Recertification Audit 2016

As part of the re-certification audit conducted by the SGS UK, a team of auditors spent three days in Instrumentaria manufacturing facility. During the audit , each department has been audited as well as the functioning of the quality system  and compliance with EU legislation which applies to manufacturers of medical devices. Auditors haven’t noticed any significant non-conformities which has been confirmed by final Audit report.

Quality management system of Instrumentaria is in accordance with the requirements of the EN ISO 13485: 2012 and new three year certificate has been issued.   In line with the upcoming regulatory changes, Instrumentaria will in the upcoming period renounce the ISO 9001 quality system, and will be harmonized only with ISO 13485.