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ISO 13485:2016

What is ISO 13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

While it remains a stand-alone document, ISO 13485:2016 is generally harmonised with 9001:2015. A fundamental difference, however, is that ISO 9001:2015 requires the organisation to demonstrate continuous improvement, whereas ISO 13485:2016 requires only that the organisation demonstrates the quality system is implemented and maintained.