ISO 13485:2003 Ensures Quality

Medela is one of the first manuafcturers in the US to be certifed 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.