ISO 9001:2000 Confusion - Process Aspects: Interactions, Inputs, Outputs, Etc.

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florin pirvulescu

I guess there are a few reasons for confusion in the 9001:2001 standard. I am QM. I designed and implemented a QMS in our company. The major problem I faced was the looking for: 1. Identification of processes; 2 a method to describe the interrelation between processes.
As most of the quality people I met the first suggestion about the QMS processes we found in the Note of 4.1 clause. The processes recommended are almost the same as chapter 5 - 8 of the standard. “Almost” because the name of the processes in the Note are slightly different then the name of chapters. The matching of the processes in the Note with the chapters is suggested also by the figure 1. So we have all the reasons to believe that processes of the QMS are actually the chapters 5 to 8 of the standard. But I wouldn’t consider “Management responsibility” a process. Inputs, outputs of an activity and measurable criteria define a process. I see chapter 5 as a requirements clause to comply with. Of course we can find inputs, outputs and measurable for management commitment but it would be forced. Unfortunately are a lot of consultants and auditors seeing things that way.
I think the idea is different then it looks in the standard. I think what is interesting is expanding the 7th Chapter (product realization). Why? As long as we are aloud to consider exclusions limited to requirements within clause 7, it means the other chapters (processes) should look the same in all organizations in the world. So why should we bother to represent them in a map (or some other method)? I found later on in www.bin.co.uk the Process Classification Framework. I like it very much and it seems to be inspired from the real business world. I found also on the Internet a very challenging point of view regarding what I am concerned. The figure 1 represents the linkages between chapters of the standard not the processes. I guess is right. If this is also the ISO’s point of view it means the representation in figure 1 and the Note of 4.1 are not the best solutions. I found a large variety of QMS processes maps. On the Internet the most often found solution for identification of processes and map representation is the Figure 1 of the standard expanded in a deeper detail.
If we consider the chapters as processes it means:
1.to define inputs and outputs for every subclause 2. To define measurable criteria for every subclause. 3. To evaluate them against the established criteria.
Besides 9004 is mentioning about key processes and support processes.
I can’t imagine the amount of work and loss of time. And time is money. If we would do that the spirit of standard is getting far from business and it would become a purpose in it self, not a management tool.
Can you comment? :confused:
Thanks,
Florin Pirvulescu, Romania
 
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I'll try....

I'm new to this but I'll give it a try.

I understand the ISO9001:2000 processes to be the processes of the Quality Management System. Examples are:

1. Management Review
2. The Quote process
3. Corrective and Preventive action
4. Product Development
5. Etc......

The way that I understand it is that we, as a business, determine what our process are. Certain processes are common to any business.

I havestruggled with this for a long time, but it seems to me that if this system is based on "Processes" then the standard should not be a part of the system, the system should be built such that it meets the standard.

Hope this helps......

:bonk:
 
Hi Florin

You can go to (broken link removed) and see document N544 Guidance on the Concept and Use of the Process Approach for management systems. If you don't know it already it's probably a good help.

The way I do it, is always the same.
I have Realization processes and QMS processes.

Realization processes:
- Customer-related Processes
- Design and development
- Purchasing
- Production
- Monitoring and measuring devices

QMS Processes:
- Management processes
- Planning
- Communication
- Documental management
- Management review

- Measurement, analysis and improvement processes
- Customer satisfaction
- Control of nonconformity
- Internal audits
- Corrective actions
- Preventive actions

- Analysis of data

- Resource Management

Of course this not more than what the standard gives us. In my opinion the QMS should be as simple and economic as it can be. Once I audited one Swiss organization that has identified more than 250 processes. They said they used ISO 9001 approach to all the areas of the company. The funny thing about this company was that all the control of these processes to check effectiveness was made by the Quality Manager...
I hope I helped.
AV. :eek:
 
Sorry again, to be a lilbit off topic, but i badly need experts advise on the following issue.

Our technical vocational education and training system is an outcome based: That is the occupational standards are set by experts in the world of work, and training providers/colleges strive to produce a workforce meeting this standard - thier own way. There will be an independent testing to assure the quality, based on the occupational standard requirenment. Some people here say that introducing TQM or other QMS contradicts with outcome based system, because it focoses on processes. Does this make sense?

Thanks
 
menkirt said:
Sorry again, to be a lilbit off topic, but i badly need experts advise on the following issue.

Our technical vocational education and training system is an outcome based: That is the occupational standards are set by experts in the world of work, and training providers/colleges strive to produce a workforce meeting this standard - thier own way. There will be an independent testing to assure the quality, based on the occupational standard requirenment. Some people here say that introducing TQM or other QMS contradicts with outcome based system, because it focoses on processes. Does this make sense?

Thanks

I do not see any conflict. The objective of a process based system like ISO 9001 is to define and improve the outcomes. No contradiction at all.
 
My definition of a Process, which I used while training over 1000 people, including Executive Management is this:

A process is any action that has an Input which results in an Output.

For a simple example: Washing clothes. The input is dirty clothes and the output is the clean clothes.

Another example would be: Payroll. The input is time and the output is your paycheck.

So, in my opinion, anything that has an input and produces an output is a process.

menkirt said:
Sorry again, to be a lilbit off topic, but i badly need experts advise on the following issue.

Our technical vocational education and training system is an outcome based: That is the occupational standards are set by experts in the world of work, and training providers/colleges strive to produce a workforce meeting this standard - thier own way. There will be an independent testing to assure the quality, based on the occupational standard requirenment. Some people here say that introducing TQM or other QMS contradicts with outcome based system, because it focoses on processes. Does this make sense?

ISO9001 is a business based Quality Management System, based on processes. Therefore, I see no contradictory issues regarding the Business, in my opinion.
 
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