Remote Auditing for QMS Registration to ISO 13485

Due to travel restrictions and risks associated with COVID-19 transmission, registrars have had to change their normal practices for on-site audits. This has brought with it an increase in the use of remote audits. Our Regulatory team supports medical device manufacturers by minimizing the risk of visitors introducing the virus to their sites while maintaining compliance with regulations by continuing their audit program.

This paper provides a summary of the key information sources:

• Your options for on-site and remote auditing and situations where an on-site audit is still required
• IT systems that are required for a remote audit
• The impact of the remote audit
• How to best prepare for the remote audit