Browse Topic: Accreditation
On December 13, 2024, the U.S. Food and Drug Administration (FDA) notified the Medical Device Innovation Consortium (MDIC) of their final approval of the MDIC Report on the MedAccred Accreditation and Audit Program for Contract Sterilizers (Final Report). FDA inspections of firms, such as contract sterilizers, are pursuant to Title 21-Food and Drugs, Chapter 9 – Federal Food, Drug, and Devices, Part A-Drugs and Devices, Section 21 USC 360: Registration of producers of drugs or devices, Subsection (h) Inspections.1 The FDA notification is the culmination of a pilot study initiated by the Performance Review Institute (PRI) in 2023 in collaboration with MDIC and the FDA to evaluate PRI’s MedAccred Sterilization Audit and Accreditation Program of contract sterilizers. The agency confirmed that MedAccred is as an acceptable audit approach that may be leveraged for regulatory purposes as well as supplier oversight.
This SAE Aerospace Standard (AS) establishes standard requirements for aerospace sealants and adhesion promoters, which may be incorporated as part of SAE Aerospace Material Specifications (AMS) for such products. This document provides for commonality of methods and procedures for responsibility for inspection, source inspection, classification of tests, establishment of/and qualification to qualified products lists, approval, reports, resampling and retesting, packaging, and marking.
This document provides interpretation of ISO/IEC 17025 and establishes additional requirements for accreditation of testing laboratories for evaluating organic coatings.
This set of criteria is intended for use by accredited Certification Bodies (CBs) to establish compliance, and grant certification to AS6081, Aerospace Standard; Fraudulent/Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition-Distributors: It may also be used by others to assess compliance to AS6081 requirements.
When qualifying prototype samples in terms of vibration response and dynamic characteristics, an accredited laboratory is required to implement monitoring procedures to assure the validity of the test results. According to ISO17025, such monitoring may include inter-laboratory comparison or proficiency testing. This paper presents a mechanical structure which has been designed specifically to be used as a generic reference sample during such a comparative study in which resonant frequencies of a structure need to be quantified. This paper elaborates on the analysis and design issues, which encompass theoretical analysis, both purely mathematical and by FEM (Finite Element Modeling). In addition, to allow statistical analysis of test data resulting from measurements performed by different test laboratories, the uncertainty budget [1] of the reference value of this sample is determined. As a first step towards a European project, a limited group of accredited test laboratories in Belgium
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