Recertification Audit 2016
As part of the recertification audit conducted by SGS UK, a team of auditors spent three days at the Instrumentaria manufacturing facility. During the audit, each department was thoroughly reviewed, along with the functioning of the quality management system and compliance with EU legislation applicable to manufacturers of medical devices. The auditors did not identify any significant non-conformities, as confirmed by the final audit report.
Instrumentaria’s quality management system complies with the requirements of EN ISO 13485:2012, and a new three-year certificate has been issued. In line with upcoming regulatory changes, Instrumentaria will phase out the ISO 9001 quality system and align exclusively with ISO 13485 going forward.
