ISO 13485 is the international standard that defines the Quality Management System (QMS) requirements for organisations that produce medical devices or offer related services. The standard was revised in 2016 and included several detailed changes such
as requirements for more thorough documentation, a risk-based approach to the QMS, an enhanced focus on regulatory requirements and increased controls over suppliers and outsourced activities.
This overview guide covers why ISO 13485:2016 is important, how it has eveloved, its structure, key clauses and steps to a successful certification.
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