Is a Generic QMS (Quality Management System) Possible?

S

SSwanson

#1
Before everyone says no, think about something...

In the US, most of the handbooks I have seen can be interchanged between companies, as they basically reiterate the ISO Norm, as well they should. The actual procedures to fulfill the requirements of ISO/Handbook elements are written in work procedures.

If the handbook serves to identify ISO requirements for all personnel in all relevant departments, then the handbook basically says what ISO says. This is important, since some departments may be tasked to develop procedures and need to know the specifics of ISO and not just the procedure for that requirement as written in a work procedure. A case in point might be the project management for the creation of organic lab procedures which will be added to the current inorganic lab's certificate.

Therefore the Handbook mirrors the ISO requirements.

Next, regarding administration of a QMS, once an acceptable control for certain activities have been identified, documented, implemented, controlled for effectiveness ( both internaly and by external certification auditors ), it is a fair bet that the practice documented in those procedures can be used in other companies so long as the other companies agree to accept the documented procedure and support forms.

In other words, if an effective internal audit program is identified, it should be able to be implemented in another firm without much modification. The internal audit procedures and support forms would simply be accepted or mildly modified to suit the new comapmy.

Therefore, it stands to reason that a generic QMS is possible, where customers simply add their specific technical procedures to the generic system that consists of a handbook and administrative procedures.

I know of course, it is not quite so simple since objectives need to be established, policy written, etc. But the basic requirement for this is in the handbook... and maybe procedure.

Generally speaking, this idea is currently employed in Europe. A consultant creates a system, gets the system certified with the first customer by an external certification company, and then the consultant starts looking for other companies that will adopt the handbook and administrative procedures. Each company simply adds their technical procedures and individual forms as part of the generic system to get certified.

Please... what is your opinion of this practice?
 
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Wes Bucey

Quite Involved in Discussions
#2
SSwanson said:
Before everyone says no, think about something...

In the US, most of the handbooks I have seen can be interchanged between companies, as they basically reiterate the ISO Norm, as well they should. The actual procedures to fulfill the requirements of ISO/Handbook elements are written in work procedures.

If the handbook serves to identify ISO requirements for all personnel in all relevant departments, then the handbook basically says what ISO says. This is important, since some departments may be tasked to develop procedures and need to know the specifics of ISO and not just the procedure for that requirement as written in a work procedure. A case in point might be the project management for the creation of organic lab procedures which will be added to the current inorganic lab's certificate.

Therefore the Handbook mirrors the ISO requirements.

Next, regarding administration of a QMS, once an acceptable control for certain activities have been identified, documented, implemented, controlled for effectiveness ( both internaly and by external certification auditors ), it is a fair bet that the practice documented in those procedures can be used in other companies so long as the other companies agree to accept the documented procedure and support forms.

In other words, if an effective internal audit program is identified, it should be able to be implemented in another firm without much modification. The internal audit procedures and support forms would simply be accepted or mildly modified to suit the new comapmy.

Therefore, it stands to reason that a generic QMS is possible, where customers simply add their specific technical procedures to the generic system that consists of a handbook and administrative procedures.

I know of course, it is not quite so simple since objectives need to be established, policy written, etc. But the basic requirement for this is in the handbook... and maybe procedure.

Generally speaking, this idea is currently employed in Europe. A consultant creates a system, gets the system certified with the first customer by an external certification company, and then the consultant starts looking for other companies that will adopt the handbook and administrative procedures. Each company simply adds their technical procedures and individual forms as part of the generic system to get certified.

Please... what is your opinion of this practice?
I prefer to reserve my opinion of the practice for private conversation. However, I will comment that literally dozens of consultants are making a living from this exact practice. One company has even been singled out here in the Cove for its notorious practice of implying registration to ISO9k2k within 40 days of adopting its "generic system" which is word processed to apply to a specific company.
 
#3
No, no, no....

SSwanson said:
In the US, most of the handbooks I have seen can be interchanged between companies, as they basically reiterate the ISO Norm,
If so, what is that in aid of? We all have copies of the standard, so we won't be needing to do so for that reason, and the standard (Clause 4.2.2) most certainly does not require us to do it that way.

SSwanson said:
Therefore the Handbook mirrors the ISO requirements.
Why? What happened to the process approach (Clause 0.2)and the possibility to tailor the system to my own needs (Clause 4.2.1, Note 2)? Imo very few employees should need to resort to the standard. They should be able to rely on a company QMS, compliant to, not repeating the standard.

SSwanson said:
Therefore, it stands to reason that a generic QMS is possible, where customers simply add their specific technical procedures to the generic system that consists of a handbook and administrative procedures.
Possible? perhaps, but is it any good? One size does not fit all, and there will always be many different ways to achieve similar results.

SSwanson said:
Generally speaking, this idea is currently employed in Europe. A consultant creates a system, gets the system certified with the first customer by an external certification company, and then the consultant starts looking for other companies that will adopt the handbook and administrative procedures.
Yep, I know it is, but I am not fond of canned systems. What happens with the managements as well as the rest of the staffs commitment? It's not their system, and none of them will treat it as such. Generally speaking this practice produces poor systems, not to mention what happens when the consultant leaves...

Did I say it? No.

/Claes
 
E

encee98

#4
SSwanson said:
Each company simply adds their technical procedures and individual forms as part of the generic system to get certified.

Please... what is your opinion of this practice?
I think this part indicates that the system ceased to become generic. Umm... so it's no. :eek:


Naomi
 
S

SSwanson

#5
Let me just add this for clarification...

Richard C. Randall, Southeast Regional Director for National Quality Assurance (NQA) USA, which is accredited by the UK NACCB and US ANSI, and RAB... in his 1995 publication entitled "Randall's Practical Guide to ISO 9000. Implementation, Registration and Beyond" says on page 52 that "The National ISO 9000 Support Group recommends that companies write their quality manual paraphrasing as much of the original wording contained in ISO 9000 as possible." (Please don't tell me this is no longer relevant since the 1995 publication references the 94 Norm. The philosophy and guidance are still applicable.)

He goes on to say that we shouldn't re-invent the wheel when it comes to the contents of the handbook... and that your QMS must be tailored to fit your business. I take that to mean document style, pt, font, logos, form layouts, actual technical procedures/instructions, company lingo, etc.

My point is... given this philosophy, a handbook echos the Norm. It is still important, since in a multi sited company, people outside the QM circle may be tasked to develop procedures that will later be intergrated within the QMS. Not all documentation is clear as to the ISO requirements. Nor do companies invest in a copy of the ISO norm ( at least $50 each ) for all employees.

When I spoke about a generic QMS, I meant only the handbook and procedures for the administation of the QMS... such as training plans, internal audit plans, document control forms, etc. The actual technical procedures must be written for every company.

Everytime a company asks a consultant to develop a procedure with support forms to fulfill an ISO requirement, that consultant will return to his office, upload a copy of a formally approved procedure and support forms, change the name of the header, form number, revision date and give it to the customer with a billing statement. The consultant might be Joe Blow down the street or Regional Director Randall.

I think the response of those who read this thread will be determined on whether the reader is a consultant, an auditor, or consumer.
 

The Taz!

Quite Involved in Discussions
#6
I'll only touch lightly on this subject. . . there is one Registrar who has instructed (recommended) one company I no longer work for to take the ISO standard, have it typed out and then substitute the company name for the word "Organization." If every company did that, you'd have a "generic" quality manual.

I abhor this practice because it promotes laziness and complacency, and requires NO BRAIN ACTIVITY to accomplish, and only makes it easy for the auditor to audit it. IMHO, the company does not take ownership of it's QMS .
 
S

SSwanson

#7
Hey Taz...

I agree... but the meat and potatos are in the procedures and instructions.

Whenever we take the standard and start interpreting it, we have a greater possibility to lose the intent of the ISO requirement. I don't know how many times I've seen that happen in the last 15 years. Nor do I know how many times this has been used as an excuse then the customer's "interpretation" is false.

When the handbook spells out the exact 100% approved requirment from the standard for each employee to read ( since they don't have access to the Norm ), there is little chance for bad input.

Work procedures for the Management Review technique, internal audit process, document control, etc., explain the "how" we are going to fulfill the unabridged ISO requirements ( the "what").
 
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The Taz!

Quite Involved in Discussions
#8
SSwanson said:
Whenever we take the standard and start interpreting it, we have a greater possibility to lose the intent of the ISO requirement.
I agree with your statement about potential interpretation gaps. . .but by copying the standard and substituting the company name, you have now pushed that interpretation task down stream to people who may not have the breadth of knowledge and understanding you have.

IMHO, once you understand the intent and requirements, word your manual so that anyone can understand what you mean.
 
C

cncmarine

#9
I just got re-registered yesterday.

Process approach and process auditing...means your process!!!!!

scope means your scope......not some canned version.
 
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