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COVID-19 business updates

Medical and Healthcare Services’ response to the outbreak

Updated on 6 April 2020

The situation with regards to the COVID-19 pandemic is evolving on a daily basis, with effects going far beyond the directly affected areas with outbreaks. During this time, the safety and well-being of our colleagues and clients is our highest priority.

Notified and Certification Bodies are in communication with their authorising or designating authorities to share contingency plans to deal with this extraordinary circumstance.

Please know that TÜV SÜD’s plans include combinations of remote and follow-up on-site audits, while minimising the risk to all Notified and Certification Bodies and manufacturer’s personnel and maintaining designation and accreditation requirements. Even though quarantine restrictions might make it impossible to perform physical audits, we are putting all our efforts to complete the remaining MDD projects as well as to support the full implementation of the MDR. At the same time at our Certification Bodies, we continue to serve clients that require certification under schemes like MDSAP or SCC. To that extent, we ask for your collaboration and flexibility.

Please remain in close contact with us and inform your client manager immediately of any potential issues, such as temporary closure of sites or delays in planned submission of documents, which may prevent delivery of a scheduled assessment.

We would like to inform you that TÜV SÜD is prioritising all medical device and in-vitro diagnostic device projects that are related to the treatment, testing, and monitoring of the coronavirus outbreak. 

Our test laboratories

Below are some important information regarding our test laboratories:

  • Our test laboratories are still available
  • Scheduled appointments will be kept
  • New appointments can be scheduled
  • Various measures are implemented to maintain operations such as introduction of split working teams which minimises physical contact, and implementation of intensive hygiene measures
  • (Visits from customers to our test laboratories are heavily restricted)
  • To minimise the risk of infection, personal supervision of tests in our laboratories should be avoided wherever possible. However, online solutions are available.
  • Business trips will only take place in exceptional cases
  • Remote audits for surveillance FSTs
  • Contacting our team is available via email, phone, Skype, Microsoft Teams
  • Virtual customer meetings through Skype, Microsoft Teams

Our notified AND CERTIFICATION bodies

Assessment of technical documentation

Technical documentation assessment continues as usual. For any outstanding issues or other questions, online meetings are also available. Please contact your project handler for more information. 

Remote audits

If COVID-19 has resulted in the prohibition of on-site assessments in your country, most accreditation bodies now allow remote audits either in combination with follow-up on-site audits or stand-alone. The applicable audit approach will be scheme specific and can be discussed in further detail with your project handler during the audit planning process. Our first experiences have shown that those remote audits are well accepted by our clients, and have similar effectiveness as normal on-site audits. Please avoid postponing your regular audits and leverage remote audits to maintain your certification status.

Below are some basics for conducting successful remote audits:

  • Your auditor will clarify the possibility of a remote audit as early as possible
  • Good preparation is key:
    • Exchange important documents prior to the audit (e.g. procedures, management review, internal audit reports)
    • Ensure that the necessary tools are available
    • Ensure that there is a possibility to exchange documents during the audit. This also applies for paper-based quality management systems.
    • Clarify how parallel sessions should be conducted
    • Agree on a procedure: online-meeting or alternating on- and offline-sessions.
  • Your auditor will perform a dry-run
  • Please be ready 15-20 minutes before the audit to solve potential technical issues
  • Your auditor will plan sufficient breaks

Other topics

If you have any questions on any other topics, our experts are available via telephone, email or online tools like Skype or Microsoft Teams.

 

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