4
A Quality Plan
BACKGROUND TO THE PLAN
We know our company. We know its organization and its culture. We know its vision for the kind of company it wants to be. We know its products and the markets it wants to serve (and thus the applicable regulations). Some key decisions have been made, such as:
- We have decided on the extent of centralized control, guided by company culture and what seems likely to provide the best opportunities for the business.
- Part of that decision has been the determination whether to seek a single QMS or several, or perhaps to work progressively toward a single system.
- We know whether the framework is to be the U.S. Food and Drug Administration (FDA) QSIT (Quality System Inspection Technique) structure or the International ...
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