Auditing Services

Is auditing necessary?

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 constantly run into the same issues:

  • 
They struggle to have in-house competency.

  • Staff unable to adequately demonstrate independence and objectivity.

  • Lack of resource to conduct effective internal audits.

  • Cultural issues with staff auditing colleagues.

  • Audit schedule is running late.

Why use The Other Consultants

  • I'm a United Kingdom Accreditation Service (UKAS) witnessed and BSI Certified Lead Auditor.

  • I have 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.

  • "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.

  • "Thanks for the immaculate work, Adam”

    Class IIb medical device manufacturer.

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