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

[Yarik]

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

We need a much clearer description of what must be contained in the Quality Manual

Another potential opportunity for the TC 176 to learn from the TC 207? ISO 14001 does not have requirements for an Environmental Management System Manual. And, guess what? Organizations are still able to implement an EMS in the absence of a manual. Maybe we should apply the same logic to Quality Management. Especially when we realize that quality manuals, for the most part, are meaningless pieces of command media.

Progressive organizations could implement effective QMS's without a quality manual, IMO. Another relic to be disposed of?

For example, all the requirements imposed on Quality Manual (4.2.2) could be imposed on QMS documentation as a whole (e.g. replace 4.2.1.b). Then it would be up to an organization to decide what specific document(s) should contain the required information.

Unlike the Standard itself, the guidance documents on QMS documentation still could recommend to have a "Quality Manual" at the top of QMS documentation pyramid (if this is a good practice)...

 

[Yarik]

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

This is rather a question than suggestion, but... here is something I was pondering on lately:

What is the rationale behind encapsulating documentation requirements in subsection 4.2 of Clause 4, "General Requirements"?

Isn't documentation just one of the resources that an organization needs to work? If it is, then why not encapsulate all the documentation requirements somewhere under Clause 6, "Resource Management"? (Perhaps, more specifically, under Clause 6.3, "Infrastructure"?)

---
P.S. Interestingly enough, the Clause 6.7 of ISO/DIS 9004, "Knowledge, Information and Technology", does mention management of data and records, but does not say anything explicitly about documentation in general...

 

[meo786]

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

[FONT=&quot]Nice discussion[/FONT]

 

[Patricia Ravanello]

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

Dear Fellow Covers,

It has long been my contention that, from the perspective of "Management System Processes", all ISO-compliant organizations should operate the same way. If we accept this premise, then, in essence their representation of that operation, that is, the description and/or model of the PROCESSES of their Management System "Sequence and Interface" (per 4.1.a and b) should also look the same (with a few noted exceptions, such as, the Phases of Product Realization.).

I have observed organizations struggle and flounder with this requirement, and seen countless auditors accept whatever these organizations have been able to produce. Most documents are too cryptic or convoluted to serve any function, other than to address the auditor's inquiry during audit.

The attached Powerpoint show is self-explanatory, and offers not only an alternative, but an improvement, and a resource which will save millions of dollars in organizational resources the world over...not only for ISO 9000 or ISO/TS 16949, but for all ISO-based systems.

Organizations don't have to re-invent the wheel...the representational model of the dynamics of an ISO-compliant system already exists...we just need to recognize it...and include this Model in the Standard, so that everyone can use it, and so that we all start out on the same page...and are speaking the same language (systemically speaking). That's what "STANDARDIZATION" is all about.

If this Universal Model had been included in the new ISO 9000 edition released in 2008, then we could all agree that the ISO Organizaiton had demonstrated admirable compliance with their own philosophy of Continual Improvement. That's not the case...The document released in 2008 is not only a "money grab", but an embarrassment, both to the ISO organization and to those organizations (registrars/auditors), who police the implementation and compliance of the standard around the world. How many millions of dollars and manpower have been wasted around the world to address this new edition???

Harsh words? Enlightened proposal? Thinking outside the box? What do you think?

Patricia Ravanello
Management Systems

 

[Jim Wynne]

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

Harsh words? Enlightened proposal? Thinking outside the box? What do you think?

Thank you for sharing, and I appreciate your effort in trying to improve things. I'm not sure you've reached your goal, however. Here's what we have--the ISO version, which many feel is oversimplified:

It seems like we've gone from one extreme to the other. Surely there's some middle ground? I find the "new and improved" version confusing. For example, it appears that Monitoring and Measurement and Analysis of Data are springing forth from Control of Documents. Preventive and Corrective action look like they're feeding into Change Control. If a reasonably intelligent and experienced person needs for someone to explain these apparent incongruities to him, I'm not sure that the diagram has served its purpose.

Perhaps the problem is that any diagram that attempts to explain all of this is going to inevitably be too complicated and busy. Why not just use text to explain the interaction of processes? Why is there a universal perception that a diagram is necessary?

 

[Marc]

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

Why not just use text to explain the interaction of processes? Why is there a universal perception that a diagram is necessary?

Because pictures/diagrams are typically more intuitive. You can see at a glance what's happening without wading through pages of text and then trying to piece everything together in your mind.

 

[Jim Wynne]

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

Because pictures/diagrams are typically more intuitive. You can see at a glance what's happening without wading through pages of text and then trying to piece everything together in your mind.

Drawings are more intuitive if they're kept simple enough, but too many of these things aren't. In attempting to cram everything into a diagram, the purpose is often defeated. It doesn't take pages of text; it can be done on one or two pages at most. I've done it. Unfortunately I don't have an example at hand, but maybe I'll try and reconstruct something when I have some time.

 

[Patricia Ravanello]

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

 

[Patricia Ravanello]

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

Drawings are more intuitive if they're kept simple enough, but too many of these things aren't. In attempting to cram everything into a diagram, the purpose is often defeated. It doesn't take pages of text; it can be done on one or two pages at most. I've done it. Unfortunately I don't have an example at hand, but maybe I'll try and reconstruct something when I have some time.

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

 

[ralphsulser]

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.