3
Key Decisions
LEVEL OF CONTROL
As noted earlier, before a quality plan can be adopted and the work started, senior management need to make some key decisions. Quality and regulatory staff should make sufficient preparations so that they can participate actively in these decisions. Initial decisions include:
- How should company size affect the QMS structure?
- How should company culture affect the approach?
- Do we want one QMS or several?
These questions are all part of the basic question: How much centralized control is appropriate? For small companies at a single location, the QMS approach is straightforward: A single QMS governing the ...
Get Excellence Beyond Compliance now with the O’Reilly learning platform.
O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.
