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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.
21 CFR 111FDA investigators (government inspection). Voluntary third-party cGMP 21 CFR 117/FSMAFDA investigators, and state agencies inspecting under contract with F21 CFR 211FDA investigators (government inspection). Foreign regulators under muAPI Q1API itself. Auditors approved by API conduct Monogram license audits aAS9100Certification bodies accredited under the IAQG scheme (9104-1) by an IAS9120Certification bodies accredited under the IAQG scheme (9104-1) by an IBRCGSBRCGS-approved certification bodies accredited to ISO/IEC 17065 for thCMMIISACA Certified CMMI Lead Appraisers sponsored by a licensed CMMI PartFDA 21 CFR 820/QMSRFDA investigators (government inspection). MDSAP-recognized auditing oFSSC 22000/ISO 22000FSSC-licensed certification bodies accredited to ISO/IEC 17021-1 with GMP/cGMPGovernment inspectors: FDA investigators in the US; national competentHACCPGovernment inspectors where HACCP is mandated (FDA investigators and sIATF 16949IATF-recognized certification bodies under contract with an IATF GlobaISO 13485Accredited certification bodies for ISO 13485 (many are also EU notifiISO 17025Accreditation bodies themselves (not certification bodies), using leadISO 9001Accredited certification body (registrar) accredited to ISO/IEC 17021-NadcapPRI-employed or PRI-contracted Nadcap auditors assigned by PRI; there R2/RIOSSERI-approved certification bodies accredited to ISO/IEC 17021-1 for tSQFSQFI-licensed certification bodies accredited to ISO/IEC 17065 for the
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