|Theme||COVID-19 – Audit|
|Target Audience||Notified Bodies, Manufacturers, Subcontractors|
|Products concerned||MD, IVD|
|Documents mentioned||IAF MD 4 (Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes)
EN – This document is valid throughout the pandemic period as defined by the WHO.
The purpose of this guide is to maintain the continuity of the work of Notified Bodies (NB) in their own interest and in the interest of manufacturers despite the health circumstances and travel restrictions they have caused. This guide took effect immediately after its publication in April 2020 and allows remote auditing when circumstances do not allow it on site. All of the audits types mentioned hereafter are concerned:
- Surveillance audits as provided for by the Directives,
- Re-certification audits under the Directives,
- If the manufacturer has submitted a “plan for change” to their NB and this would have to carry out an on-site audit or verification,
- If the manufacturer wishes to transfer its certificates to a NB other than the one that originally assessed the conformity of the device in question.
This guide is not applicable to unannounced audits and special audits which necessarily require an on-site assessment. It is the responsibility of each NB to document their chosen remote procedure and to define the criteria and choice of technology. NBs are also encouraged to take account of recent MDSAP audit data or other appropriate audit data where available. In general, the feasibility of a remote audit should be assessed on a case by case basis.