Remote Audits from the Perspective of Notified Bodies

We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to notified bodies on remote audits have been published. Out of 52 requested notified bodies, 46 had participated in the survey with a total of more than 33,000 audit days. 

In the vast majority of cases, the audits were deemed "generally successful." Only 10% of the cases resulted in a "generally unsuccessful". Interestingly, the audit results of remote audits are 87% comparable to on-site audits in terms of the number of deficiencies. In 11% of the cases even fewer deficiencies were found, in 2% of the cases more, compared to on-site audits. However, "remote audits" require more time than on-site audits. 5-33% more time needed is indicated.

What have been the experiences of "remote audits"?

Positive experiences have been:

• Reduced travel time and travel costs
• A tight focus
• It is easier to take notes
• Very effective for non-physical processes (e.g. software) and pure QMS aspects
• Verification of the quality of reports is more accurate compared to on-site audits
• Remote audits are more successful with established customers

And what negative experiences were there?

• Problems with large time differences
• Problems with internet connections
• A video does not allow the same opportunity to look around as being on site yourself
• In general, less spontaneity (e.g., further reactions to defects) during the audit

One question still deals with the issue: which requirements of the Medical Devices/IVD Regulation cannot be fully audited in a remote audit? The answers are:

• Infrastructure (ISO 13485 - § 6.3)
• Working environment and control of contamination (ISO 13485 - § 6.4)
• Production and service provision (ISO 13485 - § 7.5)
• Control of monitoring and measuring equipment (ISO 13485 - § 7.6)
• Control of non-conforming products (ISO 13485 - § 8.3)
• Requirements of the Medical Devices Regulation to be audited on site (10.1, 10.9(g), 10.9(k), 10.9 (m))
• Clean rooms
• Manufacturing processes of a physical nature
• Market surveillance issues with an in-depth look into the production process
• Production
• Medical Devices Regulation Annex VII, 4.5.2.b
• Medical Devices Regulation Annex IX, point 2.3, 3.3 - but the Commission announcement C/2021/119 is valid

The full results of the survey can be found here.