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

chetws

Starting to get Involved
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.

I agree. If TC 176 actually did what they require 9001 users to do, perhaps they would figure out why their own business is shrinking as discussed in this thread:

Annual ISO Survey of Management System Certificate Numbers - September 2019
 

Sidney Vianna

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Admin
As a reminder, the ISO TC176 SC2 declared Vision & Mission are:

Our vision is:
  • that our products should be recognized and respected worldwide, and used by organizations as an integral component of sustainable development initiatives.
Our mission is:
  • To develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation of a robust quality management system.
  • To establish generic quality management system requirements that provide the foundations to build confidence in products and services delivered throughout the supply chain to organizations and people worldwide.
  • To provide guidance and support, where needed, to ensure the continued credibility of our products.
I have already asked this before and got no answer: Why would the chairperson of the ISO TC176 be an Environmental Management System Professional? :unsure: The TC176 is a QUALITY management system committee; so you would expect we would have a Quality management system professional in charge.

Also, the ISO TC176 Strategic Plan (attached below) is long overdue for a revision, since the last publicly available version, dates back to 2013.

The structure of the TC176 is displayed below. One should wonder what the Brand Integrity Group is doing these days as, I am sure, the latest ISO Survey data does not bode well for ISO and the TC176.

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

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Tagin

Trusted Information Resource
1) Resolve inconsistency in documentation requirements.The term 'determine' is used frequently ("shall ...determine the sequence and interaction of these processes"), but there is no consistency in when the results of these 'determines' must be documented. The expectation by the auditor is that the org will have a process-interaction map or similar documentation, which implies that the org must maintain this documentation; however, there is no explicit documentation requirement in the standard for this. This occurs repeatedly throughout the standard.

2) If its a requirement, give it a number/letter: E.g., 6.2.1 contains "shalls" a-g, and then tacks on afterwards a line "The organization shall maintain documented information on the quality objectives." Why is this last "shall" unlabeled and not 6.2.1h??? 7.1.6 has 3 separate "shalls" and none of them are identified with letters.

3) Remove thought-crimes: the standard repeatedly invokes "shall consider" as a way to prompt orgs to think about some topic, but this vague wording leads essentially to what I call "thought-crimes", where the org risks a n/c for not having evidence of thinking this way or that, despite the explicit lack of a documentation requirement.
 

Big Jim

Admin
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.

Are you suggesting that TC-176 Should be ISO 9001 Certified? Or at least that they should be following their own rules? What a thought.
 

John Broomfield

Leader
Super Moderator
All organizations deliver a service to some extend if only to help differentiate their products from the competition. So, adopt the ISO 26000 definitions of service and product:

service
action of an organization to meet a demand or need

product
article or substance that is offered for sale or is part of a service delivered by an organization.

Stop saying product or service. It is more accurate to say service with or without product.

Lastly, import key principles on sustainability from ISO 26000 into ISO 9001 to reflect what is commonly accepted as good practice now that we are facing the considerable risk of a climate emergency.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I would like to see requirements for certain documentation come back, or added clarity when retained documentation is required. For example, the results of review when instruments are found to not conform to calibration requirements.
 

qualprod

Trusted Information Resource
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 always find some confusion with the 1-improvement coming from opportunities (6.1) and general improvements. (10.1)
Thanks
 

Sidney Vianna

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Leader
Admin
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.
In the late 1990's, the ISO TC 176 made a strategic decision that, in my opinion, compromised the development of ISO 9001 and, as a consequence it's future. It was a decision motivated by short sighted greed with profound implications, that are becoming apparent now, many years later.

In the early days of ISO 9001, the document was developed and presented as a quality assurance standard. It was clearly designed to provide confidence and assurance to the customers of organizations using 9001; because of that, the early adoption and explosive growth of ISO 9001 came from large customer mandates for the supply chain to implement 9001 and attain certification.

Let's face it: as long as business exist, suppliers will be perceived, simultaneously, as an asset and a liability, but robust quality systems in the supply chain have always been considered as a way to mitigate risks; thus the intrinsic appeal of a standard and it's associated certification scheme which gives "assurance" to customers about supplier's system to fulfill orders.

In the late 1990's, ISO (and the TC176) realized that, if 9001 was "sold" solely as an assurance standard where the primary beneficiaries were not the organizations implementing the standard, but their customers, the "voluntary adoption" path would be compromised, i.e., the numbers of companies adopting 9001 would be limited by the number of corporations and organizations mandating suppliers to attain certification.

Their (flawed) solution? Confound the users and sell the idea that 9001 can be also a quality management standard, differently than a quality assurance standard. So, organizations would "feel" that they too, could benefit from using the document, even if customers did not require them to be certified to it. In my opinion, this was the biggest blunder, because, in order to transform 9001 from an assurance document into a management standard, requirements have been watered down, hard-coded shalls were transformed into subjective statements, confusing users and auditors, who are supposed to assess conformance against unclear wishful thinking, such as "risk based thinking" and "opportunities". In other words, trying to pander to the (misperceived) wishes of both users and their customers made the document devolve into something that does not cater to the needs of either one.

The ongoing decline of ISO 9001 certification numbers around the world leads me to believe that this major faux pas backfired, big time. Organizations that used to mandate ISO 9001 certification to the supply chain either stopped doing it altogether or created industry controlled standards and certification schemes to deal with the lack of added assurance and confidence. Examples abound: the IAQG AS91X0 standards, the IATF 16949, TL-9000, etc... Organizations that were led to believe that ISO 9001 would improve their business performance and provide marketability did not see the promises materialized, thus dropping the voluntary adoption and certification of the standard.

Very hard to fix this major strategic mistake by ISO, who got greedy with the success of 9001 and the TC 176 which allowed it's best selling document to be "hybridized" for commercial reasons, devaluing it along the way.
 

John Broomfield

Leader
Super Moderator
Sidney,

Very good point well made.

I remember well the change from QA to QM in the industry in the late 70s at about the same time BS 5750 (and Crosby’s Quality if Free) hit the streets.

Crosby was one of the first leaders to use the term quality management.

In our attempts to engage top management in developing their management systems we were quick to embrace the term quality management. Quality management systems were recognized as the means to “deliver confidence that requirements will be fulfilled”. QA became a deliverable (feeling) instead of an action.

But I agree with you that that term QM has lead to us having to broaden our remit to consider the needs of stakeholders beyond each and every customer.

But at the time of their change in focus TC176 was trying to keep up; well less than 15 years behind! No doubt the profit motive influenced their decision too.

John
 
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Sidney Vianna

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Admin
But I agree with you that that term QM has lead to us having to broaden our remit to consider the needs of stakeholders beyond each and every customer.
Without a question, any organization has to balance the interest of many interested parties, but without customers, organizations simply do not exist; thus, attending to customer needs is paramount for the survival and prosperity of any company.

In my copy of ISO 9001:1987, I note the scope of the document, which reads, in part:
This International Standard specifies quality system requirements for use where a contract between two parties requires the demonstration of a supplier's capability to design and supply product.

I still contend that it would be better to have different versions of the standard for different contexts, such as:
  • traditional B₂B relationships between commercial and/or governamental entities
  • B₂C, such as consumer goods, where a "contract" does not exist per se,
  • service organizations, with it's intrinsic peculiarities that don't mirror manufacturing organizations,
  • software developers (remember ISO 90003 and TickIT?)
  • etc...

A document that attempts to be all inclusive and universal to all contexts is a hard sell; pun intended :naughty:
 
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