What does ISO 9001:2000's 'process orientation' mean?
ISO 9k:2k has been redesigned to be process oriented. Exactly what does that mean? Does it mean that I need to create 5 process flow charts. 4 that identify the different elements and the 5th one to show the overall picture.
Process oriented vs. Element oriented?
Well, they say it's now 'process oriented' but it really has been all along. At least that's how I've done implementations for years. You lay out what your company does in a flow chart or two (top level) and then you start an evaluation. Where do you define inspections and tests, for example, or where do you review contracts? There's no specific requirement for this, I guess, but it's total common sense (which most if not all of ISO 9001 is).
To me, this is the real heart of the matter. All businesses should be thinking systems. My definition of systems is defined processes. To me a process is a system. When one flow charts a process you are (my definition) defining that 'system'. This is why for 12 years I have been doing business as Cayman Systems (more recently Cayman Business Systems).
The standard's requirements have hardly changed - the outline and distribution of requirements of the standard is what has been changed. Don't read more into this than there is.
If you check out the requirements for a quality manual in 9001:2000, it basically asks for three things: a policy statement; a reference list of system level procedures; and an explanation of how these interrelate with your business processes. A matrix of procedures versus main work streams can do this. This also provides a reality check - are there things in our major work streams that aren't covered in the procedures (general, not specific)? If not, why not? (The answer to this question should be something like - Oops! Or, alternatively you went for ISO 9001 for marketing reasons only, and don't expect business improvement outcomes)
What does ISO 9001:2000's 'process orientation' mean?
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