QMSR Tip #1: Focus less on compliance and more on building a quality culture
FDA expects top management to embrace a culture of quality, not simply push a goal of absolute compliance.
Yes, we must comply with all applicable regulatory requirements, but that is not the real intent of QMSR.
In a response to Comment #27 in the Quality Management System Regulation (QMSR)1 related to the definition of the term top management in ISO 9000, and now incorporated in the QMSR by reference, FDA is clarifying that there no need to retain the term m…
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