People, Education & Healthcare
ISO 13485:2016 Medical Devices QMS – Lead Implementer
Overview
A programme for those responsible for designing, implementing and maintaining a management system based on ISO 13485:2016. It walks through context, leadership, risk-based planning, documentation, operation, performance evaluation and improvement, ready for certification.
The standard
About the standard
ISO 13485:2016
Medical Devices Quality Management System
Specifies requirements for a quality management system used by organizations involved in one or more stages of a medical device life cycle, including design, production, installation and servicing. It places particular weight on meeting regulatory obligations, controlling risk, and validating processes so devices are consistently safe and effective for their intended use. It can be applied by manufacturers as well as suppliers and other parties providing related services.
Key objectives
- Ensure medical devices are consistently designed, produced and delivered safely
- Support compliance with regulatory requirements across different jurisdictions
- Embed risk management throughout the medical device life cycle
- Validate and control processes critical to device safety and performance
- Provide a QMS framework usable by manufacturers and their suppliers alike
Who uses it
Manufacturers and suppliers involved in the medical device lifecycle.
Learning outcomes
What you will be able to do
- Translate the requirements of ISO 13485:2016 into an implementation plan
- Define context, scope, policy, objectives and roles
- Apply risk-based thinking and plan actions
- Build the documented information and operational controls
- Set up monitoring, internal audit and management review
- Prepare the organisation for certification
Who should attend
Managers, consultants and project leads responsible for building or maintaining a management system.
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AXIOS · Certification body
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