5/21/24, 1:50 PM ISO 13485 Medical Device QMS Certification | NSF
Quality Management Systems (QMS) Certification
ISO 13485 Medical Device Quality
Management Systems (QMS) Certification
Meet national or international regulatory requirements for medical devices and
services through ISO 13485 certification.
Based on the ISO 9001 process approach to quality management, ISO 13485 helps
organizations that provide medical devices or services meet regulatory requirements and
establish a management system.
By certifying to ISO 13485, your organization wil be able to:
Demonstrate compliance to regulatory requirements
Establish an effective system for risk management
Communicate effectively with customers, suppliers and other interested parties about
operational control
Certifying your quality management system to ISO 13485 increases your organization's
access to both U.S. and international markets. For example, ISO 13485 certification meets
Good Manufacturing Practice compliance in the United States.
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NSF-ISR certifies any organization that manufactures medical devices, including unfinished
implantable medical device components. NSF-ISR does not currently certify companies that
produce finished implantable medical devices.
Resources
World Quality Week Q&A With Quality Management Expert Janet Book
Article
NSF celebrates World Quality Week with a special Q&A with quality management expert Janet
Book, Principal Consultant for Medical Device Consulting
The Real Value of an NSF-ISR Certification
Article
Improve your company’s efficiency and metrics with a quality management system.
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