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Sec.
820.20 Management responsibility.
(a) Quality
policy. Management with executive responsibility shall establish its
policy and objectives for, and commitment to, quality. Management with
executive responsibility shall ensure that the quality policy is understood,
implemented, and maintained at all levels of the organization. Interpretation:
This is a rather important requirement which has been gaining priority with the FDA. It isn’t enough to have management establish policies and objectives but rather management with executive responsibility. The FDA wants to hold top executive’s accountable for the actions of their organization.
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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