19 January 2022. In February 2020, we announced that Incus Company Limited was ISO 13485:2016-certified by BSI. We have passed the second surveillance audit and stay certified in 2022.
On a sampling basis, BSI assessed whether we have continued to operate following an ISO 13485:2016-compliant Quality Management System for Medical Devices. Based on the audit findings, BSI maintained the certification status.
The next scheduled audit is a recertification audit. Recertification audits are conducted every three years and are more comprehensive than surveillance audits.
The auditors also carried out a site relocation audit to verify that our office relocation in June 2021 did not adversely impact our quality management system. The new address is on the updated certificate.
BSI certifies that we operate a Quality Management System for the scope of “The design, development, sales and distribution of audiometer application for smartphone and television.” complying with ISO 13485:2016 requirements.