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.
![ISO 13485 certificate issued by BSI to Incus Company Limited](https://cdn.shopify.com/s/files/1/0415/7911/8759/files/ISO_13485_certificate_Incus_Company_Limited_600x600.jpg?v=1643124721)
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.