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ISO 13485:2016 (Quality Management System for Medical Devices) - sbpm

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ISO 13485:2016 (Quality Management System for Medical Devices)

ISO 13485:2016 Specifically for Medical Devices is an internationally recognized standard and provides best framework in setting up a quality management system to those organizations who are involved in the design, production, installation and servicing of medical devices and related services. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Safety & Quality cannot be compromised in the medical industry that’s why manufacturers are adopting this standard to assure their quality management system to avoid the risks during the use of devices and instruments.

The standard is designed to assist organizations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements. Hospitals and hospital’s medical devices supplying companies demand from manufactures of medical devices for the certification of ISO 13485:2016.

ISO 13485:2016 is the current version of ISO 13485 standard, previously it was known as ISO 13485:2003 and it is a part of ISO family, ISO (The International Organization for the Standardization) is a non-profit organization and doesn’t conduct audits itself. Most of the countries have formed their own accreditation bodies to authorize the certification bodies, Accreditation and certification bodies charge their fee against their services. Accredited certificate issued by any accredited certification body is entirely accepted worldwide.

Benefits of ISO 13485:2016

  • Customer Satisfaction.
  • Reduce Operating Cost.
  • Improvement in overall performance & compliance.
  • Increased efficiency and cost saving.
  • Consistency in managing regulatory compliances.
  • Globally accepted standard.
  • Helpful in alluring new customers.
  • Helpful to retain the confidence of existing customers.
  • Acceptable for International organizations.