Virtually achieved … ISO 13485 Medical Devices Standard

Andrew Wierny, our Quality Manager spent the week “locked-down” at Falcon House participating in a four-day virtual audit, conducted with Ian Massey from NQA via Skype and phone. “The first I have ever conducted virtually … and hopefully the last!” says Andrew.

At the end of last year, in light of increasing med-tech device orders, CPL decided to seek accreditation to this standard, which officially notes our capability in this field. At that point it was not envisaged that we would also be revising work practices and dealing with the Covid-19 impact. To now be recommended to UKAS for accreditation is no mean feat!

Due to the unusual circumstances of the review, CPL will have to undertake an additional one-day audit on site when government restrictions allow. This recommendation for approval is a great achievement and in years to come, only we will know the circumstances in which the audit was undertaken – rather a special time to have been recommended for this accreditation.
Well done Andrew and all.