Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The Benefits of a QMS: 3 examples

Document and Change Control

Risk Management

Supplier Management

Standardisation of processes and recording activity allows effective

Identification, assessing and controlling risk, allows the prevention of incidents that will have financial, safety and legal consequences

Organisations live or die on the quality of suppliers. A robust mechanism for supplier assessment and control will reduce risk of supply issues

delegation of actions, and enhanced ability to identify errors, risks and improvements

Consider the size, format and scope of the QMS specific to the requirements of the company

The Organisation for Professionals in Regulatory Affairs

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Auditing…

A quality management system can be assessed by a notified body for conformity The certificate can be a useful mark of quality

Dave Spud

But

Internal auditing is essential to assess the state of the organization. The more you review the QMS the more efficient and compliant it will be.

The Organisation for Professionals in Regulatory Affairs

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