ISO 13485-2016

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

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About ISO 13485-2016

The ISO 13485-2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Difference between ISO 13485 and ISO 9001:2015

ISO 9001ISO 13485
Continous Improvement and the use of customer feedbackEstablishing Policies , Procedures and processes and demonstrating products/services as fit for required purpouse
Continual Improvement of the quality management systemMitigating Risk
Not yet required for regulatory approvalRequired to support regulatory approval in some countries