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ISO 13485:2016 Certification

ISO 13485, Medical devices – Quality management systems – Needs for regulatory purposes, is a globally agreed standard that sets out the needs for a quality management system exact to the medical devices industry. It has lately been revised, with the new version published in March 2016.

The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.

Some of the key changes between the 2003 and 2016 version include:

  • Incorporation of risk-based approaches beyond product understanding. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory needs
  • Improved linkage with regulatory needs, particularly for regulatory documentation
  • Application to organizations throughout the life cycle and supply chain for medical devices
  • Harmonization of the necessities for software validation for different software applications (QMS software, procedure control software, software for monitoring and measurement) in different clauses of the standard
  • Emphasis on suitable infrastructure, particularly for production of sterile medical devices, and addition of needs for validation of sterile barrier properties
  • Additional necessities in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory needs, and consideration of post-market surveillance
  • Planning and documenting corrective action and preventive action, and applying corrective action without undue delay