L
lucasso
Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to
Well, first of all, we must agree on what we call a Quality Manual. When I started working with 17025, I liked thinking that a Quality Manual is a combination of ALL the documents describing how a job at a laboratory is done. That is, from documents which had quality policies signed by head managers, to work instructions and calibration protocol forms.
But as time went by, i realised that only the first level documents are called Quality Manual, that is, policies. Even when our registrar asks for our Quality Manual, that means they want just the first level document, without procedures, or work instructions.
So, if we agree that a Quality Manual is only the first level document, what we get is, for example:
Requirement in 17025:
4.3.3.4 Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.
In quality manual:
"The XXXX laboratory has established procedures describing how changes in documents maintained in computerized systems are made and controled. Please, see the procedure XXX-YYY."
And procdure XXX-YYY is a seperate document, possibly, in a different location (be it physical or electronical).
Or even a more silly way:
Requirement in 17025:
4.2.7. "Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented"
In quality manual:
"Top management ensures that the integrity of the management system is maintained when changes to the management system are planned and implemented."
Can you explain to me the value to the business of having the standard re-written?
Well, first of all, we must agree on what we call a Quality Manual. When I started working with 17025, I liked thinking that a Quality Manual is a combination of ALL the documents describing how a job at a laboratory is done. That is, from documents which had quality policies signed by head managers, to work instructions and calibration protocol forms.
But as time went by, i realised that only the first level documents are called Quality Manual, that is, policies. Even when our registrar asks for our Quality Manual, that means they want just the first level document, without procedures, or work instructions.
So, if we agree that a Quality Manual is only the first level document, what we get is, for example:
Requirement in 17025:
4.3.3.4 Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.
In quality manual:
"The XXXX laboratory has established procedures describing how changes in documents maintained in computerized systems are made and controled. Please, see the procedure XXX-YYY."
And procdure XXX-YYY is a seperate document, possibly, in a different location (be it physical or electronical).
Or even a more silly way:
Requirement in 17025:
4.2.7. "Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented"
In quality manual:
"Top management ensures that the integrity of the management system is maintained when changes to the management system are planned and implemented."