Be a benchmark
ISO 9001:2008 (Quality Management System) ISO 14001:2004 (Environment Management System) ISO 18001:2007 (Occupational Health & Safety Management System) ISO 22000:2005 (Food System Management System) ISO 13485:2003 (Medical Device System) EN 16001 (Energy Management) ISO 27001:2005 (Information Security Management System) TS-1649 (Quality Management System For Automotive Suppliers)
Services
ISO 13485:2003 (MDS)

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.
  • Enables your organization to become more cost-effective.
  • 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.