. It is also not clear of the legal entanglements which might be raised if an auditor were to write a finding for a company being “discriminatory”. The result would likely be a host of lawsuits between all the parties: employees, the client organization, and the certification body. Likewise, we can expect significant problems if an auditor were to declare a company “anti-discriminatory” and the company were to later face a discrimination lawsuit. There is no possible beneficial outcome, and the language has no place in ISO 9001.

Next, the requirement for “risk-based thinking” has been met with nearly universal disdain from users and risk management professionals across the world. It has been deemed impossible to understand, and begs the question on how one implements — and certifies — “thinking.” The current draft lacks any requirements for records, processes, procedures or evidence of risk management, and avoids the term “risk management” entirely. With risk-based thinking, ISO is attempting to create from thin air a risk management approach that has never before existed, and is using the world as its petri dish with which to test unproven concepts. This runs in opposition of the goal of ISO 9001, which is to standardize universal principles, and not to invent new ones that have never before existed.

The US Must Reject Ratification of ISO 9001:2015

As a result of these major flaws, the US TAG must reject the FDIS of ISO 9001:2015, and demand that ISO return the standard to the DIS stage, and reset the publication date.

Failing that, ANSI must refuse to ratify the standard, and maintain ISO 9001:2008 as the official standard for the United States. Doing so will allow American companies to opt to include the new requirements of the 2015 standard if they choose, but not be held accountable to them since US audits would continue to certify the organization only to ISO 9001:2008.

Finally, ANSI must petition the WTO to investigate the development processes used by ISO as a potential barrier to free trade, due to ISO’s refusal to adhere to its own published rules and WTO regulations. ANSI must demand sanctions against ISO until such time as the TMB is restructured to again grant full authority for the consensus development of international standards by the member nations, and not by unelected ISO managers.





Traditional Tri-System