Our ISO 13485 internal auditing services support medical device organisations in assessing the effectiveness and compliance of their Quality Management System (QMS). Patient Guard provides expert auditors to ensure your system meets ISO 13485:2016 requirements and is fully prepared for certification or regulatory inspections.
ISO 13485 internal audits are a critical requirement of maintaining a compliant Quality Management System. They ensure your processes are effectively implemented, compliant with regulatory requirements, and aligned with medical device standards.
Regular internal audits help identify non-conformities, gaps, and opportunities for improvement before external audits or Notified Body inspections.
Patient Guard acts as your independent internal audit partner, providing objective, expert-led audits to evaluate your QMS against ISO 13485:2016 and applicable regulatory frameworks such as EU MDR and UK MDR.
Without robust internal audits, organisations risk audit findings, regulatory delays, and potential non-compliance.
Patient Guard provides expert ISO 13485 internal audit services tailored to medical device manufacturers, start-ups, and suppliers. We support audit planning, execution, reporting, and corrective action follow-up.
Whether preparing for certification or maintaining compliance, we ensure your QMS is audit-ready.
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”
Tracey Slater, Cormed
ISO 13485:2016 requires organisations to:
Internal audits are essential to demonstrate ongoing compliance and continual improvement.
We define scope, schedule, and audit objectives.
We conduct the audit, including interviews, document review, and process assessment.
We provide findings, identify non-conformities, and support corrective actions.
We support ISO 13485 internal audits across:
From
Ensure ongoing quality compliance and certification readiness with expert ISO 13485 quality audits.
1-2 weeks
1-2 days depending on organisation size
1-2 days depending on organisation size
An internal audit is a systematic review of your Quality Management System to ensure compliance with ISO 13485 and regulatory requirements.
Internal audits should be conducted at planned intervals, typically annually or based on risk and process criticality.
Yes, Patient Guard provides independent auditors to ensure objective and unbiased audit results.
Non-conformities must be addressed through corrective actions, and we can support CAPA implementation.
Audit duration depends on organisation size and scope but typically ranges from 2–5 days.
Click on the links below to discover more:
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Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
UK Office
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
