QUALITY MANAGEMENT FOR MEDICAL DEVICES
ISO 13485 certification
Build traceable quality processes for medical device activities.
Prepare for ISO 13485 certification with practical advice and documentation tailored to your organisation. We help you connect the requirements to the way you work.
What can ISO 13485 do for your organisation?
ISO 13485 sets out quality management system requirements for organisations involved with medical devices. The scope depends on the organisation’s role, activities, device types and applicable requirements.
Manage documentation
Control procedures and records linked to device quality and regulatory requirements.
Trace processes and products
Document responsibilities and relevant traceability throughout the device lifecycle.
Control suppliers and production
Define how purchasing, production and outsourced processes are evaluated and controlled.
Respond to quality issues
Set procedures for feedback, complaints, nonconformities and corrective action.
Documentation tailored to your organisation
We start with your activities, responsibilities and existing records. Together we define the certification scope and identify what needs to be prepared.
Documentation for your scope
We can help prepare or review device-related processes, traceability, supplier controls, quality records and risk-based procedures.
Submission to the certification body
We submit the prepared documentation to the certification body for assessment.
Support throughout the process
We explain the requirements and help you plan the next steps within the agreed scope of work.
How ISO 13485 certification works
Prepare the documentation
We use information about your organisation to prepare documentation that reflects your activities and the requirements of ISO 13485.
Submit the documentation
We submit the prepared documentation to the certification body.
Assess conformity
The certification body reviews the documentation and assesses how the management system is implemented in your organisation.
Certification decision
The certification body makes its own decision and issues the certificate when the requirements are met.
Clear documentation and evidence of how the system works help you prepare for the audit.
Trusted by our clients
A selection of organisations CERT Standard has worked with.
Frequently asked questions about ISO 13485
Answers to common questions about preparation, scope and the certification process.
Does ISO 13485 certification authorise a medical device for sale?
Device market access is determined by applicable regulations and the relevant conformity assessment procedure. ISO 13485 certification addresses the quality management system.
How much does certification preparation cost?
The price depends on your activities, organisation size, number of sites and the scope of support. Share your details for a quote that sets out the work involved.
How long does the process take?
Timing depends on the documentation you already have, your readiness and the certification body’s schedule. We can discuss an indicative timetable after reviewing your needs.
What information should we provide?
Start with your activities, sites and current procedures. If available, include existing information about device-related processes, traceability, supplier controls, quality records and risk-based procedures.
Who issues the certificate?
CERT Standard provides advisory and documentation support. An independent certification body audits the system, makes the certification decision and issues the certificate.
What does a ISO 13485 certificate cover?
It confirms conformity of a medical device quality management system for the activities specified in the certification scope.
Get ready for ISO 13485 certification
Tell us about your organisation and what you want to achieve. We’ll prepare a quote for the support you need.