ISO 13485 : 2016

What is ISO 13485: 2016

It is the most accepted quality management system standard worldwide for the medical devices industry. This standard is based on ISO 9001, but includes additional requirements specific to the business sector of medical equipment / medical devices.

Implementation of ISO 13485 can help reduce unexpected risks and can improve enterprise management. This applies not only to companies that produce health equipment, but also to companies that distribute and use such health equipment. This standard aims to enhance the reputation of the organization in the eyes of customers and government.

ISO 13485 implementation and certification benefits:

  1. Proof of compliance with legal and regulatory requirements.
  2. Minimize and manage risk.
  3. Emphasizes competence.
  4. Prevention error, not error correction.
  5. Improved quality of performance.
  6. Customer and employee satisfaction.
  7. Transparency and clarity of internal processes.
  8. Time and cost savings.
  9. Realization of company’s quality policy and objectives.