In connection with the pandemic situation resulting from the expansion of the coronavirus SARS-CoV-2 (COVID-19, hereinafter coronavirus) and the drastic measures taken by individual states, including the Czech Republic, the possibility of conducting supervisory activities of certification bodies in a standard way has been reduced, in the case of foreign clients, audit at the production site was completely prevented.
European Commission issued officially its recommendation, according to which all economic operators and stakeholders including notified bodies shall deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand.
In order to protect our staff from coronavirus infection, prevent contagion between our work teams and the client, and minimize negative impacts on public health protection and the economy, Our NB partner ITC Zlin- Czech Republic have issued this Decision for the Emergency Period of Lockdown.
- Measures taken to limit the spread of coronavirus make it practically impossible to supervise certified products or management systems using standard documented and approved procedures.
- This situation, which has not been influenced and cannot be influenced by ITC or its clients, shall be treated as a ‘force majeure’ and shall use available means which differ from standard procedures but lead to the same objective.
- Based on an analysis of the risks associated with each of the available options, it was decided to use procedure for conducting remote inspections (remote audits), which guarantees the highest level of public health protection and lowest impacts on the economy.
- When performing a remote inspection, account should be taken, to the extent possible, of the provisions of IAF MD 4: 2018 for the use of Information and Communication Technologies (ICT) for auditing / assessment purposes (see Annex 2 to this Decision). This document in section 0.3 gives examples of the use of ICT, which include:
- Dealing with teleconferencing facilities, including sharing audio, video and data,
- Audit / review of the document and record via remote access, either synchronously (in real time) or asynchronously (on request),
- Recording of information and evidence by means of static video, video or audio-play,
- Provide visual / audio access to remote or potentially dangerous places.
In doing so, measures must be taken to prevent abuse in order not to compromise the integrity of the audit / assessment process. At the same time, it should be stressed that due to the existing state of emergency and the requirement for immediate resolution of the problem, some of the requirements of the IAF MD 4: 2018 Mandatory Document will not be met on a case-by-case basis.
- This Decision regards all of the ITC certification activities on behalf of notified body NB 1023 as well as activities performed by the accredited ITC management systems certification body and product certification body.
- The decision shall be followed by both internal ITC employees and external experts and auditors, including foreign ones.