ISO 13485

Unlike other standards which are a part of a set of standards, this ISO 13485 is stand alone and a specific standard related to development and implementation of Quality Management Systems in medical devices and equipment in the health industry. Benefits of implementation as mentioned below but not limited to the list.

  • Improves access to bigger worldwide market with increased credibility through certification
  • Increases efficiency, cut costs through effective implementation of process approach and monitor supply chain
  • Implementation gives buyers a confidence of quality compliance that the medical devices are safer and more effective
  • Improves customer satisfaction by meeting regulatory requirements and customer expectations
  • Employee Engagement – Better people involvement to identify best solutions for improving processes
  • Business Excellence – Shorter lead times and better services through quality and process improvement initiatives

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