ISO 9001 News ISO 9001:2025 - What should be changed in the next Edition of ISO 9001? - REVISION PROCEEDING- August 2023

ISO_Man

Involved In Discussions
Back in 2008, I started the What should be changed in the ISO 9001:2015 Standard? thread. Interestingly, my very first suggestion (to re-phrase preventive action) ended up happening. In fairness, it was more to do with the structure of the High Level Structure, but and, nevertheless, the much maligned preventive action element was removed from all ISO Management System Standards and "replaced" with the ill-defined risk based thinking.

I think we should now start talking about the next revision of ISO 9001, because me and a few others here like to lead, not follow. Our own Cover Paul Simpson is now in charge of the subcommittee 2 under the TC 176 and might visit The Cove to see our ideas. Due to the ISO protocol, the next revision of ISO 9001 should not be a significant departure from the previous since the last revision cycle brought up major changes and ISO can not rock the boat too much in consecutive revisions. Also, of notice, we should realize that the ISO/IEC Directives are being changed and we already know that some changes are being proposed to the HLS, which, apparently will become Annex L, instead of Annex SL in that document.

So, it is unlikely that ISO 9001:202X will have any major revisions. Having said that, I wish Paul Simpson would drive something that I've mentioned a few times here at The Cove, as he leads the SC2. In my opinion, based on experience, it is long overdue the need for two separate standards in the ISO 9001 context. One should be meant for the typical manufacturing organizations and the other, equivalent one should be aimed at service organizations. Since 1987, ISO 9001 has been rewritten with the goal of making it more "user friendly" to service organizations, but, in all honesty, the balance is not there. Some aspects of service based organizations are totally distinct from manufacturing operations.

For example, service "design and development" does not follow the typical hardware D&D cycle. Production and service provision are, typically, handled in significantly different ways, as well. Ditto for determination of customer requirements, etc...

I know there is resistance in the TC 176 for the idea of a 9001-like standard for service organizations, but, in my professional judgement, it is long overdue. Even ISO has created a TC for "Excellence in Service". So, they realize that there is an issue which demands being addressed.

Now, what do you think? What should be changed in the next version of ISO 9001? Comments, suggestions, opinions welcomed.



I'd love to see more guidance and tips on the development of QMS structure -- i.e. not creating a separate SOP for each ISO area but rather a thematic approach. This is partly selfish as I'm now managing the audit of 28 separate SOP's based on a commitment that was made to audit each one every year - the commitment was made prior to my arrival. The auditors are not quality professionals and tend to do the minimum amount of work and avoid writing corrective actions. There has to be a more efficient means of putting a plan together.
 

mattador78

Quite Involved in Discussions
To make a bad situation worse, any standard has to be written (in English) using words which can then be translated into a variety of languages which still make sense in those languages - a difficult task made worse by the fact that some of the fundamental elements don't actually make sense or hold together in the English...

...and of course they have the daft situation whereby they have a variety of sub-committees all working on related subjects but with little or no co-ordination, and probably with conflicting interests and knowledge (oops, I almost said competence...!)
That's the worst thing trying translate some of the English into working English that includes a few profanities that everyone understands. When I first sat down to read through the standards we use here I felt like HAL 9000 was reading them to me in my head which gave it a very sinister undertone if I'm honest. I would much rather it had a more dulcet tone like Patrick Stewart or Morgan Freeman, which would then allow me to easily translate it into my brain lol
 

Bill Levinson

Industrial Statistician and Trainer
My inclination would be to take ISO 9001 beyond its focus on quality to address all seven Toyota production system wastes, some of which can be more costly than poor quality. A waste (muda) is a gap between the current state, i.e. what we are doing now, and a desired or perfect future state.

Frank Gilbreth's non-stooping scaffold is a perfect example. Prior to its introduction, brick layers had to bend over to pick up each brick, and could lay 125 per hour in this manner. The non-stooping scaffold allowed them to lay 350 per hour, thus proving that the bad job design wasted 64% of their labor. If nothing was wrong with the quality of the walls, however, there would be no quality nonconformance to initiate corrective and preventive action. I wonder if this kind of waste would even be visible to ISO 9001:2015 today.

I am in fact reading Roderick Munro's article in Quality magazine Understanding How Management Involvement Impacts the Risk of Quality Cost | 2019-11-08 | Quality Magazine which says "The ISO 9001 does not contain the word cost, cost of quality or other related term; however, in section nine – Performance Evaluation, organizations are required to document how risk-based thinking is being applied in their organizations." Perhaps this should be changed.

One reason more organizations might not use ISO 9001 is that they don't understand how it can make them any money, while they must in fact pay to maintain their quality systems and have them audited. Modification to focus on all wastes, with emphasis on quantifiable financial results, could easily change their minds and also deliver more value to them and their supply chains.
 

Big Jim

Admin
Interesting idea.

What I would rather see is better emphasis on four core KPI. Customer satisfaction, product quality, on-time delivery, and supplier performance. Tracking these four and consistently attaining high scores will bring a marked increase in profits. I have seen it time and time again. These four are specifically mentioned in AS9100D. Three of them are specifically in ISO 9001:2015. The fourth, on-time delivery is a common measure for measuring the overall performance of the quality management system.

Specifically, three were specifically mentioned in ISO 9001:2008 is element 8.3. It got a bit garbled up in its replacement in ISO 9001:2015 9.1.3 when the awkwardly reworded to to include mention of risk.

Make it clearer next time around.
 

Zearl

Starting to get Involved
Remove ambiguity. The 9001:2015 standard requirements differ greatly depending on a given auditor.
I remember trying to explain the standard to one particular manager for months (even over a year). Once
I thought he had it, the next time he would loop right back into the "this isn't clear" mode. He wanted
something more like the original manufacturing standard that was specific in requirements for manufacturing.
By trying to make the standard applicable for say raising wombats or a convenience store, while also applicable to a complex
manufacturing plant, much vagueness persist throughout.
I like the idea of splitting the standard into manufacturing and service subjects.
 
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