Structuring an ISO 9001:2000 QMS Manual

M

mr. veen

#1
Examples of Procedures

Hello everybody,

Today, I joined this group and am very happy to have found it :D . As a Quality coordinator in The Netherlands, I've been busy implementing ISO 9001:2000 since last january. In June, we got certified.

However, there are still things to improve and one of the improvements to be implemented has to do with the structure of our QMS. We have an old stucture and the company wants to make a more simple stucture. My plans are to make a structure which is identical to the structure (paragraphs) os the ISO 9001:2000 standard.

My question is: do you think this is a good idea or are there better ways :confused: ?

I would really appreciate your advice.

Kind regards,

Mr. Veen
 
#2
Hello there, and welcome to the Cove :bigwave:

Lots of people have been discussing roughly the same thing. First of all, I'll provide you with a few links:

Procedure Numbering Change?
Documentation Organization (Matrix) "HELP"
Document Numbers
Implement 92k using 1994 numbering structure
!!Quality Procedure Re Writes
Quality Manual Structure

Then I'll just say that personally I did not follow the structure of the standard (Neither 9001:2000 nor 9001:1994), but rather the flow of our processes - More or less.

/Claes
 
M

MandOS

#3
Re: Examples of Procedures

mr. veen said:
Hello everybody,
Today, I joined this group and am very happy to have found it :D . As a Quality coordinator in The Netherlands, I've been busy implementing ISO 9001:2000 since last january. In June, we got certified.
However, there are still things to improve and one of the improvements to be implemented has to do with the structure of our QMS. We have an old stucture and the company wants to make a more simple stucture. My plans are to make a structure which is identical to the structure (paragraphs) os the ISO 9001:2000 standard.
My question is: do you think this is a good idea or are there better ways :confused: ?
I would really appreciate your advice.
Kind regards,
Mr. Veen
Welcome from another newcomer!

My advice is as follows (I do not expect everyone to agree, but I do believe that it is healthy to question “perceived wisdom”!)

To quote from an article I had published in the IQA's Quality World magazine (see http://www.mandos.co.uk/articles/ - the article is ArticleQW3.PDF) when the new standard first appeared:

"Many organisations will waste a vast amount of time trying to implement ISO9001:2000 without the required understanding and knowledge of the concept of a "business process". Most managers find it difficult even to recognise their key processes, far less to define them as part of a structured management system. "Processes" have not replaced "procedures" - processes have always existed because that is how day-to-day business operates. What has changed is the focus on the flow of work through and amongst departments rather than on what happens within a department.

A process-based management system should be a simple description of what the organisation does. Process descriptions can then be reviewed in relation to the requirements of external standards, legislation and policies and refined if necessary. The involvement of people, the use of reference documents and the impact of resources and influences will be integrated into the system in the most logical way. But the starting point for designing a system which meets the requirements of ISO9001:2000 is to recognise that the wording and structure of the standard itself is not the ideal starting point!"

The new standard may(?) be a good guide against which to assess a (quality) management system, but it is not a document around which to build one. This is in part because of the “traditional” definition of a "business process", which I find confusing at best and ignores some essential elements that are key to successful process management.

The ISO9K definition is still rooted in the same manufacturing or continuous production process background associated with ISO9000:1994, which caused the service sector such difficulty in interpretation. And the standard suffers as a result.

For me, a management system is: “the structure, processes and resources needed to establish policy and objectives and to achieve those objectives”. If written down, it describes how you run the business. Decide who is going to use the system – what level of knowledge do they have, and how will they use it? This will allow you to decide on the level of detail you need, and on the most appropriate medium (paper or electronic, or a combination of both).

Then define a simple system structure with a limited number of top-level processes, broken down into sub-processes as necessary. Use a clear and logical numbering convention.

Allocate a process owner for each process. This person should be responsible for ensuring that the process works, for making sure that it is fixed if it goes wrong, and for seeking and implementing improvements. He or she should ensure that:
- required resources are available
- competent staff are allocated to work in it
- sufficient information is available to monitor how well the process is working and if it is achieving its objectives.

Create (or tidy up!) a document register. Define where documents, records and other sources of information are kept, how they should be used, how long they should be retained and who is responsible for them.
Each process listed should then be reviewed to ensure that:
- the objective(s) are clearly defined
- suitable performance measures have been defined
- appropriate records are maintained to provide evidence that the process has been followed.

The system is NOT for an external assessor (remember that he is your "supplier") - it should be a business asset which helps you to achieve your business goals as efficently as possible.

(some of the above is a quote another article - from the Q2 2003 edition of TickIT International, the quarterly journal of the TickIT software quality certification scheme - see: www.tickit.org/international.htm.)

Hope this helps

PS my wife is Dutch - she sends her regards(!)

Regards

Peter Fraser
 
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