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Both ISO 9001:2015 and ISO 13485:2016 have gone through their first standard review period to be reconfirmed for another 5-year period. These two standards for Quality Management Systems (QMS) have different structures and differences in the definition of risk and other terms.
In this paper, we are looking to see how these standards co-exist and what developments are being discussed. The intent of this document is to provide insight into some of the differences and similarities between the standards, to allow organizations to understand how they can continue to work together for organizations that are part of the medical device supply chain, without undue burden to their systems..
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Our whitepapers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.
- Implementing the European Union Medical Devices Regulations
- EUDAMED: an overview of how it is being developed and deployed by the European Commission
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