In today's global marketplace, medical device companies are utilizing ISO 13485:2003 as a platform to build their business management system. For many companies, registration to ISO 13485 is a key to securing and maintaining global business.
What is ISO 13485?
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001:2008, ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.
Created by the International Organization for Standardization, ISO 13485:2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.
Benefits of Registration to ISO 13485:2003
Why Choose NSF International Strategic Registrations (NSF-ISR)?
Whether your goal is to enhance operations, expand locally or operate internationally, the bottom line is that registration to ISO 13485 through NSF will prove your quality commitment to the world.
You can enjoy all the benefits of NSF-ISR's management systems registration at a competitive price. Our experience and technical expertise makes us the perfect partner. So if you are currently implementing ISO 13485, feel free to request a quote online or contact one of our Business Development Managers, who will be able to answer your questions.