During the ongoing COVID-19 Pandemic, Medical Device Authority (MDA) has taken a precautionary measure to allow remote auditing in the conduct of conformity assessment activities by the conformity assessment bodies (CAB) under the Act 737, due to health and safety concerns and travel restriction.

Thus, MDA has outlined the implementation for remote audit as follows:

  • Remote audit may be considered when travel to an establishment or a specific location is not reasonable due to health and safety concerns or travel restriction (Example: Movement Control Order (MCO), Phase 1 National Recovery Plan (NRP)).
  • The CAB shall establish an internal standard operating procedure (SOP) for remote auditing during Covid-19 pandemic. The remote audit shall be guided by ISO 9001 Auditing Practices Group on Remote Audits 2020. Risk assessment shall be included prior to deciding whether or not the audit should be conducted remotely.
  • CAB shall get approval on the remote audit SOP from MDA.
  • All auditors shall undergo Remote Audit Training by MDA.

Considerations in allowing remote auditing were based on NRP announced by the Malaysia Government and the conduct of remote audit shall be conducted as follows:

NRP PHASES

As more states have moved to Phase 3 and Phase 4 of NRP, all conformity assessments shall be conducted ONSITE starting 1st December 2021 . However, CAB shall follow strictly the health and safety measures as advised by the Ministry of Health and National Security Council.