The Components of the 360° Quality Initiative are:

• Aggressive Factory Inspection Programs
• Precise & Accurate Product Development
• Rigorous Product Testing
• Continuous Product Improvements
• Strategic & Diverse Supplier Relations
• Monitoring Factory Performance
• Quality Reporting & Metrics, Trending, Analysis

Graham-Field is committed to continuously improving its Quality Management System and delivering on its “Seal of Approval”.

Customer Focus
Understand current and future GF customer needs, should meet customer requirements and strive to exceed customer expectations.

Leadership
Establish unity of principle and focus of the GF organization and maintain the internal GF environment in which people can become involved in achieving the organization's objectives.

Teamwork
GF believes that people at all levels are the heartbeat of our organization.

System Approach to Quality Management
To change the mindset from traditional thinking to system thinking, by identifying, understanding and managing interconnected processes and how each contributes to the GF organization's effectiveness and efficiency in achieving its quality objectives.

Continual Improvement
Continual improvement is an ongoing effort of the GF organization, which focuses on improving products, services and processes. 

Enhanced Supplier Relationships
GF and its suppliers are interdependent.  GF will maintain a mutually beneficial relationship that enhances the ability of both to create value.

February 2007

• Receiving Inspection Acceptance Rate is equal or greater than 99%.
• Finished Product Acceptance Rate is equal or greater than 99% for manufacturing.
• Average Customer Service response time is less than or equal to 10 sec.
• Credits less than 1% of net sales.

GF Health Products’ Rhode Island operation received ISO 13485:2003 certification for medical product manufacturing in March 2007. The addition of this certification reinforces GF's demonstrated ongoing commitment to improving our business processes to consistently meet and exceed our customers' expectations.

The ISO 13485 certification is another important milestone for GF.

The ISO 13485 registration process requires a variety of stringent controls that includes compliance with U.S. Food and Drug Administration (FDA), product traceability, increased detail and control of technical data, customer complaint documentation and follow-up procedures, environment monitoring, risk identification and analysis.

This certification provides a critical building block for our continued growth in the high precision medical device market and is yet another example of the ongoing dedication to quality by our world-class Rhode Island operation.

GF Health Products, Inc. is committed to full FDA compliance. All of its factories, suppliers and products, meet CFR 21, Parts 820.

21 CFR, Part 820 is the Quality System Regulation Medical Device Manufacturers

21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure QSR compliance.

Global Quality Initiatives

GF Health Products, Inc. is committed to Global Quality. As part of this effort, our company is actively involved in initiatives related to the following:

• CE Marking of the products we market.
• ISO 13485 Certification of all its facilities
• ISO Certification of its suppliers

In its commitment to Global Quality, GF operates a Worldwide Quality Inspection Program, which assures the Quality of its products.