Registration and Certification under stress of COVID-19
Cavex Holland BV is certified as a manufacturer of medical devices and cosmetic devices according to ISO 9001, ISO 13485, Medical Device Directive 93/42 / EEC and fulfills various country-specific legal requirements. To maintain these records, Cavex is audited annually by notified body TÜV Rheinland. The year 2020 is besides the COVID-19 pandemic also a special year due to the recertification of ISO 9001, ISO 13485.
As TÜV Rheinland was not able to perform an onsite audit in the planned period due to the lock-down rules from both the German and Dutch government, additional rules and procedures were defined by TÜV Rheinland to cover this gap.
A very unique situation arose for both TÜV Rheinland and Cavex. An audit divided into two phases:
- The first phase; an online audit was carried out in April during two full day sessions via video meeting.
- The second phase; an onsite audit which has to be performed within 12 months after the first phase and is planned for first week of September 2020.
The pandemic situation caused a dramatic increase in the workload at the certifying agency resulting in a delay in the issuing of the certificates. However, based upon the good results of the first phase, the online audit, new certificates of ISO 9001 and ISO13485 were issued each with a validity of 6 months. After the second phase, the onsite audit, these certificates will be replaced by new certificates with a standard validity of 3 years. This will secure the registration and certification also under stress of COVID-19.
Just before the pandemic started and many borders were closed, Cavex had an FDA inspection of the Quality System in full. After an intensive 4 days audit, the FDA inspector concluded that the QMS is in full compliance with the US Medical Device law. Although we are not allowed to physically travel, we have secured the registration for America.
Proudly we can state that the Cavex Holland BV Quality System is in compliance with all the relevant specifications. The certificates are available at the Cavex website (see below) or directly from the independent TÜV Rheinland website : www.TUV.com and FDA website: www.FDA.gov