Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to…
The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO…
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less… In this article, we will discuss how to establish, operate and maintain a good one: Quality Manual = The Quality Bible…
Under ISO 13485:2016 clause 4.2.2, every medical device manufacturer must maintain a quality manual that defines the scope of the QMS, documents or references the procedures that support it, and describes how QMS processes interact with each other. Where a manufacturer legitimately excludes a clause…
