ISO 13485:2016 Certification

The European standard EN ISO 13485:2016 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 1 march 2016. This replaces EN ISO 13485: 2016.

It is important to note that the text of the global standard ISO 13485:2016 is unchanged. Only the foreword and annexes in the European version have been revised. The revised standard will be available in the next few weeks.

EN ISO 13485, as the EU harmonised standard for medical device quality management systems, is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation.

During 2011, the European Commission raised an objection to the harmonisation status and the implied Presumption of Conformity of a number of European standards including EN ISO 13485. Sweden also raised a formal objection to the European Commission in February 2011 on the link between adhering to the standard and compliance to the Directives.

To restore confidence and bring back the presumption of compliance indicated by the harmonised status of the standard, it was essential to revise the Annexes ZA, ZB and ZC and add further details on the link between standards and the three Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. All signs are clear for the new EN ISO 13485:2016 to be harmonised and this will most likely happen by summer 2012.

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.