How many Quality Manuals does your company have?

M

MichelleD

Involved In Discussions
Hi All,

I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses. :frust:

Thanks for any help you might offer. :)

Michelle
 
GStough

GStough

Leader
Super Moderator
MichelleD said:
Hi All,

I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses. :frust:

Thanks for any help you might offer. :)

Michelle
Click to expand...


Hi Michelle!

We only have one Quality Manual and we hold dual registrations (9001:2000 and 13485:2003). I think as long as the one manual covers all the requirements, it should be sufficient.

Hope this helps!
 
Stijloor

Stijloor

Leader
Super Moderator
MichelleD said:
Hi All,

I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses. :frust:

Thanks for any help you might offer. :)

Michelle
Click to expand...

Hi Michelle,

Please tell us about the contents of these manuals.
That would help us Covers to prepare an adequate response.

By the way, be prepared for many responses!;)
Documentation issues get Covers riled up.

Stijloor.
 
M

MichelleD

Involved In Discussions
Stijloor said:
Hi Michelle,

Please tell us about the contents of these manuals.
That would help us Covers to prepare an adequate response.

By the way, be prepared for many responses!;)
Documentation issues get Covers riled up.

Stijloor.
Click to expand...

They almost say exactly the same thing with minimal differences. The concerns go much deeper than the Quality Manual but I have to jump in somewhere. All the Quality Manuals have exactly the same number system as do all the procedures. If you print them off the system and casually look at them you really can't tell the difference. It's a very interesting system "we" have here.
 
Stijloor

Stijloor

Leader
Super Moderator
MichelleD said:
They almost say exactly the same thing with minimal differences. The concerns go much deeper than the Quality Manual but I have to jump in somewhere. All the Quality Manuals have exactly the same number system as do all the procedures. If you print them off the system and casually look at them you really can't tell the difference. It's a very interesting system "we" have here.
Click to expand...

Hi Michelle,

Looks like you've got your work cut out.

As part of a continual improvement activity, you may want to review the company's documents, determine what is required by the applicable Standard and then determine what else is necessary for the safe, effective and efficient operation of the quality system. See if you can get the Top Guy/Gal on board. You may have to work with each department head separately to clean up their systems. Not knowing how long your company has been certified/registered, documents are like weeds, they tend to grow and grow if not attended to.

I'm sure the dialogue will continue.....

Stijloor.
 
M

MichelleD

Involved In Discussions
I hope they do continue. I appreciate all the help and feedback. The company has been registered for about three years but had decided to drop their certification but wants to remain "compliant" so that at anytime a customer demands it we can pick back up our certification. I've definitely been sitting in on all the discussions on the pro's and con's of being certified.
 
Jim Wynne

Jim Wynne

Leader
Admin
MichelleD said:
They almost say exactly the same thing with minimal differences. The concerns go much deeper than the Quality Manual but I have to jump in somewhere. All the Quality Manuals have exactly the same number system as do all the procedures. If you print them off the system and casually look at them you really can't tell the difference. It's a very interesting system "we" have here.
Click to expand...

Michelle, you still haven't told us about the content. What's in these manuals? What purpose are they supposed to serve? Is there some "master" quality manual, or many different ones (regardless of the degree of difference)? How are they controlled?
 
CarolX

CarolX

Trusted Information Resource
Hi Michelle-

I echo what Jim says - can you give us some background on why so many different manuals.

Under our system we have a policy manual, QMS Procedures, and work instructions for differnt departments. but we all work under one policy manual.
 
ScottK

ScottK

Not out of the crisis
Leader
Super Moderator
My company was in a similar situation prior to my coming on board to rework the system.

There was a master quality manual with everything (a hodge podge of outline of the QMS, procedures, work instructions, appendices, drawings).
Then each deparmtent has it's own (controlled) quality manual with the main portion plus any other parts that affected that department.
On top of that each department had a "procedure manual" with stuff that was not in the quality manual.

It's now been reworked so that there is on Quality Manual that is a 13 page outline of the QMS.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
MichelleD said:
I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses.
Click to expand...
Michelle, I have experience with similar arrangements, i.e., departmental quality manuals. They definitely do not work. Because the interfaces do not connect and because it take a tremendous amount of resources to keep these meaningless documents up-to-date. This arrangement is a symptom of a maligned QMS implementation. Because they foster departmental barriers and detract from a healthy process approach to implement a QMS. Processes (many times) are multi-departmental. Suggest you peruse the following documents:
And PS, there is no "ISO System", but YOUR Quality Management System. Good luck.
 
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