Is the CEO of a hospital responsible for quality policy and implementation under the Quality System (QS) regulation?
Answer. Under 21 CFR 820.20 (Management responsibility) management with executive responsibility is the level of management that has the authority to establish and make changes to the facility’s quality policy. The implementation of the quality system may be delegated; however, it is up to the highest level of management to establish quality policy and ensure implementation. Management reinforces understanding of policies and objectives by demonstrating a commitment to the quality system visibly and actively on a continuous basis. This can be demonstrated by providing adequate training and resources to support quality system development and implementation.
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