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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 1 - General Enforcement Regulations |
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Subpart R - Laboratory Accreditation for Analyses of Foods |
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FDA Recognition of Accreditation Bodies |
§ 1.1113 - What are the eligibility requirements for a recognized accreditation body?
Latest version.
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§ 1.1113 What are the eligibility requirements for a recognized accreditation body?
A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).
(b) Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025.”
(d) Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.