Auditing Services
What we offer
Independent external auditors for ISO and regulatory compliance.
We build tailored, risk-based audit schedules aligned to ISO 13485 requirements—grouping audits efficiently to minimise disruption and maximise focus.
Operating under purchasing agreements with defined deliverables, we use a risk-based approach aligned to ISO 13485 requirements.
Our lean model minimises disruption, keeps costs efficient, and ensures consistent quality across every engagement.
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United Kingdom Accreditation Service (UKAS) witnessed and BSI Certified Lead Auditors.
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The Other Auditors have conducted over 50 audits as the lead auditor for ISO 13485 and MDR.
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We understand what certification bodies (CBs) and Notified Bodies (NBs) are looking for.
Our core services.
We cover every stage of compliance, including full-scope ISO and MDSAP audits, technical documentation reviews, supplier and multi-site programmes, and regulatory readiness assessments.
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Comprehensive audits against ISO 13485, ISO 14971, IEC 62304, MDSAP, EU MDR/IVDR and NMPA standards.
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For example, a gap assessment before your next UK Approved body, Notified Body or Competent Authority inspection.
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We undertake supplier audits on your behalf to provide you with an independent and objective expert opinion on key suppliers that may be subject to regulatory scrutiny.
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For enterprise clients, we design and execute audit programmes across multiple sites, providing a single point of contact and consistent methodology.
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Evaluate your preparedness for notified‑body inspections or MDSAP audits, highlighting gaps and systemic issues before regulators find them.
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We deliver comprehensive reports that highlight strengths, risks and opportunities for improvement, and we can assist with follow‑up actions on request.
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Expert assistance during notified-body audits, helping you interpret requests and respond with confidence.
Free internal audit schedule
Want to see how an optimised internal audit schedule could work for your QMS?
Try our free internal audit scheduling tool - answer a few simple questions, and within 24 hours you’ll receive a risk-prioritised, ISO 13485-aligned schedule, verified by The Other Auditors.
What our clients say
“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.
Ready to take the next step?