Let’s start the day with some much-needed good news from the EC. They’ve released a new guidance aimed at making it easier for notified bodies to perform remote audits for MDR certification.
The MDR certification process requires on-site quality audits of manufacturers as well as their suppliers and subcontractors. But with COVID still running wild across the globe, there are ongoing concerns about potential exposure from mingling with the unwashed masses.
(OK, that last part was me. The WHO has issued no statement regarding the hygiene of the general populace and its impact on the transmission of the virus. 😜)
With only eighteen designated as of January 2021, the notified bodies are under a lot of stress to meet demand for their services. International travel takes staff out of the office for days at a time, and remote audits would certainly save valuable time.
Don’t get me wrong – I much prefer an onsite audit. There is SO much more that can be gleaned from an onsite audit that just cannot be discerned via video conference. However, I will concede that a remote audit has its place in the MDR certification tool kit – for now.
The option to perform a remote audit – as well as other “extraordinary measures” outlined by the EC – is only temporary, as defined in the guidance, and may or may not continue once the pandemic eases. And that may be a good thing.
Notified bodies and remote audits do not seem like a good match, given MDR’s emphasis on documentation and transparency. But with careful planning, a LOT of communication, and a strong video connection, a remote audit is a good stop-gap measure. It will help keep the notified bodies on task and help manufacturers continue their slow and steady progress toward certification.
Here’s the link to the full document: CELEX_52021XC0111(01)_EN_TXT
And if you want to see the rest of the conversation, here’s the link to the original post on LinkedIn: https://www.linkedin.com/posts/michellelottraqa_ec-notice-regarding-remote-qms-audits-activity-6754775644950802432-W_1D