ISO 13485:2016 Certification

ISO 13485:2016 is a internationally acknowledged standard developed by the International Organization for Standardization (ISO) that specifies the needs for quality management systems (QMS) in the medical device industry. In order to be certified to the ISO 13485:2016 standard, companies must demonstrate the implementation, maintenance, and efficiency of a medical device quality management system that recognize, manages, and minimizes risks associated with the manufacturing of medical devices and related services.

ISO 13485:2016 specifies needs for a quality management system where an organization requirements to demonstrate its ability to give medical devices and related services that consistently meet client needs, regulatory requirements applicable to medical devices and related services.

ISO 13485 excludes few needs of ISO 9001 and includes some particular requirements for medical devices. An organization after achieving ISO 134845:2016 Certification of International Standard cannot claim conformity to ISO 9001 because of exclusions of few needs. Regardless of the type or size of the organization, all requirements of ISO 134845:2016 are particularly made for medical based organizations.

Benefits of ISO 13485:2016

  • Proven business credentials – through independent confirmation against acknowledged standards.
  • Customer satisfaction – through delivery of products that constantly meet client requirements as well as quality, safety and legal requirements.
  • Improved stakeholder relationships – including staff, clients and suppliers.
  • Improved risk management – through greater constancy and traceability of products and use of risk management techniques.
  • Reduced operating costs – through constant development of processes and resulting operational efficiencies.
  • Ability to win more business – particularly where procurement specifications need certification as a condition to supply in a highly regulated sector.
  • Legal compliance – by understanding how statutory and regulatory needs impact the organization and its clients.