ISO 13485:2016 Certification
Medical Devices Quality Management Certification
ISO 13485:2016 sets out requirements for a Quality Management System (QMS) covering the design, development, production, storage and distribution of medical devices. It demonstrates your organisation's ability to consistently meet customer and applicable regulatory requirements throughout the device lifecycle. International Assessment Bureau carries out independent, impartial audits against the standard and issues certification that gives regulators, customers and patients confidence in your products.
What ISO 13485:2016 Covers
Quality System Planning
Establishing a QMS tailored to the design, development and manufacture of medical devices.
Regulatory Requirements
Meeting the regulatory requirements that apply to medical devices in the markets you supply.
Design Controls
Formal controls over the design and development of devices, from concept through to production.
Documentation & Training
Maintaining the documents, records and staff training needed to evidence consistent practice.
What ISO 13485:2016 Does For Your Organisation
Our Certification Process at a Glance
Application & Quote
Tell us about your organisation and scope. We provide a clear, fixed quote.
Payment & Invoice
Once you accept the quote, we issue an invoice and confirm your certification agreement before scheduling the audit.
Stage 1, Stage 2 & Surveillance Audits
On-site/remote assessment of your QMS in operation against the standard, followed by ongoing surveillance audits.
Certification Decision
An independent technical review confirms the certification decision.
Certificate & Surveillance
Certificate issued, with ongoing surveillance audits to keep it valid.
See our full certification process for more detail on each stage.
About ISO 13485:2016
International Assessment Bureau is an independent certification body based in the UK. ISO 13485:2016 specifies requirements for a Quality Management System where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, covering the design, development, production, storage and distribution of medical devices.
ISO itself issues no certification or conformity test directly - certification against ISO 13485:2016 is carried out by certification bodies such as International Assessment Bureau. Organisations working in the European Union frequently reference the EN harmonized edition of the standard, which is identical word-for-word to the international edition but includes three additional annexes addressing specific requirements of the EU Medical Devices Directive.
Ready to Start Your ISO 13485:2016 Certification?
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