Audits in Germany and within Europe on site again
Over the past few months, we have all faced and mastered major challenges. Thanks to the quick reaction of our regulatory authorities, it was possible for the first time, to carry out audits partially remote, to maintain the certificate. This enabled us to grant your company market access in the past months despite the pandemic.
In the meantime, the handling of COVID-19, and thus the partial restrictions of our public life, have become somewhat normal. With a great deal of discipline, we have managed to avoid scenarios such as those in Italy or Spain. Now we have to move forward together, step by step again, and make up for or carry out those parts of the audits that have to take place on site in your company.
For DQS Medizinprodukte GmbH, the guidelines and decisions of the federal and state governments, as well as foreign governments, are decisive for the procedure. At present, these essentially determine our audit activities under COVID-19 conditions.
On June 15, 2020, the German Federal Government lifted the travel warnings within Europe for most countries and the restrictions in Germany were also eased significantly.
How does this affect our audits?
Taking into account the new framework conditions, remote audits are no longer mandatory. Therefore, DQS Medizinprodukte GmbH will carry out its audits in Germany and in most European countries on site again, starting July 1, 2020. Excepted from this are procedures already ordered as remote audits.
For us, it is a matter of course that we will continue to observe the requirements for "social distancing": such as minimum distances, number of groups of people, wearing protective masks, as well as disinfecting hands, during the audit.
Please note that internal company restrictions can unfortunately not be taken into account, as the responsible national and international authorities continue to oblige us to carry out our audits on site. In order not to jeopardize your certificate, we must find a good solution together, for carrying out the audit on your premises, which does not endanger our assessors or your employees.
Are there reasons for remote audits?
Only where country-specific restrictions or warnings from the authorities exist, that would prohibit us from conducting our audits on site, audits can still be carried out remotely.