Client Communication Unannounced Audits (UAs) onsite

All correspondence should go to the CoronaMitigation@bsigroup.com inbox.

Over the last year, we have faced the COVID-19 pandemic together; we would like to reassure you that BSI has taken extensive actions to safeguard its people by managing the risk of infection within our operations and working with our clients. Our activities are in accordance with the World Health Organization (WHO), respective local government restrictions and/or prevention guidance.

Our priority is, and always has been, patient safety. We are currently working within the relevant legal and regulatory frameworks to do everything possible to put the safety of patients, our clients, and our people first. During the global pandemic, we suspended onsite unannounced audits.

BSI would like to advise you that we are now resuming Unannounced Audits (UAs) onsite, considering governmental travel restrictions per geography.

As an EU notified body and a UK approved body, we must work with our Authorities in both the NL (IGJ) and the UK (MHRA) to ensure our actions are effective, efficient and legal. The mandatory requirement for onsite audits remains a critical part of the regulatory requirements in the EU and UK. As such, we must return to in-person auditing to ensure your products maintain market access. We will assess your requirements, and this may mean that both auditors are onsite, or one auditor will be onsite, and another auditor remotely assessing the Technical Documentation. The auditing team may use individual staggered start times to ensure efficient use of time.

What do I need to do?
As part of our resilience planning, we have instigated our business continuity and pandemic response plans and have introduced remote auditing wherever permitted. We now need to work with you to ensure that we meet all the regulatory requirements for your BSI audits, and we need your help to do this.

We ask you to please complete the following form and return to CoronaMitigation@bsigroup.com within four weeks of receiving this email.

Onsite-Audit-Risk-Review-Information-Client-Form

The form must be completed for the sites listed on your QMS certificate, including critical sub-contractors (excluding EU Authorised Representatives and UK Responsible Persons).

• An onsite risk assessment will provide us with the details of your onsite protocols and safety precautions.
• Confirm a phone number for our auditor to call on arrival at your site, i.e. they will contact you from the car once on site to check that no changes to the onsite protocols have occurred or any recent outbreaks of COVID-19 before coming into your premises. 
• For all significant changes, please ensure you follow the original procedures to inform the Approved Body or Notified Body. In addition, please ensure the risk review form attached is also updated.

I have attached a document regarding the COVID-19 testing of BSI auditors for SARS-COV-2.

Thank you so much for being supportive.