ISO 13485 Certification

Quality Management Systems for Medical Devices 

ISO 13485 certification can help build confidence in your organisation by showing that your Quality Management System (QMS) has been independently audited against an internationally recognised standard for medical device quality.  

The ISO 13485 standard sets out requirements for organisations involved in the design, manufacture, installation and servicing of medical devices, supporting compliance with regulatory frameworks and maintaining high product quality. 

Being certified to ISO 13485 could strengthen your credibility with customers and partners, support regulatory and supply chain requirements, and help you compete in regulated markets. 

Who Needs Certification?

ISO 13485 certification can be valuable for organisations across the medical device supply chain that want to demonstrate evidence of an audited Quality Management System. This may include:

• Medical device manufacturers looking to support customer, supply chain, and relevant regulatory requirements in the UK, EU, US, and other markets.
• Contract manufacturers producing devices or components on behalf of brand owners.
• Suppliers of components, materials, or services to device manufacturers.
• Distributors and importers where ISO 13485 supports their activities, customer requirements, or regulatory obligations.
• Organisations providing installation, servicing, or sterilisation services.

Integrating ISO 13485 With Other Standards  

ISO 13485 can be implemented alongside other Management System Standards, including: 

• ISO 9001 for quality management 
• ISO/IEC 27001 for information security 
• ISO 14001 for environmental management  
• and ISO/IEC 42001 for artificial intelligence management  

Where relevant to an organisation’s activities, these management systems can be coordinated to support consistent governance while retaining the specific requirements of each standard. 

What do we look at during the ISO 13485 audit? 

Our impartial auditors will look at how your QMS works in practice and whether it meets the relevant requirements of ISO 13485. 

They will review aspects such as: 

• How your organisation manages quality and risk in the areas covered by your QMS. 
• Design and development controls, where these apply to your scope. 
• Traceability of devices, components, and materials where required. 
• Complaint handling, feedback, and regulatory reporting processes. 
• Supplier controls and purchasing processes. 
• Documented procedures, records, and the medical device file. 
• Internal audits, management review, and corrective and preventive action (CAPA). 

How Much Does ISO 13485 Certification Cost?

These are some of the main factors we consider when preparing your quote. Tell us about your organisation, and we will explain the next steps, with no obligation.