What should be changed in the ISO 9001:2015 Standard?

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

Of course this is all contingent upon anyone operating a business or manufacturing systems by 2014. There may be nothing left to audit by then.

Thanks for showering us with your inspiring optimism Ralph!!

The sad truth is, you're at least partially right...I think there'll still be things that could be audited...companies just won't be wasting their money on auditors to do it.

Patricia

 

[Jim Wynne]

Re: What should be changed in the ISO 9001:2014 Standard?

Hi Jim,
Thanks for taking the time to review it and respond. I respect your demonstrated knowledge and experience relating to ISO.

I'd be pleased to address your questions.

1) Your perceptions are reasonable, considering you're not hearing the narrative that goes along with the Model. I'd be pleased to provide it to anyone who wants to call and hear it.
Anticipating erroneous or compromised "perceptions" of the Model, I put in a brief explanation of the "INPUT" and "OUTPUT" arrows before the Model, to enhance people's understanding, but, I'll repeat it hear. The arrows represent directional flow of inputs and outputs...
So, for example:

1) The System-oriented processes (the outer track, if you will), are audited and/or monitored and measured, and data analyzed (i.e. process OUTPUT).
2) The results are INPUT into Management Review.
3) Management Review then OUTPUTS CA/PA or Continual improvement into the involved Processes.​

Similarly,
For the customer-oriented processes (Product Realization, Change Control and Control of N.C. Product & Materials)

1) The processes are implemented.
2) The results of implementation (output) are monitored, measured and analyzed.
3) That OUTPUT is INPUT into Management Review.
4) Management Reviews the findings and determines appropriate CA/PA or CI and outputs it back into the process from which it originated. ...so yes, Corrective Action feeds INPUT into Change Control, if appropriate​

The Model clearly demonstrates how the Management Processes interface with all the other system processes.

It's all very simple...it clearly demonstrates the PDCA cycle for all processes. While it may not appear simple at the outset, it is in fact quite focused, comprehensive and refined...and the ISO model remains ambiguous, incomplete and inaccurate, which are reasons enough for removing it, if not replacing it.
And not to belabor a previous discussion, but almost all the Sequence and Interface Models I've seen here on the Cove fail to do this. They all focus on Product Realization, and that's not what 4.1.a and b are asking for.

2) Why not use text instead of a diagram?

Good question...I don't have a problem with narratives, but we all know what is wrong with narratives...no one reads them, and if they do, they don't all necessarily come away with a universal understanding. This pictures is worth more than a thousand words.

I think this Model takes out all the guess-work, and the wasted repetitious attempts to "say the same thing, differently".

...and it can be applied to any ISO organization, with a simple refinement of aspects like:

1) Phases of Product Realization
2) Structure of System Documentation
3) Hierarchy of Management Review.
4) System requirements (ISO/ISO-TS/ISO 14000, Customer-specifics, etc.)​

Other than that...every ISO system should operate according to the dynamics of the Model....and audits should be able to confirm that. Believe me, Managers who are introduced to and utilize this Model have a much better comprehension of the Standard and it mechanics, and are proud "owners" of their system...and are able to articulate its mechanics.

I've added another attachement that also captures the essence of the ISO standard (but is not totally comprehensive in demonstrating all the sequences and interfaces)...and might be used for audiences that are intimidated by the Model. It, too, focuses on the Management System, and not Product Realization.

Thanks again for the feedback Jim.

Patricia Ravanello

You're welcome. I'm still confused, though. You just used over 500 words to explain your approach, which seems to indicate that your diagram might have trouble standing on its own. Also, while I'm not convinced that the diagram elucidates the interactions of processes, I also don't see the sequence being depicted.

 

[John Broomfield]

Re: What should be changed in the ISO 9001:2014 Standard?

Jim,
Why bother? ...the standard is already a narrative, and few Senior Managers will read it. A diagram is much more effective in providing users with a "shared vision" - something that is sorely lacking in many organizations.

Typically this Model is enlarged to 4 ft. x 3 ft. and hung in company Conference, Meeting and Training Rooms. It provides a meaningful and dynamic reference for meetings with Customers, Suppliers, for Management Reviews, and for Employee Training. A narrative can't do that.

Management, Employees, customers and suppliers can all understand and relate to this model. The ISO model, even in it's simplicity, is not understood.
It's too vague and cryptic to be useful.

I hate to see you go to so much trouble, and you could prove your point, but I think it wouldn't accomplish anything.

Patricia Ravanello

Patricia,

In 23 years of developing process-based management systems I have not found two that are similar even if the clients are in the same buisness. Each client has their unique way of getting work, doing work, getting paid (core process), supporting the core process and managing continual improvement.

We already have too many organization's copying the standard and calling it their management system. Some organizations even copy each other's procedures!

There is no substitute for analyzing the system that actually runs the business so it can be understood, modified as necessary, used and improved.

Imposing a cookie-cutter model on organizations ignores the systems that run these organizations. So-called ISO systems cannot be sustained in a fight against the system that runs the business. That is the system that needs to meet the requirements of the system standards.

Clause 4.1 is an adequate specification for the system. It should be adopted by all system standards.

John

 

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

Patricia,

In 23 years of developing process-based management systems I have not found two that are similar even if the clients are in the same buisness. Each client has their unique way of getting work, doing work, getting paid (core process), supporting the core process and managing continual improvement.

John

Thanks for your feedback John.

I wouldn't even begin to dispute that companies have unique ways of doing things. Of course they do! This Model, however, doesn't tell them how to do anything...It only tells them what they have to do, and how these processes should interface with each other, and in what sequence. ISO compliance dictates this. Their organizational uniqueness remains intact.

If they don't operate this way...they're not ISO compliant. It doesn't matter what they're producing, or what service they're providing. This Model has been implemented in manufacturing, printing, tool and die, education and healthcare facilities. It is generic and universal.

Think of it as the system view from 30,000 meters. The uniqueness of the organization is evident only as you move to lower altitudes.

In my experience, I haven't found a single ISO-compliant company that didn't fit this model. The only need for differentiation is in the areas I've already pointed out.

Imposing a cookie-cutter model on organizations ignores the systems that run these organizations. So-called ISO systems cannot be sustained in a fight against the system that runs the business. That is the system that needs to meet the requirements of the system standards.

John, you sound as if you think there are two systems...The ISO "Management System" has to be one-and-the-same as your "system that runs the business". There aren't two systems...If they aren't consolidated into a singular system, then they need to be.

The Universal Model is not the cookie-cutter John...the standard is the cookie-cutter, and it's the standard that imposes specific requirements on every ISO-seeking organization. This model does not define the company...it defines an ISO-compliant company. From this altitude, they should all look the same.

ISO made the rules...I only mapped them out.

Patricia

 

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

You're welcome. I'm still confused, though. You just used over 500 words to explain your approach, which seems to indicate that your diagram might have trouble standing on its own. Also, while I'm not convinced that the diagram elucidates the interactions of processes, I also don't see the sequence being depicted.

Jim,

Both the sequence and the interaction of the MANAGEMENT SYSTEM PROCESSES (of which I have identified 12) are captured and demonstrated to the extent that is relevant at this level.

Here are just a few of the sequences demonstrated by the Universal MOS Model:

Process Sequence:

1) Internal Audit
2) Monitoring, Measurement and Analysis
3) Management Review
4) CA/PA and CI
5) Internal Audit

1) Purchasing and Materials Management
2) Monitoring, Measurement and Analysis
3) Management Review
4) CA/PA and CI
5) Purchasing and Materials Management

1) Employee Competence, Empowerment and Motivation
2) Monitoring, Measurement and Analysis
3) Management Review
4) CA/PA and CI
5) Employee Competence, Empowerment and Motivation

1) Control of Non-conforming Product and Materials
2) Monitoring, Measurement and Analysis
3) Management Review
4) CA/PA and CI
5) Control of Non-conforming Product and Materials​

I'm sure you get the drill.

Additionally, the sequence of activities for all the Phases of Product Realization (although not required at this level) are clearly defined.
Again, through all the Phases of Product Realization, the sub-process performances (as determined by Management) are:

1) Monitored, measured and analyzed
2) Reviewed by Management
3) CA/PA or CI identified and input back to the process
4) Continue to implement the process with CA/PA or CI...
5) ...return to No. 1.​

The details and intricacies of sub-process interactions are not required at this level, but they are well defined in the respective supporting flow charts (sample attached) (that is where companies begin to display their individual uniqueness). What is important at this level, is that you have in fact isolated your KEY MANAGEMENT PROCESSES, and captured how they sequence and interact with each other.

(In the sample Internal Audit process, attached, you can see that there are other processes, like "Employee Competence, Empowerment and Motivation", which interface with the Internal Audit process, but it is a subordinate process which supports the Internal Audit process, and that sequence/relationship is not captured/visible in the Model).

To address an earlier comment...yes...my previous explanation was more than 500 words...I see that as a "positive reflection" on the Universal Model. In fact, it could potentially take thousands of WORDS to articulate all the relationships captured in the Universal Model. I could probably write a book about it, for that matter!

That, I believe is the advantage of a visual representation over a narrative one. Whether visual, or narrative, what is most important is that it is accurate...and I believe that the Universal Model is an accurate and comprehensive representation of the sequence and interface of the Management System processes dictated by the ISO standard, as mandated in 4.1.a and b.

If people understand the Universal MOS Model, they will understand what ISO is all about.

Patricia Ravanello

 

[Patricia Ravanello]

Re: Split top management: At the beginning and at the end.

In line with ISO 14001 (a perennial sister of ISO 9001 and target for enhanced compatibility), the 5th edition of ISO 9001 should split the requirements associated with top management in two distinct sections.
In line with the PDCA cycle, top management should be addressed early in the standard, in terms of setting policy, objectives, targets demonstrating commitment to customer focus, and internal communication, etc....

Then, at the end of the standard, top management should be addressed again on management review of the performance of the QMS, need for corrections, improvement, (potentially) re-setting policy, objectives, targets, etc...

With this model, I believe, the connection with the PDCA cycle becomes clearer. Top management's involvement with the P & A (from PDCA) would be more evident.

Hi Sidney,
Sorry, this feedback is rather late, but I believe that what you are suggesting already exists in the ISO Standard.

If one maps out the requirements, one sees that the Standard already does require that Management be involved at both ends of the processes. I don't think that they have to reintroduce or restate that requirement every time it comes up throughout the system. It's already inherently mandated every time a requirement for process performance monitoring is identified.

This is clearly evident from the attached graphic which captures the incidents of Management involvement, and aligns completely with the PDCA cycle. This visual representation is already articulated in the existing standard. It's up to users to see and map out the "big picture".

If anything, I think it would be useful if the standard included a graphic similar to this attachment, because then users would have a universally consistent perception of the basic mechanics of an ISO-compliant Management System. That way, the subtleties of the written word would not have to be laboriously, and often erroneously flushed out of all the narrative requirements, subject to the skills, interpretation, perceptual abilities and understanding of the considerable body of Standard users.

Patricia Ravanello

 

[Jim Wynne]

Re: What should be changed in the ISO 9001:2014 Standard?

To address an earlier comment...yes...my previous explanation was more than 500 words...I see that as a "positive reflection" on the Universal Model. In fact, it could potentially take thousands of WORDS to articulate all the relationships captured in the Universal Model. I could probably write a book about it, for that matter!

Well, it's nearly 1000 words now, and I'm still not seeing what you say is there. How about the sequence and interaction of say, design/development and purchasing? If I can't look at the graphic and see it and need to have it explained by the designer of the graphic, the thing hasn't served the purpose and you might as well just write it out. I've seen far too many of these things that purport to explicating sequence and interaction that just don't do it. Yours is about as conscientious an effort as I've ever seen, and you're to be commended for the effort, but I just don't think it can be done.

 

[Stijloor]

Re: What should be changed in the ISO 9001:2014 Standard?

Friends,

Re: ISO 9001:2000(8), Cause 4.1 b)

What I have seen over the many years is that there is tremendous effort to try to meet the requirement rather then understanding its intent.

If the standard writers wanted to see some type of a graphical representation, they probably would have required it. Now it has become the common "default" interpretation.

A picture is worth a thousand words, but has its limitations.

Stijloor.

 

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

Well, it's nearly 1000 words now, and I'm still not seeing what you say is there. How about the sequence and interaction of say, design/development and purchasing? If I can't look at the graphic and see it and need to have it explained by the designer of the graphic, the thing hasn't served the purpose and you might as well just write it out. I've seen far too many of these things that purport to explicating sequence and interaction that just don't do it. Yours is about as conscientious an effort as I've ever seen, and you're to be commended for the effort, but I just don't think it can be done.

Jim,
Thanks for persisting with me on this...

The details of processes such as design, development and purchasing are also in the flow charts of those processes. Again, this is the view from 30,000 meters. It is not intended to capture all the intricacies of each process.

4.1.a and b don't ask for the sequence and interface of subordinate processes, only of the MANAGEMENT SYSTEM processes.

The sequence of the Purchasing or Design process are all captured within the flow charts, as is their interface with other processes. I attached the Internal Audit process as an example. All 12 of the key processes are mapped out in a similar way.

I can forward another to you if you like.

Patricia

 

[Coury Ferguson]

Re: What should be changed in the ISO 9001:2014 Standard?

My opinion on this: Get rid of all required procedures. Let the company do business as they would/do.