Current Headlines

25 Mar

During this unprecedented time with the Covid-19 pandemic we wanted to reach out and update you on how we’re approaching the situation at BQAI and how this affects your Certification including Application.

19 Jul

Despite recent flat denials of problems with Notified Body designation and the medical device industry crying for help…………

01 Feb

Last revision published in 2016 and the transition period for migration to this version has not yet ended (due date 31st Mar 2019). This is indeed a unique situation…….

18 Jul

ISO 19011:2018, Guidelines for auditing management systems, has been technically revised and now replaces the 2011 edition……

26 Jun

Many organisations are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits and the like relating to ISO 13485 certification. It is not as difficult as you may think and you could be losing out on high margin business….