The ISO DIS 9001:2015 standard was approved by a majority of ISO member nations, meaning the standard is tracking for an on-time publication date of late 2015. The countries that voted against the DIS (draft international standard) were the United States, along with Canada, Finland, Germany, Ireland, Israel, Japan, and South Africa. A simply majority is needed to push the draft onto its next stage.
Regardless of the outcome, ISO rules require that the negative comments be addressed prior to the FDIS (final draft international standard) publication, and the number of comments appears to have been massive. A source has reported to Oxebridge there were 400 pages of comments, with over 500 comments protesting content within the mandatory Annex SL. Because TC 176 is effectively disallowed from removing or editing Annex SL content, those comments will likely be deleted regardless of ISO’s rules. With only one meeting left to process the negative feedback, it is likely the comments will only be entered onto a spreadsheet, not given adequate assessment, and certainly not have any impact on content. Given that the approval rate for the DIS was nearly 90%, ISO can claim a mandate that would justify it ignoring the negative comments, and publishing the DIS as FDIS with few changes, if any.
The DIS, seen largely as a product created under the intense influence of BSI, was accepted by the UK, BSI’s home nation. Surprisingly the US rejected the standard soundly, voting unanimously to send the standard back for a re-write. Sources tell Oxebridge the approach to “risk based thinking” was a serious concern for the nations of Canada, Japan and Germany, as well as the United States. Risk based thinking is a new requirement in 9001, driven by the mandatory Annex SL requirements, and does not represent any established risk method, and has been largely ridiculed by risk management professionals and the authors of ISO’s own risk management standard, ISO 31000.
An explanation for the voting pattern could be gleaned from the makeup of the various member nation mirror committees, which are populated with a majority of representatives from large certification bodies, who have a financial interest in ensuring there are no delays in publication, so that they can offer certification services as soon as possible. Because TC 176 participation is voluntary, and requires members to travel the world, membership is largely limited to those individuals funded by vested interests, such as certification bodies.
Normally, this would be true for the United States, but the US TAG faced tremendous pressure from its aerospace and automotive industries, and was the primary target for Oxebridge’s “Public Call” campaign, which asked ISO to take a temporary pause in development of 9001 to account for user feedback. This pressure seems to have overcome the normal influence of the CBs on the US TAG.
The development process has been contentious and controversial, with numerous accounts indicating that ISO violated many of its procedures in order to get the standard published on time. For the DIS version, ISO fast-tracked the publication by making the mandatory translation and review periods run concurrently, rather than sequentially; this dramatically limited the ability of non-English language nations from properly reviewing the DIS, while ensuring the end publication date remained unaffected. An investigation into the irregularities is likely to take place once the final IS version is released in 2015, and ISO’s claim that ISO 9001 is not a barrier to free trade may be challenged before the World Trade Organization.
Once the FDIS is published, only grammatical and minor wording changes are allowed before final publication as an approved International Standard.