ISO 13485:2016 is an internationally recognized framework for medical devices quality management. It helps organizations translate policy commitments into controlled processes, measurable objectives and evidence of continual improvement.
Who should consider this program?
Medical-device manufacturers, suppliers and service organizations operating in regulated healthcare supply chains.
Business outcomes
- Control design, production and supplier processes
- Strengthen traceability and risk controls
- Support regulatory and customer expectations
- Improve complaint and post-market processes
How the assessment works
Application
We review activities, locations, personnel, requested scope and applicable requirements.
Planning
The responsible body, assessment method, timing and commercial conditions are documented.
Evaluation
Qualified personnel evaluate implementation using interviews, records, observation and sampling.
Independent review
Findings and corrective actions are reviewed before the applicable decision or statement is issued.
Preparing your organization
Define the intended scope, identify applicable legal and customer requirements, assign process ownership, maintain documented information and complete an internal review before the formal assessment. The duration depends on organization size, complexity, locations, shifts, risk and readiness.
Related frameworks
Frequently asked questions
Discuss ISO 13485:2016 with our team
Receive a proposal based on your organization, locations and intended certification or assessment scope.