BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
ISO 13485:2016 specifies the requirements for a quality management system for organizations involved in one or more stages of the life cycle of a medical device. It provides the basis for ensuring the consistent design, development, production, installation, and delivery of products that are safe for their intended purpose.
ISO 13485:2016 can be used by internal and external parties, including certification bodies, to test an organization’s ability to meet both customer and regulatory requirements. However, certification is not a requirement of ISO 13485, and organizations can reap the benefits of the standard without being certified.
You should use ISO 13485:2016 to show that you have commitment to quality through an internationally recognized standard.
By using ISO 13485:2016 you’ll be able to:
- Demonstrate compliance with regulatory and legal requirements
- Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
- Manage risk effectively
- Improve processes and efficiencies
- Gain a competitive advantage
ISO 13485:2016 Training
BSI have developed new courses to help for a smoother transition to ISO 13485:2016.
Our comprehensive courses introduce you to the new requirements and explore the changes between ISO 13485:2003/ EN 13485:2012 and the latest standard.
You’ll be able to identify the gaps in your current Quality Management System (QMS) and start planning your transition and certification to comply with ISO 13485:2016.