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    About SAMSAM

    Quality Management System

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    Our Quality Management System is based on the requirements of the legislation and ISO 9001, it also takes into account the guidelines, standards and the best practices from the Estonian and international organizations.
    Our laboratory is accredited according to the EVS-EN ISO/IEC 17025:2006 by the Estonian Accreditation Centre (accreditation certificate no L217.) The Scope of the accreditation is given in the annex to the accreditation certificate.

    Benchmarking
    The Heads of the European Medicines Agencies have established a benchmarking exercise, the aim of which is to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to the best practice standards.
    The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment in four areas: organization and management; assessment of marketing authorization applications; pharmacovigilance and inspections. The internal self-assessments are then followed up by external peer-reviews. Reports from all the visited agencies are entered into a database which forms a valuable resource for best practice across the entire EU/EEA network of medicines agencies.

    The agency’s information safety is based on German standard IT Baseline Protection Manual, which is in most parts compatible with standard ISO/IEC 27001 Information technology;  Security techniques; Information security management systems; Requirements.

    The agency’s information protection system is audited regularly by an independent auditor with CISA certificate.