CUSTOMER INFORMATION on COVID-19 (Coronavirus)
DQS Medizinprodukte GmbH observes the developments around the spread of COVID-19 very closely and focuses on the health of its employees, auditors and customers in all decisions. At this point in time, there is no evidence of COVID-19 disease either within the staff or from our auditors.
As long as this remains the case, we will continue our business operations normally.
With this document we would like to give you answers to questions which have reached us in the last few days increasingly through customers and which possibly also concern you at the moment:
An appointment with a DQS MED auditor is pending. Has he possibly visited risk areas in the last weeks?
Already since February 2020 DQS MED has prohibited business trips to the People's Republic of China to all employees. This was also communicated to all freelance auditors as an urgent recommendation for action and was extended in March 2020 to all risk areas as declared by the Robert Koch Institute.
However, if you would like to know exactly which countries the auditor was last in, please contact the auditor directly or contact your customer service representative.
We (DQS MED customer) have a COVID-19 suspected case in the company and cannot conduct a pending audit as planned. What is to be done now?
Please inform us immediately if a scheduled audit cannot be performed as planned at your site. Of course we will postpone the audit date. An extension of the deadline of initially up to 60 days is generally possible. Please note, however, that such a postponement in the case of recertification audits may result in a transition period without a valid certificate. We will discuss this with you in detail and find the best possible solution for you. Please note our general terms and conditions for any potential costs that may arise.
We have an audit appointment in the next few weeks. Should we postpone it as a precaution?
Experience shows that DQS MED auditors are already working at full capacity months in advance. Therefore, we recommend to postpone audits only for concrete reasons, but never purely as a precaution.
Can we turn an on-site audit into a remote audit?
Basically we support the use of video conferencing techniques to avoid on-site appointments, whereby the infrastructure for this must be provided by you for reasons of information and data security. The extent to which the complete audit or, if necessary, only individual parts of it can be carried out remotely must be examined in each individual case together with your customer service representative and an individual risk assessment must be prepared.
In the legally regulated area of 93/42/EEC (MDD) remote audits are not established. This is also true for certifications acc. to EN ISO 13485:2016. Each on-site-audit, which is postponed because of the Covid-19 situation hast to be evaluated on an individual basis. As mentioned above, an extension of the deadline up to 60 days is possible. After these 60 days, a combination of document audit (offsite) and remote audit is feasible. The postponed on-site-audit has to be carried out within 3 months after the remote audit.
Together with other German notified bodies, DQS-MED is currently in contact with the responsible competent authority to find further possible transitional solutions.
Due to the Covid-19 situation, we are not able to complete the audit preparation (internal audits, management review etc.). So how do we deal with this?
As soon as the audit can eventually be carried out, this particular situation must be documented and evaluated as a deviation (force majeure) in the classification of the audit finding, combined with a closure date.
Can my auditor please provide a medical certificate or health certificate as proof that he is not ill with Covid-19?
In principle, you are welcome to ask your auditor to provide (a declaration) of his or her non-illness.
At this point, however, we would like to point out that most of the laboratories currently do not carry out tests on patients without a concrete suspicion of illness due to overload and your auditor may therefore not be able to provide the desired proof.
We therefore advise against a prophylactic corona test. The number of suspected cases and contact persons is likely to increase, so all resources should be concentrated on those persons who actually present a risk.