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

[Sidney Vianna]

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.

Edit 2020-06-01 - Changed the title to ISO 9001:2024 (instead of 2023) because the revision process (to be confirmed) will start in 2021 and, with ISO's bureaucratic protocols it would be extremely unlikely for the standard revision to be finished by 2023.

 

[Pancho]

There seems to be a disconnect between acquiring information and making it useful. Service is based on knowledge. Organizations that can translate customer interactions into service improvement achieve better quality. Thus, I’d like to see some more emphasis on knowledge management.

But such emphasis would also be helpful to manufacturers. By the way, apart from its merits, splitting the standard would indeed be a major change, perhaps left to the next, deeper iteration?

 

[Sidney Vianna]

By the way, apart from its merits, splitting the standard would indeed be a major change, perhaps left to the next, deeper iteration?

The way I see it, the current (5th) edition of ISO 9001 could go through its review/revision cycle with minor amendments. As for the Service focused standard, actually, the TC176 used to have a guidance standard for service organizations and, if memory serves me, it was ISO 9004-2. It was not a requirements standard, though.

 

[Big Jim]

It would help immensely if the term "process" was better defined or perhaps an indication of when they are talking about business processes and when they are talking about manufacturing processes.

 

[chetws]

It would help immensely if the term "process" was better defined or perhaps an indication of when they are talking about business processes and when they are talking about manufacturing processes.

You would think this would be an easy thing to clarify, but my understanding is that TC 176 doesn't have any actual process engineers. This lack of process engineers is a reason why "process" is used so loosely and inconsistently in 9001.

 

[Mike S.]

Clarify the intent of these two from 9.2.2,

c. select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

e. take appropriate correction and corrective actions without undue delay;

 

[Peter Fraser]

It would help immensely if the term "process" was better defined or perhaps an indication of when they are talking about business processes and when they are talking about manufacturing processes.

Now there lies a hornets' nest! What is a process? / What is a business process? / What is a system? / What is a management system?

I understand that they are currently considering adding a comma [after (3.8) below] to the current definition of a management system <set of interrelated or interacting elements of an organization (3.1) to establish policies (3.7) and objectives (3.8) and processes (3.12) to achieve those objectives>, but since I disagree with the current definition, this punctuation change won't help. There are some more radical changes required to a number of the basic definitions, but I am not sure that ISO appreciate the need.

 

[Sidney Vianna]

It would help immensely if the term "process" was better defined or perhaps an indication of when they are talking about business processes and when they are talking about manufacturing processes.

I agree that the single most beneficial clarification that the TC 176 could offer to users of the ISO 9001 is to make it abundantly clear that the QMS processes and the quality system do not exist outside of the business, but are an integral part of the business processes. To this date, "quality professionals”scratch their heads when asked to identify the QMS processes in their organizations and, most totally ignore the whole set of what the business does every day to generate revenue and profits.

In 9001:2015, we had a start in 5.1.1.c) but the concept that the quality system is part of how the business operates should be front and center of 9001:2023.

How many organizations still operate under the false pretense that the quality department is the one responsible for "quality”and customer satisfaction? Why is that? Simply because the "leaders” of the organization have never understood that quality (and the lack thereof) happens everywhere: in purchasing, in product design, in recruiting and hiring, in management decisions, in production, in shipping, in customer support, in marketing, etc...

Why the TC176 has failed to make that aspect clear to users of the document is a mystery, to me. It shows a huge disconnect between the TC176 contributors and the real world of small and medium sized enterprises.
Long overdue clarification, in my assessment.

 

[Big Jim]

You would think this would be an easy thing to clarify, but my understanding is that TC 176 doesn't have any actual process engineers. This lack of process engineers is a reason why "process" is used so loosely and inconsistently in 9001.

What's wrong with the concept of using only terms that are well defined? Very poor writing. Very poor attention to context.

 

[jmech]

TC 176 / SC2 should follow relevant ISO 9001 principles/requirements in making the revision, including the following:
1. As per ISO 9001:2015 Section 4.2, they should understand the need and expectation of organizations that follow ISO 9001 for a clear and helpful standard.
2. As per ISO 9001:2015 Section 5.1.2 c, the top management of TC 176 / SC2 should ensure that the focus on enhancing customer satisfaction is maintained. It would be helpful if they also monitor customer satisfaction per section 9.1.2 and analyze data per 9.1.3 to help them in focusing on enhancing satisfaction and making changes that will improve customer satisfaction.
3. As per ISO 9001:2015 Section 7.1.6, they should ensure that they have the necessary knowledge to write a good standard. This should include gathering knowledge from customers (standards users) and incorporating the knowledge of standards users in how the standard is written. For subjects where the committee lacks sufficient knowledge (such as knowledge management and risk management), they should refrain from writing requirements or they should acquire sufficient knowledge.
4. As per ISO 9001:2015 Section 7.2, they should determine the necessary competence for standard writers and ensure that only competent personnel are involved in writing the standard.
5. As per ISO 9001:2015 Section 8.2.2, they should ensure that they can meet the claims that ISO makes about ISO 9001. Currently, ISO's website page for ISO 9001 claims that "Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits." Considering the recent decline in ISO 9001 certifications, and the significant user dissatisfaction with ISO 9001:2015, it is dubious that ISO 9001:2015 "brings many business benefits" - large numbers of businesses don't normally drop something which is bringing them many benefits. Either TC 176 / SC2 should write a useful standard which "brings many business benefits" or ISO should revise its claims to something more accurate, such as "ISO 9001 certification can help an organization to make sales to organizations which require external providers to have ISO 9001 certification."
6. Perhaps most importantly, as per ISO 9001:2015 Sections 8.3.3 - 8.3.5, TC 176 / SC2 should consider the functional / performance requirement for the standard that it be clear, unambiguous, and auditable, and should verify that the finished standard is clear, unambiguous, and auditable.