The International Organization for Standardization (ISO), Geneva, Switzerland, late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which was revised to respond to the latest developments in quality management, technology, and regulatory requirements governing the medical device industry.
The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.
Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, which will allow enough time for manufacturers, accreditation/certification bodies, and regulators to transition to the new standard.
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