Please, don't say that, ISO guys might read this a write some new requirement on the "new" 9001, related with AI...
ISO 9001 News ISO 9001:2025 - What should be changed in the next Edition of ISO 9001? - REVISION PROCEEDING- August 2023
- Thread starter Sidney Vianna
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Dr. IJ Arora
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I have never been in favor of having two versions of the standard. Why complicate issues. If some minor changes are required in Clauses under 8.3 those can be included in the same standard as an update (additional clauses). Other changes I may want to see I am not mentioning, as they are already under discussion. I too am a member of the TAG 176. My thought (and I agree with you here), is to not make a sea change in the next standard. HS (Harmonized Structure) is beginning to be accepted. In large organizations where they have separate quality, environment etc departments, the HS is not popular!!
Dr. IJ Arora
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The content of Clause 9.2.2 e should be removed from there and moved to Clause 10.2.1. That way addressing NCs is covered in one clause.
But there are MULTIPLE versions of 9001, if you are not aware. Standards such as IA9100, IATF 16949, ISO 13485, TL-9000, etc....these are all standards that were either augmented and/or derived from 9001 but stakeholders needed more granularity in the requirements to address specific risks not explicitly covered in 9001.
Quality assurance for service organizations has it's own set of challenges and risks that are not properly addressed in the current version of 9001, in my estimation. In addition to that, the TC176 SC2 scrambled to "justify it's existence" when the voting members voted for NO-CHANGE in 9001, before being railroaded later on. If you remember, there was an asinine, short lived proposal of transforming ISO 9004 in to a requirements standard. Apparently a make-work proposal to keep them busy when ISO 9001 was deemed to remain unchanged after a confirmation poll. When that proposal was defeated (thankfully), some committee people concerned being idle for a long period went back to the polling table to "force" the 9001 revision. If it were not for that, SC2 would probably spend many many years, doing nothing but twiddling their thumbs.
Rather than creating another different standard, it would be better to improve how ISO 9001 addresses services. This would mainly require changes to section 8 (Operation), focused mostly on subsections 8.3 (Design), 8.5 (Production and service provision), 8.6 (Release of products and services), and 8.7 (Control of nonconforming outputs). This would likely be difficult and I would be surprised if ISO does it well, but I think a separate standard for services would end up with an even worse result.
A new standard is likely to eventually deviate on all the other sections as well, creating unnecessary variation (and possible conflict) in requirements for organizations that provide both products and services.
API (American Petroleum Institute) has gone on a path that illustrates a few of the complications that can arise when creating separate standards for products and services. API Q1 has been around for decades and was focused on manufacturing, but also included "servicing" (i.e. repair of product). Then API Q2 was created for "service supply organizations", with the intent that it be used by drilling companies and others working at the well site, and maybe also organizations that service products used at the well site.
Manufacturers who also service their products did not feel that API Q2 was appropriate to their needs and did not want to have to meet both API Q1 and API Q2. Others who provide services away from the well site also did not feel that Q2 was appropriate for them.
The 10th (latest) edition of API Q1 has now broadened its scope to include a wider range of services while still trying to avoid infringing on the scope of API Q2. The current Q1 definition of product is "Output of an organization intended to be provided to a customer" with a note that this can include "hardware, software, production activities, or product related activities such as: servicing, storage, distribution, and logistics." Q1 mostly treats services the same as products (as a service is considered to be a product), but they are exempted from some requirements (such as design). The standards committee work on including services in Q1 was very time-consuming and many members were often confused on this topic.
API now has one document (Q1) that addresses products and some services and another (Q2) limited to only some services.
Dr. IJ Arora
Involved In Discussions
Not to push the point but I specialize and teach, consult and audit each of the standards you have mentioned. My point is not what they did or did not do, but that are two versions necessary, if only a few additional requirements specific to service specific requirements can be added/ updated in the same standard. Thank you for the inputs. IJ
I don't know the best answer, but I do now that currently product and service are so badly tangled that it leaves room for lots of misunderstanding and misapplication. I think it may take more than slight rewording to correct the problem.
The following list shows the obvious need and demand for appropriate international standards in the ever growing service sector. The lack of vision by TC 176 to address it is just another sign of its current state. Most of the current members don’t even know the existence of the previous 9004-2 document.
I an reminded of a quote by Einstein: You cannot fix something with the same level of thinking that created the problem…(paraphrased a bit)
Perhaps, just perhaps we need to delete the standards and start over with all different people and write them in plain English?
A dream I know, but still….
Perhaps, just perhaps we need to delete the standards and start over with all different people and write them in plain English?
A dream I know, but still….
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Should ISO 9004 be changed from a guidance document to a requirements standard?