Model ISO 13485 - Medical Devices
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
Highlights From Our Store
Read more about certification to ISO’s management system standards.
WHY WAS ISO 13485 REVISED AND WHAT ARE THE MAIN IMPROVEMENTS?All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
Customer reviews
No reviews were found for Model ISO 13485 - Medical Devices. Be the first to review!