ISO 13485:2003 Ensures Quality

Medela is one of the first manuafcturers in the US to be certified for ISO 13485:2003
ISO (International Standard Organization) 13485:2003 certification assures customers that suppliers and manufacturers have the capability to provide quality products and services.

This ISO certification confirms that Medela meets rigorous quality standards:

• An effective quality system of design development manufacturing and servicing.
• Pursuit of continuous improvement for all processes within the company.
• Valid measurements and properly calibrated test equipment.
• A product identification and tracking method, including efficient record-keeping.
• A sufficient process for all parts of the company including handling, storing, packaging and delivering products.
• Appropriate inspection and testing procedures.
• Pursuit and monitoring of customer satisfaction.
• An internal audit and surveillance system.
• Adequately trained and experienced employees.

Compliance with ISO standards ensures quality product services for Medela customers, leading to lower costs, greater customer satisfaction and better business.