ISO STANDARDS FOR MEDICAL DEVICES
Medical devices
Make quality controls and records traceable throughout your process.
We help medical device organisations prepare quality management documentation that reflects their role, product range, sites and the requirements applicable to their activities.
Quality evidence that follows the device lifecycle
We start with your activities, locations and existing practices, then identify the procedures, records and responsibilities the management system should cover.
Traceable processes
Identify the product, process and record links required for your activities.
Controlled documentation
Manage revisions, approvals and records throughout the relevant device lifecycle.
Supplier oversight
Evaluate and monitor suppliers and outsourced processes based on their role and risks.
Feedback and corrective action
Define how complaints, nonconformities and product feedback are reviewed.
Support tailored to your activities
We build on the processes and records your teams already use and agree what needs to change.
Design and manufacturing
Prepare controls for design changes, production activities, quality records and release.
Distribution and related activities
Connect purchasing, storage, handling, traceability and complaint records.
Installation, servicing and support
Define service responsibilities, installation checks and reporting back to relevant parties.
Recommended ISO standards
Use these recommendations as a starting point. The right standards depend on your activities, risks and customer requirements.
ISO 13485
Quality management for medical devices
Manage quality across activities involving medical devices.
Learn about ISO 13485ISO 9001
Quality management
Manage general business quality processes where relevant to your organisation.
Learn about ISO 9001ISO/IEC 27001
Information security management
Protect sensitive information, systems and digital services.
Learn about ISO/IEC 27001ISO 45001
Occupational health and safety
Manage occupational health and safety risks in relevant operations.
Learn about ISO 45001
Select the standards that fit your needs. An integrated management system can share procedures and documentation across several standards.
How we work with you
Review your activities
We discuss your services, locations, teams and customer requirements to agree a practical scope.
Prepare the documentation
We prepare or update procedures and records for the chosen standards using the evidence you already have.
Check readiness
We review how procedures are applied and identify what needs to be completed before the audit.
Support the certification process
We submit the agreed documentation and support you during preparation. The independent certification body assesses conformity and makes the certification decision.
Certification covers the management system within an agreed scope. Your organisation remains responsible for applicable legal and operational requirements.
Frequently asked questions
Answers on choosing standards, planning the scope and getting ready for assessment.
Is ISO 13485 relevant to distributors?
It can be, depending on your activities, regulatory obligations and customer requirements. The scope should reflect your actual role.
Does ISO 13485 grant market access?
It assesses the quality management system. Market access depends on the applicable device regulations and conformity assessment procedure.
Can existing procedures be used?
Yes. We review current records, roles and controls against the requirements and identify what needs to be adapted.
Can ISO 9001 and ISO 13485 share processes?
Yes, where appropriate. The system also needs to address the specific medical device requirements in its scope.
Can we use the documentation we already have?
Yes. We review your existing procedures and records, then identify what needs to be added or updated for the agreed scope.
Prepare your organisation for certification
Tell us about your activities, locations and goals. We’ll recommend suitable standards and prepare a quote for the agreed support.