ISO 9001 4.4.1 "...shall determine the processes needed..."

[John C. Abnet]

Good morning @Big Jim Thanks for the feedback. I am in agreement with you. However, my "dive" into this is more academic than application. While I don't disagree with your statement, I still do not see any requirement beyond what the organization determines. There is no need (as we know) to document the processes,...simply "determine" the processes. (Again, in order to benefit the organization by visualizing the organization strategy and to provide evidence of the act of "determine the processes", I recommend a simple process flow map....BUT there is no requirement to do so).
I would argue that this (in reality) occurs organically. If I own a pizza shop, I'm going to have processes beyond the examples I listed, in order to simply function. If we take the "shall determine" in context, ...it follows the opening statements "...establish, maintain, improve, a quality management system, including the processes needed...." My point in all of this is that IF an organization has the processes needed and functioning ....then they (assuming they are compliant to the balance of the 9001 standard [again, seems nearly impossible to be compliant or operate a functioning organization without the "processes needed"] ), ....then there is no nonconformance, regardless of WHICH processes they specifically "write down". Demonstration of the effectiveness of the QMS, including (not sure how you could separate it), the processes needed- is all that is needed.

What I am digging for is an actual refute of this position based objectively on the verbiage within the standard.

Thanks to all for humoring me in this. There is a reason behind my madness (in this case

Be well.

 

[John C. Abnet]

I appreciate the video you provided @Big Jim . It is well done and can be very helpful. However, it is taking liberties beyond the requirements of the standard (remember, I am in agreement with what the video proposes to be done....no argument there. HOWEVER, just because I council organizations to do it for specific benefits, there is NOT a requirement in the standard).

Here is a portion from the video, which is inconsistent with requirements of the standard.

Be well.

 

[John Broomfield]

If the business is running and reasonably successful, indeed, the processes tend already to exist.

Auditing the system and its processes for effectiveness may not be impartial and objective, however.

But the work of investing in continual improvement, maintaining facilities and equipment and recruiting and training for competence probably will be up and running unless the business has a death wish.

Dare I say risk-based thinking is alive and well but less as a process and more as a work environment touching all critical processes.

Trouble is many “implementers of the standard” are deceived by that command to establish a quality management system and fail to appreciate what they already have.

 

[John Broomfield]

I found the video as part of PJR’s corrective action for a 14-year old nonconformity very interesting.

It says their auditors are now trained to ensure their clients “identify processes in an appropriate manner” or they’ll receive a nonconformity report.

 

[John C. Abnet]

It appears I failed to attach as noted in post #12 . I have now done so here.

Be well.

 

[Big Jim]

I found the video as part of PJR’s corrective action for a 14-year old nonconformity very interesting.

It says their auditors are now trained to ensure their clients “identify processes in an appropriate manner” or they’ll receive a nonconformity report.

14 year old NCR?

ANAB wrote an NCR against PJR during a reaccreditation audit in 2014. Some PJR auditors were not auditing to the auditee's IOP, mainly because they were not written well so to perform a thorough audit the auditors tried to guess what they were.

It is evident that the writers of the standard never intended for the IOP to be used to create an an audit plan. Telling ANAB to show them the shall in ISO 9001 didn't get anywhere.

This is another case of where the writers of the standard in their ivory tower don't know what is going on in the trenches and evidently don't care.

I posted the link to the webinar for those who were seeking guidance for what the CBs are looking for and why so an IOP developed with this in mind can help set up for more effective auditing, both internal and CB.

I find it interesting that the prior widely accepted approach of flow charting led to the confusing IOPs that didn't do much to define the core processes.

If you found the link helpful, great. If you didn't, so be it.

 

[John Broomfield]

ISO 9001 first specified the process approach in the year 2000.

 

[Big Jim]

But they didn't explain it very well. Until they come up with a better definition of what they mean by "process" this confusion will still exist. What they mean by process in 4.4 must be very different than how it is used in 8.5.1f. But they only have one definition and that definition is so broad that a universe could be fit into it. TC-176 doesn't get a pass on their reckless use of the term. They own it and all the confusion it seeds.

 

[Jim Wynne]

ISO 9001 first specified the process approach in the year 2000.

They have never "specified." There has been gobbledygook about "promoting" it, but no one knows what that means.

 

[Tagin]

My point in all of this is that IF an organization has the processes needed and functioning ....then they (assuming they are compliant to the balance of the 9001 standard [again, seems nearly impossible to be compliant or operate a functioning organization without the "processes needed"] ), ....then there is no nonconformance, regardless of WHICH processes they specifically "write down".

TS9002/2016 4.4.1b seems to support this:

when determining the sequence and interaction of these processes, the links with the inputs and outputs of the previous and subsequent processes should be considered; the methods for providing details of the sequence and interaction of the processes depends on the nature of the organization; different methods can be used, such as retaining or maintaining documented information (e.g. process maps or flow diagrams), or a more simple approach, such as a verbal explanation of the sequence and interaction of the processes