For the second update period in ten years, the medical device QMS standard ISO 13485 will not adopt the so-called “mandatory text” of Annex SL. A recent post on LinkedIn indicated that the ISO Technical Committee 210 working group has decided not to update ISO 13485, leaving the current version — first published in 2016 — intact.
That 2016 version was controversial in that it did not adopt the Annex SL mandatory text, despite the ISO Technical Management Board insisting that rejecting the text could result in the TC being disbanded entirely. For that edition, TC 210 argued that the work on the draft was already too far along for the Annex SL text to be incorporated, but that it would be added in a future revision. That time is now, and TC 210 has instead rejected the text once again.
In an attempt to circumvent the authority of nominated delegates from official ISO members to write the text of standards, which can delay their publication and cost ISO revenue, ISO empowered the TMB to craft mandatory text that must then be incorporated into all management system standards. The Annex SL text, so named for its placement in an annex of the procedural Consolidated ISO Supplement document, may not be edited by TC committees and may only be voted on as part of overall voting on the final standard.
Oxebridge has argued that the Annex SL text violates two core ISO requirements, both of which were devised to placate international bodies such as the World Trade Organization (WTO) and the International Labor Organization (ILO). Those policies, which require standards to be developed via consensus and by nominated subject matter experts, are ignored entirely by the Technical Management Board, which handed the crafting of the Annex SL text over to Dick Hortenius of the Netherlands and a few of his hand-picked colleagues. Hortensius was hired out of university by the Dutch standards body NEN and has no practical experience in any of the industries or subject matter of the standards for which his Annex SL text is then inserted. According to his LinkedIn profile, Hortensius never had any job in any industry prior to working for NEN on standards.
Oxebridge alerted TC 176 in 2013 that it could ignore the Annex SL text, as ISO was unlikely to invoke its threat of disbanding the committee. TC 176 leadership refused, however, and instead agreed to comply with the demands of the TMB and ISO Executive. That led to the injection of controversial content in ISO 9001, such as “risk-based thinking.” Over one third of the ISO 9001:2015 standard was written not by TC 176 or quality management subject matter experts, but by Hortensius’ non-elected team. TC 176 members welcomed the text as a “boon” for consultants, of which the committee is largely comprised.
For the latest update to ISO 9001, TC 176 then had to violate multiple formal votes after ISO member nations repeatedly voted not to revise the standard. Because Hortensius had updated Annex SL, however, the ISO Executive insisted that ISO 9001 be updated regardless of the official votes. In the end, ISO held six different votes, using a variety of methods, until enough countries abstained, thereby granting them the authority to update ISO 9001. The new ISO 9001:2026 edition incorporates Hortensius’ Annex SL changes and continues the practice of disallowing any editing or line-item voting on his text.
The move by TC 210 for ISO 13485, however, disproves ISO’s threat to disband a TC that rejects Annex SL. Privately, members of that committee had, in 2015, said they had no intention of allowing the TMB and Hortensius to write text for a medical device QMS standard, since that Annex SL team had no expertise in that subject matter. They used the argument that they were “too far along” to skirt the issue for the 2016 edition. More recently, members began floating the idea that Annex SL would be rejected again as not complying with medical device regulatory requirements, especially as it pertains to Annex SL’s “risk-based thinking” clause, which many deem nonsensical.
TC 210 is comprised of more end-user organizations than TC 176, which is comprised nearly entirely of private consultants and certification body representatives, all of whom have a vested interest in issuing a new standard over the objections of users.
Response to the Draft International Standard (DIS) version of ISO 9002:2066 has been met with fierce criticism, with some calling it a “cash grab.” ISO 9001 is ISO’s biggest-selling standard, and so there was likely never any likelihood that ISO would not update it. An update to ISO 9001 will generate hundreds of millions of dollars in revenue for ISO within the first few years alone. ISO is currently floating an idea to have third-party certification bodies verify that ISO 9001 certificate holders not only purchase the revised standard but also purchase the correct number of copies based on employee count. Oxebridge has argued this is illegal, since there is no requirement for ISO 9001 end user organizations to buy the standard at all, and ISO cannot draft third-party auditors to perform unpaid sales and copyright policing on its behalf during audits paid for by the users.
ISO did this previously with the 2008 edition. For that year, ISO members voted against updating the standard, so ISO re-issued ISO 9001:2000 with no new requirements, but simply an updated year on the cover. CB auditors then wrote nonconformities against companies that did not update their internal documents to refer to “ISO 9001:2008,” even though there had been no practical changes.
Whether TC 176 will reverse course now that TC 210 has shown Annex SL can be ignored remains to be seen, but the current leadership of TC 176 — including private consultant Sam Somerville — appears to be willing to carry out the TMB’s directives and ignore end user rights.
The news is a relief for medical device manufacturers, who will not have to update their systems to comply with any unwarranted changes.
