Quality Assurance audit third-party

The Safety Equipment Institute (SEI), a private nonprofit organization established in 1981, administers nongovernmental, third-party certifications of a broad range of safety equipment and products. SEI certification is voluntary and available to any mannfactnrer of safety and protective equipment. Certifications include ongoing product testing and quality assurance audits. SEI conducts product testing in accordance with consensus, governmental, or other standards. 

The test plans, procedures, expected results and reports on the tests should be maintained and should be available for quality assurance audits and third party assessments. The test procedures should present the rationale for each test case and provide for tracing of the test cases to the relevant source documents. The expected test results should be stated (with their method of derivation) in the test documentation prior to execution of the tests. 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

The quality assurance department within a company will frequently conduct audits of investigator sites, either during a clinical study or after it has been completed. Companies that do not have a quality assurance department or unit may contract this service from a consultant or a third party specializing in regulatory audits. The intent and scope of these audits are the same as the FDA, but they afford a company an opportunity to verify compliance and to correct deficiencies that might otherwise delay product approval. These audits... 

Audits and inspections may be carried out by a company s/site s/plant s/project s own staff (for example, self-audit) or by independent persons (for example, corporate auditors, quality assurance department, regulators, customers or third parties). 

Industry quality assurance scheme - these are audited by third party to increase transparency and trust. This industry level can be managed either by the retail, or by the food industry (an example is EUREPGAP). 

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