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ISO 13485:2016 Certification

ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organisations for the design and development, production, installation, servicing and sales of medical devices.

The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organisations being certified to ISO 13485 can not claim conformity to ISO 9001.

Benefits of ISO 13485 Certification

  • Implementing a Quality Management System, in general, helps to motivate staff and provide a better definition of roles and key responsibilities.
  • Implementing a Quality Management System specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements (compliance) and safety standards.
  • Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted and corrected.
  • Improvements can be developed on a systematic and monitored base, resulting in less waste, less inappropriate or rejected work, and fewer complaints.
  • Provides a systematic approach to risk management.
  • Systematic, smoother, transparent and documented handling of activities required by regulation such as post-marketing follow-up and surveillance, complaints handling, CAPA implementation, field actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.
  • Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features.
  • Help creating a systematic vision embracing the medical device lifecycle, medical device packaging, its labeling, its installation, its servicing, and its usability. This includes the information provided together with the medical devices, the commercial claims, the unspoken user expectations, the feedback from users or patients, the risks associated with use, the benefits brought to the single patient and to the Community, the costs and the disposal of the medical device.

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