ISO 9001:2000 Process Approach - What is it? Is it 'Real'?

[Paul Simpson]

Process through and through

Re. the process approach:

But, this evolved more after the standard was issued. Thus, the standard makes little mention of it, but subsequent documents and clarifications emphasize it.

Can't say I agree with this part of what you say. The process approach was one of the 8 principles behind the development of the 3rd. edition of 9k. The first sections of the standard 0.1, 0.2 emphasize processes in the management system and the first element of the shall requirements (after the establishment etc. of the QMS) is that it identifies the processes. It doesn't go into the how of definition of processes but says what should be included (as a requirements document should).

 

[Helmut Jilling]

Re. the process approach:

Can't say I agree with this part of what you say. The process approach was one of the 8 principles behind the development of the 3rd. edition of 9k. The first sections of the standard 0.1, 0.2 emphasize processes in the management system and the first element of the shall requirements (after the establishment etc. of the QMS) is that it identifies the processes. It doesn't go into the how of definition of processes but says what should be included (as a requirements document should).

No argument with your statements. It certainly mentions it in the intro. And, I am the strongest advocate of the process approach as defined in cl 4.1.

My beef is, since 2000 to now, the ABs have been slowly evolving their thinking as to how far they expect this thing to be taken. They are still issuing clarifications that are less than clear as to what they actually expect from the process approach. That is why there is so much debate among us Covers. The experts at this can't agree on half of it.

As a standard, it could be much more explicit as to what is expected from the process approach, without becoming prescriptive as to the formats and processes themselves. TS has been a little better, but even there, it took the second edition of the Rules to finally become a little more clear.

I remember some of my first ISO 9001:2000 upgrades had defined their processes, but the system and management review was to the clauses. Now that would be ridiculous, but at the time, it seemed entirely reasonable.

 

[Jim Wynne]

The experts at this can't agree on half of it.

If there is no consensus, there are no experts (or everyone is an expert)

 

[Helmut Jilling]

If there is no consensus, there are no experts (or everyone is an expert)

There are many fields where there are experts with differing opinions. I don't think that is the correct criterion. Depth of knowledge or understanding might be a better definition.

 

[Jim Wynne]

There are many fields where there are experts with differing opinions. I don't think that is the correct criterion. Depth of knowledge or understanding might be a better definition.

Not when an explicit standard exists. Expert opinions may differ when no standard exists, but expert opinion is intellectual rationalization in search of a standard, or should be. Standards may change as knowledge and insight increase, but they're still standards. The fact that there is widespread confusion over the process approach (or implementation of it, or demonstrating implementation of it) indicates that there really is no standard.

 

[Helmut Jilling]

Not when an explicit standard exists. Expert opinions may differ when no standard exists, but expert opinion is intellectual rationalization in search of a standard, or should be.

We may agree more than it appears. I don't think ISO 9001 is a particularly explicit standard. There exists a general framework that the standard expects organizations to color in. That leads to many differing viewpoints. I think they are OK with that.

Standards may change as knowledge and insight increase, but they're still standards. The fact that there is widespread confusion over the process approach (or implementation of it, or demonstrating implementation of it) indicates that there really is no standard.

I do FULLY agree that the standard or some interpretations are needed to better explain what is and is not permissible. The standard launched a concept for process approach, but did not fully develop what is permissable or not. That part is inadequately standardized, as evidenced by the amount of heated debate as to what and how it can be done.

I still think there are a lot of knowledgeable people with very good, but differing ideas. I will continue to regard them as "experts," regardless of whether they agree with a single viewpoint. There are differng viewpoints among experts in many fields.

 

[michellemmm]

I still think there are a lot of knowledgeable people with very good, but differing ideas. I will continue to regard them as "experts," regardless of whether they agree with a single viewpoint. There are differng viewpoints among experts in many fields.

Is this where we start talking about the spirit of quality vs the letter of quality? ie. conformance Vs performance....

 

[sfkevin]

To me most just change the QM to fit the ISO 9001:2000 version and did not change there methods or process.

 

[H?ctor - M?xico]

please tell me where can i found info on iso 9001:2008

thank-u all of you

 

[GStough]

please tell me where can i found info on iso 9001:2008

thank-u all of you

Hello, Hector and welcome to the Cove!

There are a couple different discussions on this topic, but here is the most recent one:

http://elsmar.com/Forums/forumdisplay.php?f=148