Team,
We are having some problems where I believe some of the TS requirements are more wholistic toward the entire organisation, and others believe each piece of the standard are to be applied to each and every process. Is there any guidance on what clause applies to every process vs. what should be applied once to the entire organization?
Ex. Management review - I believe pertains to the entire organization (company) while others believe MR occurs where any process can be measured...
Qualityboi,
I think that you make this unnecessarily complex. When I start working with a Client, one of the first things the Client and I do is identify the processes that make up their Quality Management System. My son would say: "What's up?"
There is a tendency to get wrapped up (bogged down) in standards too soon. The danger is that the standard and its requirements becomes the focus of the implementation process, not the Quality Management System.
Some organizations like to categorize their processes (key, support, management) but that is not required. It can be helpful though.
Once we have a clear idea of the processes that the Client has, then we develop a simple (draft) matrix that lists all the processes, the "owner" for each process, inputs, outputs, objectives, measurements.
Now, in addition to the above, we look at each process and list the ISO or ISO/TS or other standard requirements that apply to each of these processes. If regulatory, statutory, and customer-specific requirements apply, we'll list them as well. There is a basic example of this matrix that I provided in the "Post Attachments List"
We may not be able to finalize this matrix all at once. It takes some time.
This process matrix is what I call the "Bill of Material" for the Quality Management System. The Process Map is the "Assembly Drawing."
These two documents describe the processes and their interaction (per 4.1.)
So, the standard requirements are not the drivers of the QMS, the processes are. In other words, the needs of the organization and its customers always come first. Then we look at what the Standards require and match those with the processes.
I hope this helps.
Stijloor.