Module 1: Introduction to ISO 13485:2016 (Medical Devices' QMS)

The Quality Management System, which is simply known as a QMS, is a framework of policies, processes, documented procedures, and records. This framework of documentation in a medical devices industry specifies the organization's rules that will direct how a company produces and supplies a medical device or surgical instrument to its customers. The ISO 13485 standard offers a framework for medical devices organizations to help them ensure that they do not miss any vital element of the QMS in the medical devices sector. Quality management system in medical devices industry should contain the following element:
 The QMS must be customized to the nature and environment of a medical device supplier or manufacturer.
The QMS should also be tailored according to the medical products or services, the organization opts to offer.
The QMS for medical devices should provide a structure to address all regulatory requirements.
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