TÜV Rheinland Blog - Insights from Asia and Africa

Publication of ISO13485:2016 Quality System Standard

Posted by TUV Rheinland on Jun 13, 2017 12:49:43 PM
TUV Rheinland

Did you know that as of February 28, 2019, the new revision of the ISO 13485 (2016) has to be used? This also means that as of the same date, the transition must be complete from ISO 13485:2003 and the associated European Standard EN ISO13485: 2012.

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The most important changes between the 2003 and 2016 version of the global standard for medical device quality management systems (QMS) are as follows:

  • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
  • Increased linkage with regulatory requirements, particularly for regulatory documentation
  • Application to organizations throughout the lifecycle and supply chain for medical devices
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard
  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay
  • Emphasis on:
    • Appropriate infrastructure, particularly for production of sterile medical devices
    • Addition of requirements for validation of sterile barrier properties
    • Complaint handling and reporting to regulatory authorities in accordance with regulatory requirements
    • Consideration of post-market surveillance
  • Additional requirements in design and development for:
    • Usability
    • Use of standards
    • Verification and validation planning
    • Design transfer and design records

ISO 13485 deals with the whole lifecycle from design and development, through manufacture, transport and end of life. This new standard is also used for the Medical Device Single Audit Program (MDSAP), an international effort to reduce redundant audits of medical device manufacturers.

To learn more about ISO 13485 and how TÜV Rheinland can help, please visit our website


Topics: iso13485