Industry Involvement

Keeping the Focus on Quality

As our company has grown, so has the role we play in helping to set industry standards for product quality and manufacturing processes. Today, Medline serves on the following industry quality committees:

• ASTM Cotton Products for Medical Use
• ASTM Gloves Standard
• AAMI Gown Standard
• ASTM Gowns (F23)
• AAMI Sterilization and Packaging Committee

• American Society for Quality (ASQ)
• Regulatory Affairs Professionals Society (RAPS)
• ASTM International
• Association for the Advancement of Medical Instrumentation (AAMI)
• Association of periOperative Registered Nurses (AORN)
• Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)
• Health Industry Distributors Association (HIDA)

• Sterilization validation:We assist hospitals in validating and troubleshooting sterilization equipment.
• Infection control: Medline can help a hospital's risk management team with research on specific issues. We also perform sterility studies for OR suites, reporting the results and providing recommendations.
• Continuing education: Medline offers training on a variety of topics related to safety and infection control in healthcare settings.

ISO 13485 Certification

The International Organization for Standardization (ISO) is a multinational, nongovernmental network that sets standards for product manufacturing and quality. Compliance with ISO standards is voluntary. ISO 13485:2003 is a specific standard dealing with quality management at medical device manufacturing facilities. Medline has achieved ISO 13485:2003 certification.

ISO 13485:2003 registration is an outward sign of our internal commitment to an effective, efficient quality system that conforms to standards set by our peers worldwide. In the words of ISO, "For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability.¹
1- www.iso.org

Quality Comes First

One way that Medline Industries, Inc. supports our claim of exceptional product quality and a superior quality system is by sharing our certification information with our customers. As with any business, the quality system is only part of the overall process that helps us deliver products and services that consistently exceed our customers' expectations. For example, our ISO 13485:2003 certification is concrete evidence of our effective, fully implemented quality system. This certification also covers storage and distribution, which allows us to be certified by the National Association of Chain Boards of Pharmacy (NABP) as a verified accredited wholesale distributor of prescription drugs and devices. Our product certifications – such as the Association for the Advancement of Medical Instrumentation (AAMI) PB70 certification for our isolation gowns and surgical gowns and drapes – demonstrates that our product design and development process is capable of producing products that meet or exceed industry standards.

Taken together, these system and product certifications achieve our ultimate goal of assuring you, our customers, that you are getting the products and services you need.