ISO 13485 - QUALITY MANAGEMENT SYSTEM (QMS)

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.

Benefits of ISO 13485 Certification

• Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.



• Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence.



• Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.