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

[Jim Wynne]

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

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

You're redefining the requirements. The QM, according to 4.2.2, must include "...a description of the interaction between the processes of the quality management system." (Emphasis added.) Nothing there about managementsystem processes. Purchasing and design/development are quality system processes, and simply rewording the requirement doesn't get you off the hook. If you have auxiliary or referenced diagrams that do show these interactions, then the top-level document isn't doing what you're claiming it does.

 

[Jim Wynne]

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.

Yes! And we should also rid the world of all known diseases!

 

[Sidney Vianna]

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

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

No, it doesn't. When you say "ISO Standard", I assume you are referring to ISO 9001. Because ISO 14001 is also an ISO standard. The 14001 document clearly defines the P & A (from PDCA) at separate stages in the document. ISO 9001 does not do that.

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 am very careful with choice of words. The ISO 9001 standard requires management being involved with both ends of the SYSTEM, not processes.

 

[Patricia Ravanello]

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

You're redefining the requirements. The QM, according to 4.2.2, must include "...a description of the interaction between the processes of the quality management system." (Emphasis added.) Nothing there about managementsystem processes. Purchasing and design/development are quality system processes, and simply rewording the requirement doesn't get you off the hook. If you have auxiliary or referenced diagrams that do show these interactions, then the top-level document isn't doing what you're claiming it does.

Jim,
I know that you know what the standard says, but for the purpose of discussion and easy reference, here is 4.1 a and b:

4.1 The organization shall:

a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2)

b) determine the sequence and interaction of these processes;​

Firstly, I believe that this fairly clearly is asking for the "System Processes"...and their application. I don't think it matters if you emphasize Quality or Management...it's calling for the "SYSTEM" processes...and not, for instance "Product Realization" processes, (frankly I wish they'd drop the "quality" word, because it's confusing to people),

and

Secondly, this clause is asking for the sequence and interaction of the "System Processes"...again, not Product Realization.​

Jim, the Model is doing what it should...I've identified the 12 "system" processes, and delineated their sequence and interaction.

Processes like design, design validation, verification, manufacturing, delivery, are sub-processes of "Product Realization". My objective here was to define the sequence and interface of the "System" processes. This model addresses that. It is in the Procedural Flow charts that we should delineate the dynamics of the subordinate process in the organization.

For discussion purposes, I've attached another partial Procedural flow chart covering 2 phases of Product Realization. At the flow chart level, you can again see the sequence and interaction of the processes.

In my flow charts, all linked or associated processes are readily identifiable by RED text (both procedures (SOP) and supporting work instructions (WI)). It is in these procedural flow charts that the numerous intricacies and subtleties of the interactions of the sub-processes is delineated and mapped out in sequence.

The "System" Model needn't, and quite frankly, could never capture all these activities, and was never intended to.

Jim, I hope I'm sounding more enlightening than defensive, and I very much appreciate your critique, and am grateful that you are taking the time to provide feedback...it's only in this way that I can correct or improve the model, and hopefully, in the long-run, make it more palatable and efficacious for all interested parties.

Thanks again,
Patricia

 

[Patricia Ravanello]

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

No, it doesn't. When you say "ISO Standard", I assume you are referring to ISO 9001. Because ISO 14001 is also an ISO standard. The 14001 document clearly defines the P & A (from PDCA) at separate stages in the document. ISO 9001 does not do that. I am very careful with choice of words. The ISO 9001 standard requires management being involved with both ends of the SYSTEM, not processes.

Hi Sidney,

It seems to me that all of that is covered in ISO 9001 under section 5.6.2. and 3.
Here they are for discussion purposes:

5.6.2 Review input
The input to management review shall include information on:

a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement​

5.6.3 Review output
The output from the management review shall include any decisions and actions related to:

a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements
c) resource needs​

.
​

I think that one of the problems that organizations have is that they have one annual "Management Review", and they don't understand or acknowledge that "Management Review" is conducted at multiple levels, on numerous occasions, all over the organization. This myopic view precludes the likelihood the the PDCA cycle is perpetuated and implemented throughout the organization as a process methodology.

I still contend that it's there...but, I would concede that perhaps it does merit repeating.

Patricia

 

[somerqc]

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

Patricia,

I have been looking at your flowcharts for ideas on how to improve our documentation of processes (we are implementing an ERP system that will require that I update our manual).

Although it seems that at "30,000 ft" all the requirement are covered, I have never worked in an environment where the "busy-ness" of the flowcharts would meet the intended target (except for the people responsible for the quality system). Like I have mentioned, there are many great things about your flowcharts, but, how could an average (non-systems) person be able to follow them and use them?

Do you offer "layered" versions of these flowcharts where the floor worker/ desk person gets a very basic version and the Quality Manager or MR get the fully detailed versions? I could see that working very well so that the flowchart documentation meets the needs of the audience.

 

[Sidney Vianna]

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

It seems to me that all of that is covered in ISO 9001 under section 5.6.2. and 3.

I don't think you understood me. One of the criticisms offered to ISO 9001 is that it "doesn't flow", the model doesn't follow the PDCA sequence and chronology of events.

The ISO 14001 table of contents shows sections 4.2 and 4.3 dealing with policy setting and planning. After implementation and operation, sections 4.5 and 4.6 deal with checking and management review, which makes for a sequence of events more in line with PDCA.

My proposal is that ISO 9001:2014 should follow that aspect of ISO 14001:2004, because it is easier for people to understand that (top) management have to participate in both the "front and back" ends of the system.

 

[Jim Wynne]

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

Jim, I hope I'm sounding more enlightening than defensive, and I very much appreciate your critique, and am grateful that you are taking the time to provide feedback...it's only in this way that I can correct or improve the model, and hopefully, in the long-run, make it more palatable and efficacious for all interested parties.

We just disagree, and that's not a bad thing. Others have the benefit of differing perspectives in trying to improve their systems. I know you've put a lot of work and thought into this, and it's very gracious of you to share it.

 

[Patricia Ravanello]

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

We just disagree, and that's not a bad thing. Others have the benefit of differing perspectives in trying to improve their systems. I know you've put a lot of work and thought into this, and it's very gracious of you to share it.

Agreed! Thanks Jim.

Patricia

 

[Patricia Ravanello]

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

I don't think you understood me. One of the criticisms offered to ISO 9001 is that it "doesn't flow", the model doesn't follow the PDCA sequence and chronology of events.

The ISO 14001 table of contents shows sections 4.2 and 4.3 dealing with policy setting and planning. After implementation and operation, sections 4.5 and 4.6 deal with checking and management review, which makes for a sequence of events more in line with PDCA.

My proposal is that ISO 9001:2014 should follow that aspect of ISO 14001:2004, because it is easier for people to understand that (top) management have to participate in both the "front and back" ends of the system.

Hi Sidney,

I would second that proposal.

Although the PDCA cycle is referenced in "0.2 Process Approach" of the ISO 9000 Standard, it would be logical to use the same sequence as a guide for laying out the Standard's requirements, as you said, similar to ISO 14001.

This alone would have been a more meaningful change than the collective changes/improvements?? offered in the 2008 edition.

Patricia