Historically, the output of the systematic reviews of ISO 9001 has always yielded a decision to revise. This was by happenstance—and not deliberate. There is never a predetermined outcome.
However, the misconception that arose shortly thereafter was that the “no revision” decision extended absolutely for another five years. The actuality is that a systematic review may occur at any time.
With well over one million certified organizations around the globe using this standard as the foundation of their management systems, it would be irresponsible to allow ISO 9001 to lose its prominence. There are market sectors where the “ISO 9001-certified” badge carries significant weight in the supply chain.
For example, the 2000 version of ISO 9001 abandoned the three-tiered set: 9001 (all requirements), 9002 (all requirements, except design) and 9003 (slimmed down to only reflect requirements related to inspection and testing). In the past, an organization often sought certification just to ISO 9002 because it didn’t have design processes. (This is not to be confused with the current ISO/TS 9002:2016, “Quality management systems—Guidelines for the application of ISO 9001:2015,” which is totally different. ISO likes to recycle numbers.)
It’s anticipated that both documents will be approved and ready for publication by the end of 2025, or shortly thereafter. As with any such project, there’s always the possibility of unforeseen delays.
Since ISO 9001’s inception, the revisions have alternated between major changes and minor ones. Again, this wasn’t based on directives; it’s just how things happened. The design specification for each revision takes into account multiple factors, including things like market feedback. This essentially drives how extensive the changes will be.
The technical experts for ISO 9000:2015, the fundamentals and vocabulary that are normative to ISO 9001, engaged in comparable discussions. Were there new terms that didn’t exist within the context of a quality management system 10 years ago? Are the quality management principles still applicable as described?
Per the ISO directives, a standard is required to go through systematic review no more than five years after its release date. The systematic review can be done sooner than the five-year anniversary if it’s deemed appropriate by the technical committee for a whole variety of reasons. Here’s an important point: Systematic review isn’t synonymous with automatic revision. The reviews must take place at the prescribed interval. The decision to revise or not is the output of that review. So, the persisting misperception that standards must be revised every five years is false.
And remain optimistic.
منبع: https://www.qualitydigest.com/inside/risk-management-article/iso-9001-being-revised-032824.html
Of course, as in years past, there will be the ubiquitous questions concerning the transition cycle period. That determination is under the stewardship of the International Accreditation Forum. It is responsible for promulgating the rules surrounding auditor training and transition periods. Since the standard hasn’t been approved, any decision at this time would be premature.
Work had been ongoing in the background as the eventuality of the need for a revision was undisputed. This helped to lay the groundwork and will hopefully bring efficiency to the current revision process.
A second systematic review was launched in spring 2023. On July 28, 2023, the ISO TC176 member bodies voted to revise ISO 9001. A vote to revise ISO 9000 followed several weeks later.
As a side note, it’s appropriate to point out that the recently published amendment regarding climate change is outside of the scope of the ISO 9001 revision project. This is a separate initiative that was driven by the ISO London Declaration on climate change that relates to all management system standards.
The launch of this particular revision cycle was markedly different from its predecessors. The green light for revision didn’t happen right away. ISO 9001:2015 went through its systematic review in 2020—the first year of the pandemic. While Covid-19 can’t be blamed for the decision that ensued, it would be disingenuous to ignore its influence on the decision makers. Vast areas of the globe were on lockdown; international travel had come to a near halt. Virtual meetings were in their infancy—unheard of in some areas. There was no pragmatic workaround that could be envisioned for people to come together to work on revising an ISO standard. Therefore, it was not a great surprise that the output of the systematic review was to affirm, i.e., not to revise.
The resulting products are expected to encompass minimal changes. The overall intent is to address ambiguities, improve text, resolve textual inconsistencies, and address any essential global changes that would affect an organization today.
It’s worth spending a little time talking about how we got to this point. Here’s the typical scenario for initiating a revision process.
The risk of ISO 9001 becoming a stagnant document with diminished global relevance became apparent. Things had changed around the world. To highlight just a few: digitized processes, AI, climate change, ESG initiatives, virtual companies (with no geographic address), crypto-currency, and all the smaller innovations and inventions in markets and sectors.
Now we arrive at the next revision project.
In preparation for the revision, the technical experts of TC176/SC2 considered multiple factors. These related to such issues as globally relevant business and societal changes, requests for interpretations (that often suggest ambiguity or lack of clarity in a requirement), text relating to documented information, and auditability. There were undoubtedly other multiple and varied considerations during the many discussions. Benefits to the users of potential changes were also considered.
In the months ahead, there will probably be lots written about the revision to ISO 9001. Look for opportunities to engage with quality professionals and technical experts—especially once the draft international standard (DIS) is released.
During the next two years there was further deliberation. The consequences of not revising were considered. The risk of ISO 9001 becoming a stagnant document with diminished global relevance became apparent. Things had changed around the world. To highlight just a few: digitized processes, AI, climate change, ESG initiatives, virtual companies (with no geographic address), crypto-currency, and all the smaller innovations and inventions in markets and sectors. By the end of 2022, the pandemic itself had irrevocably changed how many of us communicate and work. To retain relevance, ISO 9001 must continue to accommodate and reflect these evolving realities.
There were several inputs into the review, including market feedback, consideration of global changes, and innovations in technology. But the chief driver of the decision was the vote in November 2020 by the ISO member bodies. The world was topsy-turvy; people were otherwise focused.
With the 2000 revision, this was now handled with text in Clause 1.2 of ISO 9001:2000 defining the requirements for citing exclusions. So, this revision to the standard was a big change.
By contrast, the 2008 version of ISO 9001 was more moderate. The changes were minor and focused on clarification, alignment, and language. Then ISO 9001:2015 brought us a whole new structure, risk-based thinking, and the context of the organization. Again, a big change.
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard. So, what’s up?
The resulting design specifications (plans for revision) reflect which of the deliberations should appropriately find their way into the next revisions of both documents.
Now the technical experts are hard at work. The next two years will see the documents go through the regular cycle of working draft (WD), committee draft (CD), international draft issue (DIS), final draft issue (FDIS), and finally publication. Interspersed will be the requisite commenting and balloting periods followed by more working group meetings and lots of editing. Concurrent with the revisions will be cross-functional work to ensure that ISO 9000 and ISO 9001 remain aligned. New terms may be added; others may be revised.