Coronavirus Covid-19 update and impact on medical device assessments

The situation with regards to medical devices and the coronavirus disease 2019 (COVID-19) outbreak is evolving rapidly. With the safety and wellbeing of our clients and colleagues our highest priority, we are contacting you to advise of our plans as an organization during this global health issue.

Taking into consideration the effects of the COVID-19 outbreak, we have reviewed our processes and put in place a contingency plan, the objective being to minimize the risk to BSI clients and colleagues whilst maintaining accreditation requirements and mitigating potential global trade risks.

We have decided to proceed with a combination of remote and deferred assessments depending on the type of visit and associated risk. As our auditors are allocated to assessments based on their expertise and occasionally travel internationally to perform an audit, any health threats in their country of origin must also be considered. Our contingency plan has been shared with regulators and is aligned with IAF ID3:2011.

Affected clients will be contacted to arrange suitable alternatives to scheduled on-site assessments. During the period preceding any rescheduled visits, clients should contact BSI and inform us immediately of any potential issues, such as temporary closure of sites, which may prevent delivery of the assessment.

Please e-mail any queries to coronamitigation@bsigroup.com, quoting your certificate number to help us identify and support you.

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