Auditing Services

Auditing is a mandatory requirement of ISO 13485: 2016, every organisation that produces medical devices has a requirement to undertake audits of their Quality Management System (QMS).

Despite this, organisations run into the same issues constantly:

  • Struggle to have in-house competency

  • Staff are able to adequately demonstrate independence and objectivity

  • Lack of resource to conduct effective internal audits

  • Cultural issues with staff auditing colleague

  • Audit schedule is running late

Services

Do you have an internal audit schedule you are struggling to maintain? Or do you have an upcoming stage 1, stage 2, surveillance or MDR audit coming up?

This is where we can help you.

Competency

As a United Kingdom Accreditation Service (UKAS) witnessed, and BSI Certified Lead Auditor who has conducted over 50 audits as the lead auditor for ISO 13485 and MDR, I understand what certification bodies (CBs) and Notified Bodies (NBs) look for.

Testimonials

“Thanks for the immaculate work, Adam” - Class IIb medical device manufacturer.

“Just to let you know that today’s audit on design didn’t raise any CARs, they accepted that we had a strong internal audit conducted and that our QMS was working and flagging issues” - PRRC of a IIa medical device manufacturer.

Contact Me

There are a few ways to get in touch, you can reach out via LinkedIn - https://www.linkedin.com/in/adam-isaacs-rae/ or subscribe to my newsletter where I publish things about all things medical devices quality and regulatory - https://theotherconsultants.substack.com/