It’s been a busy week, with a lot of ISO documents finding their way into my inbox, specifically related to the Annex L / SL pending debacle. See this report to catch up to speed.
Another set of documents has arrived, and a few of these I can share. Note to ISO’s legal team: none of these documents are marked confidential, none are marked “for internal use only,” and none have copyright notices. Furthermore, there’s a clear public interest in making sure millions of standards users across the world know what will be appearing in the next crop of ISO management system standards.
First, a point of order. ISO had originally crafted its High Level Structure (HLS) and intended to publish it as ISO Guide 83. Doing so would have required international voting, so instead ISO scrapped Guide 83 and embedded the HLS text into an internal ISO procedure called the “Consolidated ISO Supplement.” Because that’s an internal procedure, it does not undergo any international voting or review. The HLS text was placed into the “S” section of annexes, into position “SL.” As a result, it became known as “Annex SL.”
More recently, however, ISO announced it would be moving the HLS text to a different section of the ISO Consolidated Supplement, to “Annex L.” This is because the S-prefixed annexes only apply to ISO standards, while those without the prefix apply to both ISO and IEC standards. By moving the HLS from Annex SL to Annex L, ISO imposed the text on the IEC.
In the most recent crop of documents, however, ISO TC 176 and other reps have resorted to calling the HLS “Annex SL” again, causing even more chaos. I’m reaching out to people to find out if this is simply people using the legacy name out of familiarity, or if the IEC rejected HLS outright.
The decision to try and mandate Annex SL on IEC never made sense anyway, since IEC writes technical specs and not “management system standards,” but presumably ISO had/has a reason. One theory is that IEC is considering developing some form of quasi-technical, industry-specific management system standard that might benefit from the HLS.
Making matters more confusing, ISO has issued the HLS under a new name, called “ISO DGuide 83,” while it’s in draft. To get around the requirement for voting on “ISO Guides,” they just invented another type of document by adding the letter “D.” But DGuide 83 will eventually become Annex SL or Annex L or something.
As a result, we may be using the wrong name, or it may change when this is all done.
UPDATE see below.
The Lorri Hunt Analysis
The first document to report is a line-by-line review of the revised HLS text against ISO 9001:2015, for its potential impact. This document was drafted by the US’ Lorri Hunt, who you may remember was a huge proponent of the first Annex SL attempt. during an open TC 176 session, Hunt literally projected slides from a PowerPoint presentation announcing that “risk-based thinking is the biggest boon to consultants ever.” Hunt is one of those ISO consultants who subsequently went on to market her services in deciphering ISO 9001:2015 and risk-based thinking.
The Hunt comparison is interesting because she clearly differentiates the needs of the “drafters” of SO 9001 and those of the user, showing that after spending nearly 4,000 years on TC 176 as its top toady, she still doesn’t really get why ISO 9001 exists.
In her comments on clause 5.1, for example, Hunt differentiates clearly that the change would have a “low impact to drafters” but “there might be impact to users.”
One of the changes pending from the new HLS will be a re-ordering of the paragraph numbers for clause 10. This will cause the expected chaos for all those organizations that numbered their QMS documents or quality manual sections to align with the paragraphs of ISO 9001:2015. Hunt appears to address this in her comments, marking the changes as “high impact,” meaning they “could require users to make a change to their QMS“:
Nevertheless, remember that Hunt and the US delegates voted to approve this text, so she doesn’t really care if this has a “high impact” on you and your company.
You can download the Hunt document here, in the original MS Word format. (You’ll see my name in the metadata only because I renamed the file.)
The Nigel Croft Commentary
The next document is one drafted by Nigel Croft, the guy who invented the “risk-based thinking” branding itself. Croft is heading up the effort to rewrite the HLS, so he owns nearly everything that results from the effort. His document provides “guidance for MSS writers and ISO editors” for each clause of the HLS. (Remember, “MSS” refers to the nearly 50 ISO management system standards that will be impacted by the HLS.)
Again, the focus here is on the impact of HLS on standards writers, not users. I daresay nearly none of the participants in the Annex SL updating committees work for companies that actually use ISO 9001 or other HLS-impacted standards. They are all seasoned, long-term committee gadflies and bureaucrats with little practical experience.
It’s a wonky read, but the big takeaway is this part, from the notes related to the “Introduction”:
The objectives of this Guidance are to promote a common understanding of the harmonized approach for writing MSS (including the identical core text, common terms and core definitions), reduce the need for deviations, and indicate opportunities for further harmonization and alignment between the various discipline-specific requirements that each MSS committee may choose to add. Such additions are at the discretion of the individual committee, provided they do not contradict any of the identical core text, common terms or core definitions.
The highlighting is added by me, but shows that in the Annex SL (L?) text cannot be deviated from. ISO likes to confuse and gaslight people by insisting TCs can request deviations, and while they can certainly ask, they will be rejected. The HLS text is mandatory, and it will be imposed on every ISO MSS published moving forward. Period.
It’s also evident that Croft, Dick Hortensius, TC 176 and others continue to bungle the concept of risk, insisting that it’s a positive thing if the ends justify the means:
If a risk potentially generates a negative effect, it is usual to concentrate on eliminating or mitigating the risk. However, if the risk (or the mitigating action) generates a potential positive effect, then it is prudent to recognize and consider leveraging this opportunity.
Notice how they conflate the risk that happens first with the mitigating action one takes afterward, and then dumps them into the same concept. That’s like saying cancer and cancer surgery are the same thing, and should be approached identically.
The Croft document can be downloaded here in PDF form.
I’d say you should provide comments to your nation’s ISO member if you object to this, but it’s already approved and the horse is out of the barn. The only thing you can do is stop buying ISO standards, and press your government to return to domestic ones.
UPDATE 28 Sept 2020, 5:30 PM EST. A source within the ISO Taskforce 4 working on the HLS has confirmed that the name “Annex L” was dropped after negotiations with the IEC on the text broke down. It will revert to its prior “Annex SL” name, and position in the ISO Consolidated Supplement.