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Iso Certification
ISO 13485: 2003

What is ISO 13485: 2003 Medical devices -- Quality Management Systems?
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. Some of the additional requirements to ISO 9001 requirements relate to

  • Design controls
  • Risk management
  • Environmental controls
  • Special processes (e.g. software validation)
  • Traceability, record retention
  • Regulatory actions (such as vigilance)

  • ISO 13485: 2003 has been harmonized against the medical device directives
  • Medical Devices Directive
  • Active Implantable Medical Devises Directive
  • In Vitro Diagnostic Directive
  • This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system. Formal certification of quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous, for medical companies which export their products to the global market.

    Who Can Go For ISO 13485 Certification?
  • Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.
  • Companies who manufacture OEM products which are sold under other company names.
  • Companies who design and/or manufacture medical device components or raw materials for the medical device market.
  • Companies selling, installing or servicing medical devices.
  • Consultants providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilization, cleaning, testing, etc. Benefits of ISO 13485 certification:-
  • Communicate high standards of quality
  • Gain a competitive advantage in the market with third-party certification
  • Evidence of adherence to legal and regulatory or contractual requirements
  • Minimize and manage risks
  • Error prevention instead of error correction
  • Customer and employee satisfaction
  • Transparency and clarity of internal processes
  • Time and cost savings
  • Work in accordance with an internationally recognized standard