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Idocument 2 review4/6/2023 ![]() Processes that change constantly might not need a formalized review date because each update already calls for a review. As there isn’t a specifically mandated FDA 21 CFR Part 820 or ISO 9001 document review frequency, it typically depends on how often a document changes and how complex and important it is. Whereas some organizations may carry out annual document review procedures, others may review and revise their documents every two or three years because there were no changes during that time. (Note that ISO 13485:2016 states, “review and update as necessary and re-approve documents,” also leaving document review frequency to the discretion of the organization.) While ISO 9001:2015 requires that organizations control the documented information required by the quality management system (QMS), the standard allows an organization flexibility in the way it chooses to document its QMS, including when to document a quality management process, as long as it still achieves its overall objectives.
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