Direct accreditation definition

Direct accreditation means accreditation of a third-party auditor/certification body by FDA and is a term used in section 808(b)(1)(A)(ii) of the FD&C Act when describing FDA accreditation of third-party auditors/certification bodies, without the involvement of a recognized accreditation body. The distinction between direct accreditation and accreditation by an FDA- recognized accreditation body is relevant for some provisions of this rule. For example, under proposed § 1.656(b), a directly accredited auditor/certification body must send its annual self- assessment reports to FDA, while an auditor/certification body accredited by a recognized accreditation body must submit its annual self-assessment reports to the accreditation body, who is responsible for monitoring and ensuring its accredited auditors/certification bodies take timely and effective corrective actions, where necessary. FDA will access the accredited
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Direct accreditation means accreditation of a third-party auditor/certification
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Examples of Direct accreditation in a sentence

  • Direct accreditation means accredita- tion of a third-party certification body by FDA.Eligible entity means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body.

  • Direct accreditation means accredita-tion of a third-party certification body by FDA.Eligible entity means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body.

  • Direct accreditation meansaccreditation of a third-party certification body by FDA.Eligible entity means a foreign entityin the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body.

  • Direct accreditation processes and the program assessment process Section IV COMMITTEES OF THE UNIT All committees serve in an advisory capacity to the unit faculty and to the Director.

  • Direct accreditation means accreditation of a third-party certification body by FDA.

  • They could thus distort both the pattern of trade and the size structure of industry by favouring larger firms, for whom the fixed compliance costs and burdens are smaller in proportion of total costs and revenues.

  • Direct accreditation by the Open Accreditor should be a last resort.

  • Direct accreditation by FDA of third-party certification bodies would be particularly resource intensive. FDA should enhance existing and create new IT data systems to capture and report on results of assessments and audits.

  • Direct accreditation outcomes were defined as specific actions taken by organizations during the process of becoming certified to meet GFAS standards of best practices.

Related to Direct accreditation

  • Accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

  • Accreditation body means an entity that has been approved by FDA to accredit mammography facilities.

  • national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

  • Joint Commission means the accrediting body whose standards are referred to in these Bylaws.

  • Insurance holding company system means a group of two or more affiliated persons, at least one of whom is an insurer.

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

  • Licensure means the status of a licensee when OCCL issued a child care license when the applicant demonstrated compliance with these regulations and applicable codes, regulations, and laws.

  • Health care system means any public or private entity whose function or purpose is the management of, processing of, enrollment of individuals for or payment for, in full or in part, health care services or health care data or health care information for its participants;

  • Health Care Authority or “HCA” means the Washington State Health Care Authority, any division, section, office, unit or other entity of HCA, or any of the officers or other officials lawfully representing HCA.

  • Authorizations means all licenses, permits and approvals required by any governmental or quasi-governmental agency, body or officer for the ownership, operation and use of the Property or any part thereof.

  • Health care services means services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Educational entity means a public school district,

  • Insurance Regulator any Person charged with the administration, oversight or enforcement of any Insurance Regulation.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.