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Procedures Required by ISO 9001:2008

Jim Wynne

Staff member
Admin
#41
Re: ISO 9001:2008 Required Procedures

Is there a difference between making scrambled eggs for yourself and making a complicated product for your customer? Do you think there is a proper way to achieve hard chrome plating of .001" thick, or do you just plate them how you feel that day?
What you seem to be missing is that there might well be a proper way to do that sort of plating, but that doesn't mean, in and of itself, that the proper way must be documented.
 
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Sidney Vianna

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Staff member
Admin
#42
Re: ISO 9001:2008 Required Procedures

Is there a difference between making scrambled eggs for yourself and making a complicated product for your customer?
Of course there is. That is exactly why the standard mentions that THE ORGANIZATION must decide the additional documents it needs to implement the processes that affect the quality system.

You should know that one of the biggest criticism to the early versions of ISO 9001 was the emphasis on documentation. Not every process is complex. Some processes can be deployed and improved by "tribal knowledge".
 
S

snappy

#43
Re: ISO 9001:2008 Required Procedures

Here you're referring to "procedure" as a document.


This is exactly the sort of confusion I alluded to in my earlier post. "Procedure" is given more than one meaning. It would have made life a lot simpler if the standard referred to documented processes instead of documented procedures.
Confused indeed.
 
S

snappy

#44
Re: ISO 9001:2008 Required Procedures

Of course there is. That is exactly why the standard mentions that THE ORGANIZATION must decide the additional documents it needs to implement the processes that affect the quality system.

You should know that one of the biggest criticism to the early versions of ISO 9001 was the emphasis on documentation. Not every process is complex. Some processes can be deployed and improved by "tribal knowledge".
The reduced emphasis on documentation was because, IMO, organizations were being told by consultants and auditors alike that the standard required 20 procedures. When surveyed, organizations expressed a disdain for the voluminous (and awful) procedures (supposedly) required by the standard. But the 20 procedures were never required and never a good idea from any clever perspective. Yet many organizations still use such documentation to define their QMSs.

So, the reduced emphasis on documentation was coupled with the endorsement of the process approach to urge documentation to be based upon processes--which would reduce the emphasis on the **** procedures organizations were depending upon to get them through audits.

Under the 1994 scheme, I would write the number of procedures that were right for my client companies--which had no correlation to the number of requirements that pertained to those processes. It was common in smaller organizations to finish with only ten or eleven QMS procedures (covering the realization and support processes). Three to five pages each.

These same documents are effective in describing those QMSs to meet current 9001 requirements despite the changes in the standard in 2000/2008. A QMS does not depend upon the standard for its existence or its definition. Rather, it depends upon the organization and its processes that impact quality.

Ha! I remember garnering criticism for "not even writing the 20 required procedures" from auditors and other consultants under the 1994 scheme. Those who made such comments didn't get it.

Some didn't even notice that the 2000 revision of 9001 rebuked the element-by-element approach. More than a few still think they are experts at the "processes" "required" of the standard.
 
J

JaneB

#45
Re: ISO 9001:2008 Required Procedures

There is a lot unclear thinking when it comes to "procedure" and "process"
Agree with that.

I distinguish between the two, and don't consider them synonyms at all.

ISO 9001 refers to "documented procedures" which is either a redundancy or intended to differentiate between documents and procedures.
I tend to think that it just is being quite clear about the need to have a documented procedure.

In other words, the way the standard is worded, "procedure" and "process" are synonymous
Really? That's not how I read it.

Documents should exist when there's a useful purpose for their existence. If a document can be eliminated without losing something, it should almost always be eliminated, or not written to begin with.
Now there, I am in total 100% agreement with you.
 

Randy

Super Moderator
#46
Re: ISO 9001:2008 Required Procedures

Time for my :2cents:

It don't really make a dribble what is and what ain't as long as:

1) 4.2.1 is effectively met for the absolutes, and for the little extra's especially, the organization uses 4.2.1d - documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

...and whatever is documented for whatever reason is controlled by effective implementation of 4.2.3 and/or 4.2.4...DUH!

Folks can document the whole world if they want and call things procedures, processes, poo-pa's or ding-a-lings as long as they know what the difference is and they control whatever must be controlled

:sarcasm: But, whatever is documented, for whatever the reason has to be on 18lb light blue paper with a lily watermark :sarcasm:
 

Paul Simpson

Trusted Information Resource
#48
Re: ISO 9001:2008 Required Procedures

Guys, guys. This is all defined in ISO 9000. Perhaps we should start from there and see where the lack of clarity is coming from. Didn't we start to discuss this in around 1847? :sarcasm:

My little homespun summary:

There may be more than one procedure for carrying out a process. Procedures can be documented or not.

Hope this helps.
 
J

JaneB

#49
Re: ISO 9001:2008 Required Procedures

Guys, guys. This is all defined in ISO 9000. Perhaps we should start from there and see where the lack of clarity is coming from. Didn't we start to discuss this in around 1847? :sarcasm:

My little homespun summary:

There may be more than one procedure for carrying out a process. Procedures can be documented or not.

Hope this helps.
Yes, exactly.
 
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