ISO 13485

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

Provides international recognition for US manufacturers in compliance with the FDA Quality System Regulations (21 CFR 820, Oct. 7, 1996).
Enables your organization to become more cost-effective.
Improves internal communications, efficiency and resilience to change.
Improves product and process quality and provides a basis for meeting regulatory requirements.
Requires your organization to monitor and improve key business and customer satisfaction measures.
Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.

Why Choose NSF International Strategic Registrations (NSF-ISR)?

NSF-ISR is the first US registrar to obtain ANAB accreditation for ISO 13485.
NSF-ISR is a world leader in quality, environmental, health and safety management systems registration.
We are internationally accredited in an extensive range of industries.
We have completed thousands of registrations to ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, AS9100, and more.
Our auditors are professionals with many years of experience in business management systems.
Audits focus on customer satisfaction, business goals and objectives.
NSF-ISR is one of the fastest growing registrars in the world.

NSF-ISR Advantages

We bring real-world knowledge and practical experience to our auditing program.
Our process is about making sure you meet internal business goals and objectives, customer requirements, and conform to the standard.
We offer value-added auditing. Our approach ensures that our audits focus on areas important to your business.
NSF-ISR's lead auditors are assigned to your organization on a long-term basis.
Our stringent auditor training and on-going evaluations ensure consistency of your audits.
You'll get results you can use.

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.