Quality & Manufacturing
19 standards, regulations and schemes in this family. A quality or manufacturing standard. Each page explains what it is, who has to follow it, what to write down, and who checks it.
What is in this family
A quality or manufacturing standard. Certification comes from an accredited registrar after a documented management system has run long enough to produce records. Typically assessed by: accredited certification body; Accredited certification bodies for ISO 13485; FDA investigators. Most asked about here: 21 CFR 111, 21 CFR 117/FSMA, 21 CFR 211.
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