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ISO 13485 Internal Auditing Services

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.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

ISO 13485 Internal Auditing Services

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.

Don’t wait for a Notified Body to find your gaps. We conduct ‘Full-Stress’ Mock Audits designed to replicate the intensity of an MDR or MHRA inspection. Our auditors look specifically for the common 2026 pitfalls: weak Post-Market Surveillance (PMS) links and outdated Clinical Evaluation Reports (CER)

New for April 2026: Are your clinical investigation files compliant with the today’s enforcement of the Clinical Trials Amendment Regulations 2025? We provide specialized audits for Trial Master Files, ensuring your data integrity and 25-year archiving protocols meet the new MHRA standards

Alex Lewis - Patient Guard - Quality Assurance Manager

"An internal audit shouldn't just be a compliance exercise; it’s your best defense against Notified Body non-conformities. We approach every 13485 audit with the same rigor as an external registrar, finding the gaps in your QMS before they become a risk to your certification."

Alex Lewis BSc, Qualified Lead Auditor

Quality Assurance Manager

Why Choose Patient Guard for ISO 13485 Internal Audits?

Established Regulatory Consultancy

Operating as a trusted industry partner since 2017, we specialise strictly in medical device quality systems and global regulatory compliance standards.

Trusted by 500+ Companies

We actively support diverse organisations across the full medical device lifecycle, from early-stage start-ups to established international manufacturers.

Independent & Objective Audits

We provide completely unbiased, detached assessments of your QMS to identify real product risks and structural gaps before external inspectors do.

Transparent Fixed Pricing

We believe in open operations. We provide clear, project-based or fixed annual pricing structures with absolutely no hidden costs.

Rigorous Regulatory Expertise

Our lead auditors completely align every evaluation with ISO 13485:2016, EU MDR, UK MDR, and ever-evolving global regulatory expectations.

Practical, Actionable Findings

We don’t just flag problems. We deliver clear, highly structured audit reports packed with practical recommendations to optimize your workflows.

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

What Our ISO 13485 Internal Auditing Service Includes

Audit Planning & Scope

We precisely define the audit scope based directly on your active QMS architectures, device classifications, and target market requirements.

Full QMS Internal Audit

Our qualified lead auditors comprehensively assess your organizational processes against every clause of the ISO 13485:2016 standard.

Process-Based Evaluation

We systematically check high-risk operational pillars, including design controls, risk management integration, and supplier validation metrics.

Records & Dossier Review

We conduct deep reviews of your standard operating procedures, historical batch records, and technical compliance documentation files.

Detailed Audit Reporting

You receive an institutional-grade audit report clearly separating minor/major non-conformities, technical gaps, and practical observations.

Proactive CAPA Support

We don't leave you stranded with findings; we actively support your team during corrective and preventive action planning and system integration.

Pre-Certification Support

We design full-stress mock audits replicating the precise intensity of a Notified Body or MHRA inspector review to build total team confidence.

Who Requires ISO 13485 Internal Audits?

ISO 13485 Internal Audit Requirements

ISO 13485:2016 requires organisations to:

Internal audits are essential to demonstrate ongoing compliance and continual improvement.

Our Process

Audit planning

We define scope, schedule, and audit objectives.

Audit execution

We conduct the audit, including interviews, document review, and process assessment.

Reporting and CAPA

We provide findings, identify non-conformities, and support corrective actions.

Industries We Support

We support ISO 13485 internal audits across:

Cost of Service

Premium

ISO 13485 Internal Auditing

£ 2,000

From

Ensure ongoing quality compliance and certification readiness with expert ISO 13485 quality audits.

Audit Costs

Small Size Organisation (<10 employees) 2 day audit £2,000
Medium Size Organisation (10-50 employees) 3 day audit £3,000
Large Size Organisation (>50 employees) 4 day audit £4,000
Medical Device File Audit, one additional day and £1,000 on top of the above costs

Get Started

Time Lines

Planning

1-2 weeks

Audit

1-2 days depending on organisation size

Reporting & CAPA

1-2 days depending on organisation size

Frequently Asked Questions (FAQs)

What is an ISO 13485 internal audit?

An internal audit is a systematic review of your Quality Management System to ensure compliance with ISO 13485 and regulatory requirements.

How often should internal audits be conducted?

Internal audits should be conducted at planned intervals, typically annually or based on risk and process criticality.

Can you act as an independent internal auditor?

Yes, Patient Guard provides independent auditors to ensure objective and unbiased audit results.

What happens if non-conformities are found?

Non-conformities must be addressed through corrective actions, and we can support CAPA implementation.

How long does an internal audit take?

Audit duration depends on organisation size and scope but typically ranges from 2–5 days.

Is an internal audit mandatory for ISO 13485?

Yes. Clause 8.2.4 of ISO 13485:2016 requires audits at 'planned intervals.' In the current 2026 regulatory climate, the MHRA and Notified Bodies expect to see a robust audit schedule that covers every process of your QMS at least once per year.

Can Patient Guard audit our Technical Files as well as our QMS?

Absolutely. We offer a specific 'Medical Device File Audit' (Technical File) as a bolt-on to our QMS audits. This ensures your Annex II/III documentation (MDR) or Part II (UK MDR) is audit-ready and aligned with your quality procedures.

What is the difference between an internal audit and a gap analysis?

A Gap Analysis is a roadmap used before you have a system in place. An Internal Audit is a compliance check used after your system is live to verify it is actually being followed. We provide both to support you at every stage of your growth.

Related Services

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   Jay Verma 
 1 days ago
 
 
 Trustindex verifies that the original source of the review is Google. I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
  
 
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   Munna P 
 54 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
  
 
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   Peter Reeve 
 81 days ago
 
 
 Trustindex verifies that the original source of the review is Google. STEPPER design, manufacture & distribute eyewear across the globe.  With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
  
 
     Posted on Google  
   
   Derek Timm 
 81 days ago
 
 
 Trustindex verifies that the original source of the review is Google. For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd   The staff are fantastıc  nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them  Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
  
 
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   BMSCriticalCare 
 118 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Great service, very helpful and always willing to answer any questions we have,
  
 
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   Thomson Software 
 789 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner.  He was friendly, patient and willing to go the extra mile.  Excellent service.
  
 
 
  
 
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