ISO9001 must be seen as a tool to achieve a certain goal or objective. It is not a solution in itself.
In fact I have had the crazy question put to me:"Where can I buy ISO9001?" And by that, I promise you, the person was not referring to a copy of the Standard.
I usually equate the ISO9001 STandard to a 4 pound hammer in a fitter's tolbox. You need to use it to do your job. The same can be said about ISO9001.
How can we use it to achieve our goal/s?
Let's say we have had one or more instances of running out of raw materials and we lost production as a result. By using Root Cause Analysis (Part of clause 8.5.2 in the Standard), we can find out the origin or clearly the "ROOT CAUSE" of the problem. We use the 5WHY approach; we simply ask the question "WHY", 5 times:
Why 1: Why could we not produce?
Ans 1: We ran out of raw materials.
Why 2: Why did we run out of raw materials?
Ans 2: We did not order in time
Why 3: Why did we not order in time?
Ans 3: The Computer stock indicated we still had enough raw materials.
Why 4: Why is there a difference between the physical stock and computer stock figures.
Ans 4: No stock take was done end of previous month.
Why 5: Why was no stock take done?
Ans 5: Person scheduled to do it was off sick, and no substitute allocated.
Conclusion: So we can see that we could not produce product, because the planning and allocation of persons to do stock takes failed.
This may sound like a simple example, but the same scenario can be used for just about any adverse situation found in an organisation.
Also remember, you may be lucky to find your root cause after only 3 or 4 Why's, or it may be go beyond 5 Why's, depending on the complexity of the problem.
Just to add a final curve ball; there may be more than one root cause to certain problems.