ISO 9001 and ISO 27001 surveillance audit at the State Agency of Medicines has been concluded

28.01.2015.

Near the end of 2014 the certification institution Bureau Veritas Latvia carried out a surveillance audit of the ISO 9001 and ISO 27001 certification at the State Agency of Medicines; also assessing the transition to the ISO 27001:2013 version. It was successfully concluded with the issuance of a new compliance document on 16th of January 2015 in accordance with the ISO/IEC 27001:2013 standard. The integrated management system of the State Agency of Medicines certified as compliant with the actual ISO 9001 and ISO 27001 requirements in the following areas of operation:

Assessment in the field of human medicines and medical devices regarding marketing authorisation and post marketing procedures;
Quality control of human medicines products;
Pharmacovigilance and vigilance of medical devices;
Licensing and marketing authorisation in accordance with power of attorney. Assessment of relevant documentation;
Management and publishing of information in accordance with power attorney.

Director Inguna Adovica: "This is a very significant acknowledgement of the quality of the professional operation of the State Agency of Medicines. This renewed verification of the compliance with certification requirements will promote trust in our operational capacity - the public and field professionals in Latvia, as well as collaboration partners in Latvia and in other countries can rely on the quality of work of the Agency."