Get your complimentary copy of our latest eBook: ISO 9001:2015 & ISO 13485:2016 for Medical Devices. A definitive guide to helping you coordinate and direct your organization’s product development activities to meet customer requirements and improve effectiveness and efficiency on a continuous basis.
A Quality Management System (QMS) helps you coordinate and direct your organization’s product development activities to meet customer requirements and improve its effectiveness and efficiency on a continuous basis. Two of the FDA requirements a QMS supports is ISO 9001:2015 and ISO 13485:2016. Our latest eBook offers a quick overview.
In the definitive guide, ISO 9001:2015 & ISO 13485:2016 for Medical Devices, you’ll learn:
- What a quality management system is and why it’s important
- The difference between ISO 9001:2015 & ISO 13485:2016
- How a QMS works and what it includes
- The 5 Aspects of ISO 13485:2016
- Management Responsibility, and more
