Information Security & Privacy

SHOEBOX Ltd. has achieved certification to the International standard for Information security, ISO/IEC 27001. With this certification, SHOEBOX has proven that it has been able to establish, implement and operationalize a more proactive information security framework in line with business requirements. As a company, we follow best practices in information security to better protect our information assets, thereby reducing risk, loss or embarrassment as a result of loss of either our own business information or our customers’.

This ISO 27001 certification complements our original ISO 13485 (for medical device, quality management) accreditation by the British Standard Institute (BSI), as proof of an external, independent recognition. We are committed to year-on-year improvement of our information security and privacy program, as we continue to better align our information security controls with the business; maintaining the ISO 13485 Medical Device Quality Management and ISO 27001 Information Security Management certified by BSI under certificate numbers FM 741745, IS 747476.

Quality

SHOEBOX Ltd. has an ISO 13485 Medical Device Quality Management System which is audited by BSI annually. In pursuit of our belief that everyone on the planet deserves good hearing health, and our commitment to customer satisfaction, product quality and regulatory compliance, SHOEBOX Ltd. has established, implemented and maintained an ISO 13485 certified quality management system. Our Quality Manual follows the format of the harmonized standard ISO 13485 in order to ensure each section is addressed.

We are committed to maintaining an effective Quality Management System that ensures that our processes are efficient and consistent. Our overall quality policy is to conform to the requirements of the ISO 13485:2016 Standard.

Regulatory Registrations

SHOEBOX Audiometry currently maintains the following medical device registrations:

• Listed as a Class II medical device with US FDA
• Licensed as a Class II medical device with Health Canada
• CE marked Class IIa in Europe under the Medical Device Directive (98/42/EEC), notified body BSI Netherlands (2797)
• Listed as a Class IIa medical device with Australian TGA and New Zealand WAND

Audiometry Standard Compliance

SHOEBOX Audiometry complies with the following product standards:

• ANSI/ASA S3.6-2018 and IEC 60645-1:2017, Type 3 Audiometer
• Algorithms comply with ISO 8253:2010 Part 1: Pure-tone air and bone conduction audiometry
• Calibrations comply with ANSI/ASA S3.6-2018 and IEC 60645-1:2017

Other Compliance

• SHOEBOX enables employers to comply with their obligations under OSHA and MSHA requirements as required by 21 CFR part 1910.95  as those obligations relate to the customer’s use of SHOEBOX Audiometry Download our 1910.95 summary here
• SHOEBOX enables customers to comply with their obligations under FRA, CSA, and other local regulations as part of their hearing conservation programs as those obligations relate to the customer’s use of SHOEBOX Audiometry
• SHOEBOX enables our customers to comply with their obligations under GDPR, HIPAA, PIPEDA and other privacy regulations as those obligations relate to the customer’s use of SHOEBOX Audiometry