How to write an ISO 13485:2016 Quality Manual

In ISO 13485 there are only 4 requirements for a quality manual. These are found in Clause 4.2.2:
a) the scope of the quality management system, including details of and justification for any exclusion
or non-application;
b) the documented procedures for the quality management system, or reference to them;
c) a description of the interaction between the processes of the quality management system.
The quality manual shall outline the structure of the documentation used in the quality management
system.
Most people copy the entire text of ISO 13485 into their manual. That is not necessary, and it is a waste of time.
If you want to purchase our quality manual, here's a link:
www.medicaldeviceacademy.com/...

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