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

Bev D

Heretical Statistician
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Data and lots of it is core element and output of our increasingly integrated data collection, monitoring and experimental organizations. Data integrity starts at the collection point and includes electronic transfers, the formulas, manipulations and transformations as well as the answers. In my last organization this was a big yet necessary undertaking. AND, unlike our effects on climate change, it has a direct effect on the quality and reliability of our products.
 

Sidney Vianna

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Personally, I am surprised ISO 9001 says nothing with respect to the integrity of data (ALCOA). This would be in my wish list for any future revisions of ISO 9001.
Documented information (aka records) protection equates to data integrity. Now, if you are concerned with ethical management of data, there is no standard in the world that will be able to stop fraud if the organization culture either promotes or allows that to happen. People will do unethical, immoral things and break laws in some circumstances.

AS9100 has requirements for ethical behavior. I doubt a single NC has been written (internally or externally) against that requirement.
 

Bev D

Heretical Statistician
Leader
Super Moderator
It really is about more than what ISO covers. It’s not just about ‘fraud’. The two areas I tend to focus on are the torturous paths of data transfer across multiple systems (been bit by that!) and the transparency and availability of data (huge area of risk).

Most of you know that what I dislike about the standards is that they are a minimal standard and too many organizations try to contract lawyer their way out of good quality as well as the abusive punitive and ignorant auditors that overstep ( no one here of course:)). So like everything, ISO is more likely to get it wrong and vaguely over reach on this too….
 

Ed Panek

QA RA Small Med Dev Company
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I suspect highly ALCOA-compliant management teams have a "Never send me bad news via email...do it in person or via a call" just to be safe. ALCOA means data that the company wants to share is authentic.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Only if they have a history of hiding things, manipulating data, corrupting data, losing data, performing incorrect mathematical/statistical calculations, censoring results they don't like, performing biased studies, etc. As a data goddess...I know the temptations and risks of these things even if unintentional ;)
 

Mike S.

Happy to be Alive
Trusted Information Resource
Only if they have a history of hiding things, manipulating data, corrupting data, losing data, performing incorrect mathematical/statistical calculations, censoring results they don't like, performing biased studies, etc. As a data goddess...I know the temptations and risks of these things even if unintentional ;)
Wait, is this the Boeing thread? :LOL:
 

Randy

Super Moderator
Wait, is this the Boeing thread? :LOL:
ISO 9001:2025 - What should be changed in the next Edition of ISO 9001? - REVISION PROCEEDING- August 2023
 

Sidney Vianna

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I had seen this document about a month ago. Some of the statements in this document are definitely part of a pipe dream. And, while I also subscribe to the idea that progressive, modern, intelligent, business-oriented quality management can be a component of an organization ESG framework, I am concerned that the TC 176 is definitely losing the focus on it's core mission.

If exposing what I consider ineptitude and terrible strategic decisions by a committee that, in my opinion, are clearly veering away of the expected path, makes me a troll, so be it. People don't like being exposed for supporting an entity that is clearly losing sight of it's mission. I don't care. History is full of examples of entities that were so refractory to external feedback that drove themselves into oblivion.
 

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