E
EJE0622
Do you have the QM, the SOP, or both? And why?? Can they be incorporated together to create one document?
Re: Quality Manual and/or SOP
It depends on how you define QM (Quality Manual) and SOP (Standard Operating Procedure). An SOP is typically not viewed as a QM.
The Quality Manual can stand on its own and include references to the SOP's. The Quality Manual can also include SOP's (Procedures). Whatever works for your company. The package is not as critical as its contents.
You may want to do a search. This topic has been discussed quite often here...
Stijloor.
It depends on how you define QM (Quality Manual) and SOP (Standard Operating Procedure). An SOP is typically not viewed as a QM.
The Quality Manual can stand on its own and include references to the SOP's. The Quality Manual can also include SOP's (Procedures). Whatever works for your company. The package is not as critical as its contents.
You may want to do a search. This topic has been discussed quite often here...Stijloor.
K
Koivisto - 2009
Re: Quality Manual and/or SOP
Our company has a QM that describes how we handle the QA system, SOP's to further describe, Process sheets act as work instructions, and forms to document what is done.
Our company has a QM that describes how we handle the QA system, SOP's to further describe, Process sheets act as work instructions, and forms to document what is done.
T
trainerbob
Re: Quality Manual and/or SOP
The requirements for the Quality Manual are very specific in 4.2.2 of the standard. You seem to be concerned about b & c.
The quality manual needs to define your organization by having its processes and the interaction between its processes in it. This defines your organization and the processes that you will audit on a regular basis.
If you choose to have your operating procedures in the manual, that is fine. However if there are a lot of SOPs in your organization it usually makes more sense to have them in another location in your documentation
and have a pointer to them in the Quality Manual.
The requirements for the Quality Manual are very specific in 4.2.2 of the standard. You seem to be concerned about b & c.
The quality manual needs to define your organization by having its processes and the interaction between its processes in it. This defines your organization and the processes that you will audit on a regular basis.
If you choose to have your operating procedures in the manual, that is fine. However if there are a lot of SOPs in your organization it usually makes more sense to have them in another location in your documentation
and have a pointer to them in the Quality Manual.
Re: Quality Manual and/or SOP
What you are asking about is the design of your quality management system. We can't really answer your question, because we don't know anything about your company, your management or your business market/product.
Just like an architect who designs buildings, with the 'output' being the drawings and specifications....just like your question about manuals, sops etc. they have to consider many inputs to the "designing" process - customer, management and regulatory requirements.
So, you might want to consider who are you writing this quality system for? Small company, big company? Do your customers have any specific requirements? - aircraft, medical etc customers sometimes do. Would your management want any of their internal systems to be 'given away' with a copy of the quality manual? A friend of mine found his competition's formulations printed in their quality manual!:mg:
Answering these questions in whole or in part will help you answer those 'design' questions and help you to decided how to structure your manual, procedures etc.
What you are asking about is the design of your quality management system. We can't really answer your question, because we don't know anything about your company, your management or your business market/product.
Just like an architect who designs buildings, with the 'output' being the drawings and specifications....just like your question about manuals, sops etc. they have to consider many inputs to the "designing" process - customer, management and regulatory requirements.
So, you might want to consider who are you writing this quality system for? Small company, big company? Do your customers have any specific requirements? - aircraft, medical etc customers sometimes do. Would your management want any of their internal systems to be 'given away' with a copy of the quality manual? A friend of mine found his competition's formulations printed in their quality manual!:mg:
Answering these questions in whole or in part will help you answer those 'design' questions and help you to decided how to structure your manual, procedures etc.
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