Is it true that the Quality Manual cannot be a Procedure?

J

jerzki

#1
Dear all quality guru's,

Good day!
Presently we are on the road for certification and we are expecting it on the 26th & 27th of this month. As per our preparation for this certification audit, our consultant brings an auditor to conduct a pre-assessment audit. On the course of the audit we come across to some debate regarding MAKING THE QUALITY MANUAL AS OUR NUMBER ONE PROCEDURE.We been debating the issue until the end of the audit. I just would like to ask anybody there regarding this issue. Is it really that the QUALITY MANUAL CANNOT BE A PROCEDURE, because as stated in the standards that the quality manual are documented procedures established for QMS or reference to them.
Thank you very much.
Appreciate your opinions.

Best regards,

jerzki :bigwave:
 
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GStough

Staff member
Super Moderator
#2
Re: Does a Quality Manual cannot be a procedure?

Usually, a quality manual is developed to show a snapshot of the QMS and is not a procedure unto itself. Although, many times a quality manual does include a list of procedures relevant to key processes, which may also be included and illustrated as flow charts. It's been my limited experience that some (certainly not all) external auditors really like to see flow charts depicting key processes and how they inter-relate within the organization.

I hope this helps and good luck with your registration! :bigwave:
 
T

Ted Schmitt

#3
Re: Does a Quality Manual cannot be a procedure?

The way I see it, you can have your procedures as an integral part of your Quality Manual... as stated in 4.2.2 b). I would only structure a QMS this way if I had about 5 employees.... on a larger scale, I don´t see it working very well.

The best way is to cross reference the standard clause with the applicable procedure (second part of 4.2.2 b)

Let us know the outcome of your audit !! Good Luck !!
 

GStough

Staff member
Super Moderator
#4
Re: Does a Quality Manual cannot be a procedure?

The way I see it, you can have your procedures as an integral part of your Quality Manual... as stated in 4.2.2 b). I would only structure a QMS this way if I had about 5 employees.... on a larger scale, I don´t see it working very well.

The best way is to cross reference the standard clause with the applicable procedure (second part of 4.2.2 b)

Let us know the outcome of your audit !! Good Luck !!
Ted's correct. :agree1: That is another thing I've noticed that external auditors (some of them) really like to see - a cross-reference matrix of standards to procedures. This is a very good tool IMO....:yes::agree1:
 
#5
Dear all quality guru's,

Good day!
... we come across to some debate regarding MAKING THE QUALITY MANUAL AS OUR NUMBER ONE PROCEDURE....
jerzki
Considering, the definition of a procedure is the specified way to carry out a process, I would doubt the QM is a procedure. One could argue that the QMS is a process, but I'm not convinced that the manual adequately describes the steps unsed to enact that process. It might describe the process but not the steps used to enact it. This might make a good philosophical debate, but doesn't really add substance to your QMS. IMNSOH
 
#6
Dear all quality guru's,

Good day!
Presently we are on the road for certification and we are expecting it on the 26th & 27th of this month. As per our preparation for this certification audit, our consultant brings an auditor to conduct a pre-assessment audit. On the course of the audit we come across to some debate regarding MAKING THE QUALITY MANUAL AS OUR NUMBER ONE PROCEDURE.We been debating the issue until the end of the audit. I just would like to ask anybody there regarding this issue. Is it really that the QUALITY MANUAL CANNOT BE A PROCEDURE, because as stated in the standards that the quality manual are documented procedures established for QMS or reference to them.
Thank you very much.
Appreciate your opinions.

Best regards,

jerzki :bigwave:
This close to your certification audit? You need to find another consultant and/or auditor! Seriously, they shouldn't be bringing this kind of surprise to you, so late in the program. What were you advised to do, in the first place? If you have a manual which meets the requirements of the ISO standards, leave it alone.

And, no, a quality manual isn't a procedure. What Ted and Gidget said is the correct answer IMHO.
 

harry

Super Moderator
#7
I am of the opinion that there are some misunderstanding or miscommunication here. Many smaller organizations over here combine the procedures and SOP's with the manual into a single booklet/document. Perhaps this is what had been suggested.
 
T

Ted Schmitt

#8
I am of the opinion that there are some misunderstanding or miscommunication here. Many smaller organizations over here combine the procedures and SOP's with the manual into a single booklet/document. Perhaps this is what had been suggested.
That´s what I understood also Harry... including the procedures into the Manual (first part of 4.2.2. b)... but I would not do this for an organization with more than a few employees...
 

Jim Wynne

Staff member
Admin
#9
Dear all quality guru's,

Good day!
Presently we are on the road for certification and we are expecting it on the 26th & 27th of this month. As per our preparation for this certification audit, our consultant brings an auditor to conduct a pre-assessment audit. On the course of the audit we come across to some debate regarding MAKING THE QUALITY MANUAL AS OUR NUMBER ONE PROCEDURE.We been debating the issue until the end of the audit. I just would like to ask anybody there regarding this issue. Is it really that the QUALITY MANUAL CANNOT BE A PROCEDURE, because as stated in the standards that the quality manual are documented procedures established for QMS or reference to them.
Thank you very much.
Appreciate your opinions.

Best regards,

jerzki :bigwave:
You can call the quality manual whatever you want to call it, so long as it meets the requirements for quality manuals. The name you give it is immaterial.
 
#10
You can call the quality manual whatever you want to call it, so long as it meets the requirements for quality manuals. The name you give it is immaterial.
We don't even have a "Quality Manual". Ours is called "Procedures Manual." It contains all of the documented procedures and other items as required by section 4.2.2. You will absolutely need a roadmap for your auditor that meets c) a description of the interaction between processes of the quality management system. Flowchart, connect-the-dots, axe-murderer, whatever, this needs to be a simple way to show everyone the connection between:
  • What the ISO section requires
  • Where the description of how you meet the requirement lives
  • Where the work of actually meeting the requirement is done
 
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